Bupropion Hydrochloride Extended-Release Tablets

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 DEFINITION

Bupropion Hydrochloride Extended-Release Tablets contain NLT 90.0% and NMT 110.0% of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl).

2 IDENTIFICATION

A. SPECTROSCOPIC IDENTIFICATION TESTS (197), Infrared Spectroscopy: 197K

Sample: Crush 1 Tablet using a mortar and pestle. Prepare an approximate 1% (w/w) dispersion of the sample in potassium bromide.

Acceptance criteria: The Sample shows strong bands at about 1690, 1560, and 1240 cm^-1 and a weaker band at about 740 cm^-1, similar to the reference preparation.

B. The retention time of the major peak of Sample solution A or Sample solution B corresponds to that of the Standard solution, as obtained in the Assay.

3 ASSAY

Change to read:

PROCEDURE

Diluent 1: Methanol and 0.001 N hydrochloric acid TS (20:80)

Solution A: Acetonitrile, trifluoroacetic acid, and water (10:0.04:90)

Solution B: Acetonitrile, trifluoroacetic acid, and water (95: 0.03:5)

Mobile phase: See Table 1.

Table 1

System suitability stock solution: 0.02 mg/mL of USP Bupropion Related Compound C RS and 0.2 mg/mL of USP Bupropion Related Compound F RS in methanol

System suitability solution: 0.002 mg/mL of bupropion related compound C and 0.02 mg/mL of bupropion related compound F from the System suitability stock solution in Diluent 1

Standard solution: 0.6 mg/ml of USP Bupropion Hydrochloride RS in Diluent 1

Sample stock solution A: Transfer a number of Tablets, intact or crushed, to a suitable homogenizer vessel containing sufficient methanol to obtain a concentration of 3.0 mg/ml. of bupropion hydrochloride. Immediately homogenize the sample for 30 s at 20,000 rpm. Allow extraction for 3 min, and follow by two additional 10-s pulses, each at 20,000 rpm, pausing 3 min between these pulses to ensure complete extraction. Pass a portion of the solution through a nylon filter of 0.45-um pore size, discarding the first 2-4 mL of the filtrate.

Sample solution A: Nominally 0.6 mg/mL of bupropion hydrochloride from Sample stock solution A in 0.001 N hydrochloric acid TS Alternatively, the Sample solution can be prepared as follows.

Buffer: Dissolve 100 g of anhydrous dibasic sodium phosphate in 1 L of water. Add 50 mL of phosphoric acid, stir or sonicate until dissolved, and mix. Adjust with phosphoric acid to a pH of 3.0.

Diluent 2: Methanol and Buffer (20:80)

Sample stock solution B: Weigh and grind NLT 20 Tablets to prepare a solution having a nominal concentration of 3 mg/mL. Initially add Diluent 2 (75% of the volume of the flask), stir for 30 min, and sonicate for 15 min. Dilute with Diluent 2 to volume. Centrifuge a portion of the resulting solution, and use the supernatant.

Sample solution B: Nominally 0.6 mg/ml of bupropion hydrochloride from Sample stock solution B in Diluent 2

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 226 nm

Column: 4.6-mm x 10-cm; 3.5-µm packing 11

Column temperature: 40°

Flow rate: 1.5 mL/min

Injection volume: 5 µL

System suitability

Samples: System suitability solution and Standard solution

[NOTE-See Table 30 (RB 1-Aug-2023) for the relative retention times.]

Suitability requirements

Resolution: NLT 1.3 between bupropion related compound F and bupropion related compound C, System suitability solution

Tailing factor: NMT 1.9, Standard solution

Relative standard deviation: NMT 1.0%, Standard solution

Analysis

Samples: Standard solution and Sample solution A or Sample solution B

Calculate the percentage of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) in the portion of Tablets taken:

Result = (r_u /r_s ) × (C_s /C_u ) × 100

r_u = peak response of bupropion hydrochloride from Sample solution A or Sample solution B

r_s = peak response of bupropion hydrochloride from the Standard solution

C_s = concentration of USP Bupropion Hydrochloride RS in the Standard solution (mg/mL)

C_u = nominal concentration of bupropion hydrochloride in Sample solution A or Sample solution B (mg/mL)

Acceptance criteria: 90.0%–110.0%

4 PERFORMANCE TESTS

Change to read:

Dissolution 〈711〉

For products labeled for dosing every 12 h

Test 1

Medium: Water; 900 mL, deaerated, if necessary

Apparatus 2: 50 rpm

Times: 1, 4, and 8 h

Standard solution: (L/900) mg/mL of USP Bupropion Hydrochloride RS in Medium, where L is the label claim, in mg/Tablet. Dilute with

Medium, if necessary.

Sample solution: Pass a portion of the solution under test through a suitable lter, and dilute with Medium, if necessary.

Instrumental conditions

(See Ultraviolet-Visible Spectroscopy 〈857〉.)

Mode: UV-Vis

Analytical wavelength: 298 nm

Blank: Medium

Analysis

Samples: Standard solution and Sample solution

Calculate the concentration (C ) of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) in the sample withdrawn from the vessel at time point i:

Result_i = (A_u /A_s ) × C_s × D

A_u = absorbance from the Sample solution at time point i

A_s = absorbance from the Standard solution

C_s = concentration of USP Bupropion Hydrochloride RS in the Standard solution (mg/mL)

D = dilution factor for the Sample solution, if needed

Calculate the percentage of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at each time point (i):

Result₁ = C₁ × V × (1/L) × 100

Result₂ = {[C₂ × (V − V_s )] + (C₁ × V_s )} × (1/L) × 100

Result₃ = ({C₃ × [V − (2 × V_s )]} + [(C₂ + C₁ ) × V_s ]) × (1/L) × 100

C_i = concentration of bupropion hydrochloride in the portion of the sample withdrawn at time point i (mg/mL)

V = volume of Medium, 900 mL

L = label claim (mg/Tablet)

V_s = volume of Sample solution withdrawn at each time point (mL)

Tolerances: See Table 2.

Table 2

The percentages of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at the times specified conform to

Dissolution (711), Acceptance Table 2.

Test 2: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 2.

Medium: 0.1 N hydrochloric acid, pH 1.5 (prepared by transferring 50 mL of hydrochloric acid to 6000 mL of water, adding 18 g of sodium hydroxide, mixing, and adjusting with either diluted sodium hydroxide or hydrochloric acid to a pH of 1.5); 900 mL, deaerated

Apparatus 1: 50 rpm

Times: 1, 2, 4, and 6 h

Buffer: 3.45 g of monobasic sodium phosphate in 996 mL of water. Add 4.0 ml. of triethylamine, and adjust with phosphoric acid to a pH of 2.80.

Mobile phase: Methanol and Buffer (35:65)

Standard solution: (L/900) mg/mL of USP Bupropion Hydrochloride RS in Medium, where L is the label claim, in mg/Tablet

Sample solution: Use portions of the solution under test, and pass through a nylon filter of 0.45-µm pore size.

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 298 nm

Column: 4.6-mm x 15-cm; packing 11

Flow rate: 1 mL/min

Injection volume: 20 µL

System suitability

Sample: Standard solution

Suitability requirements

Column efficiency: NLT 2000 theoretical plates

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

Determine the percentages of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved.

Tolerances: See Table 3.

Table 3

The percentages of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at the times specified conform to

Dissolution (711), Acceptance Table 2.

Test 3: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 3.

Medium: Water: 900 mL

Apparatus 2: 50 rpm. Use wire coil sinkers, if necessary.

Times: 1, 2, 4, and 6 h

Standard solution: (L/900) mg/mL of USP Bupropion Hydrochloride RS in Medium, where L is the label claim, in mg/Tablet. Dilute with Medium, if necessary.

Sample solution: Pass a portion of the solution under test through a suitable filter, and dilute with Medium, if necessary.

Instrumental conditions

(See Ultraviolet-Visible Spectroscopy (857).)

Mode: UV-Vis

Analytical wavelength: 250 nm

Blank: Medium

Analysis

Samples: Standard solution and Sample solution

Determine the percentages of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved.

Tolerances: See Table 4.

Table 4

The percentages of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at the times specified conform to

Dissolution (711), Acceptance Table 2.

Test 5: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 5.

Medium: Water: 900 mL

Apparatus 2: 50 rpm

Times: 1, 3, and 6 h

Standard solution: (L / 900) * mg / m * L of USP Bupropion Hydrochloride RS in Medium, where L is the label claim, in mg/Tablet. Dilute with Medium, if necessary.

Sample solution: Pass a portion of the solution under test through a suitable filter, and dilute with Medium, if necessary.

Instrumental conditions

(See Ultraviolet-Visible Spectroscopy (857).)

Mode: UV-Vis

Analytical wavelength: 298 nm

Cell: 0.5 cm

Blank: Medium

Analysis

Samples: Standard solution and Sample solution

Determine the percentages of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved.

Tolerances: See Table 5.

Table 5

The percentages of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at the times specified conform to

Dissolution (711). Acceptance Table 2.

Test 7: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 7.

Medium: 0.1 N hydrochloric acid, pH 1.5 (prepared by transferring 50 mL of hydrochloric acid to 6000 mL of water, adding 18 g of sodium hydroxide, mixing, and adjusting with either diluted sodium hydroxide or hydrochloric acid to a pH of 1.5); 900 ml, deaerated

Apparatus 1: 50 rpm

Times: 1, 2, 4, and 6 h

Buffer: 3.45 g of monobasic sodium phosphate in 996 mL of water. Add 4.0 mL of triethylamine, and adjust with phosphoric acid to a pH of 2.80.

Mobile phase: Methanol and Buffer (45:55)

Standard solution: (L/900) mg/mL of USP Bupropion Hydrochloride RS in Medium, where L is the label claim, in mg/Tablet

Sample solution: Use portions of the solution under test, and pass through a nylon filter of 0.45-µm pore size.

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 298 nm

Column: 4.6-mm x 15-cm; packing 11

Flow rate: 1 mL/min

Injection volume: 20 µL

System suitability

Sample: Standard solution

Suitability requirements

Column efficiency: NLT 2000 theoretical plates

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

Determine the percentages of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved.

Tolerances: See Table 6.

Table 6

The percentages of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at the times specified conform to

Dissolution (711), Acceptance Table 2.

Test 9: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 9.

Medium: 0.1 N hydrochloric acid, pH 1.5 (prepared by transferring 50 ml. of hydrochloric acid to 6000 mL of water, adding 18 g of sodium hydroxide, mixing, and adjusting with either diluted sodium hydroxide or hydrochloric acid to a pH of 1.5); 900 mL

Apparatus 1: 50 rpm

Times: 1, 2, 4, and 8 h

Standard solution: (L/1000) mg/mL of USP Bupropion Hydrochloride RS in Medium, where L is the label claim, in mg/Tablet

Sample solution: Pass a portion of the solution under test through a suitable filter.

Instrumental conditions

(See Ultraviolet-Visible Spectroscopy (857),.)

Mode: UV-Vis

Analytical wavelength: 298 nm

Blank: Medium

Analysis

Samples: Standard solution and Sample solution

Determine the percentages of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved.

Tolerances: See Table Z.

Table 7

The percentages of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at the times specified conform to

Dissolution (711), Acceptance Table 2.

Test 10: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 10.

Medium: Water, 900 mL

Apparatus 2: 50 rpm

Times: 1, 2, 4, and 8 h

Standard solution: (L/900) mg/mL of USP Bupropion Hydrochloride RS in Medium, where L is the label claim, in mg/Tablet

Sample solution: Pass a portion of the solution under test through a suitable filter.

Instrumental conditions

(See Ultraviolet-Visible Spectroscopy (857))

Mode: UV-Vis

Analytical wavelength: 298 nm

Cell: 0.5 cm

Blank: Medium

System suitability

Sample: Standard solution

Suitability requirements

Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at each time point (i):

Result_i = (A_i/A_s ) × C_s × V × (1/L) × 100

A_i = absorbance of bupropion hydrochloride from the Sample solution at time point i

A_s = absorbance of bupropion hydrochloride from the Standard solution

C_s = concentration of USP Bupropion Hydrochloride RS in the Standard solution (mg/mL)

V = volume of Medium, 900 mL

L = label claim (mg/Tablet)

Tolerances: See Table 8.

Table 8

The percentages of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at the times specified conform to

Dissolution (711), Acceptance Table 2.

Test 17: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 17.

Medium: 0.1 N hydrochloric acid, pH 1.5 (prepared by transferring 50 mL of hydrochloric acid to 6 L of water containing 18 g of sodium hydroxide, mixing, and adjusting with either diluted sodium hydroxide or diluted hydrochloric acid to a pH of 1.5); 900 mL, deaerated

Apparatus 1: 50 rpm

Times: 1, 2, 4, and 8 h

Buffer: To each liter of water add 6.8 g of monobasic potassium phosphate. Adjust with phosphoric acid to a pH of 3.0.

Mobile phase: Methanol and Buffer (60:40)

Standard solution: (L/900) mg/mL of USP Bupropion Hydrochloride RS in Medium, where L is the label claim, in mg/Tablet, Sonication may be used to promote dissolution.

Sample solution: Pass a portion of the solution under test through a suitable filter. [NOTE-A 0.45-µm nylon membrane filter may be suitable .]

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 298 nm

Column: 4.6-mm x 15-cm; 5-µm packing 17

Flow rate: 1 mL/min

Injection volume: 25 µL

Run time: NLT 1.5 times the retention time of bupropion

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation : NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the concentration (C_i) of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) in the sample withdrawn from the vessel at time point i:

Result = (r_i /r_s ) × C_s

r_i = peak response of bupropion from the Sample solution at time point i

r_s = peak response of bupropion from the Standard solution

C_s = concentration of USP Bupropion Hydrochloride RS in the Standard solution (mg/mL)

Calculate the percentage of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at each time point (i):

Result₁ = C₁ × V × (1/L) × 100

Result₂ = {[C₂ × (V − V_s )] + (C₁ × V_s )} × (1/L) × 100

Result₃ = ({C₃ × [V − (2 × V_s )]} + [(C₂ + C₁ ) × V_s ]) × (1/L) × 100

Result₄ = ({C₄ × [V − (3 × V_s )]} + [(C₃ + C₂ + C₁ ) × V_s ]) × (1/L) × 100

C_i = concentration of bupropion hydrochloride in the portion of the sample withdrawn at time point i (mg/mL)

V = volume of Medium, 900 mL

L = label claim (mg/Tablet)

V_s = volume of Sample solution withdrawn at each time point (mL)

Tolerances: See Table 9.

Table 9

The percentages of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at the times specified conform to

Dissolution (711), Acceptance Table 2.

Test 19: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 19.

Medium: Water, degassed; 900 mL

Apparatus 1: 50 rpm

Times: 1, 2, 4, and 8 h

Standard stock solution: 0.56 mg/mL of USP Bupropion Hydrochloride RS in Medium

Standard solution: (L/900) mg/mL of USP Bupropion Hydrochloride RS in Medium, where L is the label claim, in mg/Tablet

Sample solution: Pass a portion of the solution under test through a suitable filter of 10-um pore size.

Instrumental conditions.

(See Ultraviolet-Visible Spectroscopy (857).)

Mode: UV-Vis

Analytical wavelength: 298 nm

Cell: 1 cm

Blank: Medium

System suitability

Sample: Standard solution

Suitability requirements

Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at each time point (7):

Result_i = (A_i/A_s ) × C_s × V × (1/L) × 100

A_i = absorbance of bupropion from the Sample solution at time point i

A_s = absorbance of bupropion from the Standard solution

C_s = concentration of USP Bupropion Hydrochloride RS in the Standard solution (mg/mL)

V = volume of Medium, 900 mL

L = label claim (mg/Tablet)

Tolerances: See Table 10.

Table 10

The percentages of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at the times specified conform to

Dissolution (711), Acceptance Table 2.

For products labeled for dosing every 24 h

Test 4: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 4.

Medium: 0.1 N hydrochloric acid: 900 mL, deaerated

Apparatus 1: 75 rpm

Times: 2, 4, 8, and 16 h

Standard solution: (L/900) mg/mL of USP Bupropion Hydrochloride RS in Medium, where L is the label claim, in mg/Tablet. Dilute with Medium, if necessary.

Sample solution: Pass a portion of the solution under test through a suitable filter, and dilute with Medium, if necessary.

Instrumental conditions

(See Ultraviolet-Visible Spectroscopy (857).)

Mode: UV-Vis

Analytical wavelength: 252 nm

Blank: Medium

Analysis

Samples: Standard solution and Sample solution

Determine the percentages of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved.

Tolerances: See Table 11.

Table 11

The percentages of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at the times specied conform to

Dissolution 〈711〉, Acceptance Table 2.

Test 6: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 6.

Medium: 0.1 N hydrochloric acid; 900 mL, deaerated

Apparatus 1: 75 rpm

Times: 1, 2, 4, 8, and 12 h

Standard solution: (L/900) mg/mL of USP Bupropion Hydrochloride RS in Medium, where L is the label claim, in mg/Tablet. Dilute with

Medium, if necessary.

Sample solution: Pass a portion of the solution under test through a suitable lter, and dilute with Medium, if necessary.

Instrumental conditions

(See Ultraviolet-Visible Spectroscopy 〈857〉.)

Mode: UV-Vis

Analytical wavelength: 298 nm

Blank: Medium

Analysis

Samples: Standard solution and Sample solution

Determine the percentages of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved.

Tolerances: See Table 12.

Table 12

The percentages of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at the times specied conform to

Dissolution 〈711〉, Acceptance Table 2.

Test 8: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 8.

Acid stage medium: 0.1 N hydrochloric acid; 900 mL

Buffer stage medium: pH 6.8 phosphate buffer; 900 mL

Apparatus 1: 75 rpm

Times: 2 h in Acid stage medium; 3, 8, and 16 h in Buffer stage medium. The time in the Buffer stage medium includes the time in the Acid stage medium.

Standard solution: (L/900) mg/mL of USP Bupropion Hydrochloride RS in Acid stage medium, where L is the label claim, in mg/Tablet

Sample solution: Pass a portion of the solution under test through a suitable lter of 0.45-µm pore size.

Instrumental conditions

(See Ultraviolet-Visible Spectroscopy 〈857〉.)

Mode: UV-Vis

Analytical wavelength: 298 nm

Cell: 0.5 cm

Blank: Medium

Analysis

Samples: Standard solution and Sample solution

Determine the percentages of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved.

Tolerances: See Table 13.

Table 13

The percentages of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at the times specied conform to

Dissolution 〈711〉, Acceptance Table 2.

Test 11: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 11.

Acid stage medium: 0.1 N hydrochloric acid; 750 mL

Buffer stage medium: pH 6.8 phosphate buffer (add 250 mL of 76 g/L tribasic sodium phosphate to the Acid stage medium, adjust with 2

N hydrochloric acid TS or 2 N sodium hydroxide TS to a pH of 6.8, if necessary); 1000 mL

Apparatus 2: 50 rpm

Times: 2 h in Acid stage medium; 3, 8, and 16 h in Buffer stage medium. The time in the Buffer stage medium includes the time in the Acid

stage medium.

Acid stage standard solution: 0.06 mg/mL of USP Bupropion Hydrochloride RS in Acid stage medium, Sonication may be used to aid in dissolution.

Buffer stage standard solution: 0.15 mg/mL of USP Bupropion Hydrochloride RS in Buffer stage medium. Sonication may be used to aid in dissolution.

Sample solution: Pass a portion of the solution under test through a suitable filter of 0.45-µm pore size.

Instrumental conditions

(See Ultraviolet-Visible Spectroscopy (857).)

Mode: UV-Vis

Analytical wavelength: 298 nm

Cell: 0.5 cm

Blank: Acid stage medium or Buffer stage medium

Analysis

Samples: Acid stage standard solution, Buffer stage standard solution, and Sample solution

Calculate the concentration (C_i) of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) in the sample withdrawn from the vessel at time point i:

Result_i = (A_i/A_s ) × C_s

A_i = absorbance of bupropion hydrochloride from the Sample solution at time point i

A_s = absorbance of bupropion hydrochloride from the Acid stage standard solution or Buffer stage standard solution

C_s = concentration of USP Bupropion Hydrochloride RS in the Acid stage standard solution or Buffer stage standard solution (mg/mL)

Calculate the percentage of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at each time point (i):

Result₁ = C₁ × V_A × (1/L) × 100

Result₂ = {[C₂ × (V_B − V_s )] + (C₁ × V_s )} × (1/L) × 100

Result₃ = ({C₃ × [V_B − (2 × V_s )]} + [(C₂ + C₁ ) × V_s ]) × (1/L) × 100

Result₄ = ({C₄ × [V_B − (3 × V_s )]} + [(C₃ + C₂ + C₁ ) × V_s ]) × (1/L) × 100

C_i = concentration of bupropion hydrochloride in the portion of the sample withdrawn at time point i (mg/mL)

V_A = volume of Acid stage medium, 750 mL

L = label claim (mg/Tablet)

V_B = volume of Buffer stage medium, 1000 mL

V_s = volume of Sample solution withdrawn from the Acid stage medium or Buffer stage medium (mL)

Tolerances: See Table 14.

Table 14

The percentages of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at the times specied conform to Dissolution (711), Acceptance Table 2.

Test 12: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 12.

Medium: 0.1 N hydrochloric acid; 900 mL

Apparatus 1: 75 rpm

Times: 2, 4, 8, and 12 h

Standard solution: (L/900) mg/mL of USP Bupropion Hydrochloride RS in Medium, where L is the label claim, in mg/Tablet

Sample solution: Withdraw at least 10 mL of the solution under test and pass through a suitable filter.

Instrumental conditions

(See Ultraviolet-Visible Spectroscopy (857).)

Mode: UV-Vis

Analytical wavelength: 252 nm

Cell

For Tablets labeled to contain 150 mg: 0.1 cm

For Tablets labeled to contain 300 mg: 0.05 cm

Blank: Medium

System suitability

Sample: Standard solution

Suitability requirements

Relative standard deviation:

NMT 3.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the concentration (C_i) of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) in the sample withdrawn from the vessel at time point i:

Result_i = (A_i/A_s ) × C_s

A_i = absorbance of bupropion hydrochloride from the Sample solution at time point i

A_s = absorbance of bupropion hydrochloride from the Standard solution

C_s = concentration of USP Bupropion Hydrochloride RS in the Standard solution (mg/mL)

Calculate the percentage of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at each time point (i):

Result₁ = C₁ × V × (1/L) × 100

Result₂ = {[C₂ × (V − V_s )] + (C₁ × V_s )} × (1/L) × 100

Result₃ = ({C₃ × [V − (2 × V_s )]} + [(C₂ + C₁ ) × V_s ]) × (1/L) × 100

Result₄ = ({C₄ × [V − (3 × V_s )]} + [(C₃ + C₂ + C₁ ) × V_s ]) × (1/L) × 100

C_i = concentration of bupropion hydrochloride in the portion of the sample withdrawn at time point i (mg/mL)

V = volume of Medium, 900 mL

L = label claim (mg/Tablet)

V_s = volume of Sample solution withdrawn from the Medium (mL)

Tolerances: See Table 15.

Table 15

The percentages of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at the times specied conform to Dissolution (711), Acceptance Table 2.

Test 13: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 13.

Medium: 0.1 N hydrochloric acid: 900 mL, deaerated

Apparatus 1: 75 rpm

Times: 2, 4, 8, and 12 h

Standard solution: (L/900) mg/mL of USP Bupropion Hydrochloride RS in Medium, where L is the label claim, in mg/Tablet

Sample solution: Withdraw at least 10 mL of the solution under test and centrifuge. Use the supernatant.

Instrumental conditions

(See Ultraviolet-Visible Spectroscopy (857).)

Mode: UV-Vis

Analytical wavelength: 252 nm

Cell: 0.1 cm

Blank: Medium

System suitability

Sample: Standard solution

Suitability requirements

Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the concentration (C_i) of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) in the sample withdrawn from the vessel at time point i:

Result_i = (A_i/A_s ) × C_s

A_i = absorbance of bupropion hydrochloride from the Sample solution at time point i

A_s = absorbance of bupropion hydrochloride from the Standard solution

C_s = concentration of USP Bupropion Hydrochloride RS in the Standard solution (mg/mL)

Calculate the percentage of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at each time point (i):

Result₁ = C₁ × V × (1/L) × 100

Result₂ = {[C₂ × (V − V_s )] + (C₁ × V_s )} × (1/L) × 100

Result₃ = ({C₃ × [V − (2 × V_s )]} + [(C₂ + C₁ ) × V_s ]) × (1/L) × 100

Result₄ = ({C₄ × [V − (3 × V_s )]} + [(C₃ + C₂ + C₁ ) × V_s ]) × (1/L) × 100

C_i = concentration of bupropion hydrochloride in the portion of the sample withdrawn at time point i (mg/mL)

V = volume of Medium, 900 mL

L = label claim (mg/Tablet)

V_s = volume of Sample solution withdrawn from the Medium (mL)

Tolerances: See Table 16.

Table 16

The percentages of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at the times specied conform to Dissolution (711), Acceptance Table 2.

Test 14: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 14.

Medium: 0.1 N hydrochloric acid; 900 mL

Apparatus 1: 75 rpm

Times: 2, 4, 8, and 16 h

Standard solution: (L/900) mg/mL of USP Bupropion Hydrochloride RS in Medium, where L is the label claim, in mg/Tablet. If necessary, dilute the solution with Medium.

Sample solution: Pass a portion of the solution under test through a suitable filter. Replace the portion removed with the same volume of Medium. If necessary, dilute the filtrate with Medium.

Instrumental conditions

(See Ultraviolet-Visible Spectroscopy (857).)

Mode: UV-Vis

Analytical wavelength: 252 nm

Blank: Medium

Analysis

Samples: Standard solution and Sample solution

Calculate the concentration (C_i) of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) in the sample withdrawn from the vessel at time point i:

Result_i = (A_i/A_s ) × C_s × D

A_i = absorbance from the Sample solution at time point i

A_s = absorbance from the Standard solution

C_s = concentration of USP Bupropion Hydrochloride RS in the Standard solution (mg/mL)

D = dilution factor for the Sample solution, if needed

Calculate the percentage of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at each time point (i):

Result₁ = C₁ × V × (1/L) × 100

Result₂ = [(C₂ × V) + (C₁ × V_s )] × (1/L) × 100

Result₃ = {(C₃ × V) + [(C₂ + C₁ ) × V_s ]} × (1/L) × 100

Result₄ = {(C₄ × V) + [(C₃ + C₂ + C₁ ) × V_s ]} × (1/L) × 100

C_i = concentration of bupropion hydrochloride in the portion of the sample withdrawn at time point i (mg/mL)

V = volume of Medium, 900 mL

L = label claim (mg/Tablet)

V_s = volume of Sample solution withdrawn at each time point and replaced with Medium (mL)

Tolerances: See Table 17.

Table 17

The percentages of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at the times specied conform to Dissolution 〈711〉, Acceptance Table 2.

Test 15: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 15.

Acid stage

Acid stage medium: 0.1 N hydrochloric acid, degassed; 900 mL

Apparatus 1: 100 rpm

Time: 2 h in Acid stage medium

Buffer: 3.5 g/L of monobasic sodium phosphate prepared as follows. Dissolve 3.45 g of monobasic sodium phosphate in 996 mL of water, add 4.0 mL of triethylamine, and adjust with phosphoric acid to a pH of 2.8.

Mobile phase: Methanol and Buffer (45:55)

Acid stage standard solution: 0.033 mg/mL of USP Bupropion Hydrochloride RS in Acid stage medium. Sonication may be used to promote dissolution.

Acid stage sample solution: Pass a portion of the solution under test through a suitable filter, discard the first 5 ml., and use the filtrate. Then discard the Tablets and remaining solution. [NOTE-A 0.45-µm nylon membrane filter may be suitable.]

Chromatographic system

(See Chromatography (621). System Suitability.)

Mode: LC

Detector: UV 298 nm

Column: 4.6-mm x 15-cm; 5-um packing 11

Flow rate: 1 mL/min

Injection volume: 10 µL

Run time: NLT 1.5 times the retention time of bupropion

System suitability

Sample: Acid stage standard solution

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0%

Analysis

Samples: Acid stage standard solution and Acid stage sample solution

Calculate the percentage of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved:

Result = (r_u /r_s ) × C_s × V × (1/L) × 100

r_u = peak response of bupropion from the Acid stage sample solution

r_s = peak response of bupropion from the Acid stage standard solution

C_s = concentration of USP Bupropion Hydrochloride RS in the Acid stage standard solution (mg/mL)

V = volume of Acid stage medium, 900 mL

L = label claim (mg/Tablet)

Buffer stage: Use fresh Tablets.

Buffer stage medium: pH 6.8 tribasic sodium phosphate buffer and 0.5% sodium lauryl sulfate (Dissolve 19 g of tribasic sodium phosphate in 1 L of water, add 7 mL of hydrochloric acid, and adjust with 0.2 N sodium hydroxide TS or dilute hydrochloric acid to a pH of 6.8. Add 5 g of sodium dodecyl sulfate. To promote dissolution, the resulting solution can be continuously stirred and heated to 41. Allow the solution to cool to 37^o before use. Do not allow the temperature to fall below 36.5^o before beginning the test.); 900 mL

Apparatus 1: 100 rpm

Times: 1, 2, 4, and 8 h

Buffer: 1.4 g/L of dibasic ammonium phosphate and 0.5 g/L of sodium 1-hexanesulfonate prepared as follows. Dissolve 1.4 g of dibasic ammonium phosphate and 0.5 g of sodium 1-hexanesulfonate in 1 L of water. To each 1 L of this solution, add 2.0 mL of triethylamine, and adjust with phosphoric acid to a pH of 7.0.

Mobile phase: Acetonitrile and Buffer (60:40)

Buffer stage standard solution: 0.33 mg/mL of USP Bupropion Hydrochloride RS in Buffer stage medium

Buffer stage sample solution: Pass a portion of the solution under test through a suitable filter, discard the first 5 ml, and use the filtrate.

Chromatographic system: Proceed as directed under the Acid stage.

System suitability

Sample: Buffer stage standard solution

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0%

Analysis

Samples: Buffer stage standard solution and Buffer stage sample solution

Calculate the concentration (C_i) of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) in the sample withdrawn from the vessel at time point i:

Result_i = (r_i /r_s ) × C_s

r_i = peak response of bupropion from the Buffer stage sample solution at time point i

r_s = peak response of bupropion from the Buffer stage standard solution

C_s = concentration of USP Bupropion Hydrochloride RS in the Buffer stage standard solution (mg/mL)

Calculate the percentage of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at each time point (i):

Result₁ = C₁ × V × (1/L) × 100

Result₂ = {[C₂ × (V − V_s )] + (C₁ × V_s )} × (1/L) × 100

Result₃ = ({C₃ × [V − (2 × V_s )]} + [(C₂ + C₁ ) × V_s ]) × (1/L) × 100

Result₄ = ({C₄ × [V − (3 × V_s )]} + [(C₃ + C₂ + C₁ ) × V_s ]) × (1/L) × 100

C_i = concentration of bupropion hydrochloride in the portion of the sample withdrawn at time point i (mg/mL)

V = volume of Buffer stage medium, 900 mL

L = label claim (mg/Tablet)

V_s = volume of Buffer stage sample solution withdrawn at each time point (mL)

Tolerances

Acid stage: NMT 10%; the percentage of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at the time

specified conforms to Dissolution (711), Acceptance Table 3.

Buffer stage: See Table 18.

Table 18

The percentages of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at the times specified conform to Dissolution (711) Acceptance Table 2.

Test 16: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 16.

Medium: 0.1 N hydrochloric acid: 900 ml, deaerated

Apparatus 1: 75 rpm

Times: 2, 5, 8, and 16 h

Buffer: 3.5 g/L of monobasic sodium phosphate prepared as follows. Dissolve 3.45 g of monobasic sodium phosphate in 996 mL of water, add 4.0 mL of triethylamine, and adjust with phosphoric acid to a pH of 2.8.

Mobile phase: Methanol and Buffer (35:65)

Standard solution: 0.17 mg/ml. of USP Bupropion Hydrochloride RS in Medium. Sonication may be used to promote dissolution.

Sample solution: Pass a portion of the solution under test through a suitable filter, and discard NLT 1 mL. Dilute the filtrate with Medium if necessary. Replace the portion removed with the same volume of Medium. [NOTE-A 0.45-µm nylon membrane filter may be suitable.]

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 298 nm.

Column: 4.6 - mm x 15 - cm -µm packing 11

Column temperature: 30^o

Flow rate: 1 mL/min

Injection volume: 20 µL

Run time: NLT 1.5 times the retention time of bupropion

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the concentration (C_i ) of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) in the sample withdrawn from the vessel at time point i:

Result_i = (r_i /r_s ) × C_s × D

r_i = peak response of bupropion from the Sample solution at time point i

r_s = peak response of bupropion from the Standard solution

C_s = concentration of USP Bupropion Hydrochloride RS in the Standard solution (mg/mL)

D = dilution factor for the Sample solution, if needed

Calculate the percentage of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at each time point (i):

Result₁ = C₁ × V × (1/L) × 100

Result₂ = [(C₂ × V) + (C₁ × V_s )] × (1/L) × 100

Result₃ = {(C₃ × V) + [(C₂ + C₁ ) × V_s ]} × (1/L) × 100

Result₄ = {(C₄ × V) + [(C₃ + C₂ + C₁ ) × V_s ]} × (1/L) × 100

C_i = concentration of bupropion hydrochloride in the portion of the sample withdrawn at time point i (mg/mL)

V = volume of Medium, 900 mL

L = label claim (mg/Tablet)

V_s = volume of Sample solution withdrawn at each time point and replaced with Medium (mL)

Tolerances: See Table 19.

Table 19

The percentages of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at the times specied conform to Dissolution 〈711〉, Acceptance Table 2.

Test 18: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 18.

Medium: 0.1 N hydrochloric acid; 900 mL, deaerated

Apparatus 1: 75 rpm

Times: 2, 4, 8, and 16 h

Buffer: 6.8 g/L of monobasic potassium phosphate in water adjusted with phosphoric acid to a pH of 3.0

Mobile phase: Methanol and Buffer (60:40)

Standard solution: (L/900) mg/mL of USP Bupropion Hydrochloride RS in Medium, where L is the label claim, in mg/Tablet. Sonication

may be used to promote dissolution.

Sample solution: Centrifuge a portion of the solution under test for 15 min.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 298 nm

Column: 4.6-mm × 15-cm; 5-µm packing L7

Flow rate: 1 mL/min

Injection volume: 25 µL

Run time: NLT 1.5 times the retention time of bupropion

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the concentration (C ) of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) in the sample withdrawn from the vessel at time point i:

Result_i = (r_i /r_s ) × C_s

r_i = peak response of bupropion from the Sample solution at time point i

r_s = peak response of bupropion from the Standard solution

C_s = concentration of USP Bupropion Hydrochloride RS in the Standard solution (mg/mL)

Calculate the percentage of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at each time point (i):

Result₁ = C₁ × V × (1/L) × 100

Result₂ = {[C₂ × (V − V_s )] + (C₁ × V_s )} × (1/L) × 100

Result₃ = ({C₃ × [V − (2 × V_s )]} + [(C₂ + C₁ ) × V_s ]) × (1/L) × 100

Result₄ = ({C₄ × [V − (3 × V_s )]} + [(C₃ + C₂ + C₁ ) × V_s ]) × (1/L) × 100

C_i = concentration of bupropion hydrochloride in the portion of the sample withdrawn at time point i (mg/mL)

V = volume of Medium, 900 mL

L = label claim (mg/Tablet)

V_s = volume of Sample solution withdrawn at each time point (mL)

Tolerances: See Table 20.

Table 20

The percentages of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at the times specied conform to Dissolution 〈711〉, Acceptance Table 2.

Test 20: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 20.

Medium: 0.1 N hydrochloric acid VS; 900 mL, deaerated

Apparatus 1: 75 rpm

Times: 2, 4, 8, and 16 h

Standard solution: 0.1 mg/mL of USP Bupropion Hydrochloride RS in Medium

Sample solution: Pass a portion of the solution under test through a suitable lter, and dilute with Medium, if necessary. Replace the

portion removed with the same volume of Medium.

Instrumental conditions

(See Ultraviolet-Visible Spectroscopy 〈857〉.)

Mode: UV-Vis

Analytical wavelength: 298 nm

Blank: Medium

Analysis

Samples: Standard solution and Sample solution

Calculate the concentration (C_i ) of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) in the sample withdrawn from the vessel at time point i:

Result_i = (A_i/A_s ) × C_s × D

A_i = absorbance from the Sample solution at time point i

A_s = absorbance from the Standard solution

C_s = concentration of USP Bupropion Hydrochloride RS in the Standard solution (mg/mL)

D = dilution factor for the Sample solution, if needed

Calculate the percentage of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at each time point (i):

Result₁ = C₁ × V × (1/L) × 100

Result₂ = [(C₂ × V) + (C₁ × V_s )] × (1/L) × 100

Result₃ = {(C₃ × V) + [(C₂ + C₁ ) × V_s ]} × (1/L) × 100

Result₄ = {(C₄ × V) + [(C₃ + C₂ + C₁ ) × V_s ]} × (1/L) × 100

C_i = concentration of bupropion hydrochloride in the portion of the sample withdrawn at time point i (mg/mL)

V = volume of Medium, 900 mL

L = label claim (mg/Tablet)

V_s = volume of Sample solution withdrawn at each time point and replaced with Medium (mL)

Tolerances: See Table 21.

Table 21

The percentages of the labeled amount of bupropion hydrochloride (C H ClNO · HCl) dissolved at the times specied conform to Dissolution 〈711〉, Acceptance Table 2.

Test 21: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 21.

Medium: 0.1 N hydrochloric acid VS; 900 mL, deaerated

Apparatus 1: 75 rpm

Times: 4, 8, and 16 h

Standard stock solution 1: 0.84 mg/mL of USP Bupropion Hydrochloride RS prepared as follows. Transfer a suitable amount of USP Bupropion Hydrochloride RS to an appropriate volumetric flask. Add 50% of the flask volume of acetonitrile. Dilute with water to volume.

Standard stock solution 2: 0.17 mg/mL of USP Bupropion Hydrochloride RS from Standard stock solution 1 in Medium

Standard solution: 0.017 mg/mL of USP Bupropion Hydrochloride RS from Standard stock solution 2 in Medium passed through a suitable filter of 0.45-µm pore size

Sample solution: Dilute a portion of the solution under test with Medium. Pass a portion of the resulting solution through a suitable filter of 0.45-µm pore size. Replace the portion removed with the same volume of Medium.

Instrumental conditions

(See Ultraviolet-Visible Spectroscopy (857).)

Mode: UV-Vis

Analytical wavelength: 252 nm

Blank: Medium

Analysis

Samples: Standard solution and Sample solution

Calculate the concentration (C_i) of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) in the sample withdrawn from the vessel at time point i:

Result_i = (A_i/A_s ) × C_s × D

A_i = absorbance from the Sample solution at time point i

A_s = absorbance from the Standard solution

C_s = concentration of USP Bupropion Hydrochloride RS in the Standard solution (mg/mL)

D = dilution factor for the Sample solution, if needed

Calculate the percentage of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at each time point (i):

Result₁ = C₁ × V × (1/L) × 100

Result₂ = [(C₂ × V) + (C₁ × V_s )] × (1/L) × 100

Result₃ = {(C₃ × V) + [(C₂ + C₁ ) × V_s ]} × (1/L) × 100

C_i = concentration of bupropion hydrochloride in the portion of the sample withdrawn at time point i (mg/mL)

V = volume of Medium, 900 mL

L = label claim (mg/Tablet)

V_s = volume of Sample solution withdrawn at each time point and replaced with Medium (mL)

Tolerances: See Table 22.

Table 22

The percentages of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at the times specied conform to Dissolution 〈711〉, Acceptance Table 2.

Test 22: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 22.

Acid stage medium: 0.1 N hydrochloric acid VS; 750 mL

Buffer stage medium: Sodium phosphate buffer, pH 6.8 (after 2 h, add 250 mL of 76 g/L of tribasic sodium phosphate, previously heated to 37 ± 0.5^o, to the Acid stage medium and adjust with 2 N hydrochloric acid TS or 2 N sodium hydroxide TS, if necessary, to a pH of 6.8); 1000 mL

Apparatus 2: 50 rpm

Times: 2 h in Acid stage medium; 4 and 12 h in Buffer stage medium. The time in the Buffer stage medium includes the time in the Acid

stage medium.

Acid stage standard solution: 0.08 mg/mL of USP Bupropion Hydrochloride RS in Acid stage medium

Buffer stage standard solution: 0.3 mg/mL of USP Bupropion Hydrochloride RS in Buffer stage medium

Acid stage sample solution and Buffer stage sample solution: Use a portion of the solution under test.

Instrumental conditions

(See Ultraviolet-Visible Spectroscopy (857).)

Mode: UV-Vis

Analytical wavelength:

298 nm

Blank: Acid stage medium or Buffer stage medium

System suitability

Samples: Acid stage standard solution and Buffer stage standard solution

Suitability requirements

Relative standard deviation: NMT 2.0%, Acid stage standard solution and Buffer stage standard solution

Analysis

Samples: Acid stage standard solution, Buffer stage standard solution, Acid stage sample solution, and Buffer stage sample solution

Calculate the concentration (C_i) of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) in the sample withdrawn from the vessel at time point i:

Result_i = (A_i/A_s ) × C_s × D

A_i = absorbance from the Acid stage sample solution or Buffer stage sample solution at time point i

A_s = absorbance from the Acid stage standard solution or Buffer stage standard solution at time point i

C_s = concentration of USP Bupropion Hydrochloride RS in the Acid stage standard solution or Buffer stage standard solution (mg/mL)

D = dilution factor, if needed

Calculate the percentage of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved in Acid stage medium:

Result₁ = C₁ × V_A × (1/L) × 100

C₁ = concentration of bupropion hydrochloride in the portion of the sample withdrawn at time point 1

V_A = volume of Acid stage medium, 750 mL

L = label claim (mg/Tablet)

Calculate the percentage of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at each time point (i):

Result₂ = {[C₂ × (V_B − V_SA )] + (C₁ × V_SA )} × (1/L) × 100

Result₃ = {[C₃ × (V_B − V_SB − V_SA )] + (C₂ × V_SB ) + (C₁ × V_SA )} × (1/L) × 100

C_i = concentration of bupropion hydrochloride in the portion of the sample withdrawn at time point i (mg/mL)

V_B = volume of Buffer stage medium, 1000 mL

V_SA = volume of Acid stage sample solution withdrawn at time point 1 (mL)

L = label claim (mg/Tablet)

V_SB = volume of Buffer stage sample solution withdrawn at each time point (mL)

Tolerances: See Table 23.

Table 23

The percentages of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at the times specified conform to Dissolution (711), Acceptance Table 2.

Test 23: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 23.

Acid stage medium: 0.1 N hydrochloric acid VS: 900 mL, deaerated

Buffer stage medium: pH 6.8 phosphate buffer 900 mL, deaerated

Apparatus 1: 75 rpm

Times: 2 h in Acid stage medium; 6 and 16 h in Buffer stage medium. The time in the Buffer stage medium includes the time in the Acid stage medium.

Acid stage standard solution: (1/900) mg/mL of USP Bupropion Hydrochloride RS in Acid stage medium, where L is the label claim, in mg/Tablet

Buffer stage standard solution: (L/900) mg/mL of USP Bupropion Hydrochloride RS in Buffer stage medium, where L is the label claim, in mg/Tablet

Acid stage sample solution and Buffer stage sample solution: Pass a portion of the solution under test through a suitable filter.

Instrumental conditions

(See Ultraviolet-Visible Spectroscopy (857).)

Mode: UV-Vis

Analytical wavelength: 298 nm

Cell: 0.5 cm, flow cell

Blank: Acid stage medium or Buffer stage medium

System suitability

Samples: Acid stage standard solution and Buffer stage standard solution

Suitability requirements

Relative standard deviation: NMT 2.0%, Acid stage standard solution and Buffer stage standard solution

Analysis

Samples: Acid stage standard solution, Buffer stage standard solution, Acid stage sample solution, and Buffer stage sample solution

Calculate the concentration (C_i) of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) in the sample withdrawn from the vessel at time point i:

Result_i = (A_i/A_s ) × C_s

A_i = absorbance from the Acid stage sample solution or Buffer stage sample solution at time point i

A_s = absorbance from the Acid stage standard solution or Buffer stage standard solution at time point i

C_s = concentration of USP Bupropion Hydrochloride RS in the Acid stage standard solution or Buffer stage standard solution (mg/mL)

Calculate the percentage of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved in Acid stage medium (Q_A ):

Result₁ = C₁ × V_A × (1/L) × 100

C₁ = concentration of bupropion hydrochloride in the portion of the sample withdrawn at time point 1

V_A = volume of Acid stage medium, 900 mL

L = label claim (mg/Tablet)

Calculate the percentage of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at each time point (i):

Result₂ = [C₂ × V_B × (1/L) × 100] + Q_A

Result₃ = [C₃ × V_B × (1/L) × 100] + Q_A

C_i = concentration of bupropion hydrochloride in the portion of the sample withdrawn at time point i (mg/mL)

V_B = volume of Buffer stage medium, 900 mL

L = label claim (mg/Tablet)

Q_A = percentage of the labeled amount of bupropion hydrochloride dissolved in the Acid stage medium

Tolerances: See Table 24.

Table 24

The percentages of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at the times specified conform to Dissolution (711), Acceptance Table 2.

Test 24: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 24.

Acid stage medium: 0.1 N hydrochloric acid: 900 mL, deaerated

Buffer stage medium: pH 6.8 phosphate buffer with 0.5 M sodium chloride (Dissolve 6.8 g of monobasic potassium phosphate and 0.9 g of sodium hydroxide in 1 L of water. Adjust with 0.2 M sodium hydroxide or phosphoric acid to a pH of 6.8. Add 29.2 g of sodium chloride.); 900 mL, deaerated

Apparatus 1: 50 rpm

Times

For Tablets labeled to contain 150 mg of bupropion hydrochloride: 2 h in Acid stage medium; 3, 5, 8, and 10 h in Buffer stage medium.

The time in the Buffer stage medium includes the time in the Acid stage medium.

For Tablets labeled to contain 300 mg of bupropion hydrochloride: 2 h in Acid stage medium; 3, 6, 10, and 16 h in Buffer stage medium.

The time in the Buffer stage medium includes the time in the Acid stage medium.

Acid stage standard solution: (L/900) mg/mL of USP Bupropion Hydrochloride RS in Acid stage medium, where L is the label claim, in mg/Tablet. Sonicate to dissolve, if necessary. Pass the resulting solution through a suitable filter of 0.45-µm pore size, discarding the first 1 mL of filtrate. Use the solution within 1 h.

Buffer stage standard solution: (L/900) mg/mL of USP Bupropion Hydrochloride RS in Buffer stage medium, where L is the label claim, in mg/Tablet. Sonicate to dissolve, if necessary. Pass the resulting solution through a suitable filter of 0.45-µm pore size, discarding the first 1 mL of filtrate.

Acid stage sample solution: Pass a portion of the solution under test through a suitable filter of 0.45-µm pore size, discarding the first 1 mL of filtrate. Use the solution within 3 h. Remove the remainder of the solution under test from the vessel and proceed with testing in Buffer stage medium.

Buffer stage sample solution: Pass a portion of the solution under test through a suitable filter of 0.45-µm pore size, discarding the first 1 mL of filtrate. Replace the portion removed with the same volume of the Buffer stage medium.

Instrumental conditions

(See Ultraviolet-Visible Spectroscopy (857).)

Mode: UV

Analytical wavelength: 298 nm

Cell: 0.5 cm

Blank: Acid stage medium or Buffer stage medium

Analysis

Samples: Acid stage standard solution, Buffer stage standard solution, Acid stage sample solution, and Buffer stage sample solution

Calculate the concentration (C_i) of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) in the sample withdrawn from the vessel at time point i:

Result_i = (A_u /A_s ) × C_s

A_u = absorbance from the Acid stage sample solution or Buffer stage sample solution at time point i

A_s = absorbance from the Acid stage standard solution or Buffer stage standard solution at time point i

C_s = concentration of USP Bupropion Hydrochloride RS in the Acid stage standard solution or Buffer stage standard solution (mg/mL)

Calculate the percentage of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved in Acid stage medium (Q_A ):

Result₁ = C₁ × V_A × (1/L) × 100

C₁ = concentration of bupropion hydrochloride in the portion of the sample withdrawn at time point 1

V_A = volume of Acid stage medium, 900 mL

L = label claim (mg/Tablet)

Calculate the percentage of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at each time point (i):

Result₂ = [C₂ × V_B × (1/L) × 100] + Q_A

Result₃ = {[(C₃ × V_B ) + (C₂ × V_S )] × (1/L) × 100} + Q_A

Result₄ = ({(C₄ × V_B ) + [(C₃ + C₂ ) × V_S ]} × (1/L) × 100) + Q_A

Result₅= ({(C₅ × V_B ) + [(C₄ + C₃ + C₂ ) × V_S ]} × (1/L) × 100) + Q_A

C_i = concentration of bupropion hydrochloride in the portion of the sample withdrawn at time point i (mg/mL)

V_B = volume of Buffer stage medium, 900 mL

L = label claim (mg/Tablet)

Q_A = percentage of the labeled amount of bupropion hydrochloride dissolved in the Acid stage medium

V_S = volume of Sample solution withdrawn at each time point and replaced with Medium (mL)

Tolerances: See Table 25

Table 25

The percentages of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at the times specified conform to

Dissolution (711), Acceptance Table 2.

Test 25: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 25.

Medium: 0.1 N hydrochloric acid, 900 mL, deaerated

Apparatus 1: 75 rpm

Times: 2, 4, 8, and 12 h

Standard stock solution: 0.33 mg/mL of USP Bupropion Hydrochloride RS in Medium. Sonication may be used to promote dissolution.

Standard solution: 0.033 mg/mL of USP Bupropion Hydrochloride RS from Standard stock solution in Medium

Sample solution: Dilute a portion of the solution under test with Medium. Pass a portion of the resulting solution through a suitable filter of 0.45-µm pore size, discarding the first few milliliters of filtrate.

Instrumental conditions

(See Ultraviolet-Visible Spectroscopy (857).)

Mode: UV

Analytical wavelength: 252 nm

Blank: Medium

Analysis

Samples: Standard solution and Sample solution

Calculate the concentration (C_i ) of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) in the sample withdrawn from the vessel at time point i:

Result_i = (A_u /A_s ) × C_s × D

A_u = absorbance from the Sample solution at time point i

A_s = absorbance from the Standard solution

C_s = concentration of USP Bupropion Hydrochloride RS in the Standard solution (mg/mL)

D = dilution factor for the Sample solution

Calculate the percentage of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at each time point (i):

Result₁ = C₁ × V × (1/L) × 100

Result₂ = {[C₂ × (V − V_s )] + (C₁ × V_s )} × (1/L) × 100

Result₃ = ({C₃ × [V − (2 × V_s )]} + [(C₂ + C₁ ) × V_s ]) × (1/L) × 100

Result₄ = ({C₄ × [V − (3 × V_s )]} + [(C₃ + C₂ + C₁ ) × V_s ]) × (1/L) × 100

C_i = concentration of bupropion hydrochloride in the portion of the sample withdrawn at time point i (mg/mL)

V = volume of Medium, 900 mL

L = label claim (mg/Tablet)

V_s = volume of Sample solution withdrawn at each time point (mL)

Tolerances: See Table 26.

Table 26

The percentages of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at the times specied conform to Dissolution 〈711〉, Acceptance Table 2.

Test 26: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 26.

Medium: 0.1 N hydrochloric acid; 900 mL

Apparatus 1: 75 rpm

Times: 2, 6, and 14 h

Standard stock solution: 0.17 mg/mL of USP Bupropion Hydrochloride RS in Medium. Sonication may be used to promote dissolution.

Standard solution: 0.017 mg/mL of USP Bupropion Hydrochloride RS from Standard stock solution in Medium

Sample solution: Dilute a portion of the solution under test with Medium. Pass a portion of the resulting solution through a suitable lter of 0.45-μm pore size, discarding the rst few milliliters of ltrate. Replace the portion removed with the same volume of Medium.

Instrumental conditions

(See Ultraviolet-Visible Spectroscopy 〈857〉.)

Mode: UV-Vis

Analytical wavelength: 252 nm

Blank: Medium

Analysis

Samples: Standard solution and Sample solution

Calculate the concentration (C_i ) of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) in the sample withdrawn from the vessel at time point i:

Result_i = (A_u /A_s ) × C_s × D

A_u = absorbance from the Sample solution at time point i

A_s = absorbance from the Standard solution

C_s = concentration of USP Bupropion Hydrochloride RS in the Standard solution (mg/mL)

D = dilution factor for the Sample solution

Calculate the percentage of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at each time point (i):

Result₁ = C₁ × V_s × (1/L) × 100

Result₂ = [(C₂ × V) + (C₁ × V_s )] × (1/L) × 100

Result₃ = {(C₃ × V) + [(C₂ + C₁ ) × V_s ]} × (1/L) × 100

C_i = concentration of bupropion hydrochloride in the portion of the sample withdrawn at time point i (mg/mL)

V = volume of Medium, 900 mL

L = label claim (mg/Tablet)

V_s = volume of Sample solution withdrawn at each time point and replaced with Medium (mL)

Tolerances: See Table 27.

Table 27

The percentages of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at the times specified conform to Dissolution (711) Acceptance Table 2.

Test 27: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 27.

Acid stage medium: 0.1 N hydrochloric acid: 750 mL, deaerated

Buffer stage medium: pH 6.8 phosphate buffer (Add 250 mL of solution containing 76 g of sodium phosphate, tribasic (dodecahydrate) in 1 L water to the Acid stage medium, adjust with 2 N sodium hydroxide or 2 N hydrochloric acid to a pH of 6.8, if necessary.); 1000 mL

Apparatus 2: 50 rpm with suitable sinkers

Times: 2 h in Acid stage medium, 4 and 12 h in Buffer stage medium. The time in the Buffer stage medium includes the time in the Acid stage medium.

Buffer: Dissolve 3.45 g of sodium phosphate, monobasic (monohydrate) in 1000 mL of water. Discard 4.0 mL of the solution, then add 4.0 ml of triethylamine and adjust with phosphoric acid to a pH of 2.8.

Mobile phase: Methanol and Buffer (55:45)

Standard solution: (L/1000) mg/ml. of USP Bupropion Hydrochloride RS in Acid stage medium, where L is the label claim, in mg/Tablet. Sonicate to dissolve.

Acid stage sample solution: At the time specified, withdraw a 10-ml, aliquot of the solution under test without replacing the withdrawn volume. Pass the withdrawn portion through a suitable filter of 10-um pore size.

Buffer stage sample solution: At the times specified, withdraw a 10-mL aliquot of the solution under test without replacing the withdrawn volume. Pass the withdrawn portions at each time point through a suitable filter of 10-um pore size.

Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 298 nm

Column: 4.6-mm × 15-cm; 5-µm packing L1

Column temperature: 30°

Flow rate: 1 mL/min

Injection volume: 20 µL

Run time: NLT 2.2 times the retention time of bupropion

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution, Acid stage sample solution, and Buffer stage sample solution

Calculate the concentration (C_i ) of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) in the sample withdrawn from the vessel at each time point (i):

Result_i = (r_u /r_s ) × C_s

r_u = peak response of bupropion from the Acid stage sample solution or Buffer stage sample solution

r_s = peak response of bupropion from the Standard solution

C_s = concentration of USP Bupropion Hydrochloride RS from the Standard solution (mg/mL)

Calculate the percentage of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at each time point (i):

Result₁ = C₁ × V_A × (1/L) × 100

Result₂ = {[C₂ × (V_B − V_s )] + (C₁ × V_s )} × (1/L) × 100

Result₃ = ({C₃ × [V_B − (2 × V_s )]} + [(C₂ + C₁ ) × V_s ]) × (1/L) × 100

C_i = concentration of bupropion hydrochloride in the portion of the sample withdrawn at time point i (mg/mL)

V_A = volume of Acid stage medium, 750 mL

L = label claim (mg/Tablet)

V_B = volume of Buffer stage medium, 1000 mL

V_s = volume of Acid stage sample solution or Buffer stage sample solution withdrawn at each time point, 10 mL

Tolerances: See Table 28.

Table 28

The percentages of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at the times specied conform to Dissolution 〈711〉, Acceptance Table 2.

Test 28: If the product complies with this test, the labeling indicates that it meets USP Dissolution Test 28.

Acid stage medium: 0.1 N hydrochloric acid; 750 mL, deaerated

Buffer stage medium: 0.05 M sodium phosphate buffer, pH 6.8 with 5 g/L of sodium dodecyl sulfate (Dissolve 38.3 g of sodium

phosphate, tribasic (dodecahydrate) in 100 mL of water and transfer to a 2-L container containing 1800 mL of water. Add 12.5 mL of hydrochloric acid and adjust with sodium hydroxide or hydrochloric acid to a pH of 6.8. Dilute with water to volume. To each liter of this solution, add 5 g of sodium dodecyl sulfate and dissolve by stirring NLT 30 min.); 1000 mL, deaerated

Apparatus 1: 75 rpm

Times: 1 h in Acid stage medium; 4, 8, and 16 h in Buffer stage medium. The time in the Buffer stage medium includes the time in the Acid stage medium.

Acid stage standard solution: 0.04 mg/mL of USP Bupropion Hydrochloride RS in Acid stage medium. Sonicate to dissolve.

Buffer stage standard solution: 0.15 mg/mL of USP Bupropion Hydrochloride RS in Buffer stage medium, Sonicate to dissolve..

Acid stage sample solution: At the time specified, withdraw a 10-mL aliquot of the solution under test and pass the withdrawn portion through a suitable filter of 10-um pore size. Transfer the basket containing the Tablet to the vessel containing Buffer stage medium and proceed with testing in Buffer stage medium.

Buffer stage sample solution: At the times specified, withdraw a 10-mL aliquot of the solution under test without replacing the withdrawn volume. Pass the withdrawn portions at each time point through a suitable filter of 70-µm pore size.

Instrumental conditions

(See Ultraviolet-Visible Spectroscopy (857).)

Mode: UV

Analytical wavelength:

252 nm

Cell: 0.1 cm

Blank: Acid stage medium or Buffer stage medium

Analysis

Samples: Acid stage standard solution, Buffer stage standard solution, Acid stage sample solution, and Buffer stage sample solution

Calculate the concentration (C_i) of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) in the sample withdrawn from the vessel at each time point (i):

Result_i = (A_u /A_s ) × C_s

A_u = absorbance from the Acid stage sample solution or Buffer stage sample solution

A_s = absorbance from the Acid stage standard solution or Buffer stage standard solution

C_s = concentration of USP Bupropion Hydrochloride RS in the Acid stage standard solution or Buffer stage standard solution (mg/mL)

Calculate the percentage of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved in Acid stage medium (Q_A ):

Result₁ = C₁ × V_A × (1/L) × 100

C₁ = concentration of bupropion hydrochloride in the portion of the sample withdrawn at time point 1 (mg/mL)

V_A = volume of Acid stage medium, 750 mL

L = label claim (mg/Tablet)

Calculate the percentage of the labeled amount of bupropion hydrochloride (C₁₃H₁₈ClNO · HCl) dissolved at each time point (i):

Result₂ = [C₂ × V_B × (1/L) × 100] + Q_A

Result₃ = ({[C₃ × (V_B − V_s )] + (C₂ × V_s )} × (1/L) × 100) + Q_A

Result₄ = [({C₄ × [V_B − (2 × V_s )]} + [(C₂ + C₃ ) × V_s ]) × (1/L) × 100] + Q_A

C_i = concentration of bupropion hydrochloride in the portion of the sample withdrawn at time point i (mg/mL)

V_B = volume of Buffer stage medium, 1000 mL

L = label claim (mg/Tablet)

Q_A = percentage of the labeled amount of bupropion hydrochloride dissolved in the Acid stage medium

V_B = volume of Buffer stage sample solution withdrawn at each time point, 10 mL

Tolerances: See Table 29.

Table 29

The percentages of the labeled amount of bupropion hydrochloride (CHCINO HCI) dissolved at the times specified conform to Dissolution (711). Acceptance Table 2 _{(RB 1-Aug-2023)}

UNIFORMITY OF DOSAGE UNITS (905): Meet the requirements

5 IMPURITIES

Change to read:

ORGANIC IMPURITIES

Diluent 1, Solution A, Solution B, Mobile phase, and either Sample stock solution A and Sample solution A or Buffer, Diluent 2, Sample

stock solution B, and Sample solution B: Proceed as directed in the Assay.

System suitability stock solution A: 0.02 mg/mL of USP Bupropion Related Compound C RS, 0.02 mg/mL of USP Bupropion Related Compound F. RS, and 0.012 mg/mL of USP 3-Chlorobenzoic Acid RS in methanol

System suitability solution A: 0.002 mg/mL of bupropion related compound C, 0.002 mg/mL of bupropion related compound F, and 0.0012 mg/mL of 3-chlorobenzoic acid from System suitability stock solution A in Diluent 1

System suitability stock solution B: 0.012 mg/mL of USP 3-Chlorobenzoic Acid RS in methanol

System suitability solution B: 0.0012 mg/mL of 3-chlorobenzoic acid from System suitability stock solution B in Diluent 1

Standard solution: 0.0012 mg/mL of USP Bupropion Hydrochloride RS in Diluent 1

Sensitivity solution: 0.0006 mg/mL of USP Bupropion Hydrochloride RS from Standard solution in Diluent 1

Chromatographic system: Proceed as directed in the Assay except use a Detector as follows.

Detector: UV 226 nm, adjusted ±2 nm so that the relative response factor requirement is met. [NOTE-The peak responses of the compounds of interest are very sensitive to changes in the detection wavelength.]

System suitability

Samples: System suitability solution A, System suitability solution B, Standard solution, and Sensitivity solution

[NOTE-See Table 30 _{(RB 1-Aug-2023)} for the relative retention times.)

Suitability requirements

Resolution: NLT 1.3 between bupropion related compound F and bupropion related compound C, System suitability solution A; NLT 1.3 between bupropion related compound C and 3-chlorobenzoic acid, System suitability solution A

Relative standard deviation: NMT 10%, Standard solution

Relative response factor: 3.8-4.5 for the peak response of 3-chlorobenzoic acid in System suitability solution B divided by the peak response from bupropion in the Standard solution

Signal-to-noise ratio: NLT 10, Sensitivity solution

Analysis

Samples: System suitability solution B, Standard solution, and Sample solution A or Sample solution B

Calculate the percentage of 3-chlorobenzoic acid in the portion of Tablets taken:

Result = (r_u /r_s ) × (C_s /C_u ) × 100

r_u = peak response of 3-chlorobenzoic acid from Sample solution A or Sample solution B

r_s = peak response of 3-chlorobenzoic acid from System suitability solution B

C_s = concentration of USP 3-Chlorobenzoic Acid RS in System suitability solution B (mg/mL)

C_u = nominal concentration of bupropion hydrochloride in Sample solution A or Sample solution B (mg/mL)

Calculate the percentage of each other degradation product in the portion of Tablets taken:

Result = (r_u /r_s ) × (C_s /C_u ) × (1/F) × 100

r_u = peak response of each other degradation product from Sample solution A or Sample solution B

r_s = peak response of bupropion hydrochloride from the Standard solution

C_s = concentration of USP Bupropion Hydrochloride RS in the Standard solution (mg/mL)

C_u = nominal concentration of bupropion hydrochloride in Sample solution A or Sample solution B (mg/mL)

F = relative response factor for each other degradation product (see Table 30 _{(RB 1-Aug-2023)} )

Acceptance criteria: See Table 30 _{(RB 1-Aug-2023)} . The reporting threshold is 0.10%.

Table 30 _{(RB 1-Aug-2023)}

^a 2-Amino-1-(3-chlorophenyl)-1-propanone.

^b (3S,5S,6S)-6-(3-Chlorophenyl)-6-hydroxy-5-methyl-3-thiomorpholine carboxylic acid.

^c (3S,5R,6R)-6-(3-Chlorophenyl)-6-hydroxy-5-methyl-3-thiomorpholine carboxylic acid.

^d 1-(3-Chlorophenyl)propane-1,2-dione.

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in well-closed containers. Store at controlled room temperature. Protect from light.

Labeling: The labeling states the Dissolution test used only if Test 1 is not used.

USP Reference Standards 〈11〉

USP Bupropion Hydrochloride RS

USP Bupropion Related Compound C RS

[Note—May also be labeled as USP Bupropion Hydrochloride Related Compound C RS.]

1-(3-Chlorophenyl)-2-hydroxypropan-1-one.

C₉H₉O₂Cl         184.62

USP Bupropion Related Compound F RS

[Note—May also be labeled as USP Bupropion Hydrochloride Related Compound F RS.]

1-(3-Chlorophenyl)-1-hydroxypropan-2-one.

C₉H₉O₂Cl        184.62

USP 3-Chlorobenzoic Acid RS

3-Chlorobenzoic acid.

C₇H₅ClO₂        156.57