Galantamine Extended-Release Capsules

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

Galantamine Extended-Release Capsules contain galantamine hydrobromide (C₁₇H₂₁NO₃ · HBr) equivalent to NLT 90.0% and NMT 110.0% of the labeled amount of galantamine (C₁₇H₂₁NO₃).

[Note—Throughout the following procedures, protect samples, the Reference Standard, and solutions containing them from light.]

2 IDENTIFICATION

A. Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K

Sample: Prepare a potassium bromide dispersion as follows. Remove 4 beads from within 1 Capsule. Grind the beads into a ne powder, and combine with potassium bromide.

Standard: Prepare a potassium bromide dispersion using USP Galantamine Hydrobromide RS.

Acceptance criteria: The IR spectra of the Sample and the Standard exhibit similar absorption bands at 2800–2400 cm−1, 1700–1500 cm−1, and 850–750 cm−1.

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

3 ASSAY

Procedure

Buffer: 4.0 g/L of monobasic potassium phosphate in water; adjusted with 5 N sodium hydroxide TS to a pH of 6.5 Mobile phase: Acetonitrile and Buffer (10:90)

Standard stock solution: 0.62 mg/mL of USP Galantamine Hydrobromide RS (equivalent to 0.48 mg/mL of galantamine) prepared as follows. Transfer a suitable quantity of USP Galantamine Hydrobromide RS to a suitable ask, and dissolve in 20% of the ask volume of methanol. Dilute with Buffer to volume.

Standard solution: 0.048 mg/mL of galantamine from the Standard stock solution in Buffer

Sample stock solution: Prepare the solution using the appropriate nominal concentration of galantamine stated in Table 1. Transfer the contents of 10 Capsules to a suitable volumetric flask. Add 20% of the ask volume of methanol, sonicate for 15 min, and stir for 20 min. Add a suitable volume of Buffer such that 80% of the ask volume is filled, and stir for 90 min. Dilute with Buffer to volume.

Sample solution: Nominally 0.048 mg/mL of galantamine prepared as follows from the Sample stock solution. Transfer a suitable volume of the Sample stock solution to an appropriate volumetric flask, and dilute with Buffer to volume. Pass through a suitable filter of 0.45-µm pore size. Discard the first 5 mL, and use the filtrate.

3.1 Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 288 nm

Column: 4.6-mm × 15.0-cm; 5-µm packing L1

Flow rate: 1.2 mL/min

Injection volume: 20 µL

Run time: NLT 1.5 times the retention time of galantamine

3.2 System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 1.7

Relative standard deviation: NMT 1.0%

3.3 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of galantamine (C₁₇H₂₁NO₃) in the portion of Capsules taken:

Result = (r_U/r_S ) × (C_S /C_U ) × (M_r1 /M_r2 ) × 100

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution

C_S = concentration of USP Galantamine Hydrobromide RS in the Standard solution (mg/mL) 

C_U = nominal concentration of galantamine in the Sample solution (mg/mL)

M_r1 = molecular weight of galantamine, 287.35

M_r2 = molecular weight of galantamine hydrobromide, 368.27

Acceptance criteria: 90.0%–110.0%

4 PERFORMANCE TESTS

Dissolution 〈711〉

4.1 Test 1

Medium: 0.05 M monobasic potassium phosphate, pH 6.5; 900 mL

Apparatus 2: 50 rpm with sinkers 1

Times: 1, 4, and 12 h

Buffer: 1 g/L of sodium 1-hexanesulfonate in water. Add 0.5 mL of phosphoric acid per liter.

Mobile phase: Acetonitrile and Buffer (20:80)

Standard stock solution: 0.57 mg/mL of USP Galantamine Hydrobromide RS (equivalent to 0.44 mg/mL of galantamine) in Medium Standard solution: (L/900) mg/mL of galantamine from the Standard stock solution in Medium, where L is the label claim of galantamine in mg/Capsule

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

4.1.1 Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 280 nm

Column: 4.6-mm × 15.0-cm; 5-µm packing L1

Flow rate: 1 mL/min

Injection volume: 50 µL

Run time: NLT 1.5 times the retention time of galantamine

4.1.2 System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0%

4.1.3 Analysis

Samples: Standard solution and Sample solution

Calculate the concentration (C_i ) of galantamine (C₁₇H₂₁NO₃) in the sample with drawn from the vessel at each time point (i):

Result_i = (r_U/r_S) × C_S × (M_r1 /M_r2)

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution

_SC = concentration of USP Galantamine Hydrobromide RS in the Standard solution (mg/mL) S

M_r1 = molecular weight of galantamine, 287.35

M_r2 = molecular weight of galantamine hydrobromide, 368.27

Calculate the percentage of the labeled amount of galantamine (C₁₇H₂₁NO₃) dissolved at each time point (i):

Result₁ = C₁ × V × (1/L) × 100

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

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

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

V = volume of Medium, 900 mL

L = label claim (mg/Capsule)

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

Tolerances: See Table 2.

Table 2

The percentage of the labeled amount of galantamine (C₁₇H₂₁NO₃) dissolved at the times specied conforms to Dissolution 〈711〉,

Acceptance Table 2.

4.2 Test 2

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

Medium: 0.05 M monobasic potassium phosphate, pH 6.5; 900 mL

Apparatus 2: 50 rpm

Times: 1, 4, and 12 h

Solution A: Transfer 0.5 mL of phosphoric acid to a 100-mL volumetric flask containing 50% of the ask volume of water. Dilute with water to volume.

Mobile phase: Acetonitrile and Solution A (7:93)

Standard stock solution: 0.23 mg/mL of USP Galantamine Hydrobromide RS (equivalent to 0.18 mg/mL of galantamine) in Medium Standard solution: (L/900) mg/mL of galantamine from the Standard stock solution in Medium, where L is the label claim of galantamine, in mg/Capsule

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

4.2.1 Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 230 nm

Column: 3.0-mm × 15.0-cm; 5-µm packing L1

Column temperature: 35°

Flow rate: 0.7 mL/min

Injection volume: 10 µL

Run time: NLT 1.6 times the retention time of galantamine

4.2.2 System suitability

Sample: Standard solution

Suitability requirements

Relative standard deviation: NMT 2.0%

4.2.3 Analysis

Samples: Standard solution and Sample solution

Calculate the concentration (C_i) of galantamine (C₁₇H₂₁NO₃) in the sample withdrawn from the vessel at each time point (i):

Result_i = (r_U/r_S) × C_S × (M_r1 /M_r2)

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution

C_S = concentration of USP Galantamine Hydrobromide RS in the Standard solution (mg/mL)

M_r1 = molecular weight of galantamine, 287.35

M_r2 = molecular weight of galantamine hydrobromide, 368.27

Calculate the percentage of the labeled amount of galantamine (C₁₇H₂₁NO₃) dissolved at each time point (i):

Result₁ = C₁ × V × (1/L) × 100

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

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

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

V = volume of Medium, 900 mL

L = label claim (mg/Capsule)

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

Tolerances: See Table 3.

Table 3

The percentage of the labeled amount of galantamine (C H NO ) dissolved at the times specied conforms to Dissolution 〈711〉, 17 21 3

Acceptance Table 2.

4.3 Test 3

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

Medium: pH 6.5 phosphate buffer (6.8 g/L of monobasic potassium phosphate and 0.56 g/L of sodium hydroxide adjusted, if necessary, with phosphoric acid or 10 N sodium hydroxide TS to a pH of 6.5); 900 mL

Apparatus 2: 50 rpm, with stainless steel wire helix sinkers

Times: 1, 2, 4, and 12 h

Buffer: To each liter of 6.8 g/L of monobasic potassium phosphate in water add 3.0 mL of triethylamine, and adjust the resulting solution with phosphoric acid to a pH of 2.5. Pass through a suitable membrane filter of 0.45-µm pore size, and use the filtrate. Mobile phase: Acetonitrile and Buffer (8:92)

Standard stock solution: 0.23 mg/mL of USP Galantamine Hydrobromide RS (equivalent to 0.18 mg/mL of galantamine) in Medium Standard solution: (L/900) mg/mL of galantamine from the Standard stock solution in Medium, where L is the label claim of galantamine, in mg/Capsule

Sample solution: Pass a portion of the solution under test through a suitable filter. Replace the portion of solution withdrawn with an equal volume of Medium.

4.3.1 Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 230 nm

Column: 4.6-mm × 15.0-cm; 5-µm packing L1

Flow rate: 1.5 mL/min

Injection volume: 50 µL

Run time: NLT 2 times the retention time of galantamine

4.3.2 System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2

Relative standard deviation: NMT 3.0%

4.3.3 Analysis

Samples: Standard solution and Sample solution

Calculate the concentration (C_i) of galantamine (C₁₇H₂₁NO₃) in the sample withdrawn from the vessel at each time point (i):

Result_i = (r_U/r_S) × C_S × (M_r1 /M_r2)

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution

C_S = concentration of USP Galantamine Hydrobromide RS in the Standard solution (mg/mL)

M_r1 = molecular weight of galantamine, 287.35

M_r2 = molecular weight of galantamine hydrobromide, 368.27

Calculate the percentage of the labeled amount of galantamine (C₁₇H₂₁NO₃) dissolved at each time point (i):

Result₁ = C₁ × V × (1/L) × 100

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

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

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

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

V = volume of Medium, 900 mL

L = label claim (mg/Capsule)

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

Tolerances: See Table 4.

Table 4

The percentage of the labeled amount of galantamine (C₁₇H₂₁NO₃) dissolved at the times specied conforms to Dissolution 〈711〉, Acceptance Table 2.

5 Test 4

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

Medium: pH 6.5 phosphate buffer (6.8 g/L of monobasic potassium phosphate in water adjusted, if necessary, with 5 N sodium hydroxide TS to a pH of 6.5); 900 mL

Apparatus 2: 50 rpm, with sinkers

Times: 1, 4, and 12 h

Buffer: 6.8 g/L of monobasic potassium phosphate adjusted, if necessary, with 5 N sodium hydroxide TS to a pH of 7.5 Mobile phase: Acetonitrile and Buffer (15:85)

Standard stock solution: 0.11 mg/mL of USP Galantamine Hydrobromide RS (equivalent to 0.09 mg/mL of galantamine) in Medium Standard solution: (L/900) mg/mL of galantamine from the Standard stock solution in Medium, where L is the label claim of galantamine, in mg/Capsule

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

5.1 Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 230 nm

Column: 4.6-mm × 15.0-cm; 5-µm packing L1

Column temperature: 30°

Flow rate: 1.4 mL/min

Injection volume: 100 µL

Run time: NLT 1.5 times the retention time of galantamine

5.2 System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0%

5.3 Analysis

Samples: Standard solution and Sample solution

Calculate the concentration (C_i ) of galantamine (C₁₇H₂₁NO₃) in the sample withdrawn from the vessel at each time point (i):

Result = (r_U/r_S) × C_S × (M_r1 /M_r2)

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution

C_S = concentration of USP Galantamine Hydrobromide RS in the Standard solution (mg/mL)

M_r1 = molecular weight of galantamine, 287.35

M_r2 = molecular weight of galantamine hydrobromide, 368.27

Calculate the percentage of the labeled amount of galantamine (C₁₇H₂₁NO₃) dissolved at each time point (i):

Result₁ = C₁ × V × (1/L) × 100

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

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

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

V = volume of Medium, 900 mL

L = label claim (mg/Capsule)

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

Tolerances: See Table 5.

Table 5

The percentage of the labeled amount of galantamine (C₁₇H₂₁NO₃) dissolved at the times specied conforms to Dissolution 〈711〉, 17 21 3 

Acceptance Table 2. 

5.4 Test 5

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

Medium: pH 6.5 phosphate buffer (6.8 g/L of monobasic potassium phosphate adjusted, if necessary, with 0.2 N sodium hydroxide TS to a pH of 6.5); 900 mL 

Apparatus 2: 50 rpm with sinkers 

Times: 1, 4, and 12 h 

Buffer: To each liter of water add 7 mL of triethylamine. 

Mobile phase: Methanol and Buffer (25:75); adjusted with phosphoric acid or a solution of triethylamine and water (5:95) to a pH of 6.5 Standard solution: 0.025 mg/mL of USP Galantamine Hydrobromide RS (equivalent to 0.02 mg/mL of galantamine) in Medium Sample solution: Pass a portion of the solution under test through a suitable filter. 

5.4.1 Chromatographic system 

(See Chromatography 〈621〉, System Suitability.) 

Mode: LC 

Detector: UV 280 nm 

Column: 4.6-mm × 15.0-cm; 5-µm packing L7 

Flow rate: 1 mL/min 

Injection volume: 20 µL 

Run time: NLT 1.5 times the retention time of galantamine 

5.4.2 System suitability 

Sample: Standard solution 

Suitability requirements 

Tailing factor: NMT 2.0 

Relative standard deviation: NMT 2.0% 

5.4.3 Analysis 

Samples: Standard solution and Sample solution 

Calculate the concentration (C_i) of galantamine (C₁₇H₂₁NO₃) in the sample withdrawn from the vessel at each time point (i): 

Result_i = (r_U/r_S) × C_S × (M_r1 /M_r2)

r_U = peak response from the Sample solution 

r_S = peak response from the Standard solution

C_S = concentration of USP Galantamine Hydrobromide RS in the Standard solution (mg/mL)

M_r1 = molecular weight of galantamine, 287.35

M_r2 = molecular weight of galantamine hydrobromide, 368.27

Calculate the percentage of the labeled amount of galantamine (C₁₇H₂₁NO₃) dissolved at each time point (i):

Result₁ = C₁ × V × (1/L) × 100

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

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

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

V = volume of Medium, 900 mL

L = label claim (mg/Capsule)

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

Tolerances: See Table 6.

Table 6

The percentage of the labeled amount of galantamine (C H NO ) dissolved at the times specied conforms to Dissolution 〈711〉, 17 21 3

Acceptance Table 2.

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

Medium: pH 6.5 phosphate buffer [6.8 g/L of monobasic potassium phosphate and 0.46 g/L of sodium hydroxide in water adjusted, if necessary, with 0.2 N sodium hydroxide TS or hydrochloric acid and water (1.6:98.4) to a pH of 6.5]; 900 mL

Apparatus 2: 50 rpm

Times: 1, 4, 10, and 12 h

Buffer: 2.7 g/L of monobasic potassium phosphate in water. To each liter, add 5 mL of triethylamine and adjust with phosphoric acid, if necessary, to a pH of 4.8.

Mobile phase: Methanol and Buffer (10:90)

Standard stock solution: 0.11 mg/mL of USP Galantamine Hydrobromide RS (equivalent to 0.09 mg/mL of galantamine) in Medium. Sonication may be used to promote dissolution.

Standard solution: (L/900) mg/mL of USP Galantamine Hydrobromide RS from the Standard stock solution in Medium, where L is the label claim of galantamine, in mg/Capsule

Sample solution: Pass a portion of the solution under test through a suitable filter. Replace the portion of solution withdrawn with an equal volume of Medium.

5.4.4 Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 235 nm

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

Column temperature: 40°

 Flow rate: 1.5 mL/min 

Injection volume: 20 µL 

Run time: NLT 2 times the retention time of galantamine 

5.4.5 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 galantamine (C₁₇H₂₁NO₃) in the sample withdrawn from the vessel at each time point (i):

Result_i = (r_U/r_S) × C_S × (M_r1 /M_r2)

r_U = peak response from the Sample solution 

r_S = peak response from the Standard solution 

C_S = concentration of USP Galantamine Hydrobromide RS in the Standard solution (mg/mL) 

M_r1 = molecular weight of galantamine, 287.35 

M_r2 = molecular weight of galantamine hydrobromide, 368.27 

Calculate the percentage of the labeled amount of galantamine (C H NO ) dissolved at each time point (i): 17 21 3

Result₁ = C₁ × V × (1/L) × 100

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

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

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

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

V = volume of Medium, 900 mL

L = label claim (mg/Capsule)

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

Tolerances: See Table 7.

Table 7

The percentage of the labeled amount of galantamine (C₁₇H₂₁NO₃) dissolved at the times specied conforms to Dissolution 〈711〉, Acceptance Table 2.

Uniformity of Dosage Units 〈905〉: Meet the requirements

6 IMPURITIES

Organic Impurities

Solution A: 1.7 g/L of dibasic potassium phosphate and 3.0 g/L of monobasic potassium phosphate in water

Solution B: Acetonitrile

Mobile phase: See Table 8.

Table 8

Diluent: Methanol and Solution A (60:40)

System suitability solution: 0.31 mg/mL of USP Galantamine Hydrobromide Related Compounds Mixture RS in Diluent Standard solution: 1.5 µg/mL of USP Galantamine Hydrobromide RS (equivalent to 1.2 µg/mL of galantamine) in Diluent Sensitivity solution: 0.15 µg/mL of USP Galantamine Hydrobromide RS (equivalent to 0.12 µg/mL of galantamine) from the Standard solution in Diluent

Sample solution: Nominally 240 µg/mL of galantamine from NLT 20 Capsules prepared as follows. Transfer a suitable portion of the contents of NLT 20 Capsules to a suitable volumetric flask, and dilute with Diluent to volume. Sonication and shaking may be used to promote dissolution. Allow the solution to sit for NLT 24 h, and then clarify the solution using a suitable filter of 0.45-µm pore size.

6.1 Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 230 nm

Column: 3.0-mm × 15.0-cm; 5-µm packing L1

Column temperature: 35°

Flow rate: See Table 8.

Injection volume: 10 µL

6.2 System suitability

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

[Note—See Table 9 for relative retention times.]

Suitability requirements

Resolution: NLT 3.4 between galantamine and 6S-galantamine, System suitability solution

Relative standard deviation: NMT 5.0%, Standard solution

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

6.3 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of each degradation product in the portion of Capsules taken:

Result = (r_U /r_S ) × (C_S /C_U ) × (M_r1 /M_r2 ) × 100

r_U = peak response of each degradation product from the Sample solution

r_S = peak response of galantamine from the Standard solution

C_S = concentration of USP Galantamine Hydrobromide RS in the Standard solution (µg/mL)

C_U = nominal concentration of galantamine in the Sample solution (µg/mL)

M_r1 = molecular weight of galantamine, 287.35

M_r2 = molecular weight of galantamine hydrobromide, 368.27

Acceptance criteria: See Table 9. The reporting threshold is 0.05%.

Table 9

^a (4aS,6R,8aS)-3-Methoxy-4a,5,9,10,11,12-hexahydro-6H-benzo[2,3]benzofuro[4,3-cd]azepin-6-ol. 

^b This degradation product may be found if the drug substance is isolated from a natural source. 

^c (4aS,6R,8aS)-6-Hydroxy-3-methoxy-11-methyl-4a,5,9,10,11,12-hexahydro-6H-benzo[2,3]benzofuro[4,3-cd]azepine 11-oxide.

^d(4aS,6R,8aS)-3-Methoxy-11-methyl-4a,5,7,8,9,10,11,12-octahydro-6H-benzo[2,3]benzofuro[4,3-cd]azepin-6-ol. 

^e This is a process impurity and is listed for information only. It is controlled in the drug substance. It is not to be reported and is not to be included in the total degradation products. 

^f (4aS,6S,8aS)-3-Methoxy-11-methyl-4a,5,9,10,11,12-hexahydro-6H-benzo[2,3]benzofuro[4,3-cd]azepin-6-ol. 

^g (4aS,8aS)-3-Methoxy-11-methyl-9,10,11,12-tetrahydro-4aH-benzo[2,3]benzofuro[4,3-cd]azepine. 

7 ADDITIONAL REQUIREMENTS 

Packaging and Storage: Preserve in tight, light-resistant containers, and store at controlled room temperature. 

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

Change to read: 

USP Reference Standards 〈11〉 

USP Galantamine Hydrobromide RS 

USP Galantamine Hydrobromide Related Compounds Mixture RS 

Contains a mixture of the following ve compounds: 

Galantamine hydrobromide. 

Galantamine N-oxide; 

(4aS,6R,8aS)-6-Hydroxy-3-methoxy-11-methyl-4a,5,9,10,11,12-hexahydro-6H-benzo[2,3]benzofuro[4,3-cd]azepine 11-oxide.

C₁₇H₂₁NO₄            303.35 

Dihydrogalantamine; 

(4aS,6R,8aS)-3-Methoxy-11-methyl-4a,5,7,8,9,10,11,12-octahydro-6H-benzo[2,3]benzofuro[4,3-cd]azepin-6-ol.

C₁₇H₂₃NO₃           289.37  

6S-Galantamine; 

(4aS,6S,8aS)-3-Methoxy-11-methyl-4a,5,9,10,11,12-hexahydro-6H-benzo[2,3]benzofuro[4,3-cd]azepin-6-ol.

C₁₇H₂₁NO₃         287.35  

Anhydrogalantamine; 

(4aS,8aS)-3-Methoxy-11-methyl-9,10,11,12-tetrahydro-4aH-benzo[2,3]benzofuro[4,3-cd]azepine.

C₁₇H₁₉NO₂      269.34 _{(ERR 1-Nov 2020)}

[Note—The contents have previously been referred to as galantamine hydrobromide, 6β-hexahydrogalantamine, 6β-octahydrogalantamine, 6α hexahydrogalantamine, and tetrahydrogalantamine, respectively.]