Esomeprazole Magnesium Delayed-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

Esomeprazole Magnesium Delayed-Release Capsules contain an amount of Esomeprazole Magnesium equivalent to NLT 90.0% and NMT 110.0% of the labeled amount of esomeprazole (C₁₇H₁₉N₃O₃S)

2 IDENTIFICATION

A.

Buffer: Prepare a pH 6.0 phosphate buffer containing 26.6 g/L of dibasic sodium phosphate dibydrate and 55.2 g/L of monobasic sodium phosphate monohydrate in water.

Diluent: Prepare a pH 11.0 diluent as follows. Dissolve 5.24 g of tribasic sodium phosphate dodecahydrate in water. Add 110 mL of 0.5 M dibasic sodium phosphate solution, and dilute with water to 1000 mL.

Mobile phase: Transfer 150 mL of acetonitrile and 85 ml. of the Buffer to a 1000-ml volumetric flask, and dilute with water to volume.

Standard stock solution: Prepare a solution containing 0.2 mg/mL of USP Omeprazole RS by dissolving a suitable amount first in alcohol, using 20% of the final volume, and then diluting with Diluent to volume.

Standard solution: 0.02 mg/mL of USP Omeprazole RS from the Standard stock solution in water

Sample stock solution: Transfer a portion of the Capsule content, equivalent to 20 mg of esomeprazole, to a 200-ml volumetric flask, add 120 mL of Diluent, and shake for 20 min to dissolve the pellets. Sonicate for a few min, if needed, to completely dissolve. Add 40 ml of alcohol, and sonicate for a few min. Cool, and dilute with Diluent to volume. Pass a portion of the solution through a filter of 1-um pore size.

Sample solution: 0.01 mg/ml, of esomeprazole from the Sample stock solution in water

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 302 nm

Column: 4.0-mm × 10-cm; 5-μm packing L41

Flow rate: 1 mL/min

Injection size: 20 μL

System suitability

Sample: Standard solution

Nors-The elution order is the R-enantiomer, followed by the esomeprazole peak, which is the S-enantiomer.)

Suitability requirements

Resolution: NLT 1.0 between the enantiomer peaks

Analysis

Samples: Standard solution and Sample solution

Calculate the ratio of the retention times of the esomeprazole peak in the Standard solution and the Sample solution

Result = (t_u/t_s)

t_u = retention time of esomeprazole from the Sample solution

t_s = retention time of esomeprazole from the Standard solution

Acceptance criteria: 0.98-1.02

3 ASSAY

PROCEDURE

Buffer: Prepare a phi 7.3 phosphate buffer by mixing 10.5 mL of 1.0 M monobasic.sodium phosphate buffer and 60 mL of 0.5 M dibasic

sodium phosphate buffer, and diluting with water to 1000 ml

Diluent: Prepare as directed in Identification test A.

Mobile phase: Mix 350 ml of acetonitrile and 500 ml of the Buffer. Dilute with water to 1000 mL.

Standard solution: Transfer 10 mg of USP Omeprazole RS to a 250-mL volumetric flask, and dissolve in about 10 mL of alcohol. Add 40 ml. of Diluent, and dilute with water to volume. This solution contains 0.04 mg/mL of USP. Omeprazole RS.

Sample stock solution: Mix the contents of NLT 20 Capsules. Transfer a portion of the Capsule content, equivalent to 20 mg of esomeprazole, to a 100 ml volumetric flask, add 60 mL of Diluent, and shake for 20 min to dissolve the pellets. Sonicate for a few min, if needed, to completely dissolve. Add 20 mL of alcohol, and sonicate for a few min. Cool, and dilute with Diluent to volume. Pass a portion of the solution through a filter of 1-um pore size

Sample solution: 0.04 mg/mL of esomeprazole from the Sample stock solution in water. Store this solution protected from light.

Chromatographic system

(See Chromatography (621), System Suitability)

Mode: LC

Detector: UV 302 nm

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

Flow rate: 1 mL/min

Injection size: 20 μL

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 esomeprazole (C₁₇H₁₉N₃O₃S) in the portion of the Capsules taken:

Result = (r_U/(r_S) × (C_S /C_U) x 100

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution

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

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

Acceptance criteria: 90.0%-110.0%

4 PERFORMANCE TESTS

Change to read:

DISSOLUTION (711)

Test 1

Medium: 01. N hydrochloric acid, 300 mL. After 2 h, continue with a pH 5.8 phosphate buffer as follows. To the vessel, add 700 mL of 0.086

M dibasic sodium phosphate, and adjust with 2. N hydrochloric acid or 2 N sodium hydroxide, if necessary, to a pH of 6.8 ±0.05.

Apparatus 2: 100 rpm

Time: 30 min in a pH 6.8 phosphate buffer

Standard solution: Prepare a solution containing 2 mg/ml of USP Omeprazole RS in alcohol. Dilute this solution with pH 6.8 phosphate buffer to obtain a solution containing (L/1000) mg/ml, where L is the label claim, in mg/Capsule. Immediately add 2.0 ml of 0.25 M sodium hydroxide to 10.0 ml, of this solution, and mix. [Nore-Do not allow the solution to stand before adding the sodium hydroxide solution]

Sample solution: After 30 min in pH 6.8 phosphate buffer, pass a portion of the solution under test through a suitable filter. Transfer 5.0 mL of the filtrate to a suitable glassware containing 1.0 mL of 0.25 M sodium hydroxide. Mix well. Protect from light.

Buffer, Mobile phase, System suitability, and Chromatographic system: Proceed as directed in the Assay.

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of esomeprazole (C, H, N,O,S) dissolved:

Result = (r_U/(r_S) × (C_S /L) × V × 100

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution

C_S = concentration of the Standard solution (mg/mL)

L = label claim (mg/Capsule)

V = volume of Medium, 1000 mL

Tolerances: NLT 75% (0) of the labeled amount of esomeprazole (C₁₇H₁₉N₃O₃S) is dissolved.

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

Acid resistance stage

Acid stage medium: 0.1 N hydrochloric acid: 300 ml

Apparatus 2: 100 rpm. Use a suitable sinker, if necessary 

Time: 2 h

Solution A: Prepare a 0.05 M ammonium acetate buffer pH 7.6 as follows. Dissolve 3.85 g of ammonium acetate in 1000 ml, of water and adjust with a diluted ammonia solution to a pH of 7.6.

Solution B: Use acetonitrile

Mobile phase: See Table 1. Return to original conditions and re-equilibrate the system for 5 min.

Diluent: Dissolve 7.6 g of sodium borate in about 800 ml, of water. Add 1.0 g of edetate disodium, and adjust with 50% sodium hydroxide solution to a pH of 11 plus/minus 0.1 Transfer the solution to a 2000-ml, volumetric flask, add 400 ml, of dehydrated alcohol, and dilute with water to volume.

Standard solution: 0.12 mg/mL of USP Omeprazole RS in Diluent, using sonication at a temperature between between 10° and 15° to dissolve. Protect this solution from light.

Sample solution: After 2 h, drain the Acid stage medium from each vessel and carefully transfer the pellets into a suitable volumetric flask (use a 100-ml flask for 20-mg Capsules and a 200-ml flask for 40-mg Capsules). Add Diluent to about 70% of the final volume, and sonicate at a temperature between 10 deg and 15 deg | for about 20 min with intermittent shaking. Allow to cool, dilute with Diluent to volume, mix, and pass through a PVDF or other suitable filter of 0.45-um or finer pore size. Further dilute 5 ml of this solution with Diluent to 10 mL. Protect this solution from light.

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 302 nm

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

Column temperature: 30°

Flow rate: 1.5 mL/min

Injection volume: 20 μL

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 percentage, 7, of the labeled amount of esomeprazole (C₁₇H₁₉N₃O₃S) retained:

Result = (r_U/(r_S) × C_S x D x (1/L) x 100

r_U = peak response of esomeprazole from the Sample solution

r_S = peak response of omeprazole from the Standard solution

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

D = dilution factor used in preparing the Sample solution

L = label claim (mg/Capsule)

Calculate the percentage of the labeled amount of esomeprazole (C₁₇H₁₉N₃O₃S) r dissolved:

Result = A − T

A = esomeprazole content as a percentage of the labeled amount, as determined in the Assay

T = percentage of the labeled amount of esomeprazole retained, as determined above

[Note-If T is greater than A, then consider the result to be zero.]

Tolerances: NMT 10% of the labeled amount of esomeprazole (C₁₇H₁₉N₃O₃S) is dissolved.

Buffer stage

Buffer stage medium: pH 6.8 phosphate buffer. Proceed as directed in Acid resistance stage with a new set of Capsules. After 2 h with Acid stage medium, continue with a pH 6.8 phosphate buffer as follows. To the vessel, add 700 mL of 0.086 M dibasic sodium phosphate, and adjust with 2 N hydrochloric acid or 2 N sodium hydroxide, if necessary, to a pH of 6.8 ±0.05.

Apparatus 2: 100 rpm. Use a suitable sinker, if necessary 

Time: 30 min

Solution A: Prepare a 0.05 M ammonium acetate buffer pH 7.6 as follows. Dissolve 3.85 g of ammonium acetate in 1000 ml of water. and adjust with a diluted ammonia solution to a pH of 7.6 ±0.05.

Mobile phase: Acetonitrile and Solution A (27:73)

Diluent: 0.086 M dibasic sodium phosphate buffer and 0.1 N hydrochloric acid (70:30). Adjust with 2 N hydrochloric acid or 2. N. sodium hydroxide, if necessary, to a pH of 6.8 ±0.05.

Standard stock solution: Prepare a solution containing 0.4 mg/ml. of USP Omeprazole RS as follows. Dissolve first in alcohol, using 10% of the final volume, and then dilute with Diluent to volume. Protect this solution from light.

Standard solution: Dilute the Standard stock solution with Diluent to obtain a solution containing (1/1000) mg/ml, where L is the label claim, in mg/Capsule. Immediately transfer 10 ml, of this solution to a test tube containing 2.0 mL of 0.25 M sodium hydroxide, and mix. Protect this solution from light

Sample solution: After 30 min, pass a portion of the solution under test through a PVDF or other suitable filter of 0.45-um pore size. Immediately transfer 5.0 mL of the filtrate to a test tube containing 1.0 mL of 0.25 M sodium hydroxide. Mix well. Protect this solution from light.

Chromatographic system: Proceed as directed in Acid resistance stage, except use a flow rate of 1.0 ml/min. ICIA

System suitability

Sample: Standard solution

Suitability requirements

Tailing factor: NMT 20

Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of esomeprazole (C₁₇H₁₉N₃O₃S) dissolved.

Result = (r_U/(r_S) × (C_S /L) × D x V × 100

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution

C_S = concentration of the Standard solution (mg/mL)

L = label claim (mg/Capsule)

D = dilution factor used in preparing the Sample solution

V = volume of Medium, 1000 mL

Tolerances: NLT 80% (Q) of the labeled amount of esomeprazole (C₁₇H₁₉N₃O₃S) is dissolved.

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

[NOTE-Use only glass bowls.]

Acid resistance stage

Acid stage medium: 0.1. N hydrochloric acid; 300 mL

Apparatus 2: 100 rpm (Acid stage medium)

Time: 2 h

Buffer: Prepare a 25 mM potassium phosphate buffer pH 8.0 as follows. Dissolve 3.4 g of monobasic potassium phosphate in 1000 ml of water, add 8.0 ml of triethylamine, and adjust with phosphoric acid to a pH of 8.0.

Solution A: Buffer: methanol (90:10)

Solution B: Acetonitrile: methanol (50:50)

Mobile phase: See Table 2.

Diluent 1: 0.3 N sodium hydroxide: methanol (10:90)

Diluent 2: 01 N sodium hydroxide: methanol (75:25)

[NOTE-Protect all standard and sample solutions from light.]

Standard stock solution: 0.4 mg/mL of USP Omeprazole RS prepared as follows. Dissolve a suitable amount of USP Omeprazole RS in a suitable volumetric flask containing 30% volume of 0.3 N sodium hydroxide, sonicate as needed to dissolve, and dilute to volume with Diluent 1.

Standard solution: Dilute the Standard stock solution with Diluent 2 to obtain a solution containing (L / 500) * mg / m * L where L is the label claim, in mg/Capsule

Sample solution: After 2 h, drain the Acid stage medium from each vessel carefully without losing any pellet. Add 250 ml. of 0.25 N sodium hydroxide to each vessel and run the dissolution apparatus at 200 rpm for 30 min or until the pellet is completely dissolved. Centrifuge a portion of this solution at 3000 rpm for 10 min. Transfer 5.0 ml of this solution to a 10-mL volumetric flask and dilute to volume with Diluent 2.

Chromatographic system

(See Chromatography (621) System Suitability)

Mode: LC

Detector: UV 305 nm

Column: 4.6-mm × 20-mm; 5-μm packing L1

[Note—A suitable L1 guard column may be used.]

Column temperature: 30°

Flow rate: 1.2 mL/min

Injection volume: 10 μL

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 percentage, T, of the labeled amount of esomeprazole (C₁₇H₁₉N₃O₃S) retained:

Result = (r_U/(r_S) × C_S x D x (1/L) x V x 100

r_U = peak response of esomeprazole from the Sample solution

r_S = peak response of omeprazole from the Standard solution

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

D = dilution factor used in preparing the Sample solution

L = label claim (mg/Capsule)

V = volume of 0.25 N sodium hydroxide, 250 mL

Calculate the percentage of the labeled amount of esomeprazole (C₁₇H₁₉N₃O₃S) dissolved:

Result = A − T

A = esomeprazole content as a percentage of the labeled amount, as determined in the Assay

T = percentage of the labeled amount of esomeprazole retained, as determined above

[Note—If T is greater than A, then consider the result to be zero.]

Tolerances: NMT 10% of the labeled amount of esomeprazole (C₁₇H₁₉N₃O₃S) is dissolved.

Buffer stage

Buffer stock solution: Prepare a 76 g/L solution of sodium phosphate tribasic in water

Buffer stage medium: 0.1 N hydrochloric acid: Buffer stock solution (3:1). Adjust with 1 N hydrochloric acid or 1 N sodium hydroxide, if necessary, to pH 6.8.

Apparatus 2: 100 rpm

Time: 30 min

Standard solution: Dilute the Standard stock solution with Buffer stage medium to obtain a solution containing (L/1000) mg/ml, where L. is the label claim, in mg/Capsule. Immediately transfer 5 mL of this solution to a test tube containing 1.0 mL of 0.25 N sodium hydroxide. and mix

Sample solution: Proceed as directed in Acid resistance stage with a new set of Capsules. After 2 h with Acid stage medium, continue with Buffer stage medium as follows. Completely drain the vessel of Acid stage medium carefully without losing any pellet. Add 1000 ml of preheated Buffer stage medium to each vessel. After 30 min, pass a portion of the solution under test through a full flow or other suitable filter of 10-um pore size. Immediately transfer 5 ml, of the filtrate to a test tube containing 1 ml of 0.25 N sodium hydroxide. and mix.

Chromatographic system: Proceed as directed in Acid resistance stage, except use Injection volume of 20 µL

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 percentage of the labeled amount of esomeprazole (C H N O S) dissolved:

Result = (r_U/(r_S) × C_S x D x (1/L) x 100

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution

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

D = dilution factor used in preparing the Sample solution

L = label claim (mg/Capsule)

V = volume of Buffer stage medium, 1000 mL

Tolerances: NLT 75% (Q) of the labeled amount of esomeprazole (C H N O S) is dissolved.

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

Acid resistance stage

Acid stage medium: 0.1 N hydrochloric acid, 300 mL

Apparatus 2: 100 rpm

Time: 2 h

Buffer: 2.72 g/L of monobasic potassium phosphate in water. Adjust with 50% potassium hydroxide or 20% phosphoric acid TS to a pH of 8.0.

Solution A: Buffer and acetonitrile (85:15)

Solution B: Acetonitrile

Mobile phase: See Table 3.

Diluent: 10 mM sodium borate and 1.3 mM edetate disodium as follows. Transfer 7.6 g of sodium borate to a 2-L volumetric flask and dissolve in 800 ml of water. Add 1.0 g of edetate disodium, and adjust with 50% sodium hydroxide or acetic acid to a pH of 11.0 ±0.1. Add 400 ml. of Ethanol, and dilute to volume with water

Standard solution: 0.23 mg/ml, of USP Esomeprazole Magnesium RS as follows. Transfer 23 mg of USP Esomeprazole Magnesium. RS to a 100-ml volumetric flask containing approximately 80 ml. of Diluent and sonicate with intermittent vigorous shaking until dissolved. Dilute with Diluent to volume.

Sample solution: After 2 h, drain the Acid stage mediurn from each vessel and carefully transfer the pellets into a suitable volumetric flask (use a 100-mi, flask for 20-mg Capsules and a 200-mL flask for 40-mg Capsules). Add Diluent to about 80% of the final volume, stir for NLT 2 h and NMT 3 h, and dilute with Diluent to volume. Mix by inverting the flask and shaking multiple times. Pass a portion of the Sample solution through a suitable filter of 0.2-um pore size and discard the first few milliliters..

Chromatographic system

(See Chromatography (621). Sostem. Suitability)

Mode: LC

Detector: UV 305 nm

Column: 4.6-mm x 15-cm, 5 µm packing L1

Temperatures

Autosampler: 5

Column: 30

Flow rate: 1.2 mL/min

Injection volume: 15 µL

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage, T, of the labeled amount of esomeprazole (C₁₇H₁₉N₃O₃S) retained:

Result = (r_U/(r_S) × C_S x (1/L) x V x (M_r1 /M_r2) x 100

r_U = peak response of esomeprazole from the Sample solution

r_S = peak response of omeprazole from the Standard solution

C_S = concentration of USP Esomeprazole Magnesium RS in the Standard solution (mg/mL)mL)

L = label claim (mg/Capsule)

V = volume of the Sample solution, 100 mL (20-mg Capsules) and 200 mL (40-mg Capsules)

M_r1 = molecular weight of esomeprazole, 690.84

M_r2 = molecular weight of esomeprazole magnesium trihydrate, 767.17

Calculate the percentage of the labeled amount of esomeprazole (C₁₇H₁₉N₃O₃S) dissolved:

Result = A − T

A = esomeprazole content as a percentage of the labeled amount of esomeprazole, as determined in the Assay

T = percentage of the labeled amount of esomeprazole retained, as determined above

[Note—If T is greater than A, then consider the result to be zero.]

Tolerances: NMT 10% of the labeled amount of esomeprazole (C H N O S) is dissolved.

Buffer stage

Buffer: 23.1 g/L of dibasic sodium phosphate in water

Buffer stage medium: 0.1 N hydrochloric acid and Buffer (30:70), Adjust with 2. N hydrochloric acid or 2. N sodium hydroxide to a pH of 6.8, if necessary, 1000 mL

Apparatus 2: 100 rpm

Time: 45 min

Solution A: Combine 10.5 mL of 1.0 M monobasic sodium phosphate and 60 mL of 0.5 M dibasic sodium phosphate in a 1-L volumetric flask, and dilute to volume with water. Adjust with 2. N sodium hydroxide or phosphoric acid to a pH of 7.3, if necessary.

Mobile phase: Solution A, acetonitrile, and water (50:35:15)

Diluent: 5.24 g/l, of tribasic sodium phosphate in 110 ml, of 0.5 M dibasic sodium phosphate and diluted with water to volume. Adjust with 2. N sodium hydroxide or phosphoric acid to a pH of 11.0, if necessary.

System suitability solution: 0.04 mg/mL of USP Omeprazole RS prepared as follows. Transfer 10 mg of USP Omeprazole RS to a 250-ml volumetric flask containing 10 ml of methanol, add 40 ml of Diluent, and dilute with water to volume.

Standard stock solution: 2 mg/mL of USP Omeprazole RS in ethanol

Standard solution: Dilute the Standard stock solution to obtain a solution containing (L/1000 mg/mL), where L is the label claim, in mg/Capsule, with Buffer stage medium. Immediately transfer 10 ml, of this solution to a test tube containing 2 ml of 0.25 M sodium hydroxide

Sample solution: Prepare by placing a new set of Capsules in vessels containing 300 ml of Acid stage medium. After 2 h with Acid stage medium, add 700 mL of Buffer to each vessel and adjust with 2 N hydrochloric acid or 2 N sodium hydroxide to a pH of 6.8. After 45 min immediately withdraw a suitable amount of solution from each vessel and pass through a suitable filter 0.45 µm pore size. Pass the filtrate through a suitable filter of 0.2-um pore size. Transfer 5 mL of the filtrate to a suitable container containing 1 mL of 0.25 M sodium hydroxide.

Chromatographic system

(See Chromatography (6211 Systern Suitability)

Mode: LC

Detector: UV 302 nm

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

Flow rate: 1 mL/min

Injection volume: 20 µL

System suitability

Sample: System suitability solution

Suitability requirements

Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of esomeprazole (C₁₇H₁₉N₃O₃S) dissolved:

Result = (r_U/(r_S) × C_s x (1/L) x V x 100

r_U = peak response of esomeprazole from the Sample solution

r_S = peak response of omeprazole from the Standard solution

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

L = label claim (mg/Capsule)

V = volume of the Buffer stage medium, 1000 mL

Tolerances: NLT 75% (Q) of the labeled amount of esomeprazole (C₁₇H₁₉N₃O₃S) is dissolved.

Uniformity of Dosage Units 〈905〉: Meet the requirements

5 IMPURITIES

ORGANIC INPURITIES

Buffer: Prepare a pH 7.6 phosphate buffer by mixing 5.2 ml. of 1.0 M monobasic sodium phosphate buffer and 63 mL of 0.5 M dibasic sodium phosphate buffer, and diluting with water to 1000 ml.

Solution A: Mix 100 mL of acetonitrile and 100 mL of the Buffer. Dilute with water to 1000 mL

Solution B: Mix 800 ml, of acetonitrile and 10 ml of the Buffer. Dilute with water to 1000 mL

Mobile phase: See Table 4

Diluent: Prepare as directed in identification test A

System suitability stock solution: 1 mg/ml wach of LSP Omeprazole Fis and USF Drowarazione lelated Compound A RS in methans

System suitability solution: 1 ugim each of USE Omeprazole 85 and USP Omeprazole Related Compound. ARS from System suitability stock solution, in a mixture of Diluent and (1:4)

Sample solution: Transfer a portion of the powdered pellets (about 30-90 mg) from the Capsule content, to a 200-mi volumetric flask, add 20 ml of methanol, and shake for 30 s. Add 40 ml of Dilvent, shake for 30 s by frand, and annicate for a few min. Cool, and dilute with wat to volume. Pass a portion of the solution through a filter of 0.45-um pore size. (Nors-The solution is stable for 3 h if stoned protected from ght

Chromatographic system

(See Cheumatograuly (21) System Sullah)

Mode: LC

Detector: LV 382 nm

Column: 45mm 10-cm um packing 11

Flow rate: 1 mL/m

Injection size: 20

System suitability

Sample: System multability solution

Note-Bes Tab 5 for the relative retention times

Suitability requirements

Resahrtion: NLT 2.5 between omeprazole related compound A and omeprazole

Analysis

Sample: Sample solution

Calculate the percentage of any individual impurity in the portion of the Capsules taken:

peak response for each impurity

Result = (r_U/(r_S) x 100

r_U = peak response for each impurity

r_S = sum of all peak responses

Acceptance criteria: See Table 5.

^a Omeprazole related compound A

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight containers. Store at room temperature.

Labeling: When more than one Dissolution test is given, the labeling states the Dissolution test used only if Test 1 is not used.