Published on USP Medicines Compendium (https://)
Esomeprazole for Injection
For Comment Version 0.2
DEFINITION Esomeprazole for Injection contains an amount of esomeprazole sodium (C17H19N3NaO3S) equivalent to NLT 95.0% and NMT 105.0% of the labeled amount of esomeprazole (C17H19N3O3S).
rU = response of each impurity in the Sample solution rS = response of each appropriate USP Impurity RS from the Standard solution. [Note—If no USP Impurity RSs are available, use the response of esomeprazole.] CS = concentration of standard material in the Standard solution esomeprazole sodium in the Sample solution CU = nominal concentration of esomeprazole sodium in the Sample solution Acceptance criteria Any individual impurity: NMT 0.2%
Analysis Samples: Standard solution and Sample solution Calculate the percentage of the labeled amount of esomeprazole (C17H19N3O3S) in the Sample solution:
IMPURITIES • ELEMENTAL IMPURITIES <232>: Proceed as directed in the chapter. • RESIDUAL SOLVENTS <467>: Proceed as directed in the chapter.
• ORGANIC IMPURITIES Standard solution: USP Esomeprazole Sodium CRM and all appropriate USP Impurity RSs, at concentrations corresponding to the Acceptance criteria of the impurity, in an appropriate diluent Sample solution: Dilute a portion of constituted Injection in an appropriate diluent to obtain a concentration approximately the same as that of the Standard solution. Analytical system: Use a procedure validated as described in MC general chapter Assessing Validation Parameters for Reference and Acceptable Procedures <10>.
SPECIFIC TESTS • BACTERIAL ENDOTOXINS TEST <85>: Proceed as directed in the chapter.
• INJECTIONS <1>: Proceed as directed in the chapter.
ADDITIONAL REQUIREMENTS • REFERENCE STANDARDS <11>
1,3-Dimethyl-9-methoxy-12-thioxopyrido[1’,2’:3,4] imidazo[1,2-a] benzimidazol-2(12H)-one. USP Omeprazole Impurity I RS
Omeprazole sulfone N-oxide, 4-methoxy-2-[[(5-methoxy-1H-benzimidazol-2-yl)sulphonyl]methyl]-3,5-dimethylpyridine 1-oxide. USP R-Omeprazole RS
Table 1
Time (min)
Solution A (%)
Solution B (%)
0
60
40
30
45
55
35
30
70
45
30
70
47
60
40
50
60
40
System suitability solution: 0.01 mg/mL each of USP Esomeprazole Sodium CRM and USP Omeprazole Impurity A RS in methanol Standard solution: 0.2 mg/mL of USP Esomeprazole Sodium CRM in methanol Sample solution: Constitute the content of the vial in methanol, and dilute quantitatively with methanol to obtain a nominal esomeprazole concentration of 0.2 mg/mL. Chromatographic system
5-Methoxy-2-[(R)-[(4-methoxy-3,5-dimethyl-2-pyridyl)methyl]sulfinyl]-1H-benzimidazole.
REFERENCE PROCEDURES (This section provides detailed descriptions of procedures that may be used for the evaluation of the material under test. These procedures have been fully validated, and the data is available on the MC website.)
Mr1 = molecular weight of esomeprazole, 345.42 Mr2 = molecular weight of esomeprazole sodium, 368.41 Acceptance criteria: 95.0%–105.0%
PERFORMANCE TESTS • UNIFORMITY OFrequirements
Omeprazole N-oxide, 4-methoxy-2-[[(RS)-(5-methoxy-1H-benzimidazol-2-yl)sulphinyl]methyl]-3,5-dimethylpyridine 1-oxide. USP Omeprazole Impurity F RS
1,3-Dimethyl-8-methoxy-12-thioxopyrido[1’,2’:3,4] imidazo[1,2-a] benzimidazol-2(12H)-one. USP Omeprazole Impurity G RS
Result = (rU/rS) × (CS/CU) × (Mr1/Mr2) × 100
rU = response from the Sample solution rS = response from the Standard solution CS = concentration of USP Esomeprazole Sodium CRM in the Standard solution CU = nominal concentration of esomeprazole in the Sample solution
Standard solution: USP Esomeprazole Sodium CRM in an appropriate diluent Sample solution: Dilute a portion of constituted Injection in an appropriate diluent to obtain a concentration approximately the same as that of the Standard solution. Analytical system: Use a procedure validated as described in MC general chapter Assessing Validation Parameters for Reference and Acceptable Procedures <10>.
System performance requirements Precision: Meets the requirements for 98.0%–102.0% Accuracy: Meets the requirements for 98.0%–102.0% Specificity: Meets the requirements Range: Meets the requirements
USP Esomeprazole Sodium CRM USP Omeprazole Impurity A RS
Omeprazole sulfone, 5-methoxy-2-[[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfonyl]-1H-benzimidazole. USP Omeprazole Impurity E RS