Omeprazole USP Pyrazines Test Specification Min Max PURITY

Test Specification Min Max PURITY (GC) 98% 98% PURITY (Neutralization titration) 98% 98% SPECIFIC GRAVITY (20/20) 1

HAZE-FREE MELTING RANGE 184 - 188 C 184 - 188 C ARSENIC (As) 0

010 SOLUBILITY IN WATER TO PASS TEST TO PASS TEST RETEST DATE

Test Specification Min Max PURITY (GC) 70

Test Specification Min Max ASSAY (as EUCALYPTOL: C[@10@]H[@18@]O) 70

Omeprazole USP Pyrazines Test Specification Min Max PURITYTest Specification Min Max ASSAY (DRIED BASIS) 98 102. 00% COMPLETENESS OF SOLUTION TO PASS TEST TO PASS TEST LIMIT OF OMEPRAZOLE RELATED COMPOUNDS F AND G 350 PPM LOSS ON DRYING 0. 50% RESIDUE ON IGNITION 0. 10% ELEMENTAL IMPURITIES AS REPORTED AS REPORTED ORGANIC IMPURITIES TO PASS TEST TO PASS TEST IDENTIFICATION TO PASS TEST TO PASS TEST EXPIRATION DATE DATE OF MANUFACTURE APPEARANCE RESIDUAL SOLVENTS TO PASS TEST TO PASS TEST