Omeprazole Pellets

CAS number: 73590-58-6

Molecular formula: C17H19N3O3S

molecular weight: 345.42 g/mol

Chemical structure:

TESTSSPECIFICATIONRESULT
DescriptionWhite to off - white spherical pellets.White spherical pellets
IdentificationPositive for OmeprazoleComplies
Moisture content by KFNot more than 5.0%1.54%
Bulk DensityBetween 0.70 & 0.90 gm/ml0.85 gm/ml
Particle sizeNot less than 10% retain on 12 # & Not more than 10% pass   through 16 # (ASTM)Complies
Dissolution
a) Acid Resistance stage: In 0.1 NHCLa) Not more than 10.0% of the labeled amount of Omeprazole is   dissolved in 2 hrs1.84%
b) Buffer Stage: In Phosphate buffer of 6.8 Phb) Not less than 80.0%(Q) of the labeled amount of Omeprazole is   dissolved in 30 minutes.90.89%
ASSAYNLT 90.0% and NMT 110.0% of label claim100.82% -8.57%