CAS number: 73590-58-6
Molecular formula: C17H19N3O3S
molecular weight: 345.42 g/mol
Chemical structure:
TESTS | SPECIFICATION | RESULT | |||||
Description | White to off - white spherical pellets. | White spherical pellets | |||||
Identification | Positive for Omeprazole | Complies | |||||
Moisture content by KF | Not more than 5.0% | 1.54% | |||||
Bulk Density | Between 0.70 & 0.90 gm/ml | 0.85 gm/ml | |||||
Particle size | Not less than 10% retain on 12 # & Not more than 10% pass through 16 # (ASTM) | Complies | |||||
Dissolution | |||||||
a) Acid Resistance stage: In 0.1 NHCL | a) Not more than 10.0% of the labeled amount of Omeprazole is dissolved in 2 hrs | 1.84% | |||||
b) Buffer Stage: In Phosphate buffer of 6.8 Ph | b) Not less than 80.0%(Q) of the labeled amount of Omeprazole is dissolved in 30 minutes. | 90.89% | |||||
ASSAY | NLT 90.0% and NMT 110.0% of label claim | 100.82% (-8.57%) | |||||