Subcategory & Sub-subcategory
Product Name
Omeprazole Pellets
Specifications
- CAS Number: 73590-58-6
- EC Number: 277-731-7
- Molecular Weight: 345.42
- Chemical Formula: C17H19N3O3S
- IUPAC Name:
- Assay: Assay (HPLC): 90.0–110.0% of the labeled strength of omeprazole in the enteric-coated pellets on the anhydrous/dried basis, meeting the applicable pharmacopoeial monograph limit.
- Particle Size: Particle size distribution: pellet core size distribution controlled to ensure uniform enteric coating thickness (typical 0.7–1.2 mm), controlled by laser diffraction to support consistent dissolution/micronization performance.
- Impurity Profile: Individual unspecified impurities ≤ 0.10% and total impurities ≤ 0.5%, for use in encapsulated finished products treating ulcers, GERD and Zollinger-Ellison syndrome, controlled by validated HPLC/UPLC methods.
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