Bharat Sterile Pvt Ltd sell "Omeprazole Sodium Sterile (Lyophilized)"
Basic Information
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Category
Subcategory & Sub-subcategory
Trade Type
Sell
Service Name
Omeprazole Sodium Sterile (Lyophilized)
Service Provider(s)
Specifications
- Assay: Assay (HPLC): 90.0–110.0% of the labeled strength of omeprazole sodium (lyophilized sterile powder for IV injection) on the anhydrous/dried basis, meeting the applicable pharmacopoeial monograph limit.
- Clarity of Solution: Solution is clear and practically free from particulate matter, clear reconstituted solution, free from visible particulate matter, suitable for intravenous administration, assessed visually against pharmacopoeial clarity standards.
- Color of Solution: Solution color does not exceed the reference color standard (colorless to pale yellow reconstituted solution typical of lyophilized omeprazole sodium), verified by comparison with pharmacopoeial reference solutions.
- Impurity Profile: Individual unspecified impurities ≤ 0.10% and total impurities ≤ 0.5%, per Bharat Sterile Private Limited's pharmacopoeial-compliant release testing, controlled by validated HPLC/UPLC methods.
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