Subcategory & Sub-subcategory
Product Name
Ampicillin Injection
Specifications
- CAS Number: 69-53-4
- Molecular Weight: 349.4
- Chemical Formula: C16H19N3O4S
- Purity: Complies with pharmacopeial or in-house purity specification, confirmed per batch by validated analytical methods (e.g., HPLC) and documented in the Certificate of Analysis.
- IUPAC Name: (2S,5R,6R)-6-[[(2R)-2-amino-2-phenylacetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid
- EC Number: 200-709-7
- Assay: Assay content determined by a validated HPLC or titrimetric method and reported on an as-is or anhydrous basis in the Certificate of Analysis.
- Impurity Profile: Individual and total related-substance impurities are controlled and reported in line with ICH Q3A/Q3B guidance, as documented in the Certificate of Analysis.
- Loss on Drying: Loss on drying is determined by the relevant pharmacopeial method (e.g., USP/Ph. Eur.); the batch-specific result is reported in the Certificate of Analysis.
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