Subcategory & Sub-subcategory
Product Name
Nalbuphine Hydrochloride
Specifications
- EC Number: 245-549-9
- Chemical Formula: C21H28ClNO4
- CAS Number: 23277-43-2
- IUPAC Name: (4R,4aS,7S,7aR,12bS)-3-(cyclobutylmethyl)-1,2,4,5,6,7,7a,13-octahydro-4,12-methanobenzofuro[3,2-e]isoquinoline-4a,7,9-triol;hydrochloride
- Molecular Weight: 393.9
- Assay: Complies with pharmacopoeial or in-house specification; active substance content typically ≥98.0% w/w by validated HPLC assay, confirmed batch-by-batch by Certificate of Analysis.
- Impurity Profile: Related substances and process impurities controlled within ICH Q3A/Q3B limits (each unspecified impurity ≤0.10%, total impurities ≤0.5%), verified by a validated stability-indicating HPLC method.
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