Subcategory & Sub-subcategory
Product Name
AMOROLFINE HCl
Specifications
- CAS Number: 78613-38-4
- Molecular Weight: 354
- Chemical Formula: C21H36ClNO
- 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: (2R,6S)-2,6-dimethyl-4-[2-methyl-3-[4-(2-methylbutan-2-yl)phenyl]propyl]morpholine;hydrochloride
- EC Number: 689-236-9
- 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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