Sichuan Qingmu Pharmaceutical Co., Ltd sell "Apalutamide"
Basic Information
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Category
Subcategory & Sub-subcategory
Trade Type
Sell
Product Name
Apalutamide
Details
Substance
Manufacturer(s)
Specifications
- CAS Number: 956104-40-8
- Molecular Weight: 477.4
- Chemical Formula: C21H15F4N5O2S
- 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: 4-[7-[6-cyano-5-(trifluoromethyl)-3-pyridinyl]-8-oxo-6-sulfanylidene-5,7-diazaspiro[3.4]octan-5-yl]-2-fluoro-N-methylbenzamide
- EC Number: 807-449-9
- 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.
Other Information
Additional Description:
An active pharmaceutical ingredient with the chemical name 4-[7-[6-cyano-5-(trifluoromethyl)pyridin-3-yl]-8-oxo-6-sulfanylidene-5,7-diazaspiro[3.4]octan-5-yl]-2-fluoro-N-methylbenzamide, molecular formula C21H15F4N5O2S, molecular weight 477.43 g/mol. Manufactured to an enterprise standard aligned with ChP/USP/EP, it appears as a white to light-yellow powder with total impurities under 0.5% and purity of at least 99%. Residual solvents fully comply with ICH Q3C and mutagenic impurities with ICH M8, with nitrosamine assessment available; supplied in regular or micronized grade (D90 < 10 um) and stored at room temperature.
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