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非那雄胺CAS号98319-26-7糖皮质原料生产企业,非那雄胺COA
中文名称: 非那雄胺
中文同义词: N-叔丁基-3-氧代-4-氮杂-5a-雄甾-1-烯-17b-甲酰胺;非那雄胺;非那甾胺;非那甾胺(FTD);非那甾安;N-叔丁基-3-氧代-4-氮杂-5Α-雄甾-1-烯-17Β-甲酰胺;非那甾铵;非那甾胺/N-叔丁基-3-氧代-4-氮杂-5A-雄甾-1-烯-17B-甲酰胺/非那雄胺
英文名称: Finasteride
英文同义词: PROSCAR;PROSTIDE;N-(2-METHYL-2-PROPYL)-3-OXO-4-AZA-5ALPHA-ANDROST-1-ENE-17BETA-CARBOXAMIDE;MK-906;(5alpha,17beta)-(1,1-dimethylethyl)-3-oxo-4-azaandrost-1-ene-17-carboxamide;17beta-(n-tert-butylcarbamoyl)-4-aza-5alpha-androst-1-en-3-one;4-azaandrost-1-ene-17-carboxamide,n-(1,1-dimethylethyl)-3-oxo-,(5-alpha,17-be;4-azaandrost-1-ene-17-carboxamide,n-(1,1-dimethylethyl)-3-oxo-,(5alpha,17beta
CAS号: 98319-26-7
分子式: C23H36N2O2
分子量: 372.54
非那雄胺CAS号98319-26-7糖皮质原料生产企业,非那雄胺COA
化学性质 白色或类白色结晶性粉末
标准:USP
包装:1KG/听
用途 5α-还原酶抑制剂,可抑制睾酮转化为二氢睾酮。用于良性前列腺增生症的治疗。
用于治疗男子前列腺肥大及秃发等病症
非那雄胺COA
Product name | 非那雄胺 Finasteride | |||
CAS号 CAS No. | 98319-26-7 | 包装规格 Outer Packing | 1KG/drum | |
生产日期 Production date | Jun.,01, 2016 | 有效期 Shelf life | May.,31, 2021 | |
执行标准 Standard adopted | USP38 | |||
分析项目 Items of analysis | 质量标准 Specification | 实测结果 Results | ||
Description | white or almost white crystalline powder | almost white crystalline powder | ||
Identification(IR,HPLC) | complies with the standard | complies | ||
Solubility | Free soluble in chloroform and in alcohol ,very slightly soluble in water. | complies | ||
Melting point | About 257℃ | 256.0~257.0℃ | ||
Specific rotation | -56.0°~-60.0° | -58.4° | ||
Water | max.0.3% | 0.25% | ||
Residue on ignition | max.0.1% | 0.04% | ||
Heavy Metals | max.10ppm | complies | ||
Loose Density (g/cm3) | 0.27~0.37 | 0.31 | ||
Tapped Density (g/cm3) | 0.40~0.56 | 0.52 | ||
Particle size | *≤20um 90%≤10um | complies | ||
Any individual impurity | max.0.5% | 0.12% | ||
Total impurities | max.1.0% | 0.44% | ||
Assay (HPLC, based on drying) | 98.5%~101.0% | 99.2% | ||
Acetone | Max.5000ppm | complies | ||
Chloroform | Max.60ppm | complies | ||
THF | Max.720ppm | complies | ||
Dichloromethane | Max.600ppm | complies | ||
Toluene | Max.890ppm | complies | ||
Methanol | Max3000ppm | complies | ||
Organic volatile substances | Meet the ICH requirements | complies | ||
结论 Conclusion | 合格 Qualified |
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