盐酸氨溴索
中文通用名 | ：盐酸氨溴索 |
用途类型 | ： |
规格 | ：USP/EP |
HS Code | ：2921.5900.90 |
- Tel: +86-532-83876123
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结构式 | ： |
CAS | ：23828-92-4 |
分子式 | ：C13H19Br2ClN2O |
用途 | ：镇咳祛痰药，用于急、慢性呼吸道疾病，特别是慢性支气管炎的祛痰治疗 |
| Items | Standard |
|---|---|
Appearance | White or yellowish crystalline powder |
Solubility | Sparingly soluble in water, soluble in methanol, practically insoluble in methylene chloride |
I | |
Identification First identification B,D Second identification A,C,D | A. Ultraviolet and visible absorption spectrophotmetry: Absorption at 245-31 Onm B. Infrared absorption spectrophotometry: Should comply with ambroxol hcl CRS C. Thin-layer chromatography D. Chlorides test |
Clarity | The solution must be clear |
Chromaticity | Not more intensely colored than the reference solution Y6 |
PH | 4.5-6.0 |
Related substances(HPLC) | Unspecified impuritied ≤0.10% Total impurity ≤0.3% |
Heavy metals | ≤20ppm |
Loss on drying | ≤0.5% |
Sulphated ash | ≤0.1% |
Residual solvents | Methanol≤3000ppm Acetone≤5000ppm |
Microbiological | Total aerobie counts <1000cfu/g Total fungi<100cfu/g E-coli: should be absent |
Assay(on dried basis) | 99.0%-101.0% |
Package and storage | Double PE bag placed in plastic to carton drum. In dry protected from light place under, temperature below 25℃ |
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Chinese GMP
CEP
DMF/CTD format
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阿尔及利亚
欧盟
澳大利亚