Ambroxol Hydrochloride
Chemical Name | ：Ambroxol hydrochloride |
Category | ： |
Specification | ：EP/USP |
HS Code | ：2921.5900.90 |
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Structure Formula | ： |
CAS Number | ：23828-92-4 |
Molecular | ：C13H19Br2ClN2O |
Usage | ：Cough expectorant, used for acute and chronic respiratory diseases, especially the expectorant treatment of chronic bronchitis. |
Items | Standard |
|---|---|
Appearance | White or yellowish crystalline powder |
Solubility | Sparingly soluble in water, soluble in methanol, practically insoluble in methylene chloride |
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 | ≤0.5% |
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℃ |
1， Argentinian National Institute of Drugs
Instituto Nacional de Medicamentos (INAME)
2， Australian Therapeutic Goods Administration (TGA)
3， Belgian Federal Agency for Medicines and Health Products
Agence Fédérale des Médicaments et des Produits de Santé(AFMPS)
Federaal Agentschap voor Geneesmiddelen enGezondheidsproducten (FAGG)
4， Canadian Health Products and Food Branch Inspectorate(HPFBI)
5， Taiwan Food and Drug Administration (TFDA)
7， Czech State Institute for Drug Control
Státní Ústav pro Kontrolu Léčiv (SÚKL)
8， Czech Institute for State Control of Veterinary Biologicals and Medicines (ISCVBM)
9， Danish Health and Medicines Authority (DHMA)
10， Finnish Medicines Agency (FIMEA)
11， French National Agency for Medicines and Health Products Safety
Agence nationale de sécurité du médicament et des produits de santé (ANSM)
12， French Agency for Food, Environmental & Occupational Health Safety
Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES)
13， German Federal Ministry of Health *
Bundesministerium für Gesundheit (BMG)
14， Icelandic Medicines Agency (IMA)
20， Indonesian National Agency for Drug and Food Control (NADFC)
21， Health Products Regulatory Authority (HPRA)
22， Italian Medicines Agency
Agenzia Italiana del Farmaco (AIFA)
23， Japanese Pharmaceuticals and Medical Devices Agency(PMDA)
24， Korea (Republic of) Ministry of Food and Drug Safety (MFDS)
25， Malaysian National Pharmaceutical Control Bureau (NPCB)
26， Dutch Health Care Inspectorate*
Inspectie voor de Gezondheidszorg (IGZ)
27， New Zealand's Medicines and Medical Devices Safety Authority (Medsafe)
28， Norwegian Medicines Agency (NOMA)
29， Polish Main Pharmaceutical Inspectorate (MPI)
30， Romanian National Agency for Medicines and MedicalDevices (NAMMD)
31， South African Medicines Control Council (MCC)
32， Spanish Agency of Medicines and Medical Devices *
Agencia Española de Medicamentos y Productos Sanitarios(AEMPS)
33， Swedish Medical Products Agency (MPA)
34， United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA)
35， United Kingdom's Veterinary Medicine Directorate (VMD)
36， U.S. Food and Drug Administration (US FDA)
37， European Directorate for the Quality of Medicines & HealthCare （EDQM）
38， European Medicines Agency（EMA）
39， World Health Organization（WHO）