Ambroxol hydrochloride
CHEMICAL
STRUCTURE |
|
| CHEMICAL STRUCTURE |  |
CAS NO. |
23828-92-4 |
SPECIFICATION |
|
| Product Name | Ambroxol Hcl |
| Specification | EP2001 |
| Packing | 25Kg/Drum |
| Appearance | White or yellowish crystalline powder |
| Appearance of solution | Not more intensely colored than the reference solution |
| Identification | |
| a) UV Absorption | 3.2-3.4 Ratio |
| b) IR Spectrum | As stipulated |
| c) Thin layer chromatography | As stipulated |
| d) Chloride test | As stipulated |
| Related substances | |
a) Single impurity |
0.1% Max. |
| b) Toatl impurity | 0.3% Max. |
M.P. |
235-240°C |
| Heavy metals | 20ppm Max. |
Loss on drying |
0.5% Max. |
| Sulfated ash | 0.1% Max. |
| PH (1% Aqueous solution) | 4.5-6.0 |
Assay
(Potentiometric titration) |
98.0-101.0% |