Ambroxol Hydrochloride (98%)
| TESTS | SPECIFICATIONS
|
| Description | A white or almost white crystalline powder |
| pH | 4 - 6 |
| Identification | IR, UV/VIS Spectrum |
| Melting Point | 235 - 240 ¡ÆC |
| Solubility | Passed |
| Related substances | NMT 1.0% |
| Compound
of CIS form
2-Amino-3,5- |
NMT 0.05% |
| Dibromobenzaldehyde | NMT 0.2% |
| Heavy metals | NMT 10 PPM |
| Loss on drying | NMT 1.0 % (105 ¡ÆC) |
| Residue on ignition | NMT 0.1% |
| Ionic chlorine | 8.3 ~ 8.8% |
| Assay | 99.0 ~ 101.0% |
|
Clarity of solution - 400nm - 450nm - 500nm |
¡¡ NLT 80% NLT 80% NLT 99% |
| Storage | Keep in a well-closed container. |
| Expiration Date | 5 years from manufacturing date. |
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