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Product name: Ambroxol Hydrochloride
CAS No.:23828-92-4
Molecule Formula:C13H19Br2ClN2O
Molecule Weight:414.56
Purity: 99%
Package: 25kg/drum
Description:White or yellowish, crystalline powder
Manufacture Standards:USP/EP
Testing items |
Specifications |
Results |
Description |
White or yellowish, crystalline powder |
Conforms |
Solubility |
Sparingly soluble in water, soluble in methanol, practically insoluble in methylene chloride |
Conforms |
Identification |
|
Conforms |
|
Conforms |
|
|
Conforms |
|
|
Conforms |
|
PH |
4.5~6.0 |
5.2 |
Loss on drying |
≤0.50% |
0.1% |
Residue on ignition |
≤0.10% |
0.05% |
Heavy metals |
≤20ppm |
<20ppm |
Related substances |
Impurity A ≤0.10% |
Conforms |
Impurity B ≤0.10% |
Conforms |
|
Impurity C ≤0.10% |
Conforms |
|
Impurity D ≤0.10% |
Conforms |
|
Impurity E ≤0.10% |
Conforms |
|
Unspecified impurities ≤0.10% |
0.06% |
|
Total impurities ≤0.30% |
0.10% |
|
Assay |
99.0%~101.0% |
99.80% |
Conclusion: The Product Conforms to USP/EP. |
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