23828-92-4 AMBROXOL HCL Veterinary Drugs
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ITEMS |
SPECIFICATION |
RESULTS |
---|---|---|
Appearance |
White or yellowish crystalline powder |
Conforms |
Appearance of solution |
Not more intensely colored than the reference solution Y6 |
Conforms |
Solubility Water Methanol Methylene chloride |
Sparingly soluble Soluble Practically insoluble |
Conforms Conforms Conforms |
Identification A) UV absorption B) IR spectrum C) Thin layer chromotography D) Chlorides test |
3.2-3.4 ratio |
Conforms Conforms Conforms Conforms |
Tests A) Related substance i) single impurity ii) total impurity B) Heavy metals C) Loss on drying D) Sulphated ash E) PH(1% aqueous solution) |
≤0.1% ≤0.3% ≤20ppm ≤0.5% ≤0.1% 4.5-6.0 |
<0.02% <0.04% <20ppm 0.24% 0.05% 5.0 |
Assay |
99.0%-101.0% |
100.2% |
SUMMARY: |
MEETS THE STANDARD OF EP7.0
THIS PRODUCE DOES NOT INCLUDE ANY ANIMAL ORIGIN INGREDIENTS. |
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