Tinidazole
CAS Number: 19387-91-8
Molecular Formula: C8H13N3O4S
Standard: USP32/BP2010/EP6
Package: 25kg/drum
Tinidazole
CAS Number: 19387-91-8
Molecular Formula: C8H13N3O4S
Standard: USP32/BP2010/EP6
Package: 25kg/drum
ITEMS | LIMIT |
Appearance | White or pale yellow crystalline powder |
Solubility | Practically insoluble in water, soluble in acetone and in methylene chloride, sparingly soluble in methanol |
Melting range | 125-128 |
Identification | The IR spectrum corresponds to Tinidazole reference standard |
Appearance of solution | 5.0%(g/ml)solution in acetone should be clear and not more intensely colored than reference solution Y5 |
Related substances(TLC) | Impurity-A:NMT 0.5% |
Impurity-B:NMT 0.5% | |
Any other unspecified impurity: NMT 0.5% | |
At most one impurity more than 0.2% | |
Residual solvents(GC) | Ethanol: NMT 1000 ppm |
O-xylene: NMT 195.3 ppm | |
Loss on drying | NMT 0.5% |
Sulphated ash | NMT 0.1% |
Heavy metals | NMT 20 ppm |
Assay | NLT 98.0% & NMT 101.0% (dried substance) |