Tinidazole

White or pale yellow crystalline powder

Tests
Standards
Results
Appearance
White or pale yellow crystalline powder
Pale yellow crystalline powder
Solubility
Practically insoluble in water, soluble in acetone and in methylene chloride, sparingly soluble in methanol
Conforms
Melting range
125-128
126
Identification
The IR spectrum corresponds to Tinidazole reference standard
Conforms
Appearance of solution
5.0%(g/ml)solution in acetone should be clear and not more intensely colored than reference solution Y5
Conforms
Related substances(TLC)
Impurity-A:NMT 0.5%
0.5%
Impurity-B:NMT 0.5%
0.5%
Any other unspecified impurity: NMT 0.5%
0.5%
At most one impurity more than 0.2%
Conforms
Residual solvents(GC)
Ethanol: NMT 1000 ppm
190 ppm
O-xylene: NMT 195.3 ppm
90 ppm
Loss on drying
NMT 0.5%
0.08%
Sulphated ash
NMT 0.1%
0.04%
Heavy metals
NMT 20 ppm
20 ppm
Assay
NLT 98.0% & NMT 101.0% (dried substance)
99.4%
Storage
Protected from light