|
Item |
Specification |
Results |
|
Appearance |
Almost white or pale yellow crystalline powder |
Conforms |
|
Solubility |
Practically insoluble in water, soluble in acetone and in methylene chloride, sparingly soluble in methanol |
Conforms |
|
Identification |
B. The IR spectrum corresponds to Tinidazole reference standard |
127℃ Conforms |
|
Appearance of solution |
5.0% (g/ml)solution in acetone should be clear and not more intensely colored than reference solution Y5 |
Conforms |
|
Identification |
Meets the requirements |
Conforms |
|
Related substances (HPLC) |
Impurity-A≤0.20% Impurity-B≤0.20% Any other unspecified impurity: ≤0.10% Total impurities: ≤0.40% |
0.05% 0.05% |
|
Residual solvents (GC) |
Ethanol: ≤1000ppm O-xylene: ≤195.3ppm |
130ppm 97ppm |
|
Heavy metals (Pb) |
≤20ppm |
＜20ppm |
|
Loss on drying |
≤0.50% |
0.08% |
|
Sulphated Ash |
≤0.10% |
0.04% |
|
Assay |
98.0～101.0% |
99.7% |
|
Conclusion: The Product Conforms to EP/USP.
Impurity: A: 2-methyl-5-nitro-1H-imidazole B: 1[2-(ethylsulphonyl) ethyl]-2-methyl-4-nitro-1H-imidazole
|
||
