| Product name |
Ornidazole |
| CAS No. |
16773-42-5 |
Outer Packing |
25kg/drum |
| Production date |
2017.8.16 |
Shelf life |
2020.8.15 |
| Standard adopted |
Enterprise Standard |
| Items of analysis |
Specification |
Results |
| Character |
Appearrance:A white up to slightly yellowish crystalline powder
Solubility:It is sparingly soluble in water,freely soluble in alcohol |
A white crystalline powder
Conforms |
| Identification(A) |
Melting point 80~90℃
A.Chemical reaction |
87.0~8.0℃
Positiwe reaction |
| B
C |
B.Chemical reaction
C.UV:The solution show maxima at 230±2nm and 312±2 nm |
Positiwe reaction
The solution show maxima at 230.0nm and 312.0 nm |
| D
Clarity and colour of ethyl alcohol solution |
D.Infared absorption spectrophtotmetry:The IR spectrum is consistent with that obtained with Ornidazole RS.
The solution is clear and not more intensely coloured than reference colour solutionGY 3 |
The IR spectrum is consistent with that obtained with Ornidazole RS.
The solution is clear and less intensely coloured than reference colour solutionGY 3 |
| Heavy metals
Ammonium |
Not more than 0.001 percent
Not more than 0.03 percent |
Not more than 0.001 percent
Not more than 0.03 percent |
| Iron
Chlorides |
Not more than 0.002 percent
Not more than 0.02 percent |
Not more than 0.002 percent
Not more than 0.02 percent |
| Sulfate
2-methyl-5-nitroimidazole |
Not more than 0.02 percent
Not more than 0.2 percent |
Not more than 0.02 percent
0.09 percent |
| Total impurities
Loss on dying |
Not more than 1.0 percent
Not more than 0.5 percent |
0.07 percent
Less than 0.1 percent |
| Sulphated ash
Ethanol |
Not more than 0.1 percent
NMT 5000ppm |
Less than 0.1 percent
not detected |
| Ethylacetate
Microbiological purity(1) |
NMT 5000ppm
Bacterial count:not more than 1000 CFU/g |
not detected
Less than 10 CFU/g |
| (2)
(3) |
Fingi and mould:not more than 100 CFU/g
E-coli:negative |
Less than 10 CFU/g
negative |
| Assay |
Ornidazole contains not less than 99.0% and not more than 101.0% of C7H10ClN3O3,calculated to the dried substance |
99.6 percent |
| Conclusion |
Qualified |
