| Product name |
Secnidazole |
| CAS No. |
3366-95-8 |
Outer Packing |
25kg/drum |
| Production date |
2017.4.23 |
Shelf life |
2020.4.22 |
| Standard adopted |
Enterprise Standard |
| Items of analysis |
Specification |
Results |
| Appearance
|
A almost white slightly yellowish crystalline powder
|
It is slightly yellowish crystalline powder
|
| Solubility |
Freely soluble in ethanol,choroform,methnol,glacial acetic acid.Soluble in 0.1N diluted hydrochloric acid,0.1N sodium hydroxide,sparingly soluble in water |
conforms |
| Melting point
|
74℃~78℃
|
75.5℃~76.0℃
|
| Identification(A) |
A.Chemical reaction:The solution to be examined gives positive chemical reactions. |
The solution be examined give positive chemical reactions. |
| (B)
|
B.UV(water) Max320 nm,min 263 nm UV(0.1mol/aHcl) Max 276 nm
|
conforms
|
| (C) |
C.Infrared Absorption:The spectrum obtained with the substance to be examined corresponds to that of the reference standard of Secnidazole |
The spectrum obtained with the substance to be examined corresponds to that of the reference standard of Secnidazole |
| Clarity and colour of solution
|
The solution should be clear and colorless,if turbid,It should be not more than intense than 0.5 reference turbidity solution;if coloration,it should be not more intense than reference solution GY3 |
conforms
|
| Acidity and Alkalinity |
5.5~5.7 |
6.0 |
| Loss on drying |
4.0 per cent to 6.0 per cent |
4.6 per cent |
| Related substance(HPLC) |
Total impurity:NMT1.0 per cent |
0.3 per cent |
| Residual solvents |
Ethyl acetate:NMT:5000ppm |
Not detectable |
| Heavy metals |
Not more than 10ppm |
Less than 0.001 per cent |
| Residue on ignition
|
Not more than 0.1 percent
It contains not less than 98.5 per cent of C7H11N3O3,calculated to be tried substance |
Less than 0.1 per cent
|
| Assay |
≥99% |
99.6% |
| Conclusion |
Qualified |
