CAS number: 16773-42-5
Molecular formula: C7H10ClN3O3
molecular weight: 219.625 g/mol
Chemical structure:
Sr. No. | Test | Specification | Result | |||||||||
1 | Description | White to yellowish white crystalline powder | White crystalline powder | |||||||||
2 | Solubility | Soluble in chloroform and in methanol | Complies | |||||||||
3 | Identification | It responds to the following test A and B | ||||||||||
A, IR: The infrared absorption spectrum of the test substance exhibits maximum at the same wave-length as that of a similar preparation of Ornidazole WRS. | Complies | |||||||||||
B, UV : In the range of 230 nm to 360 nm, a 0.002% w/v solution of test sample in 0.1M hydrochloric acid shows absorption maximum at about 277 nm and Absorbance at 277 nm should be between 0.580 to 0.63 | Complies 0.587 | |||||||||||
4 | Assay on anhydrous basis (by potentiometer) | Not less than 98.0% and not more than 101.0% w/w of C7H10CIN3O3 calculated on anhydrous basis. | 99.890% | |||||||||
5 | Heavy metals | Not more than 20 ppm | Complies | |||||||||
6 | Water | Not more than 0.5% | 0.040% | |||||||||
7 | Sulphated Ash | Not more than 0.1% | 0.080% | |||||||||
8 | Related compounds by HPLC | i) Individual known impurity 2-methyl-5-nitro imidazole : Not more than 0.1% | 0.006% | |||||||||
ii) Unknown impurity Any single maximum impurity: Not more than 0.1% | 0.009% | |||||||||||
iii) Total impurities : Not more than 0.5% | 0.023% |