Ornidazole

CAS number: 16773-42-5

Molecular formula: C7H10ClN3O3

molecular weight: 219.625 g/mol

Chemical structure:

Sr. No.TestSpecificationResult
1DescriptionWhite to yellowish white crystalline powderWhite crystalline powder
2SolubilitySoluble in chloroform and in methanolComplies
3IdentificationIt 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   0.63Complies 0.587
4Assay 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%
5Heavy metalsNot more than 20 ppmComplies
6WaterNot more than 0.5%0.040%
7Sulphated AshNot more than 0.1%0.080%
8Related compounds by HPLCi) 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%