Product Name : NITAZOXANIDE
Molecular Formula : C12H9N3O5S
Molecular Weight : 307.28
Synonyms : 2-((5-nitrothiazol-2-yl)carbamoyl)phenyl acetate; 2- (Acetolyloxy)-N-(5-nitro-2-thiazolyl)benzamide
CAS No : 55981-09-4
| Sr. No. | Test | Specifications |
|---|---|---|
| 1 | Description | White or yellowish, crystalline powder |
| 2 | Solubility | Soluble in N,N-dimethyl acetamide, very slightly soluble in alcohol, practically insoluble in water. |
| 3 | Identification – By IR – By HPLC |
IR absorption spectrum of test substance to be concordant with that of working standard spectrum. Retention time of major peak in sample solution corresponds to that of the standard solution. |
| 4 | Heavy metals | Not more than 10 ppm |
| 5 | Residue Ignition | Not more than 0.1% w/w |
| 6 | Loss on drying (60 °C for 3 hours) |
Not more than 0.50% w/w |
| 7 | Assay (By HPLC, ODB) | 98.0 to 102.0% w/w |
| 8 | Related substances (By HPLC) Nitazoxanide Related Compound A Aspirin Salicylic acid Any individual unspecified impurity Total impurities |
Not more than 0.1% Not more than 0.1% Not more than 0.1% Not more than 0.1% Not more than 1.0% |