Item | Specification |
Appearance | Light yellow crystalline powder |
Identification | The IR absorption spectrum of substance being examined must be concordant with the spectrum obtained from Nitazoxanide WS. |
In the test for assay the retention time of principal peak from the sample should match with that from Nitazoxanide WS. | |
Solubility | Slightly soluble in methanol. |
Melting point | 197-206℃ |
Loss on drying | ≤0.5% |
Sulphated ash | ≤0.2% |
Heavy metals | ≤20ppm |
Related substance | Nitazoxanide related compound A (5-Nitrothiazole-2-amine) ≤0.25% |
Aspirin (2-Acetoxybenzoic acid) ≤0.25% | |
Salicylic acid (2-Hydroxybenzoic acid) ≤0.25% | |
Single impurity ≤0.5% | |
Total impurities ≤1% | |
Assay | 98%-102% by HPLC, on dried basis |