Varieties: | Other |
---|---|
Component: | Chemical Synthetic Drugs |
Type: | Other |
Pharmacodynamic Influential Factors: | Other |
Storage Method: | Prevent Exceeding Quality Guarantee Period |
Veterinary Reg. No.: | Other |
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Name of Product: | Sulfadiazine/Sulphadiazine | |
Shelf Life: | 3 years | |
Specification: | BP2007 | |
Test Items | Specification | Results of Analysis |
Description | White, yellowish-white or pinkish-white, crystalline powder or crystals, it melts at about 255ºC, with decomposition | Conforms |
identification | A. The infrared absorption spectrum concordant with the spectrum of sulfadiazine CRS. | Meets test A |
B. The principal spot in TLC chromatogram obtained in position and size corresponds with sulfadiazine CRS. | Meets test B | |
Heavy metals | ≤20ppm(Pb) | <20PPM |
Acidity | ≤0.2ml (0.1mol/LNaOH) | <0.2ml |
Color of Solution | ≤Y5BY5GY5 | |
Related Substances | Single impurity≤0.5% | <0.5% |
Loss on Drying | ≤0.5% | 0.12% |
Suphated ash | ≤0.1% | 0.06% |
Assay | 99.0% to 101.0% (on the dried basis) | 99.62% |
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