| 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 255℃, 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 | ＜Y5 |
| 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% |