Silver Sulfadiazine USP
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PRODUCT SPECIFICATIONS
| Name of Product: | SILVER SULFADIAZINE USP |
| Synonyms: | (4-Amino-N-2-pyrimidinylbenzenesulfonamidato-NN,01)-silver, sulfadiazine silver, silver (I) sulfadiazine, 4-amino-N-(2-pyrimidinyl) benzenesulfonamide silver salt, dermazine, geben, silvadene |
| CAS No: | 22199-08-2 |
SPECIFICATIONS
| Sr. No | Criteria | Limit/Specification | ||||||||||||||||||
| 1. | Appearance | White to creamy- white, crystalline powder. Odorless to having it slight odor. Is stable in air, but turns yellow on exposure to light. | ||||||||||||||||||
| 2. | Solubility | Freely soluble in 30% of ammonia solution; slightly soluble in acetone; practically insoluble in ethanol (95%), chloroform and ether. | ||||||||||||||||||
| 3. | Identification | |||||||||||||||||||
| A. By IR | The IR Spectrum is concordant with the reference spectrum of Silver Sulfadiazine | |||||||||||||||||||
| B. By HPLC | The RT of the major peak of the Sample solution corresponds t O that of the Standard solution, as obtained in the Assay | |||||||||||||||||||
| C. Test for Silver | Meets the Requirement of test for Silver | |||||||||||||||||||
| 4. | Silver Content | 29.3% – 30.5% of Silver is found | ||||||||||||||||||
| 5. | Limit of Nitrate (By UV-Vis) | Nmt 0.5% | ||||||||||||||||||
| 6. | Organic Impurities (By HPLC ) |
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| 7. | Loss of Drying | NMT 0.5% | ||||||||||||||||||
| 8. | Assay (By HPLC) | 98.0% – 102.0% on the dried basis | ||||||||||||||||||
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