Sulfadiazine
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Pharmaceutical Chemicals
| Traits | Creamy white or light brown crystal |
| TEST ITEMS | SPECIFICATIONS | RESULTS |
| Appearance | White, yellowish-white or pinkish-white, crystalline powder or crystals | White crystalline powder |
| Solubility | Practically insoluble in water, slightly soluble in acetone, very slightly soluble in ethanol (96 per cent). It dissolves in solutions of alkali hydroxides and in dilute mineralacids | Practically insoluble in water, slightly soluble in acetone, very slightly soluble in ethanol (96 per cent). It is dissolved in 85 g/L sodium hydroxide solution and 73g/L dilute hydrochloric acid |
| IR | The IR spectrum is concordant with the reference spectrum of sulphadiazine | Conforms |
| Thin-layer chromatography |
The principal spot in the chromatogram obtained with the test solution is similar in position and size to the principal spot in the chromatogram obtained with the reference solution | Conforms |
| Melting point after recrystallization |
After recrystallisation from toluene R and drying at 100℃, melts at 123℃ to 127℃ | Conforms |
| Chemical reaction | The differential response of primary aromatic amines | Conforms |
| Appearance and color of solution |
The solution is clear and not more intensely coloured than reference solution Y5, BY5 or GY5 | The solution is clear and not more intensely colored than reference solution Y5 |
| Acidity | Not more than 0.20ml of 0.1M sodium hydroxide is required to change the colour of the indicator | 0.09ml |
| Related substances | Impurity A≤0.3% Impurity B≤0.3% Impurity E≤0.2% Impurity F≤0.15% Unspecified Impurities≤0.05% Total Impurities≤0.5% |
Impurity A: 0.005% Impurity B: 0.004% Impurity E: ND Impurity F: 0.11% Unspecified Impurities: 0.03% Total: 0.15% |
| Sulphated ash | NMT0.1% | 0.0005 |
| Loss on drying | NMT0.5% | 0.002 |
| Assay | 99.0% to101.0% of C10H10N4O2S, on dried basis | 0.997 |
| Residual solvents | Acetic Acid≤2000ppm Dimethylformamide (DMF)≤800ppm |
Acetic Acid: 405ppm; DMF: ND |
| Conclusion | Qualified | Qualified |
As an excellent variety of sulfonamides, it has strong antibacterial effect, good curative effect, faster absorption, slower excretion, and higher effective concentration in the blood. It is clinically used to treat upper respiratory tract infections. Epidemic meningitis, otitis media, furuncle, puerperal fever, urinary tract infection and acute dysentery.
Sulfonamides have bacteriostatic and sword inhibiting effects, and sulfonamides antibiotics can inhibit prokaryotic folate synthesis by inhibiting dihydropteric acid synthase and preventing the synthesis of dihydropteric acid. Sulfonamides are used to treat infections caused by hemolytic streptococcus, pneumococcus, meningococcus, diplococcus gonorrhoeae, and E. coli.
