56818 盐酸非索非那定 98.0% 5G 6600
56819 盐酸非索非那定 98.0% 1G 1850
熔点 148-150oC
S.No. Test Specification RESULTS 1. Description A White to off white powder Off white powder 2. Solubility Soluble in Methanol Complies 3. Indemnification IR spectrum concordant with reference standard Complies 4. Melting range 192.0℃to200.0℃ 192.8℃to194.0℃ 5. Colour absorbance Not more than 0.1 0.02 6. Sulphated ash Not more than 0.2%w/w 0.09%w/w 7. Loss on drying Not more than 0.5%w/w 0.11%w/w 8. Related substances by HPLC -TRS-1: Not more than 0.3%w/w Not detectable -TRS-2: Not more than 0.3%w/w 0.01%w/w` Meta Fexofenadine: Not more than 0.3%w/w Not detectable Any other known impurity: Not more than 0.3%w/w 0.06%w/w Any unknown impurity : Not more than0.1%w/w 0.04%w/w Total Impurities : Not more than1.0%w/w 0.30%w/w 9. Organic Volatile Impurities Ethylene Chloride : Not more than100ppm Not detectable 10. Assay on dried basis 98.5%to101.0% 99.52% 11. Residual solvents Isopropyl Alcohol : Not more than5000ppm 1485ppm Ethyl acetate : Not more than4000ppm 965ppm Isopropyl acetate : Not more than500ppm 85ppm Methanol : Not more than100ppm Not Detectable Acetone :Not more than100ppm Not Detectable 12. Bulk density Not less than 0.25gm/ml 0.29gm/ml 13. Particle size Particles less than 25 microns:Not less than90% 96.5% Particles less than 10 microns:Not less than50% 88
危险品标志 Xi 危险类别码 36/37/38 安全说明 26-36
医药中间体