课件：FDA对药物杂质的控制要求.pptVIP

Limits of Residual Solvents: Class 1 Class 1 Residual solvents (Table 1): Should not be used in the manufacturing of drug substances, excipients or drug products because of unacceptable toxicities or deleterious environmental effects of the residual solvents. However, if there use is unavoidable, their levels should be restricted as shown in Table 1. Table 1. Class 1 Residual Solvents Solvent Concentration Limit (ppm) Concern Benzene 2 Carcinogen Carbon tetrachloride 4 Toxic and environmental Hazard 1,2-Dichlorothane 5 Toxic 1,1-Dichlorothane 5 Toxic 1,1,1-Trichlorothane 1500 Environmental Ha