Pharmacopoeia 2020 Residual Solvent Limit Standards

The limit standards for residual solvents in Pharmacopoeia 2020 are as follows: 1 Alcohol solvent (ppm): - Ethanol ≤ 5000- Propanol ≤ 5000- Butanol ≤ 5000- Isopropanol ≤ 5000- Ethylene glycol ≤ 620- Propylene glycol ≤ 620- Hexanediol ≤ 720- Phenylethanol ≤ 890- Glycerol ≤ 2500 2 Ketone solvent (ppm): - Ketone ≤ 500- Acetone ≤ 500- Butanone ≤ 500 3 Ester solvents (ppm): - Ethyl acetate ≤ 5000- Methyl methacrylate ≤ 5000- Dimethyl butyrate ≤ 300- Ethyl lactate ≤ 360- Isobutyl acetate ≤ 1500 4 Chlorinated hydrocarbon solvents (ppm): - Methyl chloride ≤ 60- Chloroform ≤ 60-1,2-dichloroethane ≤ 600-1,1,2-trichloroethane ≤ 60- Chloroethylene ≤ 80

5. Ether solvents (ppm): - Ether ≤ 5000- Propylene ether ≤ 250 6 Hydrocarbon solvents (ppm): - Benzene ≤ 100- Water gas ≤ 500- Petroleum ether ≤ 5000 These limit standards are strictly followed to ensure drug quality and safety.