残留溶剂测定法（Residual solvent method）.docVIP

残留溶剂测定法（Residual solvent method） One Determination of residual solvents in Appendix VIII P Residual solvents in a drug are defined in the manufacture of API or excipients, and in the preparation of the drug An organic solvent that has not been completely removed in the process. Common residual solvents and limits in pharmaceuticals See Schedule 1, unless otherwise specified, the residue limits of the first, second and third solvents shall be consistent with the regulations in the table For other solvents, according to the characteristics of the production process, the corresponding limits should be formulated to meet the product specifications, Drug production quality management specification (GMP) or other basic quality requirements. This method was determined by gas chromatography (Appendix V, E). chromatographic column 1. capillary column Unless otherwise specified, columns of similar polarity may be used interchangeably. (1) non-polar chromatographic column fixed liquid is 100% capillary column of two methyl polysiloxane. (2) polar chromatographic column fixed liquid is capillary column of polyethylene glycol (PEG-20M). (3) the stationary liquid of medium polar chromatographic column is (35%) two phenyl - (65%) methyl silane, (50%) Two phenyl - (50%) two methyl silane, (35%) two phenyl - (65%) two methyl silane, (14%) Cyano phenyl - (86%) two methyl polysiloxane, (6%) propyl phenyl - (86%) two methyl poly silicon A capillary column of oxygen. (4) the stationary liquid of weak polar chromatographic column is (5%) phenyl - (95%) - methyl silane, (5%) Capillary column of two phenyl - (95%) two methyl siloxane copolymer. 2. packed column With a diameter of 0.25-0. 18mm two vinyl benzene ethyl vinyl benzene type polymer porous ball or other suitable Suitable packing is used as stationary phase. System suitability test (1) the theoretical plate number of capillary column is generally not less than 5000 by calculating the chromatographic peak of the sample to be measur