【正文】 deline by foreign pharmacopoeias ? USP27 普通雜質(zhì)的限度，一般為 % ? The value of %was selected as the general limit on ordinary impurities in monograph where documentation did not support adoption of other values ICH關(guān)于雜質(zhì)指導(dǎo)原則在國(guó)外藥典中的引用 Citation of ICH impurity guideline by foreign pharmacopoeias ? 如正文設(shè)置共存物、信號(hào)雜質(zhì)和毒性雜質(zhì)限度，除另有規(guī)定外，這些不作為普通雜質(zhì) ? Where a monograph sets limits on conitant pounds, signal impurities, and/or toxic impurities, these species are not to be included in the estimation of ordinary impurities unless so stated in the individual monograph ICH關(guān)于雜質(zhì)指導(dǎo)原則在國(guó)外藥典中的引用 Citation of ICH impurity guideline by foreign pharmacopoeias ? 有關(guān)物質(zhì) 與原料藥結(jié)構(gòu)有關(guān)，有關(guān)物質(zhì)可能是已知或未知的降解產(chǎn)物，或從生產(chǎn)工藝及貯存中產(chǎn)生 ? Related substances are structurally related to a drug substance. These substances may be identified or unidentified degradation products or impurities arising from a manufacturing process or during storage of a material ICH關(guān)于雜質(zhì)指導(dǎo)原則在國(guó)外藥典中的引用 Citation of ICH impurity guideline by foreign pharmacopoeias ? 工藝污染物 工藝污染物為已知或未知物質(zhì)（有關(guān)物質(zhì)和水分除外），包括試劑、無機(jī)物、原料和溶劑，可能從生產(chǎn)及處置過程中引入 ? Process contaminants are identified or unidentified substances (excluding related substances and water), including reagents, inanics, raw materials, and solvents. These substances may be introduced during manufacturing or handling procedures ICH關(guān)于雜質(zhì)指導(dǎo)原則在國(guó)外藥典中的引用 Citation of ICH impurity guideline by foreign pharmacopoeias ? USP27 凡例（ General Notices)對(duì)其他雜質(zhì)的規(guī)定 ? 法定原料藥中出現(xiàn)（正文）未標(biāo)明的雜質(zhì)，其量為 %或以上時(shí)，且是由于變更工藝或其他可說明原因產(chǎn)生的，檢測(cè)方法應(yīng)報(bào) USP，申請(qǐng)收載入正文，否則應(yīng)在分析證其他雜質(zhì)項(xiàng)下標(biāo)明，并注明量。不僅作為申報(bào)新藥的要求，有的還作為修訂藥典正文的要求。新原料藥中含有的一定量的任何雜質(zhì)，經(jīng)安全性試驗(yàn)或臨床研究，即認(rèn)為是論證了的。對(duì)于假劣藥品，必要時(shí)應(yīng)根據(jù)各該具體情況，采用非法定分析方法予以檢測(cè) ? Drugs shall not be adulterated or contaminated by foreign substances. Nonofficial methods can be adopted to monitor the counterfeit drugs 中國(guó)藥典 (2022)藥品雜質(zhì)分析指導(dǎo)原則 Ch P( 2022) Guideline on Analysis of Drug Impurities ? 項(xiàng)目名稱 ? The classification of impurities and their testing item titles in the drug standards 中國(guó)藥典 (2022)藥品雜質(zhì)分析指導(dǎo)原則 Ch P( 2022) Guideline on Analysis of Drug Impurities ? 按化學(xué)類別和特性，雜質(zhì)可分為：有機(jī)雜質(zhì)、無機(jī)雜質(zhì)、有機(jī)揮發(fā)性雜質(zhì) ? According to the chemical category and characteristics, impurities could be classified as anic impurities, inanic impurities and anic volatile impurities 中國(guó)藥典 (2022)藥品雜質(zhì)分析指導(dǎo)原則 Ch P( 2022) Guideline on Analysis of Drug Impurities ? 按其來源，雜質(zhì)可分為：有關(guān)物質(zhì) ,其他雜質(zhì)和外來物質(zhì)等 ? According to the source, impurities could be classified as related substances (including degradation products), other impurities, foreign substances, etc. 中國(guó)藥典 (2022)藥品雜質(zhì)分析指導(dǎo)原則 Ch P( 2022) Guideline on Analysis of Drug Impurities ? 按結(jié)構(gòu)關(guān)系，雜質(zhì)又可分為：其他甾體、其他生物堿、幾何異構(gòu)體、光學(xué)異構(gòu)體等 ? Impurities could be classified as other steroids, other alkaloids ,geometric isomers, optical isomers, etc based upon the structure relationship 中國(guó)藥典 (2022)藥品雜質(zhì)分析指導(dǎo)原則 Ch P( 2022) Guideline on Analysis of Drug Impurities ? 按其毒性，雜質(zhì)又可分為毒性雜質(zhì)和普通雜質(zhì)等。 ? The suitability of an established method should be considered, equipments and materials should be available, the special materials should be described in the specification when necessary 中國(guó)藥典 (2022)藥品雜質(zhì)分析指導(dǎo)原則 Ch P( 2022) Guideline on Analysis of Drug Impurities ? 新藥研究中的雜質(zhì)和降解產(chǎn)物，或在非新藥中發(fā)現(xiàn)的新雜質(zhì)和新降解產(chǎn)物，應(yīng)進(jìn)行分離純化制備，或合成制備，以供進(jìn)行安全性和質(zhì)量研究 ? Impurities and degradation products of the new drug developed , and new impurities and new degradation products found in the generic drugs should be prepared by isolation and purification, or by synthesis for the safety study and quality study 中國(guó)藥典 (2022)藥品雜質(zhì)分析指導(dǎo)原則 Ch P( 2022) Guideline on Analysis of Drug Impurities ? 對(duì)確實(shí)無法獲得的雜質(zhì)和降解產(chǎn)物 ， 研制部門應(yīng)在申報(bào)資料和質(zhì)量標(biāo)準(zhǔn)起草說明中寫明理由 。消旋體藥物，當(dāng)已有其單一對(duì)映體藥物的法定質(zhì)量標(biāo)準(zhǔn)時(shí)，應(yīng)在該消旋體藥物的質(zhì)量標(biāo)準(zhǔn)中設(shè)旋光度檢查項(xiàng)目 ? Where the drug is a single enantiomer, other coexistent enantiomers shall be impurities. Where there is an official standard for a single enantiomer drug, the testing item of optical rotation should be set for the standard of the corresponding racemic drug 中國(guó)藥典 (2022)藥品雜質(zhì)分析指導(dǎo)原則 Ch P( 2022) Guideline on Analysis of Drug Impurities ? 3. 雜質(zhì)檢查分析方法和雜質(zhì)的限度 ? Analytical methods for impurity testing and impurity limit ? 雜質(zhì)檢查分析方法應(yīng)專屬、靈敏 ? The analytical methods for impurity testing should be specific and sensitive 中國(guó)藥典 (2022)藥品雜質(zhì)分析指導(dǎo)原則 Ch P( 2022) Guideline on Analysis of Drug Impurities ? 雜質(zhì)檢查應(yīng)盡量采用現(xiàn)代分離分析手段，主成分與雜質(zhì)和降解產(chǎn)物均能分開，其檢測(cè)限應(yīng)滿足限度檢查的要求 ? Modern analytical methods for separation should be used for impurity testing. The substance should be well resolved with impurities and degradation products, The detection limits shall meet the requirement for the limit tests 中國(guó)藥典 (2022)藥品雜質(zhì)分析指導(dǎo)原則 Ch P( 2022) Guideline on Analysis of Drug Impurities ? 對(duì)于需作定量檢查的雜質(zhì) ， 方法的定量限應(yīng)滿足相應(yīng)的要求 。(2) a chromatographic purityindicating method that serves as the assay。 ? This part of the program will focus on the new guideline of the 2022 Chinese Pharmacopoeia for the analysis of drug impurities,including relevant requirements of ICH and other pharmacopoeias 原料藥中雜質(zhì)的控制 The Control of Impurities in Drug Substances ? 本討論包括： ? ICH新原料藥中對(duì)雜質(zhì)的指導(dǎo)原則 ? ICH關(guān)于雜質(zhì)指導(dǎo)原則在國(guó)外藥典中的引用 ? 中國(guó)藥典 (2022)藥品雜質(zhì)分析指導(dǎo)原則 原料藥中雜質(zhì)的控制 The Control of Impurities in Drug Substances ? 雖然 ICH指導(dǎo)原則是對(duì)申報(bào)新化學(xué)藥和新生物制品的技術(shù)要求，但經(jīng) ICH三方成員國(guó)制藥工業(yè)部門和藥品管理部門的協(xié)調(diào)，其原則切實(shí)可行，在保證藥品安全有效，藥品的生產(chǎn)按 GMP的要求，起一定作用，逐步為各國(guó)采用。 ICH新原料藥中的雜質(zhì)指導(dǎo)原則 ICH Guideline on Impurities in New Drug Substances ? ICH規(guī)定的雜質(zhì)報(bào)告限 鑒定限 論證限 ICH新原料藥中的雜質(zhì)指導(dǎo)原則 ICH Guideline on Impurities in New Drug Substances ? 1. 說明在合成、純化和貯存中該新原料藥實(shí)際和可能存在的雜質(zhì) ? The applicant should summaries the actual and potential impurities most likely to arise during synthesis, purification and storage ? 應(yīng)依據(jù)合成的化學(xué)反應(yīng)，可能帶來雜質(zhì)的原料，以及降解產(chǎn)物 ICH新原料藥中的雜質(zhì)指導(dǎo)原則 ICH Guideline on Impurities in New Drug Substances ? 2. 申報(bào)者應(yīng)敘述檢測(cè)新原料藥中雜質(zhì)的實(shí)驗(yàn)研究 ? The applicant should summarize the