【正文】 s of ICH relevant requirements and recent progress in pharmaceutical research and drug standard development in China 中國藥典 (2022)藥品雜質分析指導原則 Ch P( 2022) Guideline on Analysis of Drug Impurities ? 本附錄為藥品質量標準中化學合成或半合成的有機原料藥及其制劑雜質分析的指導原則 ,供藥品研究、生產、質量標準起草和修訂參考 ? This is the guideline on the analysis of impurities in synthesized or semisynthesized anic drug substances and their preparations for drug research, pharmaceutical manufacturing, and revision of drug standards 中國藥典 (2022)藥品雜質分析指導原則 Ch P( 2022) Guideline on Analysis of Drug Impurities ? 任何影響藥品純度的物質均稱為雜質 ? Any substance that affects the purity of a drug is considered as an impurity 中國藥典 (2022)藥品雜質分析指導原則 Ch P( 2022) Guideline on Analysis of Drug Impurities ? 藥品質量標準中的雜質系指，在按照經國家有關藥品監(jiān)督管理部門依法審查批準的規(guī)定工藝和規(guī)定原輔料生產的藥品中，由其生產工藝或原輔料帶入的雜質，或經穩(wěn)定性試驗確證的在貯存過程中產生的降解產物 ? Impurities listed in a drug standard may be introduced from production process, starting materials or excipients of the drug produced with specified process and materials officially approved by the petent drug regulatory authority . The impurities may be the degradation products arising in the storage period , that is validated by stability testing 中國藥典 (2022)藥品雜質分析指導原則 Ch P( 2022) Guideline on Analysis of Drug Impurities ? 藥品質量標準中的雜質不包括變更生產工藝或變更原輔料而產生的新的雜質，也不包括摻入或污染的外來物質 ? The new impurities caused by change of production process or materials ,or from foreign substances adulterated or contaminated are not included in the impurities of the drug standard 中國藥典 (2022)藥品雜質分析指導原則 Ch P( 2022) Guideline on Analysis of Drug Impurities ? 藥品生產企業(yè)變更生產工藝或原輔料，并因由此帶進新的雜質對原質量標準的修訂，均應依法向有關藥品監(jiān)督管理部門申報批準 ? Application for changing in production process or materials,and requesting for revision of the drug standard due to new impurities caused by the changing shall be submitted to the petent authority for approval according to the law 中國藥典 (2022)藥品雜質分析指導原則 Ch P( 2022) Guideline on Analysis of Drug Impurities ? 藥品中不得摻入或污染藥品或其組分以外的外來物質。對于假劣藥品，必要時應根據各該具體情況，采用非法定分析方法予以檢測 ? Drugs shall not be adulterated or contaminated by foreign substances. Nonofficial methods can be adopted to monitor the counterfeit drugs 中國藥典 (2022)藥品雜質分析指導原則 Ch P( 2022) Guideline on Analysis of Drug Impurities ? 項目名稱 ? The classification of impurities and their testing item titles in the drug standards 中國藥典 (2022)藥品雜質分析指導原則 Ch P( 2022) Guideline on Analysis of Drug Impurities ? 按化學類別和特性，雜質可分為：有機雜質、無機雜質、有機揮發(fā)性雜質 ? According to the chemical category and characteristics, impurities could be classified as anic impurities, inanic impurities and anic volatile impurities 中國藥典 (2022)藥品雜質分析指導原則 Ch P( 2022) Guideline on Analysis of Drug Impurities ? 按其來源，雜質可分為：有關物質 ,其他雜質和外來物質等 ? According to the source, impurities could be classified as related substances (including degradation products), other impurities, foreign substances, etc. 中國藥典 (2022)藥品雜質分析指導原則 Ch P( 2022) Guideline on Analysis of Drug Impurities ? 按結構關系，雜質又可分為：其他甾體、其他生物堿、幾何異構體、光學異構體等 ? Impurities could be classified as other steroids, other alkaloids ,geometric isomers, optical isomers, etc based upon the structure relationship 中國藥典 (2022)藥品雜質分析指導原則 Ch P( 2022) Guideline on Analysis of Drug Impurities ? 按其毒性，雜質又可分為毒性雜質和普通雜質等。普通雜質即為在存在量下無顯著不良生理作用的雜質，而毒性雜質為具強烈不良生理作用的雜質 ? Impurities could be classified as toxic and ordinary impurities according to the toxicity 中國藥典 (2022)藥品雜質分析指導原則 Ch P( 2022) Guideline on Analysis of Drug Impurities ? 由于雜質的分類方法甚多 ， 所以 ， 藥品質量標準中檢查項下雜質的項目名稱 ， 應根據國家藥典會編寫的 《 國家藥品標準工作手冊 》 的要求進行規(guī)范 ? The item title for a impurity in a drug specification shall be normalized based on the requirements of the Manual for Revising to National Drug Standards published by the Commission of the Chinese Pharmacopoeia 中國藥典 (2022)藥品雜質分析指導原則 Ch P( 2022) Guideline on Analysis of Drug Impurities ? 2. 質量標準中雜質檢查項目的確定 ? Selection of impurity testing items for drug standard ? 新原料藥和新制劑中的雜質，應按國家有關新藥申報要求進行研究 ? Studies on impurities in new drug substances and new preparations shall be conducted in accord with the relevant requirements for registration application of new drugs in China 中國藥典 (2022)藥品雜質分析指導原則 Ch P( 2022) Guideline on Analysis of Drug Impurities ? 也可參考 ICH（人用藥品注冊技術要求國際協(xié)調會）的文本 Q3A（新原料藥中的雜質）和 Q3B（新制劑中的雜質）進行研究，并對雜質和降解產物進行安全性評價 ? The studies on impurities in new drug substances and new preparations could be performed by referring to the ICH guidelines Q3A or Q3B, too. The safety evaluation for impurities and degradation products should be made 中國藥典 (2022)藥品雜質分析指導原則 Ch P( 2022) Guideline on Analysis of Drug Impurities ? 新藥研制部門對在合成、純化和貯存中實際存在的雜質和潛在的雜質，應采用有效的分離分析方法進行檢測 ? Effective analytical method of separation shall be adopted by the new drug research institutions for determining actually present and potential impurities arising from synthesis, purification and storage 中國藥典 (2022)藥品雜質分析指導原則 Ch P( 2022) Guideline on Analysis of Drug Impurities ? 對于表觀含量在 %及其以上的雜質，以及表觀含量在 %以下的具強烈藥理作用的雜質或毒性雜質，予以定性，或確證其結構 ? Characterization or structure confirmation shall be carried out for the impurity that its apparent level is % or above, and for the toxic impurity or impurity with significant pharmacological effect that its apparent level is under % 中國藥典 (2022)藥品雜質分析指導原則 Ch P( 2022) Guideline on Analysis of Drug Impurities ? 對在穩(wěn)定性試驗中出現(xiàn)的降解產物，也應按上述要求進行研究 ? The degradation products found in the stability testing (accelerate and long term) shall be studied according to the above requirement 中國藥典 (2022)藥品雜質分析指導原則 Ch P( 2022) Guideline on Analysis of Drug Impurities ? 新藥質量標準中的雜質檢查項目應包括經研究和穩(wěn)定性考察檢出的，并在批量生產中出現(xiàn)的雜質和降解產物，并包括相應的限度 ? Impurity testing items in the new drug standard should include the impurities and degr