【正文】 adation products detected in the quality study and stability testing, and appeared in the batches produced in an industrial scale. The corresponding limit shall be provided 中國藥典 (2022)藥品雜質分析指導原則 Ch P( 2022) Guideline on Analysis of Drug Impurities ? 除降解產物和毒性雜質外，在原料中已控制的雜質，在制劑中一般不再控制 ? Impurities controlled in the drug substance specification will not be controlled in its preparation specification except degradation products and toxic 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 ? 原料藥和制劑中的無機雜質，應根據(jù)其生產工藝、起始原料情況確定檢查項目，但對于毒性無機雜質，應在質量標準中規(guī)定其檢查項 ? Inanic impurity testing items for drug substances and preparations shall be selected according to the manufacturing process and starting materials. Testing items for toxic inanic impurities shall be established for 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 ? 在仿制藥品的研制和生產中 ， 如發(fā)現(xiàn)其雜質模式與其原始開發(fā)藥品的不同 ， 或與已有法定質量標準規(guī)定不同 ， 需增加新的雜質檢查項目的 ， 應按上述方法進行研究 ， 申報新的質量標準或對原質量標準進行修訂 ， 并報有關藥品監(jiān)督管理部門審批 。 ? Where the impurity profile found in the study or production of a generic drug is different from that of the innovated one or from the existing official standard, the new impurities shall be studied according to the above requirements, and an application for revising to the original standard or establishing a new standard shall be submitted to the relevant drug regulatory authority for review and approval 中國藥典 (2022)藥品雜質分析指導原則 Ch P( 2022) Guideline on Analysis of Drug Impurities ? 共存的異構體和抗生素多組分一般不作為雜質檢查項目，作為共存物質，必要時，在質量標準中規(guī)定其比例，以保證生產用的原料藥與申報注冊時的一致性。但當共存物質為毒性雜質時，該物質就不再認為是共存物質 ? The conitant isomers and the antibiotics multiponents are generally not the testing items of impurities. For conitants, their proportion may be specified in the specification to ensure the consistency of drug substances used for production and those for registration application. The toxic conitants will be considered as impurities instead of conitants 中國藥典 (2022)藥品雜質分析指導原則 Ch P( 2022) Guideline on Analysis of Drug Impurities ? 單一對映體藥物，其可能共存的其他對映體，應作為雜質檢查。消旋體藥物，當已有其單一對映體藥物的法定質量標準時，應在該消旋體藥物的質量標準中設旋光度檢查項目 ? 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 中國藥典 (2022)藥品雜質分析指導原則 Ch P( 2022) Guideline on Analysis of Drug Impurities ? 3. 雜質檢查分析方法和雜質的限度 ? Analytical methods for impurity testing and impurity limit ? 雜質檢查分析方法應專屬、靈敏 ? The analytical methods for impurity testing should be specific and sensitive 中國藥典 (2022)藥品雜質分析指導原則 Ch P( 2022) Guideline on Analysis of Drug Impurities ? 雜質檢查應盡量采用現(xiàn)代分離分析手段，主成分與雜質和降解產物均能分開，其檢測限應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 中國藥典 (2022)藥品雜質分析指導原則 Ch P( 2022) Guideline on Analysis of Drug Impurities ? 對于需作定量檢查的雜質 ， 方法的定量限應滿足相應的要求 。 ? For the impurities to be quantified, the quantification limit shall meet the intended 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 ? 雜質檢查分析方法的建立應按本藥典的要求作方法驗證。在研究時，應采用幾種不同的分離分析方法或不同測試條件 以便比對結果，選擇較佳的方法作為質量標準的檢查方法 ? The analytical methods for impurity testing should be validated according to the requirements of the Ch P. Different methods may be adopted in the research stage, results should be pared to select a suitable method as the pendium method 中國藥典 (2022)藥品雜質分析指導原則 Ch P( 2022) Guideline on Analysis of Drug Impurities ? 雜質檢查分析方法的建立 ， 應考慮普遍適用性 ， 所用的儀器和試材應容易獲得 。對于特殊試材 ， 應在質量標準中寫明 。 ? 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 ? 新藥研究中的雜質和降解產物，或在非新藥中發(fā)現(xiàn)的新雜質和新降解產物，應進行分離純化制備，或合成制備，以供進行安全性和質量研究 ? 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 中國藥典 (2022)藥品雜質分析指導原則 Ch P( 2022) Guideline on Analysis of Drug Impurities ? 對確實無法獲得的雜質和降解產物 ， 研制部門應在申報資料和質量標準起草說明中寫明理由 。 ? When the impurities or degradation products could not be obtained, rationals should be provided in the dossier submitted and the illustration of the specification by the research institution 中國藥典 (2022)藥品雜質分析指導原則 Ch P( 2022) Guideline on Analysis of Drug Impurities ? 在用現(xiàn)代色譜技術對雜質進行分離分析的情況下，對已知雜質和毒性雜質，應使用雜質對照品進行定位，如無法獲得該對照品時，可用相對保留值進行定位 ? Where modern chromatographic method is used for the separation of impurities, known impurities and toxic impurities may be identified using impurity reference substances, relative retention values could be used for the identification when the reference standards are not available 中國藥典 (2022)藥品雜質分析指導原則 Ch P( 2022) Guideline on Analysis of Drug Impurities ? 應使用多波長檢測器研究雜質在不同波長下的檢測情況，并求得在確定的一個波長下，已知雜質，特別是毒性雜質對主成分的相對響應因子 ? Impurities can be studied at different wavelengths using multiwavelength detector, relative response factors of known and/or toxic impurities at a fixed wavelength to the substance to be tested should be calculated 中國藥典 (2022)藥品雜質分析指導原則 Ch P( 2022) Guideline on Analysis of Drug Impurities ? 已知雜質或毒性雜質對主成分的相對響應因子在 ~，可以用主成分的自身對照法計算含量 ? Where the relative response factor is in the range of ~, content of impurity could be calculate