【文章內(nèi)容簡介】 bstances 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)原則在國外藥典中的引用 Citation of ICH impurity guideline by foreign pharmacopoeias ? USP27 凡例（ General Notices)對其他雜質(zhì)的規(guī)定 ? 法定原料藥中出現(xiàn)（正文）未標明的雜質(zhì)，其量為 %或以上時，且是由于變更工藝或其他可說明原因產(chǎn)生的，檢測方法應(yīng)報 USP，申請收載入正文，否則應(yīng)在分析證其他雜質(zhì)項下標明，并注明量。其他雜質(zhì)加上正文檢出的雜質(zhì)總量不得過 % ICH關(guān)于雜質(zhì)指導(dǎo)原則在國外藥典中的引用 Citation of ICH impurity guideline by foreign pharmacopoeias ? The presence of any unlabeled impurity in an official substance is a variance from the standard if the content is % or greater. Tests suitable for detection and quantitating unlabeled impurities ,when present as the result of process change or other identifiable, consistent occurrence , shall be submitted to the USP for inclusion in the individual monograph. Otherwise, the impurity shall be identified, preferably by name, and the amount listed under the heading Other Impurities in the labeling (COA) of the official substance. The sum of all other impurities bined with the monographdetected impurities does not exceed %, unless otherwise stated in the monograph ICH關(guān)于雜質(zhì)指導(dǎo)原則在國外藥典中的引用 Citation of ICH impurity guideline by foreign pharmacopoeias ? USP關(guān)于修訂 USPNF申報要求指導(dǎo)原則（征求意見稿）中，非復(fù)雜有效成分中雜質(zhì)檢查新要求 ? New requirement for testing of impurities in the nonplex actives ? See USP Guideline for Submitting Requests for Revision to the USPNF ICH關(guān)于雜質(zhì)指導(dǎo)原則在國外藥典中的引用 Citation of ICH impurity guideline by foreign pharmacopoeias ? 對于新的原料藥正文（ New monograph for a drug substance), 雜質(zhì)檢查應(yīng)對全部指定雜質(zhì)規(guī)定限度，所有非指定雜質(zhì)的限度均為 % ? The impurity test of a drug substance monograph is intended to limit all specified impurities, with a further limit of % for all unspecified impurities ICH關(guān)于雜質(zhì)指導(dǎo)原則在國外藥典中的引用 Citation of ICH impurity guideline by foreign pharmacopoeias ? USP 新的正文（ new monographs) 的雜質(zhì)將按表中的命名法 ? For new monographs, USP will follow nomenclature and approaches shown in the table ICH關(guān)于雜質(zhì)指導(dǎo)原則在國外藥典中的引用 Citation of ICH impurity guideline by foreign pharmacopoeias ICH關(guān)于雜質(zhì)指導(dǎo)原則在國外藥典中的引用 Citation of ICH impurity guideline by foreign pharmacopoeias ? USP原料藥正文僅收載檢查實際存在的，而不是理論存在雜質(zhì)的方法 ? USP drug substance monographs will include only procedures that control actual, not theoretical , impurities ICH關(guān)于雜質(zhì)指導(dǎo)原則在國外藥典中的引用 Citation of ICH impurity guideline by foreign pharmacopoeias ? 由于合成路線不同，產(chǎn)生不同的雜質(zhì)，需用不同方法檢查，此情況下，在有關(guān)文件上（如COA）應(yīng)說明附加的可行方法 ? Where different routes of synthesis yield different impurity profiles, different impurity procedure may be needed. In this case, the additional applicable procedure should be included in the labeling ICH關(guān)于雜質(zhì)指導(dǎo)原則在國外藥典中的引用 Citation of ICH impurity guideline by foreign pharmacopoeias ? 如果申報資料中有 FDA未評價過的已知毒性的雜質(zhì)，則在申報資料中應(yīng)包括毒性數(shù)據(jù) ? If the request for revision describes an impurity of known toxicity that has not previously been evaluated by the FDA, toxicity data should be included in the Request for Revision ICH關(guān)于雜質(zhì)指導(dǎo)原則在國外藥典中的引用 Citation of ICH impurity guideline by foreign pharmacopoeias ? 對有機雜質(zhì)（ for anic impurities) ? 色譜識別和定量用外標法 ? To identify and quantify impurities, an external rather than an internal standard is preferred. The use of external standards is preferable, as internal standards may obscure other impurities ICH關(guān)于雜質(zhì)指導(dǎo)原則在國外藥典中的引用 Citation of ICH impurity guideline by foreign pharmacopoeias ? 有機雜質(zhì)用原料藥對照標準品或外標雜質(zhì)對照品比對定量。盡可能用需要限量的指定雜質(zhì)的USP對照標準品對已知雜質(zhì)進行定量 ? The quantification of anic impurities should be done by parison to either the drug substance reference standard or to an external impurity reference standard. Where possible, official USP Reference Standards of specified impurities to be limited are the best option when quantifying identified impurities ICH關(guān)于雜質(zhì)指導(dǎo)原則在國外藥典中的引用 Citation of ICH impurity guideline by foreign pharmacopoeias ? 雜質(zhì)的限度應(yīng)符合 ICHQ3A的要求，并對每個指定雜質(zhì)規(guī)定限度，并在必要時規(guī)定非指定雜質(zhì)的限度，總雜質(zhì)限度，報告限度，雜質(zhì)的限度應(yīng)適應(yīng)于貨架效期 ? Acceptance criteria should ply with ICH Q3A and should be provided for each specified impurity, any unspecified impurity as appropriate, total impurities, and report thresholds. These acceptance criteria are applicable throughout shelflife ICH關(guān)于雜質(zhì)指導(dǎo)原則在國外藥典中的引用 Citation of ICH impurity guideline by foreign pharmacopoeias ? 英國藥典 2022版補充附錄“雜質(zhì)檢查”，其中的有關(guān)物質(zhì) ? The supplementary chapters of BP 2022, A. Control of Impurities ? related substances ICH關(guān)于雜質(zhì)指導(dǎo)原則在國外藥典中的引用 Citation of ICH impurity guideline by foreign pharmacopoeias ? 起草正文時，要求企業(yè)提供雜質(zhì)的性質(zhì)、雜質(zhì)存在的理由、按 GMP生產(chǎn)條件下雜質(zhì)的量，貯存期變化情況，與原料藥本身有關(guān)的雜質(zhì)毒性說明 ? When preparation of a monograph is initiated the manufacturer is asked to provide information concerning the nature of such impurities, the reason for their presence, the amounts that may be encountered in material prepared under conditions of GMP and the manner in which proportions may vary on storage, together with an indication of the toxicity of any impurities in relation to that of the substance itself ICH關(guān)于雜質(zhì)指導(dǎo)原則在國外藥典中的引用 Citation of ICH impurity guideline by foreign pharmacopoeias ? 生產(chǎn)工藝或降解產(chǎn)生的特殊雜質(zhì)，根據(jù)毒性等理由，需規(guī)定限度的，用專屬檢查 ? A specific test is included where a particular impurity arising from the manufacturing process or from degradation needs to be limited on ground of toxicity or for another special reason ICH關(guān)于雜質(zhì)指導(dǎo)原則在國外藥典中的引用 Citation of ICH impurity guideline by foreign pharmacopoeias ? 該補充附錄說明了，與生產(chǎn)企業(yè)有關(guān)的指導(dǎo)原則，見 ICH Q3A 和 Q3B ? Other guidance related to manufacturers is provided in, for example, ICH guidelines on impurities in new drug substances(Q3A) and new drug preparations(Q3B) 中國藥典 (2022)藥品雜質(zhì)分析指導(dǎo)原則 Ch P( 2022) Guideline on Analysis of Drug Impurities ? 本指導(dǎo)原則為參考人用藥品注冊申報技術(shù)要求國際協(xié)調(diào)會，根據(jù)中國的具體情況起草的 2022年版中國藥典新增附錄 ? This is a new guideline to be included in the Chinese Pharmacopoeia 2022 ,drafted on the basi