EP 51000 药用物质的杂质控制（中英文）
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51000E 药用物质的杂质控制
04/2012:51000
5.10. CONTROL OF IMPURITIES IN SUBSTANCES FOR PHARMACEUTICAL
USE 药用物质的杂质控制
Preamble 前言
The monographs of the European Pharmacopoeia on substances for pharmaceutical u are designed to ensure acceptable quality for urs. The role of the pharmacopoeia in public health protection requires that adequate control of impurities be provided by monographs. The quality required is bad
on scientific, technical and regulatory considerations.
欧洲药典对药用物质的各论是设计以保证其达到用户可接受品质的。药典在公众健康保护中的作用是要求对各论中所列的杂质进行充分控制。这些所要求的品质是基于科学、技术和法规的考虑的。
Requirements concerning impurities are given in specific monographs and in the general monograph Substances for pharmaceutical u (2034). Specific monographs and the general monograph are complementary: specific monographs prescribe acceptance criteria for impurities whereas the general monograph deals with the need for qualification, identification and reporting of any organic impurities that occur in active substances.
在各论中和通论2034（药用物质）中给出的杂质要求是互补的：各论描述各杂质的可接受标准，而通论指出所有在活性物质中出现的有机杂质的界定、鉴别和报告阈值。The thresholds for reporting, identification and qualification contained in the general monograph Substances for pharmaceutical u (2034) apply to all related substances. However, if a monograph does not contain a related substances test bad on a quantitative method, any new impurities occurring above a threshold may be overlooked since the test is not capable to detect tho impurities.
panda是什么意思在通论2034（药用物质）中的报告阈、鉴别阈和界定阈适用于所有有关物质。但是，如果各论中没有
有关物质的定量检测方法，则需要关注所有在阈值以上的新杂质，因为该方法无法检测到这些杂质。
The provisions of the Related substances ction of the general monograph Substances for pharmaceutical u (2034), notably tho concerning thresholds, do not apply to excipients; also excluded from the provisions of this ction are: biological and biotechnological products; oligonucleotides; radiopharmaceuticals; fermentation products and misynthetic products derived therefrom; herbal products and crude products of animal and plant origin. Although the thresholds stated in the general monograph do not apply, the general concepts of reporting, identification (wherever possible) and qualification of impurities are equally valid for the class. 通论2034（药用物质）中“有关物质”条款，特别是那些关于阈值的内容，不适用于辅料，也不适用于以下品种：生物和生物技术产品、寡聚核苷酸、放射药品、发酵产品和半合成产品及其衍生物、草药制品和动植物来源粗品。尽管在通论中的阈值并不适用，关于杂质报告阈、鉴别阈（可能时）和界定阈对这些品种仍然有效。
Basis for the elaboration of monographs of the European Pharmacopoeia 欧洲药典各论起草的基础
European Pharmacopoeia monographs are elaborated on substances that are prent in medicinal products that have been authorized by the competent authorities of Parties to the European Pharma
copoeia Convention. Conquently, the monographs do not necessarily cover all sources of substances for pharmaceutical u on the world market.
从零开始学法语欧洲药典各论是针对用于由欧洲药典委员会相关方药监局批准的药用产品的物质而起
草的。因此，这些各论不一定包括在世界范围内使用的所有来源药用物质。
Organic and inorganic impurities prent in tho substances that have been evaluated by the competent authorities are qualified with respect to safety at the maximum authorized content (at the maximum daily do) unless new safety data that become available following evaluation justify lower limits.
这些物质里的有机和无机杂质已由适当的药监机构进行评估，认为其符合安全要求的最大许可含量（基于最大日服用量），除非有新的安全数据证明其可以采用更低的限度。
European Pharmacopoeia monographs on substances for pharmaceutical u are elaborated by groups of experts and working parties collaborating with national pharmacopoeia authorities, the competent authorities for marketing authorization,
national control laboratories and the European Pharmacopoeia laboratory; they are also assisted by
the producers of the substances and/or the pharmaceutical manufacturers that u the substances.
欧洲药典中药用物质的各论由专家工作组和与国家药典机构合作的工作团队、适当的上市批准药监机构、国家控制实验室和欧洲药典实验室起草；同时还有物质的生产商和/或使用该物质的药品生产商进行协助。
Control of impurities in substances for pharmaceutical u 药用物质的杂质控制
The quality with respect to impurities is controlled by a t of tests within a monograph. The tests are intended to cover organic and inorganic impurities that are relevant in view of the sources of active substances in authorized medicinal products.
杂质的质量由各论中一系列的检测来控制。这些检查的需要包括用于批准的药用产品的活性物质中所有与来源有关的有机和无机的杂质，
Control of residual solvents is provided by the general monograph Substances for pharmaceutical u (2034) and general chapter 5.4. Residual solvents. The certificate of suitability of a monograph of the European Pharmacopoeia for a given source of a substance indicates the residual solvents th
at are controlled together with the specified acceptance criteria and the validated control method where this differs from tho described in general chapter 2.4.24. Identification and control of residual solvents.
残留溶剂的控制在通论2034（药用物质）和通则5.4残留溶剂中给出。CEP会对特定来源的物质指明其中残留溶剂，及其可接受标准，如果检测方法与通则2.4.24残留溶剂的鉴别和控制不同，则会在CEP中列出。
Monographs on organic chemicals usually have a test entitled “Related substance” that covers relevant organic impurities. This test may be supplemented by specific test there the general test does not control a given impurity or where there are particular reasons (for example, safety reasons) for requiring special control.
有机化学物的各论通常有一个检测项目称为“有关物质”，其中包括了有关的有机杂质。如果通用检测无法控制一个给定的杂质，或者有一些特殊原因，该测试可能需要其它特定的检测项目加以补充。
Where a monograph has no Related substances (or equivalent) test but only specific tests, the ur of a substance must nevertheless ensure that there is suitable control of organic impurities; tho occurring above the identification threshold are to be identified (wherever possible) and, unless justifi
ed, tho occurring above the
中秋节的英文翻译qualification threshold are to be qualified (e also under Recommendations to urs of monographs of active substances).
如果各论中没有“有关物质”项（或相当的项目），而只有特定检测项目，物质使用者必须保证有必要的方法来控制有机杂质。凡高于鉴别阈的杂质需要进行鉴别（只要可能），除非经过论证，凡高于界定阈的杂质需要进行界定（参见本通论“对活性物质各论使用者的建议”部分）
Where the monograph covers substances with different impurities profiles, it may
have a single related substances test to cover all impurities mentioned in the Impurities ction or veral tests may be necessary to give control of all known profiles. Compliance may be established by carrying out only the tests relevant to the known impurity profile for the source of the substance.
如果各论包括了不同杂质概况的物质，可能有一个单独的有关物质检测包括在杂质部分提及的所有杂质，或可能需要几个不同的检测方法对所有已知杂质概况进行控制。如要证明物质符合要求，可能只需要根据所采用工艺分析物质的杂质概况，采用针对该杂质概况的检测方法即可。
Instructions for control of impurities may be included in the Production ction of a monograph, for e
xample where the only analytical method appropriate for the control
of a given impurities is to be performed by the manufacturer since the method is too technically complex for general u or cannot be applied to the final drug substance and/or where validation of the production process (including the purification step) will give sufficient control.
对杂质控制要求可能包括在各论的生产部分，例如，如果仅有一个分析方法适用于某给定的杂质，生产商需要采用该方法检测，但该方法技术太复杂，无法普遍使用，或无法应用于原料药成品和/或生产工艺验证（包括精制步骤）可能会给出足够的控制。Impurities ction in monographs on active substances 活性物质各论的杂质部分The Impurities ction in a monograph includes impurities (chemical structure and name wherever possible), which are usually organic, that are known to be detected by the tests prescribed in the monograph. It is bad on information available at the time of elaboration or revision of the monograph and is not necessarily exhaustive. The ction includes specified impurities and, where so indicated, other detectable impurities.
各论中的杂质部分包括杂质（可能时会列出化学结构和名称）通常为无机物，可以由各论的方法检测出。这是基于在各论起草或修订时已有的信息，不一定包括了所有杂质。这部分包括了已识别杂质和，如果有指出，其它可检出杂质。
Specified impurities have an acceptance criterion not greater than that authorized by the competent authorities.
已识别杂质可接受标准应不大于相关药监机构指定的限度。
Other detectable impurities are potential impurities with a defined structure but not known to be normally prent above the identification threshold in substances ud in medicinal products that have been authorized by the competent authorities of Parties to the Convention. They are given in the Impurities ction for information.
turkiye在被相关药监机构批准的药品中使用的物质中，其它可检出杂质是一些具有已知结构的潜在杂质，但并通常不在鉴别阈以上。这些杂质信息在杂质部分给出供参考。
Where an impurity other than a specified impurity is found in an active substance it is the responsibility of the ur of the substance to check whether it has to be
be my wife
identified/qualified, depending on its content, nature, maximum daily do and relevant identification/qualification threshold, in accordance with the general monograph on Substances for pharmaceutical u (2034), Related substances ction.
如果在活性物质中发现有特定杂质以外的杂质，活性物质的使用者应根据通论2034（药用物质）有关物质部分的要求，检查是否需要对该杂质地鉴别/界定，判定的依据是其成份、特性、最大日服用量或相应的识别/界定阈。
It should be noted that specific thresholds are applied to substances exclusively for veterinary u.
需要注意的是识别阈不适用于兽用物质。
Interpretation of the test for related substances in the monographs on active substances
瑜伽课程培训活性物质各论中有关物质检测的解释
touchpanelA specific monograph on a substance for pharmaceutical u is to be read and interpreted in conjunction with the general monograph on Substances for pharmaceutical u (2034).
药用物质的各论应与通论2034（药用物质）结合解读。
