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General Notices and Requirements凡例

Applying to Standards, Tests, Assays, and Other Specifications of the United States Pharmacopeia

应用于美国药典的标准、测试、定量分析、其他质量标准

The General Notices and Requirements (hereinafter referred to as the General Notices) and general requirements appearing in General Chapters provide in summary form the basic guidelines for the interpretation and application of the standards, tests, assays, and other specifications of the United States Pharmacopeia and eliminate the need to repeat throughout the book those requirements that are pertinent in numerous instances. Where no specific language is given to the contrary, the requirements under the General Notices and General Chapters apply.

凡例（下文中称为凡例）和出现在通则中的常规要求以总结的形式为理解和应用美国药典的标准、测试、定量分析、其他质量标准，提供了基本指导原则，并消除了在全书的无数个案中重复那些要求的必要。在没有具体的言语指向对立情况时，就适用在凡例和通则下的要求。

Where exceptions to the General Notices or General Chapters are made, the wording in the individual monograph takes precedence and specifically indicates the directions or the intent. To emphasize that such exceptions do exist, the General Notices or General Chapters in some places employ where indicated a qualifying expression such as “unless otherwise specified.” In the individual monograph, it is understood that the specific wording of standards, tests, assays, and other specifications is binding wherever deviations from the General Notices or General Chapters exist whether or not a statement of exception is made.

当不同于凡例和通则的例外发生时，在具体各论中的语句具优先权，并具体地指明了方向或目的。为了强调此类例外确实存在，凡例和通则在某些地方使用了指明适用情况的表达方式，例如“除非另有规定。”在具体的各论中，只要存在与凡例和通则的差异，而不论是否有关于例外的声明，均要认为各论的标准、测试、定量分析、其他质量标准的具体语句必须遵守。

TITLE名称

The full title of this publication, including its supplements, is The Pharmacopeia of the United States of America, Thirtieth revision. This title may be abbreviated to United States Pharmacopeia, Thirtieth Revision, or to USP 30. The United States Pharmacopeia, Thirtieth Revision, supersedes all earlier revisions. Where the term “USP ” is used, without further qualification, it refers only to USP 30 and any supplement(s) thereto. The same titles, with no further distinction, apply equally to print or electronic presentation of these contents.

此出版物包括其增补本的全称为美利坚合众国药典，30版。这个名称可以简称为美国药典30版，或USP 30。美国药典30版取代了所有早前的版本。当用到“USP”这个名词时，无需进一步确认，它仅指USP 30和对其的任何增补本。同样的名称，没有任何进一步的区别，适用于这些内容的打印或电子版本。

“OFFICIAL” AND “OFFICIAL ARTICLES”

“官方的”和“官方物品”

The word “official”, as used in this Pharmacopeia or with reference hereto, is synonymous with “Pharmacopeial”, with “USP”, and with “compendial”. “官方的”一词，在此药典中使用或提到时，是“药典”、“USP”、“药典”的同义词。

The designation “USP” in conjunction with the official title or elsewhere on the label of an article indicates that a monograph is included in the USP and that the article purports to comply with all applicable USP standards. The designation “USP” on the label may not and does not constitute a representation, endorsement, or incorporation by the manufacture’s labeling of the informational material contained in the USP monograph, nor does it constitute assurance by USP that the article is known to comply with a USP standard or other requirements only when the article is recognized in the USP. The standards apply equally to articles bearing the official titles or names derived by transposition of the definitive words of official titles or transposition in the order of the names of two or more active ingredients in official titles, whether or not the added designation “USP” is used. Names considered to be synonyms of the official titles may not be used for official titles.

与药典名称有关或在某个物品标签上的“USP”字样说明在美国药典（USP）中包含了某个各论，并且该物品声称符合所有适用的USP标准。在标签上的“USP”的字样

Although both compendia, the United States Pharmacopeia and the National Formulary, currently are published under one cover, they remain separate compendia. The designation USP-NF or similar combination may be used on the label of an article, provided the label also bears a statement such as “Meets NF standards as published by the USP,” indicating the particular compendium to which the article purports to apply.

Where an article differs from the standards of strength, quality, and purity, as determined by the application of the assays and tests set forth for it in the Pharmacopeia, its difference shall be plainly stated on its label. Where an article fails to comply in identity with the identity prescribed in the USP, or contains an added substance that interferes with the prescribed assays and tests, such article shall be designated by a name that is clearly distinguishing and differentiating from any name recognized in the Pharmacopeia.

Articles listed herein are official and the standards set forth in the monographs apply to them only when the articles are intended or labeled for use as drugs, as nutritional or dietary supplements, or as medical devices and when bought, sold, or dispensed for these purposes or when labeled as conforming to this Pharmacopeia.

An article is deemed to be recognized in this Pharmacopeia when a monograph for the article is published in it, including its supplements, addenda, or other interim revisions, and an official date is generally or specifically assigned to it.

The following terminology is used for distinguishing the articles for which monographs are provided: an official substance is an active drug entity, a recognized nutrient, a dietary supplement ingredient, or a pharmaceutic ingredient (see also NF 26) or a component of a finished device for which the monograph title includes no indication of the nature of the finished form: an official preparation is a drug product, a nutritional supplement, dietary supplement, or a finished device. It is the finished or partially finished (e.g., as in the case of a sterile solid to be constituted into a solution for administration) preparation or product of one or more official substances formulated for use on or for the patient or consumer; an article is an item for which a monograph is provided, whether an official substance or an official preparation.

Designating Conformance with Official Standards－When the letters “USP” or “NF” or “USP-NF” are used on the label of an article to indicate compliance with compendial standards, the letters shall appear in conjunction with the official title of the article or when appropriate, with the ingredients contained therein. The letters are not to be enclosed in any symbol such as a circle, square, etc., and must appear in block capital letters.

标明与药典标准的符合性—当在某个物品的标签上使用“USP”或“NF”等字母以显示与药典标准的合规性时，这些字母与该物品的药典名称一起出现，或在适当时，与其中装有的组分一起出现。这些字符不得以诸如圆字、方字之类的符号出现，而必须为印刷体大写字母。

If a dietary supplement purports to be or is represented as an official product and such claim is determined by the USP not to be made in good faith, it is the policy of the USP to seek appropriate legal redress.

Products Not Marketed in the United States－Interest in the USP outside the United States has always existed. From time to time, monographs may be adopted for articles not legally marketed in the United States as a service to authorities in other countries where USP standards are recognized and applied. Appearance of any such monograph does not grant any marketing rights whatsoever, and the status of the article in the United States must be checked with the U.S. Food and Drug Administration in the event of any question.

Nutritional and Other Dietary Supplements－The designation of an official preparation containing one or more recognized nutrients or dietary supplement ingredients as “USP” or the use of the designation “USP” in conjunction with the title of such nutritional or dietary supplement preparation may be made only if the preparation meets all the applicable requirements contained in the individual