美国药典凡例中英文USPNFGeneralNotice

美国药典凡例中英文USPNFGeneralNotice
USP32-NF27
General Notices 凡例
USP32 (2)
Introduction 简介 (2)
4. MONOGRAPHS AND GENERAL CHAPTERS 正文和附录 (3)
5. MONOGRAPH COMPONENTS 专论构成 (7)
6. TESTING PRACTICES AND PROCEDURES 试验规范和过程(18)
7. TEST RESULTS 测试结果 (28)
8. TERMS AND DEFINITIONS 术语及定义 (31)
9. PRESCRIBING AND DISPENSING 开方和配方 (41)
10. PRESERV ATION, PACKAGING, STORAGE, AND LABELING 防腐，包装，贮藏和标签 (42)
NF27 (66)
Introduction 简介 (66)
TITLE 标题 (67)
“OFFICIAL” AND “OFFICIAL ARTICLES” “药典的”和“药典药物” (68)
STORAGE UNDER NONSPECIFIC CONDITIONS 非特定条件下的贮存 (70)
OTHER GENERAL NOTICES 其他凡例 (71)
USP32
Introduction 简介
GENERAL NOTICES AND REQUIREMENTS
凡例和要求
Change to read:
The General Notices and Requirements section (the General Notices) presents the basic assumptions, definitions, and default
conditions for the interpretation and application of the United States Pharmacopeia (USP) and the National Formulary (NF).
凡例和要求部分（凡例）给出对USP和NF中假设、定义、默认条件的解释和应用。

Requirements stated in these General Notices apply to all articles recognized in the USP and NF (the “compendia”) and to all general chapters unless specifically stated otherwise. Where the requirements of an individual monograph differ from the General Notices or a general chapter, the monograph requirements apply and supersede the requirements of the General Notices or the general chapter, whether or not the monograph explicitly states the difference.
除另有规定外，凡例中的要求应用于所有USP和NF公认的(即药典的)药品，也适用于所有附录。

如果专论的要求与凡例或附录要求不同，无论专论是否说明改差别，都应使用专论要求取代凡例或附录的要求。

4. MONOGRAPHS AND GENERAL CHAPTERS 正文和附录
4.10 Monographs专论
Monographs set forth the article's name, definition, specification, and other requirements related to packaging, storage, and labeling. The specification consists of tests, procedures, and acceptance criteria that help ensure the identity, strength, quality, and purity of the article. For general requirements relating to specific monograph sections, see section 5, Monograph Components.
专论阐述了药品的名称，定义，质量标准，及其他和包装，储存和标签相关的要求。

质量标准包括测试，过程，及可接受范围，保证了药品的特性，规格，质量和纯度。

对于特定专论相关的一般要求，参见章节5“专论构成”。

Because monographs may not provide standards for all relevant characteristics, some official substances may conform to
the USP or NF standard but differ with regard to nonstandardized properties that are relevant to their use in specific preparations. To assure interchangeability in such instances, users may wish to ascertain functional equivalence or determine such characteristics before use.
由于专论可能无法提供全部特性的标准，有些药物可能符合USP 或NF标准，但是其在特定的制备中使用的相关非标准性质可能有所不同。

为确保这个情况的互通性，使用者在使用前须确定其功能对等或确定其特征。

4.10.10 Applicability of Test Procedures 测试过程的适用性
A single monograph may include several different tests, procedures, and/or acceptance criteria that reflect attributes of different manufacturers' articles. Such alternatives may be presented for different polymorphic forms, impurities, hydrates, and dissolution cases. Monographs indicate the
tests, procedures, and/or acceptance criteria to be used and the required labeling.
单个专论中可能包括几个测试，过程，和/或验收标准，来反映不同的厂商药品的特性。

其中可能包括不同的多晶型，杂质，水合物，和溶出度等。

专论涉及到使用的测试，过程，和/或验收标准，和需要的标签。

4.10.20 Acceptance Criteria 验收标准
The acceptance criteria allow for analytical error, for unavoidable variations in manufacturing and compounding, and for deterioration to an extent considered acceptable under practical conditions. The existence of compendial acceptance criteria does not constitute a basis for a claim that an official substance that more nearly approaches 100 percent purity “exceeds” compendial quality. Similarly, th e fact that an article has been prepared to tighter criteria than those specified in the
monograph does not constitute a basis for a claim that the article “exceeds” the compendial requirements.
验收标准允许分析误差、生产中不可能避免的变化，及根据实际情况在一定可接受范围内调整。

药典标准的存在并不说明一个药物接近100%纯度就是超过了药典质量标准。

同样的，如果一个药品按照比专论更严格的标准制备也不能说明该药品超过了药典质量标准。

An official product shall be formulated with the intent to provide 100 percent of the quantity of each ingredient declared on the label. Where the minimum amount of a substance present in a dietary supplement is required by law to be higher than the lower acceptance criterion allowed for in the monograph, the upper acceptance criterion contained in the monograph may be increased by a corresponding amount.
一个药品必须100%保证其标签上所有成分的质量。

当法律要求食品添加剂中某一成分使用最小量，标准比专论允许的较低标准要高，这时专论中较高的验收标准需做相应的提高。

The acceptance criteria specified in individual monographs and in the general chapters for compounded preparations are based on such attributes of quality as might be expected to characterize an article compounded from suitable bulk drug substances and ingredients, using the procedures provided or recognized principles of good compounding practice, as described in these compendia.
专论和附录中复方制剂的验收标准，是基于这样的质量特性：这些质量特性可能用于检测由适当原辅料制备得到的制剂，并采用药物混合操作提供的规程或公认规则，如药典阐述的。

4.20 General Chapters附录
Each general chapter is assigned a number that appears in angle brackets adjacent to the chapter name (e.g., Chromatography <621>). General chapters may contain the
following: ?Descriptions of tests and procedures for application through individual monographs,
Descriptions and specifications of conditions and practices for pharmaceutical compounding,
General information for the interpretation of the compendial requirements,
Descriptions of general pharmaceutical storage, dispensing, and packaging practices, or ?General guidance to manufacturers of official substances or official products.
每个附录标题旁边都有一个带尖括号的数字（如：色谱<621>），附录一般包括一下内容：z应用到正文中的测试和方法的说明；
z药物混合的说明，条件要求和操作；
z一般信息：药典标准的诠释；
z一般药品的储存，分装和包装的说明；
z对药典原料药或制剂生产商的指南。

When a general chapter is referenced in a monograph, acceptance criteria may be presented after a colon.
如果正文中引用附录，其验收标准会出现在冒号后。

Some chapters may serve as introductory overviews of a test or of analytical techniques. They may reference other general chapters that contain techniques, details of the procedures, and, at times, acceptance criteria.
有些附录可能作是某个测试或分析技术的概述，其可能参考其他附录中的技术，过程细节，有时还有验收标准。

5. MONOGRAPH COMPONENTS 专论构成
5.10 Molecular Formula分子式
The use of the molecular formula for the active ingredient(s) named in defining the required strength of a compendial article is intended to designate the chemical entity or entities, as given in the complete chemical name of the article, having absolute
(100 percent) purity.
用于表示化学实体或实体的活性组分分子式的使用，是完整的化学名称，具有绝对（100%）的纯度。

5.20. Added Substances, Excipients, and Ingredients 添加剂，辅料，和成分
Substances are regarded as unsuitable for inclusion in an official article and therefore prohibited unless: (1) they do not exceed the minimum quantity required for providing their intended effect;
(2) their presence does not impair the bioavailability, therapeutic efficacy, or safety of the official article; and (3) they do not interfere with the assays and tests prescribed for determining compliance with the compendial standards.
不适合用于药品的物质，则不能使用，除非以下情况：（1）其含量没有超过发挥其作用的最低限度；（2）其存在不会影响药品的生物利用度，疗效或安全性；（3）其不会影响药典标准的含量和测试要求。

The air in a container of an official article may, where appropriate, be evacuated or be replaced by carbon dioxide, helium, argon, or nitrogen, or by a mixture of these gases. The use of such gas need not be declared in the labeling.
药品包装中的空气，如果需要，可抽真空，或用二氧化碳，氦气，氩气，氮气，或这些气体的混合物替代。

使用这些气体无需在标签中标明。

5.20.10. Added Substances, Excipients, and Ingredients in Official Substances 药物的添加剂，辅料，和成分
Official substances may contain only the specific added substances that are permitted by the individual monograph. Where such addition is permitted, the label shall indicate the name(s) and amount(s) of any added substance(s).
药物可能只包含了专论允许的特定添加剂。

如果添加剂是允许的，
则标签上必须标明所有添加剂的名称和质量。

5.20.20. Added Substances, Excipients, and Ingredients in Official Products 制剂的添加剂，辅料，和成分
Suitable substances and excipients such as antimicrobial agents, pharmaceutical bases, carriers, coatings, flavors, preservatives, stabilizers, and vehicles may be added to an official product to enhance its stability, usefulness, or elegance, or to facilitate its preparation, unless otherwise specified in the individual monograph.
为增强制剂的稳定性，作用，或外观，或方便其制备，制剂中经常加入适当的成分和辅料，如抗菌剂，药物基质，载体，包衣辅料，香料，防腐剂，稳定剂和媒介物，除专论中另有规定外。

Added substances and excipients employed solely to impart color may be incorporated into official products other than those intended for parenteral or ophthalmic use, in accordance with the regulations pertaining to the use of colors issued by the U.S. Food and Drug Administration (FDA), provided such added substances or excipients are otherwise appropriate in all respects. (See also Added Substances under Injection <1>)
根据美国FDA发布的关于着色剂使用的法规，除了注射剂或眼科制剂以外的制剂产品可以加
入着色剂，只要加入物质符合各方面的要求（见“注射剂<1>”下的添加剂）
The proportions of the substances constituting the base in ointment and suppository products and preparations may be varied to maintain a suitable consistency under different climatic conditions, provided that the concentrations of active ingredients are not varied and provided that the bioavailability, therapeutic efficacy, and safety of the preparation are not impaired.
为保证产品在不同的气候条件下的一致性，软膏和栓剂的基本处方比例和制备可进行适当调整，前提是活性成分的浓度不会改变，且制剂的生物利用度、疗效和安全性不会受影响。

5.20.20.1. In Compounded Preparations 复方制剂
Compounded preparations for which a complete composition is given shall contain only the ingredients named in the formulas unless specifically exempted herein or in the individual monograph. Deviation from the specified processes or methods of compounding, although not from the ingredients or proportions thereof, may occur provided that the finished preparation conforms to the relevant standards and to preparations produced by following the specified process.
对于有完整处方的复方制剂，在本文或专利没有特殊说明的情况下，只能包含处方上的成分。

假如最终产品符合相关标准并按照指定工艺生产，尽管成分和比例相同，实际操作与指定工艺或方法仍可能存在一定偏差。

Where a monograph for a compounded preparation calls for an ingredient in an amount expressed on the dried basis, the ingredient need not be dried before use if due allowance is made for the water or other volatile substances present in the quantity taken.
如果专论要求某一成分以干品计，若其取用量所含水分或其他挥发性物质有明确的允许范围，则不必在使用前预先干燥。

Specially denatured alcohol formulas are available for use in accordance with federal statutes and regulations of the Internal Revenue Service. A suitable formula of specially denatured alcohol may be substituted for Alcohol in the manufacture of official preparations intended for internal or topical use, provided that the denaturant is volatile and does not remain in the finished product. A preparation that is intended for topical application to
the skin may contain specially denatured alcohol, provided that the denaturant is either a usual ingredient in the preparation or a permissible added substance; in either case the denaturant shall be identified on the label of the topical preparation. Where a process is given in the individual monograph, any preparation compounded using denatured alcohol shall be identical to that prepared by the monograph process.
根据美国国内税局的联邦法和相关规程，可以使用指定的变性乙醇。

内用或外用的制剂生产过程可以使用指定的变性乙醇替代乙醇，只要变性剂是易挥发且不会在终产品中残留。

外用皮肤制剂可含特定的变性乙醇，只要变性剂是普通制剂成分或允许添加物，或在标签上标示。

只要是专论中给出了工艺，则使用了特定变性乙醇的制剂，必须与专论工艺生产出来的制剂一致。

5.20.20.2. In Dietary Supplements 食品添加剂
Additional ingredients may be added to dietary supplement products provided that the additional ingredients: (1) comply with applicable regulatory requirements; and (2) do not interfere with the assays and tests prescribed for determining compliance with compendial standards
可在食品中加入添加剂，只要添加剂符合以下情况：（1）符合相关法规；（2）不影响药典标准的含量和测试要求。

5.30. Description and Solubility 性状和溶解度
Only where a quantitative solubility test is given in a monograph and is designated as such is it a
test for purity.
只有给出定量溶解度试验且指定内容时，方可用于纯度的检查。

A monograph may include information regarding the article's description. Information about an article's “description and so lubility” also is provided in the reference table Description and Relative Solubility of USP and NF Articles. The
reference table merely denotes the properties of articles that comply with monograph standards. The reference table is intended primarily for those who use, prepare, and dispense drugs and/or related articles. Although the information provided in monographs and the information in the reference table may indirectly assist in the preliminary evaluation of an article, it is not intended to serve as a standard or test for purity.
专论中可能包含药品性状的信息。

参考表中也有“性状和溶解度”的信息和USP/NF产品相对溶解度。

参考表只提供符合专论标准的药品特性。

参考表主要用于使用，制备，分装药品和相关物品。

尽管专论和参考表提供的信息可间接作为初步评估药品的参考，但并不能作为纯度的检测和标准。

The approximate solubility of a compendial substance is indicated by one of the following descriptive terms:
原料药可用以下说明之一表述其溶解性。

Descriptive Term 说明项Parts of Solvent Required for 1 Part of Solute
一份溶质需要的溶剂
Very soluble 极易溶解
Less than 1 不到1
Descriptive Term 说明项Parts of Solvent Required for 1 Part of Solute
一份溶质需要的溶剂
Freely soluble 易容
From 1 to 10 1到10
Soluble 溶解
From 10 to 30 10到30
Sparingly soluble 略溶
From 30 to 100 30到100
Slightly soluble 微溶
From 100 to 1,000 100到1000
Very slightly soluble 极微溶
From 1,000 to 10,000 1000到10000
Practically insoluble, or Insoluble
几乎不容或不溶
Greater than or equal to 10,000
大于或等于10000
5.40. Identification Test 鉴定测试
The compendial test titled Identification is provided as an aid in verifying the identity of articles as they are purported to be, e.g., those taken from labeled containers. Tests presented in the Identification section shall be used to assist in establishing the identity of the substance but are not necessarily sufficient to establish proof of identity. Other tests and specifications in the monograph
often are necessary to establish or confirm the identity of an article. Failure of an article to meet the requirements of a prescribed Identification test may indicate that the article is mislabeled.
药典中的鉴定项是作为鉴定药物（如从贴了标签的容器中取出的药物）的辅助手段。

鉴定项的测试用于辅助鉴定原料药，但并不足以鉴定该药品，其鉴定通常还需要专论中其他的测试及质量标准。

药品如达不到鉴定测试的要求则可视为贴错标签。

5.50. Assay 含量
Assay tests for compounded preparations are not intended for evaluating a compounded preparation before dispensing, but instead are intended to serve as the official test in the event of a question or dispute regarding the preparation's conformance to official standards.
复方制剂的含量测定不是用于发放前对复方制剂评估，而是当制
剂与药典标志一致性有争议时，作为法定的测试。

5.50.10. Units of Potency (Biological) 效价（生物学的）单位
For substances that cannot be completely characterized by chemical and physical means, it may be necessary to express quantities of activity in biological units of potency, each defined by an authoritative, designated reference standard.
如果某一物质不能通过化学和物理学方法鉴定，可能需要采用生物效价单位来表示活性成分的含量。

每一个单位均由权威的，指定的参考标准来定义。

Units of biological potency defined by the World Health Organization (WHO) for International Biological Standards and International Biological Reference Preparations are termed International Units (IU). Monographs refer to the units defined by USP Reference Standards as “USP Units.” For biological products, units of potency are defined by the corresponding U.S. Standard established by FDA, whether or not International Units or USP Units have been defined (see
Biologics <1041>).
以WHO规定的国际生物学标准和国际生物学对照品的形式定义的生物效价单位称为国际单位（IU）。

专论引用USP对照品标定的单位，即USP单位。

对生物制品，无论是否有国际单位或USP单位（见“生物制剂<1041>”），效价均由FDA规定的相应US标准确定。

5.60. Impurities and Foreign Substances 杂质和外来物质
Tests for the presence of impurities and foreign substances are provided to limit such substances to amounts that are unobjectionable under conditions in which the article is customarily employed (see also Impurities in Official Articles<1086>).
杂质和外来物质的检测是为了限制这些物质在药品一般条件中可接受的含量（见“药品杂质<1086>”）。

Nonmonograph tests and acceptance criteria suitable for detecting and controlling impurities that may result from a change in the processing methods or that may be introduced from external sources should be employed in addition to the tests provided in the individual monograph, where the presence of the impurity is inconsistent with applicable good manufacturing practices or good pharmaceutical practice.
由工艺方法变更或外来物质所引入的杂质，且杂质不符合GMP或制药操作时，可用专论的杂质测试和验收标准进行检测和控制。

5.60.10. Other Impurities in USP and NF Articles USP和NF药品的其他杂质
If a USP or NF monograph includes an assay or organic impurity test based on chromatography, other than a test for residual solvents, and that monograph procedure does not detect an impurity present in the substance, the amount and identity of the impurity, where both are known, shall be stated in the labeling (certificate of analysis) of the official substance, under the heading Other Impurity(ies).
除了溶残，如果USP或NF专论中用色谱法做含量或有机杂质检测，而这个方法又检测不到样品中的某一杂质，在这种情况下，如果能鉴别出这个杂质并测出其含量，则必须在标签（分析报告）上列出，同时标明“其他杂质”。

The presence of any unlabeled other impurity in an official substance is a variance from the standard if the content is 0.1% or greater. The sum of all Other Impurities combined with the monograph-detected impurities may not exceed 2.0% (see Ordinary Impurities <466>), unless otherwise stated in the monograph.
其他任何未报告杂质如果大于或等于0.1%，则超出了标准范围。

除专论另有规定外，其他专论列出的杂质总杂可能不超过2.0%（见
“一般杂质<466>）。

The following categories of drug substances are excluded from Other Impurities requirements:
其他杂质要求不包括以下类型产品：
fermentation products and semi-synthetics derived therefrom, 发酵产品和由发酵产品半合成得到的衍生物；
radiopharmaceuticals, 发射性药品；
biologics, 生物制剂；
biotechnology-derived products, 用生物技术得到的衍生物；
peptides, 多肽；
herbals, and 中草药及
crude products of animal or plant origin. 动物或植物的提取物Any substance known to be toxic shall not be listed under Other Impurities.
其他任何有毒物质必须列出，并标明“其它杂质”。

5.60.20. Residual Solvents in USP and NF Articles USP和NF 药品的溶剂残留
All USP and NF articles are subject to relevant control of residual solvents, even when no test is specified in the individual monograph. If solvents are used during production, they must be of suitable quality. In addition, the toxicity and residual level of each solvent shall be taken into consideration, and the solvents limited according to the principles defined and the requirements specified in Residual Solvent <467>, using the general methods presented therein or other suitable methods.
即使专论中没有特定的检测，所有USP和NF药品都必须控制其溶剂残留。

生产中用到溶剂必须符合一定的质量要求。

另外，必须考虑每个溶剂的毒性及残留，具体的溶剂限度见“残留溶剂<467>”中的规定和要求，溶剂残留检测可使用这里的一般方法或其他适当的方法。

5.70. Performance Tests 性能测试
Where content uniformity determinations have been made using the same analytical methodology specified in the Assay, with appropriate allowances made for differences in sample preparation, the average of all of the individual content uniformity determinations may be used as the Assay value.
如果含量均匀度使用与含量测定一样的方法，且样品制备方法不同，则含量均匀度的平均值可作为含量使用。

5.80. USP Reference Standards USP对照品
USP Reference Standards are authentic specimens that have been approved by the USP Reference Standards Expert Committee as suitable for use as comparison standards in USP or NF tests and assays. (See USP Reference Standards <11>) Current official lots of USP Reference Standards are
published in the USP Reference Standards Catalog. Where a procedure calls for the use of a compendial article rather than for a USP Reference Standard as a material standard of reference, a substance meeting all of the compendial monograph requirements for that article shall be used. No new USP or NF standard or procedure requiring the use of a new USP Reference Standard shall be official until the specified USP Reference Standard is available.
USP对照品是USP对照品专家委员会批准的用作USP/NF检测或含量测定对照标准的可信的样本（见“USP对照品<11>”）。

当前的官方USP对照品批号见USP 对照品目录。

如果某一检测需要的参照标准物质是官方物质而且不是USP对照品，这个参照物必须符合药典专论的要求。

在新USP对照品生效之前，任何新的、需要使用新USP对照品的USP或NF 标准、规程都是不合法。

Unless a reference standard label bears a specific potency or content, assume the reference standard is 100.0% pure in the
official application. Unless otherwise directed in the procedure in the individual monograph or in a general chapter, USP Reference Standards are to be used in accordance with the instructions on the label of the Reference Standard.
除非对照品标签中另有效价或含量的说明，一般对照品都认为是100%纯度。

除非专利或附录中另有直接规定，USP对照品一般需按对照品说明使用。

6. TESTING PRACTICES AND PROCEDURES 试验规范和过程
6.10. Safe Laboratory Practices 安全实验室规范
In performing compendial procedures, safe laboratory practices shall be followed, including precautionary measures, protective equipment, and work practices consistent with the chemicals and procedures used. Before undertaking any procedure described in the compendia, the analyst should be aware of the hazards associated with the chemicals and the techniques and means of protecting against them. These compendia are not designed to describe such hazards or protective measures.
实施药典检测过程，需要遵守安全实验室规范，包括预防性措施，保护设备，与实验物和实验过程一致的操作规程。

实验之前，操作人员必需知道相关化合物的危害及对付的技能和方法。

药典中不体现这些保护措施。

6.20. Automated Procedures 自动化过程
Automated and manual procedures employing the same basic chemistry are considered equivalent. 基于相同化学技术的自动化及人工操作可认为是等同的。

6.30. Alternative and Harmonized Methods and Procedures 变通和协调的方法和规程Alternative methods and/or procedures may be used if they provide advantages in terms of accuracy, sensitivity, precision, selectivity, or adaptability to automation or
computerized data reduction, or in other special circumstances. Such alternative procedures and methods shall be validated as described in the general chapter Validation of Compendial Procedures <1225> and must be shown to give equivalent or better results. Only those results obtained by the methods and procedures given in the compendium are conclusive.
当某个方法或规程有更高的准确性、灵敏度、精确度，或较高的自动化适应性，或能简化计算机数据处理，或在其他特定的环境下，可变通地使用该方法或规程。

这些变通的方法和规程必须按照章节“药典规程的验证<1225>”中的方法进行验证，同时必须证明具有同等或更好的实验效果。

只有与药典方法和规程相比较的结果才具有权威性。

Alternative procedures should be submitted to USP for evaluation as a potential replacement or addition to the standard (see section 4.10, Monographs).
变通的规程必须递交给USP进行评估，以作为替代现有标准的选择（见专论的章节 4.10）Certain general chapters contain a statement that the text in question is harmonized with the corresponding text of the European Pharmacopoeia and/or the Japanese Pharmacopoeia and that these texts are interchangeable. Therefore, if a substance or preparation is found to comply with a requirement using an interchangeable method or procedure from one of these pharmacopeias, it should comply with the requirements of the USP. When a difference appears, or in the event of dispute, only the result obtained by the method and/or procedure given in the USP is conclusive.
有些附录中申明，美国药典某些部分与欧洲药典或日本药典是相一致并可相互替换。

因此，某一原料药或制剂，如果需要使用这些药典，其中一个可相互替换的方法或规程，其必须符合美国药典的要求。

如果有差异或争论，只有使用USP的方法或规程得到的结论才具有权
威性。

6.40. Dried, Anhydrous, Ignited, or Solvent-Free Basis 干燥的，无水的，灼烧的，无溶剂的成分
All calculations in the compendia assume an “as-is” basis unless otherwise specified.
Test procedures may be performed on the undried or unignited substance and the results calculated on the dried, anhydrous, or ignited basis, provided a test for Loss on drying, or Water, or Loss on。