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)
include中文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, the 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：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；

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