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【每日一句(段)有奖翻译】<二十五> Monographs and General Chapters (4)

专业英语


  • General Chapters


    1. Each general chapter is assigned a number that appears in angle brackets adjacent to the chapter name (e.g., Chromatography <621>).

    2. General chapters may contain the following:

    2.1 Descriptions of tests and procedures for application through individual monographs,

    2.2 Descriptions and specifications of conditions and practices for pharmaceutical compounding,

    2.3 General information for the interpretation of the compendial requirements,

    2.4 Descriptions of general pharmaceutical storage, dispensing, and packaging practices, or

    2.5 General guidance to manufacturers of official substances or official products.

    3. When a general chapter is referenced in a monograph, acceptance criteria may be presented after a
    colon.


    4. Some chapters may serve as introductory overviews of a test or of analytical techniques.

    5. They may reference other general chapters that contain techniques, details of the procedures, and,
    at times, acceptance criteria.
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  • ljzkevin

    第1楼2011/01/11

    General Chapters 通则

    1. Each general chapter is assigned a number that appears in angle brackets adjacent to the chapter name (e.g., Chromatography <621>).
    1、 每一通则均有相应的鉴别号,在章节名称的后面的尖括号中,如色谱法<621>
    2. General chapters may contain the following:
    2、通则可能含有如下内容:
    2.1 Descriptions of tests and procedures for application through individual monographs,
    2.1 各品种项下规定的试验和测定法的具体描述;
    2.2 Descriptions and specifications of conditions and practices for pharmaceutical compounding,
    药物合成条件和规范的描述及合格标准;
    2.3 General information for the interpretation of the compendial requirements,
    2.3、药典通用信息要求的解释;
    2.4 Descriptions of general pharmaceutical storage, dispensing, and packaging practices, or
    2.4、 通用药物储存、配方以及包装规范的描述;
    2.5 General guidance to manufacturers of official substances or official products.
    2.5、 法定原料药或法定制剂生产商的通用指南。
    3. When a general chapter is referenced in a monograph, acceptance criteria may be presented after a
    colon.
    3、 当各论中规定使用通则中的测定法,则可能在冒号后给出验收标准。
    4. Some chapters may serve as introductory overviews of a test or of analytical techniques.
    4、 一些通则中的章节可能充当测试或分析技术的概况。
    5. They may reference other general chapters that contain techniques, details of the procedures, and, at times, acceptance criteria.
    5。 通则中的一些章节有时会引用其他章节的内容,包括技术、测定法的细节以及有时包含验收标准。

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  • f4forever

    第2楼2011/01/11

    总论章节

    1.每个总论章节都指定了章节号,以尖括号括起,位于章节名之后(如,色谱法<621>)。

    2.总论章节包括以下内容:

    2.1 对各专论都通用的测试和程序说明,

    2.2 药物合成条件和操作的说明及其质量标准,

    2.3 药典要求的一般性说明

    2.4 药物贮藏、分发和包装的基本操作说明,或者

    2.5 法定标准品(原料药)或法定标准品(药物成品)生产的通用指南(“official substances”和“official products”有什么区别?一直搞不清楚,望高人指点!)

    3. 专论引用总论章节时,可接受标准会出现在冒号之后。

    4. 某些章节可能会对某一测试或分析方法进行介绍性的概述。

    5. 这些章节可能引用其他总论章节的内容,包括技术、程序细节,有时还会引用其中的可接受标准。

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