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fackelmann欧洲药典-凡例(中英文对照)

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2021-01-19 12:21
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驱逐令-fackelmann

2021年1月19日发(作者:不差上下)
欧洲药典
-
凡例

1.1. GENERAL STATEMENTS
The General Notices apply to all monographs and other texts of the European Pharmacopoeia.
总论的内容适用于各论和欧洲药典中的其它章节。

The official texts of the European Pharmacopoeia are published in English and French. Translations in
other languages may be prepared by the signatory States of the European Pharmacopoeia Convention. In
case of doubt or dispute, the English and French versions are alone authoritative.
欧洲药典以英语和法语形式发行,欧洲药典委员会的签署国可将药典内 容译成其它语言,但若发
生争议,应以英语和法语版为权威。

In the texts of the European Pharmacopoeia, the word
European Pharmacopoeia. The official abbreviation Ph. Eur. may be used to indicate the European
Pharmacopoeia.
在欧洲药典中,如无特殊规定,

药典

是指欧洲药典,缩写

Ph. Eur.
也指欧洲药典。

The use of the title or the subtitle of a monograph implies that the article complies with the requirements
of the relevant monograph. Such references to monographs in the texts of the Pharmacopoeia are shown
using the monograph title and reference number in
italics.
文章中如果引用了各论中的标题和副标题意味着文章内容符合相关各 论的要求。文章参考药典中
各论内容时,以斜体的各论题目或相关数字表示。

A
preparation must comply throughout its period of validity; a distinct period of validity and/or
specifications for opened or broached containers may be decided by the competent authority. The
subject of any other monograph must comply throughout its period of use. The period of validity that is
assigned to any given article and the time from which that period is to be calculated are decided by the
competent authority in the light of experimental results of stability studies.
药品在 有效期内必须性质稳定,明确的有效期或说明应由权力机构批准。专论的题目在使用时必
须一致。任何药 品的有效期和有效期的起始时间由权力机构经稳定性研究的试验结果决定。

Unless
otherwise
indicated
in
the
General
Notices
or
in
the
monographs,
statements
in
monographs
constitute
mandatory
requirements.
General
chapters
become
mandatory
when
referred
to
in
a
monograph, unless such reference is made in a way that indicates that it is not the intention to make the
text referred to mandatory but rather to cite it for information.
除总论和各论中另有说明,各论中的说明为法定要求;除为了提供特定信息 ,如果各论引用总论
中内容时,总论为法定要求。

The active ingredients (medicinal substances), excipients

(auxiliary substances), pharmaceutical
preparations and other articles described in the monographs are intended for human and veterinary use
(unless explicitly restricted to one of these uses). An article is not of Pharmacopoeia quality unless it
complies with all the requirements stated in the monograph. This does not imply that performance of all
the tests in a monograph is necessarily a prerequisite for a manufacturer in assessing compliance with
the Pharmacopoeia before release of a product. The manufacturer may obtain assurance that a product is
of Pharmacopoeia quality from data derived, for example, from validation studies of the manufacturing
process and from in-process controls. Parametric release in circumstances deemed appropriate by the
competent authority is thus not precluded by the need to comply with the Pharmacopoeia. The tests and
assays described are the official methods upon which the standards of the Pharmacoooeia are based.
With the agreement of the competent authority, alternative methods of analysis may be used for control
purposes,

provided that the methods used enable an unequivocal decision to be made as to whether

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compliance with the standards of the monographs would be achieved if the official methods were used.
In the event of doubt or dispute,

the methods of analysis of the Pharmacopoeia are alone authoritative
各论中描述的有效成分(药用物质),赋形剂(辅料),药物制剂和其它 成分用于人和兽的使用
(除非明确限制不可使用)。一种药品只有在符合各论中各项要求时,才算药典中 的药品。但并
不要求药品上市前,供应商要做各论中的每项试验以满足药典要求。生产商可通过原始数据 ,例
如生产过程验证,和过程控制,自检药品是否符合药典要求。权力机构认为充分的环境条件应符合药典要求。
检测和试验方法应基于药典的标准
.
经权利机构允许可采用其它的分 析方法以达到控
制目的,若出现争论或异议,应以药典方法为准。

Certain materials that are the subject of a pharmacopoeia1 monograph may exist in different grades
suitable for different purposes. Unless otherwise indicated in the monograph,

the requirements apply
to all grades of the material. In some monographs, particularly those on excipients, a list of
functionality-related characteristics that are important for the use of the substance may be appended to
the monograph for information. Test methods for determination of one or more of these characteristics
may be given, also for information.
药典各论中的某些物质有多个等级可满 足各种需要,除各论中另有说明,要求适用于各等级。在
一些各论中,
特别是赋形剂,
一系列相关的功能特性都有介绍,
其中给出了一些特性的检测方法。

General monographs.
Substances and preparations that are the subject of an individual monograph are
also required to comply with relevant, applicable general monographs.
总论:各论中介绍的药物和制剂也应符合总论中的相关要求。

Cross- references to applicable general monographs are not normally given in individual monographs.
参照总论中的一些内容在各论中不特别指出。

General monographs apply to all substances and preparations within the scope of the Definition section
of the general monograph, except where a preamble limits the application, for example to substances
and preparations that are the
subject of a monograph of the Pharmacopoeia. < br>除非限定了适用条件,如规定适用于药典各论中的物质,总论的内容适用于各论定义范围内的所
有 药物和制剂。

General monographs on dosage forms apply to all preparations of the type defined. The requirements are
not necessarily comprehensive for a given specific preparation and requirements additional to those
prescribed in the general monograph may be imposed by the competent authority.
总论中介绍的剂量形式适用于典型定义的所有制剂。
对于一特定制剂不 必要对所有特性进行限定,
一些要求可由相关的机构补充。

Conventional terms.
The term
body or organisation vested with the authority for making decisions concerning the issue in question. It
may, for example, be a national pharmacopoeia authority, a licensing authority or an official control
laboratory.
惯用术语:

权力机构

是指对一些问题进行仲裁的国家、超国家、国际机构或授权组织。例如,
国家药典委员会等。

The expression
unless the competent authority authorises a modification or an exemption where justified in a particular
case.

除另有批准

是指一些要求修改后,经权利机构允许的。

Statements containing the word
一段话中出现

可以

是指此段描述作为信息提供或建议。


2
In certain monographs or other texts, the terms
reagent,

micro- organism, test method etc.; if criteria for suitability are not described in the monograph,
suitability is demonstrated
to the satisfaction of the competent authority.
在某些各论 或文章中出现了

合适的



适当的

用于描述一种试剂、微生物、检测方法等;若各
论中没有介绍适用性标准,适用性的论述应符合权力机构 的要求。

Interchangeable methods.
Certain general chapters contain a statement that the text in question is
harmonised with the corresponding text of the Japanese Pharmacopoeia and/or the United States
Pharmacopeia and that these texts are interchangeable. This implies that if a substance or preparation is
found to comply with a requirement using an interchangeable method from one of these pharmacopoeias
it complies with the requirements of the European Pharmacopoeia. In the event of doubt or dispute, the
text of the European Pharmacopoeia is alone authoritative.
可供选择的方法:一些章节中会出现这样的描述,此篇文 章与
JP

USP
一致,这意味着一种药
物或制剂采用
JP

USP
中的任意一种方法时,同样符合
EP
的要求。若出现争论或 异议时,以
EP
为准。

1.2. OTHER

PROVISIONS

APPLYING
TO

GENERAL

CHAPTERS

AND

MONOGRAPHS

为总论和各论提供的信息

Quantities.
In tests with numerical limits and assays, the quantity stated to be taken for examination is
approximate. The amount actually used, which may deviate by not more than 10 per cent from that
stated, is
accurately weighed or measured
and the result is calculated from this exact quantity. In tests
where the limit is not numerical, but usually depends upon comparison with the behaviour of a reference
in the same conditions, the stated quantity is taken for examination. Reagents are used in the prescribed
amounts.
用量:用于试 验的量有具体限度时,规定用于检测的量为一大约值。实际用量
不得超过规定量的
10%

由实际用量计算结果。对于限度无规定值的试验,限度依赖于相同条件下与对照品测试结
果 相比较,取规定量用于试验。使用规定量的试剂。

Quantities are weighed or measured with an accuracy commensurate with the indicated degree of
precision. For weighings, the precision corresponds to
plus or minus 5 units after the last figure
stated
(for example, 0.25 g is to be interpreted as 0.245 g to 0.255 g). For the measurement of

volumes, if the
figure after the decimal point is a zero or ends in a zero (for example, 10.0 ml or 0.50 ml), the volume is
measured using a pipette, a volumetric flask or a burette, as appropriate; otherwise, a graduated
measuring cylinder or a

graduated pipette may be used. Volumes stated in microlitres are measured
using a micropipette or microsyringe.
用精密度和准确度相当的仪器量取一定量的被测物。
称重时,< br>精密度为末位数字的正负
0.5
个单位
(例如,
0.25g
是 指
0.245-0.255g
)。
体积测量时,如果
小数点后的数字为零或末 位数字为零时
(例

10.0ml

0.50ml
),体积 由吸液管、量瓶或滴定管测量

;否则,用量筒或刻度吸量管测定。使
用微量吸液管和微量注射器测量可精确到微升。

It is recognised, however, that in certain cases the precision with which quantities are stated does not
correspond to the number of significant figures stated in a specified numerical limit. The weighings and
measurements are then carried out with a sufficiently improved accuracy.




在某些情况下,如果精确度不符合要求,称重或测量时可通过提高准确度来弥补。

Apparatus and procedures.
Volumetric glassware complies with Class A requirements of the
appropriate International Standard issued by the International Organisation for Standardisation.

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