EP 2034 药用物质(中英文)

条件下进行。

The provisions of general chapter 5.10 apply to the control of impurities in substances for

pharmaceutical use.

总论

5.10

适用于药用物质中的杂质控制。

Whether or not it is specifically stated in the individual monograph that the substance for

pharmaceutical use:

无论在各论中是否申明为药用，该药用物质

—

Is a recombinant protein or another substance obtained as a direct gene product

based on genetic modification, where

applicable, the substance also complies with

the

requirements

of

general

monograph

Products

of

recombinant

DNA

technology

(0784);

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药用物质

—

< br>如果是重组蛋白质或另一物质为基于基因修饰的直接基因产品，

适当时，该物质应 符

合通论

0784

重组

DNA

技术产品要求

—

Is obtained from animals susceptible to transmissible spongiform encephalopathies

other than by experimental challenge, where applicable, the substance also complies

with

the

requirements

of

the

general

monograph

Products

with

risk

of

transmitting

agents of animal spongiform encephalopathies (1483);

—

如果是动物来源物质 ，可能会有

TSE

风险，适用时，该物质还应符合通论

1483

具

有

TSE< /p>

风险的产品要求

—

Is

a

substance

derived

from

a

fermentation

process,

whether

or

not

the

micro-orgnisms involved are modified by traditional procedures or recombinant DNA

(rDNA)

technology,

where

applicable,

the

substance

also

complies

with

the

requirements of the general monograph Products of fermentation (1468).

—

如果是经发酵工艺生 产获得，无论是传统发酵还是采用

DNA

重组微生物发酵技术，

适用时，该物质应符合通论

1468

发 酵产品的要求。

If solvents are used during production, they are of suitable quality. In addition, their toxicity

and

their

residual

level

are

taken

into

consideration

(5.4).

If

water

is

used

during

production, it is of suitable quality.

如果在生产中有使用溶剂，则溶剂应具有适当的品质。另外，其毒性和残留水平应加以考 虑

（

5.4

）。如果生产中使用水，则 水应具有适当的品质。

If substances are

produced or processed to yield a certain form or grade, that specific

form or grade of the substance complies with the requirements of the monograph. Certain

functionality-related tests may be described to control properties that may influence the

suitability

of

the

substance

and

subsequently

the

properties

of

dosage

forms

prepared

from it.

如果该物质生产工艺会生成特定形状或级别，

该特定形状或级别应符合各论要求。

应说明特

定的检测，

用于控制那此可能会对 物质稳定性造成影响的特性

，这些特性可能会对采用该物

质生产 的制剂产生影响。

Powdered substances may be processed to obtain a certain

< /p>

粉状物质可能需要进一步处理以获得一定的细度（

2.9.35< /p>

）

Compacted substances are processed to increase the particle size or to obtain particles of

a specific form and/or to obtain a substance with a higher bulk density.

重粉是指经过压制，增加其粒径，或获得 指定形态的颗粒和

/

或获得较大堆密度的产品。

Coated active substances consist of particles of the active substance coated with one or

more suitable excipients.

带涂层的物质包含了活性物质和一种或多种合适的辅料。

Granulated active substances are particles of a specified size and/or form produced from

the active substance by granulation directly or with one or more suitable excipients.

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药用物质

整粒过的活性物质具有一定的粒径和

/

或形态，这种特性是将物质经过直接整粒或添加一种

或多种辅 料获得。

If

substances

are

processed

with

exeipients,

these

excipients

comply

with

the

requirements

of

the

relevant

monograph

or,

where

no

such

monograph

exists,

the

approved specification.

如果物质与辅料一起加工，这些辅料应符合相应的各论要求，或者如果没有适合的各论， 则

应符合批准过的质量标准。

Where active substance have been processed with excipients to produced, for example,

coated or granulated substances, the processing is carried out under conditions of good

manufacturing practice and the processed substances are regarded as intermediates in

the manufacture of a medicinal product.

如果活性物质 与辅料一起加工而得到

，

例如

，

带涂层或整粒过的物质

，

该加工过程应在

GMP

条件下进行，所获得的产品作为药用产品生产过程的中间体。

CHARACTERS

性状

The statements under the heading Characters (e.g. statements about the solubility or a

decomposition point) are not to be interpreted in a strict sense and are not requirements.

They are given for information.

在性状项下给出的说明（例如，溶解 度或降解温度）不应进行严格意义的解释，不是质量标

准的要求，而是给出的参考信息。

Where

a

substance

may

show

polymorphism,

this

may

be

stated

under

Characters

in

order to draw this to the attention of the user who may have to take this characteristic into

consideration during formulation of a preparation.

如果物质可能表现出多晶型，则可能会在性状项 下给出，以引起使用者的注意，因为使用者

可能在生产制剂时会需要考虑该特性。

IDENTIFICATION

鉴别

Where under Identification an individual monograph contains subdivisions entitled “First

identification”

and

“Second

identification”,

the

test

or

tests

that

constitute

the

“First

identification”

may

be

used

in

all

circumstances.

The

test

or

tests

that

constitute

the

“Second identification” may be used in pharmacies provided it can be demonstrated that

the substance or preparation is fully traceable to a batch certified to comply with all the

other requirements of the monograph.

如果各论中在鉴别项下包括了子项

“

第一鉴别

”

和

“

第二鉴别

”

，

在

“

”

中的测试项目可以

在任何情况下使用。在

“

第二鉴别

”

中的测试项目如果能确认该物质或制剂完全可追踪到某个

符合 各论所有其它要求的批次，则可以在药房使用。

Certain monographs give two or more sets of test for the purpose of the first identification,

which are equivalent and may be used independently. One or more of these sets usually

contain a cross- reference to a test prescribed in the Tests section of the monograph. It

may

be

used

to

simplify

the

work

of

the

analyst

carrying

out

the

identification

and

the

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