2011年9月5日星期一

Indication of permitted limit of impurities

Indication of permitted limit of impurities
For comparative tests, the approximate content of impurity tolerated, or the sum of impurities, may be indicated for information only. Acceptance or rejection is determined on the basis of compliance or non-compliance with the stated test. If the use of a reference substance for the named impurity is not prescribed, this content may be expressed as a nominal concentration of the substance used to prepare the reference solution specified in the monograph, unless otherwise described.
Vegetable drugs
For vegetable drugs, the sulphated ash, total ash, water-soluble matter, alcohol-soluble matter, water content, content of essential oil and content of active principle are calculated with reference to the drug that has not been specially dried, unless otherwise prescribed in the monograph.
Equivalents
Where an equivalent is given, for the purposes of the Pharmacopoeia only the figures shown are to be used in applying the requirements of the monograph.
STORAGE
The information and recommendations given under the heading Storage do not constitute a pharmacopoeial requirement but the competent authority may specify particular storage conditions that must be met.
The articles described in the Pharmacopoeia are stored in such a way as to prevent contamination and, as far as possible, deterioration. Where special conditions of storage are recommended, including the type of container (see 1.3. General chapters) and limits of temperature, they are stated in the monograph.
The following expressions are used in monographs under Storage with the meaning shown.
In an airtight containermeans that the product is stored in an airtight container(3.2). Care is to be taken when the container is opened in a damp atmosphere. A low moisture content may be maintained, if necessary, by the use of a desiccant in the container provided that direct contact with the product is avoided.
Protected from light means that the product is stored either in a container made of a material that absorbs actinic light sufficiently to protect the contents from change induced by such light or in a container enclosed in an outer cover that provides such protection or stored in a place from which all such light is excluded.

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