2011年9月10日星期六

Storage

Storage
The General Notice on Storage included in Part II of the General Notices has been amended to specify that, unless otherwise stated in the monograph, the substances and preparations described in the British Pharmacopoeia are kept in well-closed containers and stored at a temperature not exceeding 25°. The monographs for medicinal substances and formulated preparations have therefore been amended to reflect the change in the General Notice.
European Pharmacopoeia
In accordance with previous practice, all monographs and requirements of the European Pharmacopoeia are reproduced in this edition of the British Pharmacopoeia or, where appropriate, within its companion edition, the British Pharmacopoeia (Veterinary).
Where a monograph has been reproduced from the European Pharmacopoeia this is signified by the presence of a European chaplet of stars alongside its title. Additionally, reference to the European Pharmacopoeia monograph number is included immediately below the title in italics in the form 'Ph Eur xxx'. Where the title in the British Pharmacopoeia is different from that in the European Pharmacopoeia, an approved synonym has been created (see Appendix XXI B) and a cross-reference to the Ph Eur title has been included in the Index. The entire European Pharmacopoeia text is then bounded by two horizontal lines bearing the symbol ¢Ph Eur¢.
The European Pharmacopoeia texts have been reproduced in their entirety without editorial modification but, where deemed appropriate, additional statements of relevance to UK usage have been added (e.g. action and use statement, a list of BP preparations). It should be noted, however, that in the event of doubt of interpretation in any text of the European Pharmacopoeia, the text published in English under the direction of the Council of Europe should be consulted.
Correspondence between the general methods of the European Pharmacopoeia and the appendices of the British Pharmacopoeia 2003 is indicated in each appendix and by inclusion of a check list at the beginning of the appendices section.
Pharmacopoeial Requirements
It should be noted that any article intended for medicinal use which is described by a name at the head of a monograph in the current edition of the Pharmacopoeia must comply with that monograph ¢whether or not it is referred to as BP¢.
It is also important to note that no requirement of the Pharmacopoeia can be taken in isolation. A valid interpretation of any particular requirement depends upon it being read in the context of (i) the monograph as a whole, (ii) the specified method of analysis, (iii) the relevant General Notices and (iv) where appropriate, the relevant general monograph. Familiarity with the General Notices of the Pharmacopoeia will facilitate the correct application of the requirements. Additional guidance and information on the basis of pharmacopoeial requirements is provided in Supplementary Chapter I. This non-mandatory text describes the general underlying philosophy and current approaches to particular aspects of pharmacopoeial control.

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