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.

Storage

Storage
Statements under the side-heading Storage constitute non-mandatory advice. The substances and preparations described in the Pharmacopoeia are to be stored under conditions that prevent contamination and, as far as possible, deterioration. Unless otherwise stated in the monograph, the substances and preparations described in the Pharmacopoeia are kept in well-closed containers and stored at a temperature not exceeding 25°. Precautions that should be taken in relation to the effects of the atmosphere, moisture, heat and light are indicated, where appropriate, in the monographs. Further precautions may be necessary when some materials are stored in tropical climates or under other severe conditions. The expression ¢protected from moisture¢ means that the product is to be stored in an airtight container . 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. The expression ¢protected from light¢ means that the product is to be 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. The expression ¢tamper-evident container ¢ means a closed container fitted with a device that reveals irreversibly whether the container has been opened.