Functionalityrelated Characteristics

A list of functionality-related characteristics that are not the subject of official requirements but which are nevertheless important for the use of a substance may be appended to a monograph, for information (see also above 1.1. General statements).

REFERENCE SUBSTANCES, REFERENCE PREPARATIONS AND REFERENCE SPECTRA

Certain monographs require the use of a reference substance, a reference preparation or a reference spectrum. These are chosen with regard to their intended use as prescribed in the monographs of the Pharmacopoeia and are not necessarily suitable in other circumstances. The European Pharmacopoeia Commission does not accept responsibility for any errors arising from use other than as prescribed.

The reference substances, the reference preparations and the reference spectra are established by the European Pharmacopoeia Commission and may be obtained from the Technical Secretariat. They are the official standards to be used in cases of arbitration. A list of reference substances, reference preparations and reference spectra may be obtained from the Technical Secretariat.

Local standards may be used for routine analysis, provided they are calibrated against the standards established by the European Pharmacopoeia Commission.

Any information necessary for proper use of the reference substance or reference preparation is given on the label or in the accompanying leaflet or brochure. Where no drying conditions are stated in the leaflet or on the label, the substance is to be used as received. No certificate of analysis or other data not relevant to the prescribed use of the product are provided. No expiry date is indicated: the products are guaranteed to be suitable for use when dispatched. The stability of the contents of opened containers cannot be guaranteed.

Chemical Reference Substances. The abbreviation CRS indicates a Chemical Reference Substance established by the European Pharmacopoeia Commission. Some Chemical Reference Substances are used for the microbiological assay of antibiotics and their activity is stated, in International Units, on the label or on the accompanying leaflet and defined in the same manner as for Biological Reference Preparations.

Biological Reference Preparations. The majority of the primary biological reference preparations referred to in the European Pharmacopoeia are the appropriate International Standards and Reference Preparations established by the World Health Organisation. Because these reference materials are usually available only in limited quantities, the Commission has established Biological Reference Preparations (indicated by the abbreviation BRP) where appropriate. Where applicable, the potency of the Biological Reference Preparations is expressed in International Units. For some Biological Reference Preparations, where an international standard or reference preparation does not exist, the potency is expressed in European Pharmacopoeia Units.

Reference spectra. The reference spectrum is accompanied by information concerning the conditions used for sample preparation and recording the spectrum.

01/2005:10500 Lp/10 dose

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