By British Pharmacopoeia Commission
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Additional info for British Pharmacopoeia 2009
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, whereas, the expression 'tamperproof container' means a closed container in which access to the contents is prevented under normal conditions of use.
Unless otherwise stated in the monograph or general chapter, validation of the test methods by the analyst is not required. Conventional Terms The term 'competent authority' means the national, supranational or international body or organisation vested with the authority for making decisions concerning the issue in question. It may, for example, be a national pharmacopoeia authority, a licensing authority or an official control laboratory. The expression 'unless otherwise justified and authorised' means that the requirements have to be met, unless the competent authority authorises a modification or an exemption where justified in a particular case.
All amino acids, except glycine, have the L-configuration unless otherwise indicated. The three-letter and one-letter symbols used for amino acids in peptide and protein sequences are those recommended by the Joint Commission on Biochemical Nomenclature of the International Union of Pure and Applied Chemistry and the International Union of Biochemistry. In the graphic formulae the following abbreviations are used: Me –CH3 Bus– CH(CH3)CH2CH3 Et –CH2CH3 Bun– CH2CH2CH2CH3 Pri –CH(CH3)2 But– C(CH3)3 Prn –CH2CH2CH3 Ph– C 6H5 Bui –CH2CH(CH3)2 Ac– COCH3 Definition Statements given under the heading Definition constitute an official definition of the substance, preparation or other article that is the subject of the monograph.
British Pharmacopoeia 2009 by British Pharmacopoeia Commission