SC I D. Excipients

1. The General Notice on Excipients states that 'any substances added in preparing an official preparation shall... not interfere with the assays and tests of the Pharmacopoeia'.

2. The British Pharmacopoeia Commission wishes to stress that any preparation described by a name at the head of a monograph in the current edition of the Pharmacopoeia, whether or not it is referred to as BP, is not of pharmacopoeial quality unless it meets all of the requirements of the monograph when tested by the methods set down.

3. It is recognised that new formulations of existing preparations may from time to time be developed and that the excipients and other ingredients used might result in interference with the official assays and tests. In such cases the Commission is prepared to consider modification of methods to overcome the difficulties thus caused.

4. When seeking modification manufacturers are invited to submit details of the nature of the interference together with proposals for change that will allow the valid testing, by an independent analyst, not only of the proposed new formulation but also of all similar preparations already on the market. Practical evaluation in the Laboratory will usually be necessary before any amendments to a British Pharmacopoeia monograph can be considered. It is therefore in the interests of a manufacturer to submit any proposals at the earliest possible date.