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Dear members of this forum,

Excuse me for this kind of question, a little outside the main subject of this forum. I work in pharmaceutical industry and always I analysed the pharmaceutical products according to USP Pharmacopeia but I analysed raw materials according to Europeian or United States Pharmacopeia.
In my country are allowed to work with both pharmacopeias but in several opportunities I asked this question, in Europe where there is an official pharmacopeia what the people do with pharmaceutical products such as tablets, syrups, capsules and so on with the disoluttion test and the assay when this monograph is not present in the official pharmacopeia.
I know the british has methods for pharmaceutical dosage forms but I would like any advices.
Excuse me for this simple question but someone works in liquid chromatography in an european pharmaceutical laboratory and may be get any information.
Thanks a lot in advance for your help,

Diego

from the experience i have, when topics are delt by both pharmacopeias, you should use the one that satisfies the needs of the market where you are going to sell your products. sounds illogical to performe a certain test according to EP if your drug product will be sold in the US market especially if the USP provides guidelines for the tests. do not forget that on many levels the pharmacopeias do not see eye to eye there are differences between them, eventhou they do see eye too eye on many others.
if on the other hand you do not find the information in one of the pharmacopeias, some times you will see that you are directed to perform according to another pharmacopeia. some times you have the procedure in both pharmacopeias and also it tells you that if you performed according to another pharmacopeia it is still ok.
when like you say you do not find an answer in one pharmacopeia and decide to use another one then make sure that you have it in you SOP's. what is very important always to remember is to be consistent in your decisions and that they are well documented. both USP and EP will let you use in house or other pharmacopeias solutions to problems for which they do not have proper procedures if your procedures have been validated through a thourough and rigourous validation procedures and that the correct SOP's are being applied and that you have a well regulated mechanisem for the entire process.
again the key is consistancy. when in doubt never have two options available. always have a well regulated action procedure.
hope this helps you
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