Chromatography Forum

Could anybody please explain the calculation of Residual Solvents<467>? It is not official till july 2008.

Jayashree

If I may make a suggestion, you will have more people look at your post if you do not give such a general description of your question. For example, you might have posted using a title:

Calculations for the USP chapter <467> ????

For the Class 1 and 2 solvents the test is a limit test. This assumes a determined amount of exposure that a drug dosage can contain, based on a certain amount of drug taken daily.

So if your drug matrix is less than the standards in the USP test, the drug batch passes.

Other solvents that do not have established limits are to be measured based on the calculations in the chapter using headspace analysis, unless there is a special test specified, or the manufacturer has validated his own testing procedure.

Does this answer your question?

best wishes,

Rod

Hi Rod,

Thank you and yes it answers my question.
Your suggestion as how to get more response for the query raised is appreciated.

Thanks again,

Jayashree