Chromatography Forum

Our lab is in the middle of trying to craft a well thought out SOP for USP verification of compenial procedures <1226>. Residual solvents will be specifically addressed since it covers such a vast amount of raw materials.

Now I've been looking for information on this forum and came across this thread.
viewtopic.php?f=1&t=10231&hilit=USP+1226
Not the most exciting read, but a lot of information nonetheless.

Bottom line question here, how much is really needed to verify APIs with USP <467>? Regarding USP <1226>, as stated by krickos in the earlier thread;

One thing to be kept in mind, though: The article is from oct 2005, after a quick glance, most likely based on the early drafts of chapter <1226> that in some cases more or less called for a complete revalidation in some drug product cases.

The final version of <1226> came out quite different in certain aspects. For the intrested I refer to Pharmacopeial Forum Vol 31(2) Mar.-Apr. 2005 page 555-558 if you like to compare.

the versions are different. The original version of <1226> presented in 2005 had guidelines to some of the specific analytical performance characteristics applied to each catogory and whether it was for a raw material or finished product. The current version does not have this. Why is that the case?

Finally, does the standard addition aspect of the residual solvents procedure change how the verification chould be handled?

Too lazy to go to the 4th floor for various publications of the American Pharmacopoeia, and compare them page by page.
But how I remember the 467 and 1226 page talking about different things.
First on the principles of inclusion to different groups of solvents danger, the second - on the specific implementation of the method used laboratories FDA.
You asked a very interesting question and over the need to think twice ...