FDA Q&As for standards in USP <467> residual solve

[krickos]

Hi

Just wanted to share that FDA posted a number of questions and answers late October, see link for details.

http://www.fda.gov/cder/ogd/residualsolvents.pdf

For example Q11:

Q: Would it be acceptable to use a high purity solvent in place of the USP reference standard?
A: Yes a high purity solvent may be used in lieu of the reference standard if suiteble documentation (ie certificate of analysis) of the purity and source is provided

[Terry]

Thanks, Krickos.

It is very very helpful.

Terry

[JA]

Does anybody happen to know the new whereabouts of the FDA Q&A document as the link results in a "Page Not Found" error for myself.

There also appears to be a follow-up document apparently put online on 20-Apr-09 by the International Pharmaceutical Excipients Council @ http://www.ipecamericas.org/newsletters ... cument.pdf

[Bruce Hamilton]

How about...

http://www.fda.gov/downloads/AboutFDA/C ... 119607.pdf

Please keep having fun,

Bruce Hamilton