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What is the difference b/w OVI Solvents and Residual
Solvents in case of Gas Chromatogaphy and What is its
Detection Limit?
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Answer Posted / kaushal
There are many different solvents which are used in
pharmaceutical manufacturing. Previously this test was
called Organic Volatile Impurities (OVI). As most of you
probably already know, major changes to USP <467> are on
the horizon (July 1, 2007). These changes have been in the
works for a few years now, in an effort to harmonize USP
requirements to the European Pharmacopoeia (EP).
The first change is in the title of the Chapter itself:
Residual Solvents (RS) is replacing Organic Volatile
Impurities (OVI). The new RS chapter now potentially tests
for 53 individual solvents, instead of the four under OVI.
However, the test methodology has (in some ways) been
simplified, as the Chapter now describes only headspace
conditions for analysis, similar to the old OVI Method IV.
| Is This Answer Correct ? | 9 Yes | 4 No |
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