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 / venkatesh
For pharmacopeial purposes, residual solvents in
pharmaceuticals are defined as organic volatile chemicals
that are used or produced in the manufacture of drug
substances or excipients, or in the preparation of drug
products. The residual solvents are not completely removed
by practical manufacturing techniques. Appropriate
selection of the solvent for the synthesis of a drug
substance or an excipient may enhance the yield, or
determine characteristics such as crystal form, purity, and
solubility. Therefore, the solvent may sometimes be a
critical element in the synthetic process. This General
Chapter does not address solvents deliberately used as
excipients nor does it address solvates. However, the
content of solvents in such products should be evaluated
and justified.
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