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Abstract: A systematic approach for the
identification and quantification of organic volatile
impurities (OVIs) in pharmaceutical excipients was
described in the proposed Analytical method was
developed utilizing capillary gas chromatography with
flame ionization detector and validated as per ICH
guidelines for residual solvent analysis in different
pharmaceutical excipients. The separation was carried
out on BP 624 column (30m X 0.53mm i.d. X 0.25µm coating
thickness), using GC 17 A shimadzu, with nitrogen as
carrier gas in the split mode by direct injection
method. The method described was simple, sensitive,
rugged, reliable and reproducible for the quantitation
of organic volatile impurities (OVIs) at residual levels
as per ICH guidelines from pharmaceutical excipients.
Introduction
There is a growing appreciation of the role that
pharmaceutical excipients play in enhancing stability,
bioavailability, and delivery of active drugs. Purity of
excipients is becoming increasingly important in the
development and manufacture of pharmaceutical products
as the quality of excipients can have a significant
impact on the safety and efficacy of drug products.
Organic solvents, which are widely used in the
production of excipients for synthesis and purification,
may not be completely removed by practical manufacturing
techniques. The residue of these solvents offers no
therapeutic benefit, but can present a serious potential
hazard to human health. Therefore, it is essential to
ensure that the residual solvents, (organic volatile
impurities (OVIs)) should be below the acceptable levels
stipulated in worldwide regulatory standards, such as
ICH3 and USP4. The use of some highly toxic/carcinogenic
solvents has to be controlled to extremely low levels
and demands extremely sensitive detection methods.
Analysis of OVIs is known to be one of the most
challenging analytical tasks in pharmaceutical analysis
and control. Excipients present an even greater
challenge due to the fact that information regarding the
presence of OVIs in excipients may be difficult to
obtain from a supplier who is unwilling to provide
comprehensive data on the materials because of fear that
the information could be exploited by a competitor.
Unknown OVIs are often detected during the routine
quality control testing of OVIs in excipients using
official methods, resulting in lengthy laboratory
investigations which can cause costly delays in
manufacturing. Hence, the situation necessitates the
development of a rapid, sensitive, and reliable
analytical method to screen, identify, and quantitate
any OVIs in pharmaceutical excipients.
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