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Acta Biomedica Scientia

Volume 1, Issue 2, 2013
Mcmed International
Acta Biomedica Scientia
Issn
2348 - 215X (Print), 2348 - 2168 (Online)
Frequency
bi-annual
Email
editorabs@mcmed.us
Journal Home page
http://mcmed.us/journal/abs
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Purchase
Abstract
Title
ORGANIC VOLATILE IMPURITIES IN PHARMACEUTICALS
Author
G.Swarnalatha*, V.Rajini Sekhar, B.Vijayakumar, D.Jothieswari, K.Anil, D.Kezia
Email
swarnampharm@gmail.com
keyword
Residual solvents, Organic volatile impurities (OVI,s), gas chromatography, headspace, solid-phase micro extraction, single drop micro extraction.
Abstract
In pharmaceuticals, Organic volatile impurities (OVIs) are residual solvents that are used in and are produced during synthesis of drug substances, or in excipients used in the production of drug formulations. These residual solvents are potentially undesirable substances, they either modify the properties of certain compounds or are hazardous to the health of individual. OVIs(Organic volatile impurities) also affect physico-chemical properties of the bulk drug substance. The intention of this paper was to review and discuss some of the current analytical procedures including gas chromatographic (GC) and other alternative techniques which are used for residual solvents determination. GC methods have been developed to monitor this kind of impurities routinely. The most popular techniques of sample introduction into the gas chromatograph include direct injection, static or dynamic headspace, solid-phase micro extraction and single drop micro extraction.
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