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RESIDUAL SOLVENT ANALYSIS IN HYDROCHLORIDE SALTS OF ACTIVE PHARMACEUTICAL INGREDIENTS

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dc.contributor.author PURANIK, SB PURANIK
dc.contributor.author PAWAR, R PAWAR
dc.contributor.author LALITHA, N LALITHA
dc.contributor.author PAI AND GK RAO, PN SANJAY
dc.date.accessioned 2022-11-29T07:09:15Z
dc.date.available 2022-11-29T07:09:15Z
dc.date.issued 2009-10
dc.identifier.citation Puranik, S. B., Pawar, V. R., Lalitha, N., Pai, P. S., & Rao, G. K. (2009). Residual solvent analysis in hydrochloride salts of active pharmaceutical ingredients. Pak. J. Pharm. Sci, 22(4), 410-414. en_US
dc.identifier.issn 1011-601X
dc.identifier.uri http://142.54.178.187:9060/xmlui/handle/123456789/14226
dc.description.abstract GMP conditions commands to control adequately the quality of APIs by checking the levels of residual solvents. Organic solvents such as acetone, ethyl acetate, isopropyl alcohol, methanol, tetrahydrofuran and toluene frequently used in pharmaceutical industry for the manufacturing of Active Pharmaceutical ingredients (APIs). A selective Gas Chromatographic (GC) method has been developed and validated as per ICH guidelines for residual solvent analysis in 10 different hydro chloride salts of APIs. Residual solvents in APIs were monitored using gas chromatography (GC) with Flame Ionisation detector (FID). 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 is simple, sensitive, rugged, reliable and reproducible for the quantitation of acetone, ethyl acetate, isopropyl alcohol, methanol, tetrahydrofuran and toluene at residual level from hydrochloride chloride salts of APIs. en_US
dc.language.iso en en_US
dc.publisher Karachi: Faculty of Pharmacy, University of Karachi en_US
dc.subject Hydrochloride salts en_US
dc.subject API en_US
dc.subject residual solvents en_US
dc.subject gas chromatography en_US
dc.title RESIDUAL SOLVENT ANALYSIS IN HYDROCHLORIDE SALTS OF ACTIVE PHARMACEUTICAL INGREDIENTS en_US
dc.type Article en_US


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