Residual solvents in biodegradable microparticles: Determination by a dynamic headspace gas chromatographic method

1996 ◽  
Vol 142 (1) ◽  
pp. 67-73 ◽  
Author(s):  
F. Ruchatz ◽  
P. Kleinebudde ◽  
B.W. Müller
Keyword(s):  
Chromatographic Method ◽  
Dynamic Headspace ◽  
Residual Solvents ◽  
Headspace Gas ◽  
Gas Chromatographic Method ◽  
Biodegradable Microparticles

Determination of Residual Ethylene Oxide in Spectinomycin Hydrochloride Bulk Drug by Dynamic Headspace Gas Chromatography

1993 ◽  
Vol 76 (2) ◽  
pp. 313-319
Author(s):  
Tore Ramstad ◽  
Lisa S Miller ◽  
Virginia N Thomas
Keyword(s):  
Detection Limit ◽  
Ethylene Oxide ◽  
Chromatographic Method ◽  
Headspace Gas Chromatography ◽  
Dynamic Headspace ◽  
Relative Standard ◽  
Headspace Gas ◽  
Bulk Drug ◽  
Gas Chromatographic Method

Abstract A dynamic headspace gas chromatographic method was developed for the determination of residual ethylene oxide (EtO) in a pharmaceutical bulk drug, spectinomycin hydrochloride. The recommended column is PoraPLOT Q; PoraPLOT U was demonstrated to be equivalent. A detection limit of 2 ppb was achieved, and linearity was established to the highest value tested (5 ppm). The detection limit was 2-3 orders of magnitude lower than that achieved in previously published methods for EtO in pharmaceutical bulk drugs. Precision studies yielded relative standard deviations ranging from 2 to 10% over the 10-575 ppb concentration range. The method was applied to support EtO sterilization studies conducted at The Upjohn Company and was implemented for routine use. The sterilization studies demonstrated that residual levels of EtO <10 ppb are achievable.

Static headspace gas chromatographic method for the determination of residual solvents in cephalosporins

RSC Advances ◽  
2015 ◽  
Vol 5 (22) ◽  
pp. 17150-17159 ◽  
Author(s):  
Mohamed Gad ◽  
Hala Zaazaa ◽  
Sawsan Amer ◽  
Mohamed Korany
Keyword(s):  
Pharmaceutical Industry ◽  
Chromatographic Method ◽  
Static Headspace ◽  
Residual Solvents ◽  
Headspace Gas ◽  
Gas Chromatographic Method ◽  
Daunting Challenge

The pharmaceutical industry is facing a daunting challenge in the control of impurities.

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