A New Analytical Method Validation and Quantification of Residual Solvents in Telmisartan Bulk Drug Product by Headspace gas Chromatographic Method

2018 ◽  
Vol 10 (2) ◽  
pp. 98
Author(s):  
Tentu Nageswara Rao ◽  
T.B. Patrudu ◽  
A Suneel. Kumar ◽  
N. Krishna Rao ◽  
Karri Apparao
Keyword(s):  
Method Validation ◽  
Analytical Method ◽  
Chromatographic Method ◽  
Drug Product ◽  
Residual Solvents ◽  
Analytical Method Validation ◽  
Validation And Quantification ◽  
Headspace Gas ◽  
Bulk Drug ◽  
Gas Chromatographic Method

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.

scholarly journals A Robust Static Headspace GC-FID Method to Detect and Quantify Formaldehyde Impurity in Pharmaceutical Excipients

2018 ◽  
Vol 2018 ◽  
pp. 1-8 ◽  
Author(s):  
Bashir Daoud Agha Dit Daoudy ◽  
Mohammad Ammar Al-Khayat ◽  
Francois Karabet ◽  
Mohammad Amer Al-Mardini
Keyword(s):  
Chromatographic Method ◽  
Drug Product ◽  
Static Headspace ◽  
Pharmaceutical Excipients ◽  
Accuracy And Precision ◽  
Headspace Gas ◽  
And Performance ◽  
Gas Chromatographic Method ◽  
Headspace Gc ◽  
Detection And Quantification

Formaldehyde is a highly reactive impurity that can be found in many pharmaceutical excipients. Trace levels of this impurity may affect drug product stability, safety, efficacy, and performance. A static headspace gas chromatographic method was developed and validated to determine formaldehyde in pharmaceutical excipients after an effective derivatization procedure using acidified ethanol. Diethoxymethane, the derivative of formaldehyde, was then directly analyzed by GC-FID. Despite the simplicity of the developed method, however, it is characterized by its specificity, accuracy, and precision. The limits of detection and quantification of formaldehyde in the samples were of 2.44 and 8.12 µg/g, respectively. This method is characterized by using simple and economic GC-FID technique instead of MS detection, and it is successfully used to analyze formaldehyde in commonly used pharmaceutical excipients.

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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