Static headspace gas chromatography of residual solvents in pharmaceutical products

1994 ◽  
Vol 39 (11-12) ◽  
pp. 645-648 ◽  
Author(s):  
M. V. Russo
Keyword(s):  
Gas Chromatography ◽  
Pharmaceutical Products ◽  
Headspace Gas Chromatography ◽  
Static Headspace ◽  
Residual Solvents ◽  
Static Headspace Gas Chromatography ◽  
Headspace Gas

Analysis of thermolabile residual solvents in a spray dried dispersion using static headspace gas chromatography

2019 ◽  
Vol 42 (6) ◽  
pp. 1222-1229 ◽  
Author(s):  
Antonio Oliveira ◽  
Stephen T. Bambrick ◽  
Laura Y. Pfund ◽  
Panos Diamandopoulos ◽  
Xiaoyi Gong ◽  
...  
Keyword(s):  
Gas Chromatography ◽  
Headspace Gas Chromatography ◽  
Static Headspace ◽  
Residual Solvents ◽  
Static Headspace Gas Chromatography ◽  
Headspace Gas ◽  
Spray Dried

scholarly journals A Full Evaporation Static Headspace Gas Chromatography Method with Nitrogen Phosphorous Detection for Ultrasensitive Analysis of Semi-volatile Nitrosamines in Pharmaceutical Products

2022 ◽  
Vol 24 (1) ◽  
Author(s):  
Jinjian Zheng ◽  
Christine L. Kirkpatrick ◽  
Daniel Lee ◽  
Xinxin Han ◽  
Ana I. Martinez ◽  
...  
Keyword(s):  
Gas Chromatography ◽  
Low Cost ◽  
Pharmaceutical Products ◽  
Universal Method ◽  
Headspace Gas Chromatography ◽  
Static Headspace ◽  
Chromatography Method ◽  
Static Headspace Gas Chromatography ◽  
Headspace Gas ◽  
Volatile Nitrosamines

AbstractThe recent detection of potent carcinogenic nitrosamine impurities in several human medicines has triggered product recalls and interrupted the supply of critical medications for hundreds of millions of patients, illuminating the need for increased testing of nitrosamines in pharmaceutical products. However, the development of analytical methods for nitrosamine detection is challenging due to high sensitivity requirements, complex matrices, and the large number and variety of samples requiring testing. Herein, we report an analytical method for the analysis of a common nitrosamine, N-nitrosodimethylamine (NDMA), in pharmaceutical products using full evaporation static headspace gas chromatography with nitrogen phosphorous detection (FE-SHSGC-NPD). This method is sensitive, specific, accurate, and precise and has the potential to serve as a universal method for testing all semi-volatile nitrosamines across different drug products. Through elimination of the detrimental headspace-liquid partition, a quantitation limit of 0.25 ppb is achieved for NDMA, a significant improvement upon traditional LC-MS methods. The extraction of nitrosamines directly from solid sample not only simplifies the sample preparation procedure but also enables the method to be used for different products as is or with minor modifications, as demonstrated by the analysis of NDMA in 10+ pharmaceutical products. The in situ nitrosation that is commonly observed in GC methods for nitrosamine analysis was completely inhibited by the addition of a small volume solvent containing pyrogallol, phosphoric acid, and isopropanol. Employing simple procedures and low-cost instrumentation, this method can be implemented in any analytical laboratory for routine nitrosamine analysis, ensuring patient safety and uninterrupted supply of critical medications.

Mixed aqueous solutions as dilution media in the determination of residual solvents by static headspace gas chromatography

2011 ◽  
Vol 34 (11) ◽  
pp. 1299-1308 ◽  
Author(s):  
Ward D'Autry ◽  
Chao Zheng ◽  
Kris Wolfs ◽  
Sitaramaraju Yarramraju ◽  
Jos Hoogmartens ◽  
...  
Keyword(s):  
Gas Chromatography ◽  
Aqueous Solutions ◽  
Headspace Gas Chromatography ◽  
Static Headspace ◽  
Residual Solvents ◽  
Static Headspace Gas Chromatography ◽  
Headspace Gas
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