Analysis of potential genotoxic impurities in pharmaceuticals by two-dimensional gas chromatography with Deans switching and independent column temperature control using a low-thermal-mass oven module

Analytical and Bioanalytical Chemistry
Frank DavidMatthew S Klee

Abstract

The analysis of potential genotoxic impurities (PGIs) in active pharmaceutical ingredients (APIs) is a challenging task. The target limit of detection for a PGI in an API is typically 1 ppm (1 microg/g API). This is about 500 times lower than for classical impurity analysis. Consequently, analytical methods for trace analysis, mostly in combination with MS detection, need to be applied for the qualitative and quantitative determination of these impurities. A two-dimensional capillary GC method is presented that can be used for the determination of some target PGIs. A concentrated solution of the API sample is directly introduced in the GC-MS system, using an apolar column for first-dimension separation. The fraction (heart-cut) containing the PGIs is transferred to a second capillary column, installed in a low-thermal-mass oven (LTM). The LTM focuses the heart-cut(s) and allows independent temperature-programmed analysis with a polar second-dimension column. The API, solvent, and derivatization agents are not introduced in the second column or in the MS detector, avoiding contamination, column degradation, and target analyte peak detection/integration issues. The performance of this set-up is illustrated by the analysis of some...Continue Reading

References

Jun 7, 2002·Journal of Chromatographic Science·Matthew S Klee, Leonid M Blumberg
Dec 7, 2007·Journal of Pharmaceutical and Biomedical Analysis·D P ElderA M Lipczynski
Dec 23, 2008·Journal of Pharmaceutical and Biomedical Analysis·Mingjiang SunDavid Q Liu
Mar 10, 2009·European Neuropsychopharmacology : the Journal of the European College of Neuropsychopharmacology·Karl Broich, UNKNOWN Committee for Medicinal Products for Human Use
Jul 7, 2009·Journal of Pharmaceutical and Biomedical Analysis·Jie ZhengSteve Wittenberger

❮ Previous
Next ❯

Citations

Feb 1, 2011·Journal of Pharmaceutical Sciences·Frederick G Vogt, Alireza S Kord
Mar 23, 2011·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Antonio GiordaniHans Ulrich Gally
Jan 5, 2011·Journal of Pharmaceutical and Biomedical Analysis·N V V S S RamanK Ratnakar Reddy
Jul 20, 2011·Analytical and Bioanalytical Chemistry·Blagoj MitrevskiPhilip J Marriott
Mar 13, 2014·Analytical Sciences : the International Journal of the Japan Society for Analytical Chemistry·Koki HarigayaJun Haginaka
Aug 12, 2014·Analytical Sciences : the International Journal of the Japan Society for Analytical Chemistry·Koki HarigayaJun Haginaka
Sep 3, 2020·ISA Transactions·Uğur Demiroğlu, Bilal Şenol

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.