Genotoxic Impurities Analysis

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Through our global network of testing experts and analytical equipment including chromatography (HPLC, GC, GC/MS) and atomic absorption spectroscopy (AAS, GFA, FIAS), Our goal is to provide test services as efficiently as possible to maximize our customers' profits. For more information about our services, contact one of our experts today.

Note: this service is for Research Use Only and Not intended for clinical use.

Genotoxic impurities are compounds that directly or indirectly damage cellular DNA, produce genetic mutations or mutagenesis in vivo, and have carcinogenic potential or propensity. It is characterized by damage to human genetic material at very low concentrations, leading to genetic mutations and possibly tumorigenesis. Genotoxic impurities commonly found in the pharmaceutical industry include:

Sulfonates
Alkyl Halides and Esters
Hydrazines

Epoxides
Aromatic Compounds
β-lactam Related Impurities

Genotoxic Impurities Analysis Fig. 1. Structures of common sulfonate salts¹

Because genotoxic impurities are highly toxic and threaten the public's medication safety, they need to be risk assessed and controlled. Alfa Chemistry is an expert in the analytical chemistry industry, providing solutions for the development and analysis of chemical methods for the detection of trace amounts of genetic impurities for the complex pharmaceutical industry. We design custom-compliant inspection methods according to your needs and provide you with an evaluation report. If you have any questions about genotoxic impurities analysis, please feel free to contact us.

Alfa Chemistry's technology for impurities analysis include but not limited to:

Inductively-Coupled Plasma Mass Spectrometry (ICP-MS)
Inductively Coupled Plasma Optical Emission Spectrometer (ICP-OES)
Gas Chromatography (GC)
Gas Chromatography-Mass Spectrometry (GC-MS)
Fourier Transform Infrared Spectroscopy (FT-IR)
Liquid Chromatography-Ultraviolet Spectrometry (LC-UV)
Liquid Chromatography-Mass Spectrometry (LC-MS)
Capillary Electrophoresis (CE)
Supercritical Fluid Chromatography (SFC)
Nuclear Magnetic Resonance Spectroscopy (NMR)

Some guidelines on genotoxic impurities include:

Alfa Chemistry's advantages:

Short Detection Cycle
Competitive Price
Experienced Team of Experts

First-class Equipment
Reliable Results
Familiarity with Various Standards

Reference

Jouyban, Abolghasem & Parsa Khankandi, Hamed. (2012). Genotoxic Impurities in Pharmaceuticals. 'Toxicity and Drug Testing' 387-414.

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