Genotoxic Impurities Test

The control of genotoxic impurities is a complex and delicate project throughout the whole life cycle of drug development, and an important part of it is the assessment of genotoxic impurities. The study of genotoxic impurities involves a combination of organic chemistry, biochemistry, toxicology, pharmaceutical process, analytical chemistry and other disciplines. With CD Formulation's professional technical team, we are committed to providing a complete set of services for the assessment of genotoxic impurities in pharmaceuticals, providing a basis for drug development and marketing registration.

Background

Genotoxic impurity analysis is critical to address the purity, safety and quality of APIs or finished drugs. Genotoxic substances are substances that can directly or indirectly damage DNA and cause genetic mutations or cancer. The damaging effects of genotoxic substances on DNA include chromosome breakage, DNA recombination, covalent bonding or insertion during DNA replication, and also mutation through activation of cells to produce genotoxic substances. Genotoxic impurities are mainly derived from starting materials, intermediates, reagents and reaction by-products during the synthesis of APIs. In addition, genotoxic impurities may also be generated by the degradation of drugs during synthesis, storage or formulation.

Our Services

CD Formulation's compliance laboratory offers genotoxic impurity testing services to detect and evaluate the GI potential of your API and/or API to support your product development from early stage to market launch. With scientists who specialize in method development and validation of appropriate analytical procedures, we can overcome the challenges of low detection levels and difficult matrices.

Services contents

• Genotoxic impurity assessment classification
• Impurity isolation and purification and structure identification
• Analytical method development and validation for genotoxic impurities

In addition to the above services, we can provide you with complete data reports, including raw data, data analysis and product solutions from our professionals.

Genotoxic impurity characterization techniques

• High Performance Liquid Chromatography (HPLC) & Liquid Chromatography-Mass Spectrometry (LC-MS)
• Gas Chromatography (GC) & GC-MS
• (ICP-OES) and Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
• Nuclear Magnetic Resonance Spectroscopy (NMR)

We provide highly sensitive and specific method development and validation expertise to perform risk assessments to address issues related to exposure to genotoxic impurities and other substances of concern.

The Need for Genotoxic Impurity Control

The most important characteristic of genotoxic impurities is that they can cause damage to human genetic material at very low concentrations, leading to genetic mutations and tumorigenesis. Because of their high toxicity, they pose a strong threat to the safety of drugs. If the control of genotoxic impurities is not compliant, it will cause great losses to the company.

Quality Assurance

Genotoxic impurity testing is one aspect of a laboratory service solution that includes drug impurity analysis, stability testing, and quality control. We provide comprehensive quality assurance expertise to help you meet and exceed quality, safety and regulatory standards.

If you have a requirement about our services, please contact us by phone or email, our colleagues will reply to you within three working days.