The importance of ensuring the safety and efficacy of pharmaceutical products cannot be overstated In the pharmaceutical industry. One critical aspect of this is the analysis and control of genotoxic impurities. Genotoxic impurities are chemical compounds found in trace amounts in pharmaceutical products that have the potential to cause genetic mutations or damage to the DNA, even in minute quantities. These impurities can arise from various sources, including raw materials, intermediates, or by-products formed during the manufacturing process. Therefore, regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have stringent guidelines on the permissible levels of genotoxic impurities to ensure the safety, quality and effectiveness of pharmaceutical products. As the world's leading drug development and research company, we have rich experience and expertise in the research and analysis of impurities, and have established an advanced genotoxicity analysis platform. Our genotoxic impurities analysis platform offers comprehensive testing and analysis services to identify and quantify genotoxic impurities in pharmaceutical products.
Our Genotoxic Impurities Analysis Platform
Our platform supports a range of services related to the analysis of genotoxic impurities, including but not limited to:
- Provide genotoxic impurities testing in adherence to ICH M7 guidelines, USFDA, EMA, and customer requirements and provide scientific control strategies.
- Provide development and optimization of genotoxic impurities analysis methods.
- Provide validation of genotoxic impurities analysis methods to meet different regulatory requirements.
- Evaluate genotoxic impurities that may arise during the synthetic process.
- Utilize (Q) SAR prediction software for genotoxicity prediction.
- Perform bacterial mutation experiments (Ames test) to assess genotoxicity.
- Calculate genotoxic impurity limits in drugs according to ICH M7 guidelines.
- Supports toxicity testing research.
- On-line monitoring of genotoxic impurities during synthesis.
Our platform can provide genotoxic impurity service for:
- APIs / drug substance
- Raw material
- Pharmaceutical intermediate
- Drug preparations
- Starting material
- Pharmaceutical packaging material
Instruments and Equipment
Our platform utilizes state-of-the-art analytical techniques to ensure the most accurate and reliable results such as:
- Liquid Chromatography-tandem Mass Spectrometry (LC-MS/MS)
- High Performance Liquid Chromatography (HPLC)
- Gas Chromatography - Mass Spectrometry (GC-MS)
- Inductively Coupled Plasma - Optical Emission Spectrometry (ICP-OES)
- Direct Headspace Gas Chromatography - Mass Spectrometry (DHS-GC-MS)
- Nuclear Magnetic Resonance (NMR)
- Gas Chromatography - Tandem Mass Spectrometry (GC-MS/MS)
- High Resolution Mass Spectrometry (HRMS)
- Headspace Gas Chromatography - Mass Spectrometry (HS-GC-MS)
- Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
- Ion Chromatography (IC)
- Ultraviolet-Visible spectroscopy (UV-Vis)
Platform Advantages
- Expertise and Experience: Our team comprises highly experienced scientists and industry experts specializing in genotoxic impurity analysis. Their extensive knowledge and expertise ensure that we provide the most accurate and dependable services to our clients.
- State-of-the-Art Facilities: Our laboratories are equipped with the latest technologies and adhere to the highest standards of quality and safety. This ensures that our analyses are performed with the utmost accuracy and reliability.
- Regulatory Expertise: We stay abreast of the latest regulatory guidelines and requirements set by global regulatory bodies. This enables us to provide advice and services that ensure our clients' products are fully compliant with all necessary regulations.
- Customized Solutions: We offer tailored solutions that meet the unique needs and challenges of each client. Whether it's developing a risk-based assessment or creating a custom analytical method, our services are designed to provide the most effective solutions.
With our expert team, advanced instruments, and personalized solutions, our genotoxic impurities analysis platform offers comprehensive, state-of-the-art services and support to help pharmaceutical companies navigate the complexities of genotoxic impurities analysis and ensure their products are safe, effective, and compliant with regulatory standards. Contact us today to learn more about how our platform and services can benefit your projects.
Related Services
It should be noted that our service is only used for research, not for clinical use.
