The ICH guidelines classify API-related impurities into three categories: organic impurities (including genotoxic impurities), inorganic impurities, and solvent residues. The study of impurities is an important part of drug research and development. It includes selecting appropriate analysis methods, accurately distinguishing and determining the content of impurities, and integrating the results of pharmaceutical, toxicological and clinical studies to determine the reasonable limits of impurities. This research runs through the entire process of drug development.
Quality by design (QbD), the quality of the product must be considered from the beginning of drug development. In-depth research should be conducted in various aspects such as formula design, process route determination, process parameter selection, material control, etc. to accumulate detailed data, and then determine the best product formula and production process accordingly. We and scientists work together on R&D research to provide scientists with separation, purification, identification and safety evaluation services. To provide customers with scientific and efficient drug quality and safety research CRO services.
A team led by professional scientists and data reports that meet the registration requirements of various countries
Our Lab currently has 6 sets of LC-MSMS, 2 sets of GC-MSMS, and 1 set of ICP-MS. And Thermo Orbitrap QE is mainly used for the detection of nitrosamines such as NDMA, NDEA, and NDIPA.
Established a powerful spectrum library that can share data with customers and continuously update
Complies with GMP regulations and FDA 21CFR Part 11 data requirements
CMA / CNAS（ISO/IEC17025） accreditation, cGMP compliance laboratory
Genotoxic Impurities Research
Impurity Study Services
Current Regulations and Guidelines for Impurity Study
Q3A(R2): Impurities in New Drug Substances
Q3B(R2): Impurities in New Drug Products (Revised Guideline)
Q3C(R3): Impurities: Guideline for Residual Solvents
Q3D: Impurities: Guideline for Elemental Impurities
ICH M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk Reference