Welcome to Jiangsu Assure Pharma Biotechnology Co., Ltd.
Impurity Study on Drug Substances (GTls)

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.

Our Advantages

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

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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

国家药典委员会:《遗传毒性杂质控制指导原则》(征求意见稿),2019

EMA:《基因毒性杂质限度指南》,2006

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