Pony Biomedical is equipped with perfect analytical instruments, and the analytical laboratory has established an integrated drug quality system to support the development of new generic drugs, drug registration and application, and production and release, which meets the GMP requirements and obtains the CMA and CNAS qualifications. He is good at drug genotoxic impurity research, drug impurity spectrum research, elemental impurity research and package material compatibility and sealing research.

Service Items:
Development and validation of analytical methods for substances and isomers: Assay, Related Substances, Isomers, Residual Solvents, etc.
Organic and inorganic impurity method development and validation: Develop and validate elemental impurity detection methods and set limits according to ICH Q3D requirements.
Genotoxic impurity Method development and validation: Determination of carcinogenicity and mutagenicity of impurities using software prediction and AMES assay as required by ICH M7,the establishment of TTC-based impurity limits, development and validation of assay methods for genotoxic impurities.
Impurity research: qualitative and quantitative analysis of impurities, degradation pathway and degradation mechanism of impurities.
Development and verification of compatibility methods for drug packaging materials: draft and implement plans for extracts, extract plan drafting and implementation, test method development and validation.
Quality standard research: It can complete the quality research of raw materials, intermediates and finished products of drugs and establish a standard of quality.