Pony has an experienced quality research team, which is able to conduct drug analytical method development and validation, analytical testing and release, separation and analysis of trace toxic and harmful impurities, stability study, CTD declaration document writing and standardized drug testing services in strict accordance with ICH guidelines.

Service Items:
Development and validation of analytical methods: Assay, Related Substances, Isomers, Residual Solvents, etc.
Elemental 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, 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 Standard of quality.