Aktinpharm

Services

Based on professional analysis and development, QC and QA teams, to provide customers with quality research and stability research services for APIs, Formulations, intermediates and registered raw materials that meet the application requirements. Including analytical method development/optimization, analytical method validation/transfer, physical and chemical property research, structure confirmation, control standardization, product release testing, stability research, quality standard research, etc., can meet the various needs of drug development process.


Analytical method development and validation

· Provide method development reports for IND/NDA filings

· Systematic method screening system, combined with software evaluation and forced degradation experiments, quickly establish the stability indicator of relevant substances, content analysis methods

· Chiral impurity and purity analysis method (Chiral HPLC or SFC)

· Salt/acid/base ion analysis method (Titration or Ion chromatography)

· Development of software prediction and analysis methods (LC/MS/MS or GC/MS) for (potentially) genotoxic impurities

· Based on the general method, the solvent residue control method of specific products can be quickly established

· Water, XRPD, PSD, microbial method development

· Comply with ICH Q3D method of elemental impurity analysis

· Methods for qualitative/quantitative NMR and other impurity structure analysis, identification, and content calibration

· Methods that comply with ICH and NMPA guidelines are fully validated or transferred


Stability study

· Forced degradation test and influencing factor test (light, acid, alkali, oxidation, high temperature, high humidity)

· Comply with ICH Q1 and NMPA guidelines (40°C/75%RH, 30°C/65%RH, 25°C/60%RH, 5°C)

· Generate plans and reports for IND filings

· Support product stability research in the commercialization phase

· Study on compatibility of packaging materials


Reference standardization and Product release testing

· Establish an impurity control strategy

· Research and establish IND/NDA declaration quality standard

· Technical support in the lifecycle management of analytical methods

· Research supports for QRA, DoE, and QbD


Quality control strategy

· Establish an impurity control strategy

· Research and establish IND/NDA declaration quality standard

· Technical support in the lifecycle management of analytical methods

· Research supports for QRA, DoE, and QbD