The laboratory covers an area of more than 5000 square meters. The laboratory system has passed ISO 9000, CNAS certification and many on-site inspections by NMPA, and can accept official on-site inspections by drug administrations of various countries. The research center has more than 400 experience in drug method development and validation, and has established a complete test data database to meet various standards for import registration in various countries.
Determination of drug crystal form in the original drug
Formulation of API crystal form compound standard
Element impurity, genotoxic impurity, fermentation residue (DNA, RNA, protein, polysaccharide) detection, histidine research
Compliance test and validation of national pharmacopoeia of API
Testing and validation of
API registered in China