R&D and services

R&D and services


Beijing Xinkaiyuan Pharmaceuticals has been focusing on R&D of generic drug ingredients and preparations, technological innovation and industrialization. With the R&D concept of quality from design (QbD), we have established an R&D and management system that meets international standards. According to advanced standards of drug R&D in the Europe and United States, we provide domestic and foreign customers with high-quality, high-standard and high-efficiency one-stop services in the field of oral solid preparations from research projects, prescription process research, quality standard research, pilot test, registration to industrialization.
API process research

Process route selection

Process parameter optimization

Three small batch tests process repeatability test

Pilot transition

Impurities preparation and research

(Dissolution apparatus)
Pre-prescription study

Pre-prescription information research

Project risk assessment

Selection and inspection of raw materials and auxiliary materials

Preliminary establishment of quality standard

Analysis of four media release curves of the original reagent

Develop a general experiment scheme

Quality research

Analytical methods establishment, optimization, and validation

Comparative study on quality standard

Comparative study on product quality

Sample stability test