Research on Quality Control
1.The development and validation of analytical method
Develop and validate the analytical method according to the features of dosage form and the APIs.
1)Method validation for enantiomers 2)Method validation for impurities 3)Method validation for content uniformity 4)Method validation for assay 5)Method validation for microbiology 6)Dissolution method validation
2.Quality research of the products
Quality research base on the character of dosage form and compound and relevant guideline.
1)Identification 2)Assay 3)Enantiomers 4)Related substances 5)Disintegration 6)Dissolution 7)Dissolution curve (12 units/lot) 8)Moisture or loss on drying. 9)Microbiological test
3.Determine the specification for final products
1)Analytical reports 2)Protocol of quality standard
