The test items are based on the Chinese Pharmacopoeia, US Pharmacopoeia, European
Pharmacopoeia, US Federal 9CFR, US Food and Drug Administration PTC (1993/1997/2010), International
Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Q5A
& Q5D for method development, which can meet the biopharmaceutical customers' requirements for dual
filing of IND/BLA Chinese and US regulations, and at the same time can help the post-marketing commercial
products to perform release testing.