Business challenges
1、 Because of the high toxicity and low limit value of the impurity, the sensitivity of the instrument is required to be high.
2、 It is difficult to pretreat the samples because of the difference of the properties between the sample matrix and the genotoxic impurities.
service content
1、 According to the client's entrustment, develop a sensitive analysis method for genotoxic impurities.
2、 Under the GMP system, the methodology validation is carried out to meet the requirements of registration and application in the U.S. market and European market.
Our strengths
1、 Shenzhen light is an advocate of the international network of analytical laboratories (all over the United States, Europe and Asia).
2、 In China, Shenguang has a high-level GMP compliance service laboratory, which passed the FDA site audit and local management structure audit in June 2015.
3、 In China, deep light has high-quality analysis equipment, such as q-tof-ms, GC-MS / FID, LC-MS / MS, etc.
