Recognized Analytical Capability for Nitrosamine GTIs by CNAS

On April 1, 2022, Beijing Zhongke PUYAN Science & Technology Co., Ltd. received the laboratory accreditation certificate issued by the National Accreditation Commission for conformity assessment of China, which is another milestone after Guangzhou Zhongke PUYAN Testing Co., Ltd. received the laboratory accreditation certificate issued by the National Accreditation Commission for conformity assessment of China on March 17, 2022.

The approved testing objects of Zhongke PUYAN are drugs and pharmaceutical excipients, including 48 items/parameters. In addition to the common analysis items, e.g. related substances, assay, residual solvents, elemental impurities and pesticides residues of traditional Chinese medicine, Zhongke PUYAN has focused on the detection capacity of Nitrosamine Genotoxic Impurities, involving general rule 2.5.42 of the 10th edition of European Pharmacopoeia and general rule 1469 of the United States Pharmacopoeia (effective in December 2021). HPLC-HRMS, GC-MS and GC-MS/MS methods are used to detect Nitrosamine Genotoxic Impurities. In addition, Zhongke PUYAN has also built the detection capacity of detecting the average degree of substitution by capillary electrophoresis and related substances by ion chromatography, so as to meet the daily detection requirements of sulfobutyl betahcyclodextrin sodium, one medicinal excipient in the United States Pharmacopoeia. The detection capability of detecting fatty acid composition by gas chromatography was established to meet the daily detection requirements of polysorbate (Tween) and sorbitan (Sipan) in Chinese Pharmacopoeia.

Founded in June 2017, Beijing Zhongke PUYAN Science & Technology Co., Ltd. has built three laboratories across the country, which are located in Changping District of Beijing, High-tech Zone of Chengdu and Huangpu District of Guangzhou. The laboratories cover an area of about 3000 square meters and are equipped with high-end precision instruments such as HPLC-HRMS, LC-MS/MS, GC-MS/MS, ICPMS, HPLC, IC, CE, IR, ICP, microwave digestion instrument and so on. The company was verified by FDA in March 2022 and was notified of passing the review on site. We can provide professional and compliant method development and verification, sample detection, technology transfer, analytical instrument verification (3Q) and computerized system verification (CSV) services for pharmaceutical enterprises.