Regulatory & Safety

Waters to open laboratory with Chinese Pharmacopoeia

Last updated on 10-Jul-2014 at 09:30 GMT2014-07-10T09:30:09Z - By Zachary Brennan+
Both the ChP and Waters expect the lab to become one of the national technical support centers in the field of Chinese pharmaceutical standards
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Pharma technology provider Waters as agreed with the Chinese Pharmacopoeia Commission (ChP) to establish a joint open laboratory to develop new pharmacopoeia standards.

Scheduled to open before the end of 2014, the new 1,400 square foot lab will focus on the research of pharmacopoeia standards, development of testing methods, methods validations and basic and advanced technical training of pharmacopoeia detection methods. The lab will be outfitted with Waters chromatography and mass spectrometry technologies, including a range of Acquity UPLC systems, Acquity UPC System, Xevo tandem quadrupole and time-of-flight mass spectrometers, and a Natural Products Application Solution with UNIFI.

Both the ChP and Waters expect the lab to become one of the national technical support centers in the field of Chinese pharmaceutical standards.

ChP has developed methodologies for a wide range of drugs and pharmaceuticals and now the desire and drive is to develop more of a library for natural products and traditional Chinese medicine, Waters spokesman Jeff Tarmy told us. “They have thousands of years of experience with these products and they’re looking to create standards for those active ingredients.”

Waters’ past work with the USP (US Pharmacopoeia), as well as its work helping companies develop testing methods should be a boon for the company’s efforts in China, Tarmy said.

At the collaboration agreement signing ceremony in Beijing, Secretary General Zhang Wei of the ChP pointed out that "the ChP-Waters Joint Open Laboratory cooperation would become another milestone of the development of the ChP. This cooperation not only meets the needs of ChP’s own development, but also meets the demands of enhanced pharmacopoeia standards and improved public drug safety.”

Art Caputo, President of the Waters Division, added: "I am confident that this new Joint Open Laboratory will make positive contributions to assuring drug quality control in China, it will quickly become an international leader in the field of traditional Chinese pharmaceutical standards."

Related topics: Regulatory & Safety, QA/QC, APIs (active pharmaceutical ingredients), Regulations

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