China Lab Joins USP Spectral Libraries Alliance

Apr 04, 2013
By PharmTech Editors

The United States Pharmacopeial Convention (USP) has inaugurated the first satellite site of the USP Spectral Library Global Laboratory Network at the China Shandong Institute for Food and Drug Control (SDIFDC).

USP initiated the development of the USP Spectral Library project, an authoritative and comprehensive food and drug informatics database in 2012, as reported in an April 9 statement (PDF). Once operational, the library will be a valuable tool in the development of quality standards using spectral images as well as for material identification and rapid, non-invasive screening of counterfeit and substandard food and drugs.

“The USP Spectral Library project has the potential to help ensure the quality of medicines and foods throughout the world based on partnerships like the one USP has forged with the Shandong Institute for Food and Drug Control,” said Roger L. Williams, MD, USP’s chief executive officer. “Through the establishment of alliances globally, USP hopes to engage partners worldwide to join USP in its effort to help protect and advance public health.”

In 2012, Dr. Feng Shi of the SDIFDC spent six months as a visiting scientist at USP and worked on advancing the USP Spectral Library project. As director of the SIFDC Spectral Library Laboratory, Shi will help lead expanded efforts of the Spectral Library Global Laboratory Network at the Shandong site.

Every pharmaceutical ingredient and formulated product, together with its packaging materials, has a unique set of physical and chemical properties. Collectively, these properties generate characteristic signals within various regions of the electromagnetic spectrum of wavelengths that can be probed and captured using analytical instrumentation and advanced informatics. A large collection of spectral fingerprints, also called a spectral library, can aid regulatory authorities, law enforcement agencies, hospitals, pharmacies, manufacturers and distributors worldwide to screen for potential counterfeit and substandard food and drug substances and products in any part of the world via Internet access.

USP has established a consortium of representatives from the pharmaceutical industry, manufacturers of analytical technologies, regulatory bodies and other pharmacopoeias and partnered with an analytical software company to develop the informatics infrastructure for the USP Spectral Library.

To fully characterize a substance, USP has adopted an orthogonal methodology for the development of the library, using multiple analytical technologies, including Fourier-Transform Infrared (FTIR) spectroscopy, gas chromatography-mass spectrometry (GC-MS); near infrared spectroscopy (NIR), nuclear magnetic resonance spectroscopy (NMR), X-ray fluorescence (XRF) and Raman technology, among others, to gather spectral information. Advances in many of these technological areas have enabled the development of hand-held or portable versions of these instruments.