NSF International Launches Pharmaceutical Reference Standards

NSF International (Ann Arbor, MI) has delved into the world of reference standards, launching the NSF Reference Standards program for pharmaceuticals. The company says that the program will produce reference standards that are “traceable” to official U.S. and European pharmacopeial standards. (Association representatives told Nutritional Outlook that there are no plans to launch a similar reference standards program for dietary supplements.)

The first of the standards are available on the NSF Reference Standards website, www.nsf-rs.org. NSF says that additional standards will be added through 2012, and that the company is aiming for an offering of more than 300 items.

NSF says the reference standards are:

• Tested independently by a minimum of three collaborating laboratories

• Traceable to both United States Pharmacopeia (USP) and European Pharmacopeia (EP) reference standards

• Verified to conform to FDA and European Directorate for the Quality of Medicines & HealthCare (EDQM) regulatory requirements

• Produced and tested following the principles of current Good Manufacturing Practices

• Accompanied by documentation that includes a Certificate of Analysis and Material Safety Data Sheet

“NSF Reference Standards will set the bar for the quality and purity of pharmaceutical products while also offering companies favorable pricing,” stated Lori Bestervelt, PhD, chief technical officer and senior vice president of the NSF Health Sciences Division.

She continued, “Developing the NSF Reference Standards program is a natural step for NSF’s Health Science Division, which has over 25 years of pharmaceutical industry experience gained through NSF-DBA, NSF Pharmalytica, and through the team of experts leading the NSF Reference Standards program…This is in addition to NSF’s 66-year history developing public health standards and providing testing and inspection services to the food, water, dietary supplement, and consumer products industry.”

Reference standards are used as comparative standards to test the identity, purity, quality, and strength of pharmaceutical products and ingredients.

In addition to NSF Reference Standards, the NSF Health Sciences Division includes NSF Pharmalytica, a GLP and GMP contract laboratory that offers analytical testing, consulting, training, registration, and R&D services; NSF-DBA, which offers training, auditing, and consulting to the pharmaceutical, medical devices, and dietary supplements industries; and the NSF Dietary Supplement program, which offers dietary supplement testing and certification, banned substances screening and certification, and GMP audits.