Organic and enantiomeric impurities kits are traceable to both U.S. and European pharmacopeial standards

ANN ARBOR, Mich. — NSF International, an independent global public health organization that develops high quality reference standards, now has Atorvastatin Calcium Reference Standard Kits, which are traceable to official U.S. (USP) and European pharmacopeial (EP) standards. Two versions are available, the compendial organic impurities and the required series of enantiomeric impurities.  Pharmaceutical manufacturers can utilize the kits to demonstrate the identity, purity, quality and strength of their Atorvastatin Calcium products.

The patent protection for Lipitor® expired in November 2011, opening up a significant opportunity to pharmaceutical manufacturers to capture a piece of the estimated $14 billion annual market for Atorvastatin. However, Atorvastatin is an incredibly complex compound with many opportunities for impurities to be introduced during its synthesis. NSF International developed the Atorvastatin Reference Standard Kit to provide a cost-effective way to ensure the quality and purity of Atorvastatin products and reduce the risk of regulatory noncompliances.

Since NSF’s Atorvastatin Calcium Reference Standard Kits are demonstrated as traceable to the compendial primary standards, their use is cited as acceptable in numerous regulatory and compendial guidance for qualitative and quantitative tests — including qualitative tests for identification, impurity determinations and chromatographic system suitability.

In addition to the Atorvastatin Calcium standard, the two kits include compendial organic impurities and the required series of enantiomeric impurities and each meet the following NSF Reference Standards requirements:

  •     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 U.S. Food and Drug Administration (FDA) and European Directorate for the Quality of Medicines & HealthCare (EDQM) regulatory requirements
  •     Produced and tested following the principles of current Good Manufacturing Practices (cGMPs)
  •     Accompanied by documentation that includes a Certificate of Analysis and Material Safety Data Sheet

“Regulatory agencies in the United States and Europe require manufacturers of Atorvastatin Calcium to demonstrate adherence to compendial monographs for the drug. NSF developed Atorvastatin Calcium kits to help the global pharmaceutical sector capture the growing Atorvastatin market by providing high quality, regulatory compliant and economical alternatives to primary Atorvastatin Calcium reference standards,” said Lori Bestervelt, Ph.D., NSF Chief Technical Officer and Senior Vice President over the NSF International Health Sciences Division.

NSF Reference Standards for many commonly tested products are available for purchase on NSF’s website at nsf-rs.org.

For additional information about NSF Reference Standards or to place an order, visit www.nsf-rs.org or contact Robert Rhodes (U.S.) at rrhodes@nsf.org, Haresh Jeswani (India) at hjeswani@nsf.org or Ajay Goud (India) at agoud@nsf.org.

Editor’s Note: NSF Reference Standards Director of Quality & Regulatory Affairs Tom Savage will be available at CPHi India in person or by phone. To schedule an interview, contact Senior Communications Manager Greta Houlahan at houlahan@nsf.org or 734-913-5723. NSF International Reference Standards will be at booth V10 at CPHi India.

About NSF International (www.nsf.org): Based in Ann Arbor, Mich., USA, NSF International is a global independent public health organization that writes standards, and tests and certifies products for food, water, health sciences and consumer goods industries. Established in 1944, NSF is committed to protecting human health and safety worldwide and operates in more than 150 countries. NSF is a World Health Organization Collaborating Centre for Food and Water Safety and Indoor Environment.

NSF Health Sciences Division offers training and education, consulting, auditing, GMP and GLP testing, certification, R&D and regulatory guidance for the pharmaceutical, medical device and dietary supplement industries throughout the product lifecycle. The division also supplies pharmaceutical secondary reference standards, traceable to USP and EP standards. NSF wrote the only accredited American National Standard (NSF/ANSI 173) that verifies the health and safety of dietary supplements and also tests and certifies products to this standard. The NSF Health Sciences Division operates globally throughout North America, Europe, the Middle East, Africa, Asia and Latin America.

NSF International offers ISO 13485 registrations for medical devices and CE Marking delivered through NSF International Strategic Registrations, Ltd. (NSF-ISR), as well as drinking water filtration certification through the NSF Water Division. Additional services include safety audits for the food and water industries, environmental and sustainability services through NSF Sustainability and training courses through the NSF Training and Education.