Atorvastatin Calcium Kits Ensure Product Quality and Purity

NSF International now has Atorvastatin Calcium Reference Standard Kits, which are traceable to official US and European pharmacopeial (USP and EP) standards. Two versions are available, the compendial organic impurities and the required series of enantiomeric impurities. Pharmaceutical manufacturers can utilise 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 US FDA and European Directorate for the Quality of Medicines & HealthCare (EDQM) regulatory requirements

• produced and tested following the principles of cGMPs

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

NSF International, Robert Rhodes rrhodes@nsf.org (US), Haresh Jeswani, hjeswani@nsf.org (India), www.nsf-rs.org.