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 US (USP) and European pharmacopeial (EP) standards. Two versions are available, the compendial organic impurities and the required series of enantiomeric impurities. Indian-based 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 Indian pharmaceutical manufacturers to capture a piece of the estimated $14bn 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 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 India’s 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.