Rockville, MD, February 14, 2020 — A recent study published in Frontiers in Medicine reported that bovine heparin – an alternative to the conventional porcine heparin available in the US – can be produced to meet acceptable impurity levels defined by the US Pharmacopeia (USP). An impurity is any substance that is not intended to be in the final drug product.
Heparin, an anticoagulant used in surgery, kidney dialysis and other clinical applications, is produced from a single source of raw material: porcine intestine – a by-product of the pork industry. The US Food and Drug Administration (FDA) has encouraged the reintroduction of heparin derived from other sources to proactively address the possibility of shortages should disruptions occur in the global porcine heparin supply. Causes of disruption to porcine sources could include health, agricultural and economic factors.
Heparin – and all drugs marketed in the US – meet USP quality standards. In collaboration with scientists from around the world, USP establishes quality standards for the identity, purity, potency, and performance of drug ingredients and drug products. Part of the USP standard for heparin is a set of specific analytical tests to detect and measure impurities, along with acceptable levels that can be present in a drug ingredient or product.
To evaluate whether the tests and limits for impurities in the USP heparin standard could be applied to bovine heparin, USP collaborated with multiple independent laboratories to analyze test and control samples for impurities. Among the impurities tested was oversulfated chondroitin sulfate (OSCS) which, in 2007-2008, was intentionally added to heparin, causing hundreds of adverse reactions in patients around the world.
Test results for bovine heparin were comparable to porcine heparin with respect to impurity levels, with both falling within acceptable ranges. This finding supports the use of bovine heparin as a viable alternative to porcine heparin. Details of the study are published in an article entitled "Quantitative Analysis of Impurities in Unfractionated Heparin of Bovine Origin" in the January 2020 issue of Frontiers in Medicine.
"Heparin shortages would have serious – in some cases life-threatening – repercussions for patients," said Dr. Jaap Venema, executive vice president, chief science officer at USP. "USP will continue to research and develop science-based solutions to help address public health challenges and medicine quality."
During its 200-year history, USP has responded to public health needs with new and revised standards that help ensure medicine quality and protect patient health. Ongoing in-house research and collaborations with scientific experts will continue to identify emerging therapeutic areas in which standards can contribute to the availability of medicines that people can trust.
USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. Through our standards, advocacy and education, USP helps increase the availability of quality medicines, supplements and food for billions of people worldwide. For more information about USP, visit www.usp.org.