Standards-Setting Activities on Impurities

USP's focus in 2013 involves standards relating to organic impurities, measurement of residual DNA and host-cell proteins in biotechnology products, and elemental impurities.
Mar 01, 2013

As pharmaceutical products have evolved over the decades, so have processes for their manufacture and analytical techniques for understanding their composition. For every medicine taken by a patient, it is important for a drug maker to be able to identify impurities of any significance that can result from its manufacturing process and to take measures to control for unwanted impurities, especially because they may affect the safety and efficacy of a product.

An impurity is a substance occurring in a finished drug product that plays no functional role and is not an inherent component of the pure form of the intentionally used ingredients. It can be the result of a manufacturing process, can be added intentionally as a catalyst during drug synthesis, or can be a byproduct of degradation that emerges during the lifecycle of a drug.

Beginning in the 1990s, the International Conference on Harmonization (ICH) began the development of guidelines relating to impurities in pharmaceuticals. ICH guidelines provide a framework for regulatory filings for new drugs. This body of work on impurities led to what is now well-recognized as the ICH Q3 series, which includes guidelines (allowable levels) for organic and inorganic impurities as well as residual solvents. In developing its own standards for impurities, the US Pharmacopeial Convention (USP) has worked to harmonize with ICH, where feasible, while maintaining its goals of modernizing and creating standards that reflect current-day practices in industry that help to ensure drug quality.

A nonprofit scientific organization, USP develops standards for the identity, strength, quality, and purity of medicines and their ingredients. In addition, USP's standards include those for specific impurities associated with drug substances and drug products. Documentary standards in USP's compendia—United States Pharmacopeia and the National Formulary (USP–NF)—are published as individual monographs and general chapters as well as General Notices.

With regard to organic impurities, USP established in recent years standards for residual solvents in drug products, drug substances, and excipients. In addition, USP has initiated a review of other general chapters relevant to organic impurities overall and has developed revised standards for elemental impurities. In 2013, USP will host a workshop on yet another group of impurities—residual host-cell proteins and DNA in biotechnology products.