Regardless of whether it’s prescription or over-the-counter, the ingredients on a drug product label typically include one, maybe two, active pharmaceutical ingredients (APIs). The rest of the list is comprised of “inactive” ingredients (excipients) which in reality are far from inactive. Variability may be acceptable for products such as printer ink and paintballs, but not pharmaceuticals, making quality standards for excipients critical to ensuring consistent drug quality.
Discover convenient tools and helpful tips related to using USP Reference Standards in your work. USP Reference Standards are intended for quality control use in conducting assays and tests in USP’s documentary standards for drugs, dietary supplements, and foods.
Today, approximately 80% of all active pharmaceutical ingredients in medicines sold in the U.S. are manufactured in another part of the world. While manufacturers have to ensure the quality and consistency of ingredients that go into final pharmaceutical products, they must also employ measures for the proper control of unwanted impurities in drugs and drug ingredients.
Dr. Greg Amidon, member of USP’s Council of Experts Nominating Committee and President-Elect of AAPS, discusses the importance of volunteering.
What are medicine impurities and from where do they come? Identifying and describing impurities is a critical safety issue concerning manufacturers, regulators, and patients. This post describes the types of impurities found in medicines and how they may impact drug quality.
