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.
In simple terms, risk is the possibility of something bad happening. It’s the uncertainty around the consequences of an activity with respect to something that we value.
The presence of objectionable levels of chemical impurities in pharmaceuticals can have serious public health impacts.
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.
Thank you for helping Quality Matters spread the word in 2015 about USP quality standards and the important role our work plays in industry, public health and lives around the world. These five posts are the ones that you, our readers, found to be the most engaging and useful in 2015.
With the debate about the safety of food additives recently revived in the media, proper identification of the additives themselves is an aspect of food safety often forgotten. It is assumed food ingredients are well known before safety assessments are performed, but that might not be always true.
Here in the United States, we enjoy one of the safest drug and food supplies in the world. It is a huge accomplishment, and the result of a vast safety net created by the coordinated efforts of multiple government agencies, health organizations, industry and non-profits. This article explains the role they play in ensuring that drug, drug ingredients, dietary supplements and food ingredients sold in the U.S. can be safely consumed.
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.