Quality-control guidelines and processes have progressed considerably in the past eight years since the first publication of the United States Pharmacopeia regulations. Many state boards of pharmacy have put additional emphasis on quality control in their regulations. Fortunately, there are many resources available to the compounding pharmacist today, from third-party quality-control testing la...

فهرست مقالات شماره 18

Dodoneine (Ddn) is one of the active compounds identified from Agelanthusdodoneifolius, which is a medicinal plant used in African pharmacopeia and traditional medicine for the treatment of hypertension. In the context of a scientific program aiming at discovering new hypotensive agents through the original combination of natural product discovery and superacid chemistry diversification, and af...

Introduction Dissolution testing is routinely carried out in the pharmaceutical industry to determine the rate of dissolution of solid dosage forms. In addition to being a regulatory requirement, in-vitro dissolution testing is used to assist with formulation design, process development, and the demonstration of batch-to-batch reproducibility in production. The most common of such dissolution t...

The US Pharmacopeia (USP) Therapeutic Peptides Expert Panel was formed in 2013 to evaluate quality attributes for synthetic peptide APIs based on currently available regulatory guidance and expectations. This series of three articles by the panel explores the current manufacturing and regulatory landscape and provides a comprehensive overview of quality attributes to be considered for successfu...