Whitepapers
An Overview of Dissolution Method Development and Validation for Semisolid Dosage Forms
When most of us think of drug product dissolution testing, images of solid oral dosage forms like capsules and tablets using Apparatus 1 or 2 come to mind. But other dosage forms are also characterized by dissolution, including semisolid forms often used for topical drug delivery. It’s worthwhile to look at some of the things ... An Overview of Dissolution Method Development and Validation for Semisolid Dosage Forms
An Introduction to Dissolution and Available Apparatuses
Dissolution testing has been a customary United States Pharmacopeia (USP) test for solid oral dosage forms for more than four decades and for semisolid oral dosage forms for the last decade. This article provides some background on dissolution testing, then defines USP dissolution apparatus 1 through 7 and provides practical examples of the use of ... An Introduction to Dissolution and Available Apparatuses
A Primer on Photostability in the Development of Pharmaceuticals
The storage conditions of a drug product can put it under a lot of stress. Environmental conditions, such as light, can have a huge impact on how well a drug works and whether the drug is breaking down and forming toxic degradation products. The shelf life of a drug product depends a great deal on ... A Primer on Photostability in the Development of Pharmaceuticals
Nitrosamines Analysis
Since the FDA’s discovery of nitrosamines impurities, which led to the voluntary recall of valsartan in 2018, the pharmaceutical industry has undertaken a thorough investigation of this class of compounds to ensure patient safety. Since nitrosamines are a class of organic compounds identified as probable human carcinogens, the potential presence of these compounds in drug ... Nitrosamines Analysis