The United States Pharmacopeia emphasizes mechanical calibration and a performance test to esnure integrity of the dissolution procedure. The intent of the USP performance verification test (PVT), ...
When it comes to dissolution testing, research is focusing on ways to extend its reach, improve in-vitro and in-vivo correlation, and make real-time release testing a reality. Studying how a drug ...
Teva is voluntarily recalling a single lot of Anagrelide Capsules, USP 0.5mg, due to dissolution failure that was detected during a routine stability test. Teva is voluntarily recalling a single lot ...
The FDA has initiated a recall of over 11,000 bottles of Chlorthalidone Tablets USP, 25 mg, due to concerns about their ...
The purpose of this study was to design a convenient, small-scale dissolution test for extracting potential substandard and falsified (SF) medicines that require full pharmacopoeial analysis. The ...
In addition to use of dissolution testers, this three-day course will also cover equipment qualification, development and validation of dissolution procedures, and the use of dissolution testing in ...
The dissolution profile of inhaled drugs underpins therapeutic efficacy and is an area of increasing regulatory scrutiny, particularly for the demonstration of bioequivalence in a generic. The new ...
that would penetrate the first stage of the impactor), the ex-throat dose or the Fine Particle Dose (FPD); the fraction of the dose defined as respirable on the basis of size. The dose is collected on ...