In Part I of a three-part article, the authors discuss what constitutes an impurity and the potential sources of impurities in APIs and finished drug products. To ensure the quality of APIs and ...

In 2018, a nitrosamine impurity (N-nitrosodimethylamine or “NDMA”) was detected in several pharmaceutical drugs containing the active ingredient valsartan, which resulted in a voluntary product recall ...

The ritual of the Red Heifer is one of the most mysterious rituals in the entire Torah. (I have no doubt that this first sentence has been written many times before, but the ritual is so mysterious — ...

All perfect praise be to Allaah, The Lord of the Worlds. I testify that there is none worthy of worship except Allaah, and that Muhammad, sallallaahu ‘alayhi wa sallam, is His slave and Messenger.

Having intelligent analytical tools can advance the detection of unknown impurities, which is important for ensuring small-molecule ingredient purity. The United States Pharmacopeia (USP) defines an ...

Usage: Reference standards serve as quality control benchmarks for equipment calibration and verification of measurement methods and analytical accuracy. Characteristics: Chemicals with established ...

Presently ICH M7 and other guidelines give an overview of evaluation and assessment of limits of pharmaceutical impurities categorized as mutagenic. These could be degradation products of ...

Pharmaceutical process chemists want to make the compound, the whole compound, and nothing but the compound. They know, however, that chemistry isn’t that simple and that a multistep synthesis often ...