To support method validation and verification, the FDA recommends the use of certified reference standards, such as those for nicotine or other harmful and potentially harmful constituents (HPHCs).

Trueness and precision are a measure of the systematic and random errors of measurement, respectively. The important causes of errors in measurement are influences of the procedure, instrumental ...

This article presents a simple and systematic approach to HPLC method development, beginning with sample preparation and finishing with practical analytical method validation. The wide variety of ...

The agency’s Executive Steering Group on Shortages and Safety of Medicinal Products has issued recommendations to address vulnerabilities in the supply chain of anti-D immunoglobulins.