FDA and USP allow new technology for gravimetric sample preparation - METTLER TOLEDO

FDA and USP allow new technology for gravimetric sample preparation

FDA and USP allow new technology for gravimetric sample preparation

Quantitative testing of solutions prepared from samples of drug substance or drug product is at the foundation of pharmaceutical analysis. Traditionally, this testing has involved weighing sample materials into a volumetric flask, dissolving the sample in an appropriate solvent, and filling the flask to a calibration mark on the neck of the flask.
In this regulated environment, where regulatory and compendial requirements define what is or is not allowed, the FDA and USP have made specific allowances for adoption of new technology, when it will have a beneficial effect on product quality.

Download the reviewed article and learn how the introduction of new instrumentation for Gravimetric Sample Preparation presents a significant opportunity to improve the quality of results from analytical procedures for pharmaceuticals by reducing the uncertainty associated with the preparation.