Bio/Pharmaceutical Analysis, GC-MS

February 2nd 2019

Spectroscopic-based control methods were introduced as equivalent alternative methods, first to a gas chromatographic method to monitor an in-process solvent exchange step and second to a potentiometric titration method to release a process input material for drug substance manufacturing.

February 2nd 2019

Leveraging vast quantities of analytical data requires digitalization and platform integration.

September 4th 2018

As it investigates the root cause of an impurity discovered in valsartan, FDA extends its studies to APIs with similar synthesis processes.

August 2nd 2018

Materials in contact with a drug must be fully characterized to ensure they do not negatively affect the safety and efficacy of the product.