OR WAIT null SECS
March 02, 2019
Determination of sodium chloride level is critical for assessment of purity of yeast extracts. This case study demonstrates the validation of an ion chromatography method as a suitable analytical approach.
HPLC coupled with charged aerosol detection is a suitable analytical technique to quantitate and characterize polysorbate-80 in therapeutic products; allowing quality assessment of raw material, content confirmation during manufacturing, and monitoring product stability.
Harmonization of best practices and regulatory requirements will enable developers to find the best stability testing approach.
March 01, 2019
Investigation of peak purity failure during HPLC method validation led to discovery of a co-eluting impurity under the main peak. Spectral analysis, including three-dimensional modelling, was used to characterize the peak, leading to the development of a new HPLC method for analysing impurity content.
February 19, 2019
The acquisition would strengthen Charles River’s contract research capabilities.
February 02, 2019
Novel analytical methods may help biologics manufacturers respond to stricter regulations on particulate matter.
February 01, 2019
Outsourcing of analytical testing and processes can help bio/pharmaceutical companies expand their product profiles.
Pharmaceutical Technology spoke with Lisa Crandall, MS, associate director CMC Project Management, and Peter Angus, PhD, director of Pharmaceutical Sciences, at Velesco Pharma, which provides a full range of stability testing of API and drug products, about best practices in stability testing.
January 31, 2019
SGS announces expansion of cell bank and bulk harvest testing services.
January 15, 2019
The company will invest $4 million to increase topical and transdermal formulation development and performance testing services at its Durham, NC, facility.