June 6th 2025
ICH Q6B provides expectations and a clear framework for the structural characterization of biopharmaceutical products.
Nanoscale Technique Measures Surface Physical Properties of APIs
July 3rd 2008Molecular Profiles created a poster that demonstrates the efficacy of its "nanoPASS" (nanoscale predictive analytical screening solution) technique to characterize an active pharmaceutical ingredient's (API) surface energy.
EMEA Report Assesses Contaminated-Heparin Risk
June 12th 2008In an assessment report about medicinal products containing heparin, the European Medicines Agency (EMEA)'s Committee for Medicinal Products for Human Use (CHMP) said it could not draw firm conclusions about the level of risk associated with unfractionated heparins (UFH) contaminated with oversulfated chondroitin sulfate (OSCS). Nevertheless, CHMP recommended that contaminated lots be withdrawn completely.
EFPIA Recommends Drug Anticounterfeiting Measures
May 20th 2008The European Federation of Pharmaceutical Industries and Associations (EFPIA), the trade association representing European pharmaceutical manufacturers, issued recommendations to the public consultation launched in March by the European Commission's proposed drug anticounterfeiting measures. EFPIA's proposal includes a ban on drug repackaging.
Developments in Scanning Electron Microscopy for Tablet and Granule Characterization
May 1st 2008Recent advances in SEM, particularly the incorporation of automation and software, have made simpler, lower-end SEM instruments easy to operate and have improved the capabilities of larger, sophisticated instruments.
Powder Characterization for Formulation and Processing
May 1st 2008The current trend within the pharmaceutical industry toward more efficient development, manufacturing, and specification is fueling demand for analytical tools that provide highly relevant information. Effective powder characterization has a valuable role to play.