US FDA in august 2009 published a guidance for industry titled Pharmaceutical Components at Risk for Melamine Contamination after it received reports of food products in China been contaminated with melamine, leading to thousands of hospitalizations and at least three deaths by September 2008. Though till the time there had been no reports of pharmaceutical products [...]
US FDA guidance recommends melamine testing in at risk pharmaceutical components
March 17, 2012 By Leave a Comment
LCMSMS Method for Beta-lactam Facility Decontamination
October 25, 2010 By Leave a Comment
Globally their is a trend that manufacturing facilities for Beta-lactam antibiotics are being converted for the manufacture of Cephalosporin products. An important part of this changeover is to establish that there are no residues of Beta-lactams in the facility and no cross contamination of the new product range. We have developed and validated a simultaneous [...]
