The test for particulate contamination in parenteral preparations is a critical test and is a mandatory pharmacopoeial requirement. The pharmacopeias prescribe either a microscopic particle count or a light obscuration liquid particle counter, to carry out this test. We at Arbro have been offering the microscopic particle count test for many years now and are […]
Malvern Mastersizer 3000 Particle Size Analyzer Installed at Arbro
Particle size analysis is routinely required by industries as a critical control parameter for raw materials, manufacturing processes, and finished products. To fulfill this requirement of our esteemed customers, like you, we have installed the latest; Laser Diffraction based Particle Size Analyzer, the Malvern Mastersizer 3000, in our laboratory in New Delhi. The System is […]
US FDA recommends melamine testing in the pharmaceutical components
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 still the time there had been no reports of pharmaceutical products […]
LCMSMS Method for Beta-lactam Facility Decontamination
Globally there 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 […]