Pharmaceutical process chemists want to make the compound, the whole compound, and nothing but the compound. They know, however, that chemistry isn’t that simple and that a multistep synthesis often ...

The European Pharmacopeia Commission has published the General Information chapter "Potentially Genotoxic Impurities and European Pharmacopoeia Monographs on Substances for Human Use" in the July 2008 ...

AAPS, San Antonio (Oct. 31)-Excipient manufacturers are raising concerns over recently adopted European guidelines, set to become effective January 1, 2007, which provide a framework and approach for ...

Since 2007, guidelines from the European Medicines Agency and a draft version from the U.S. Food & Drug Administration have called on the drug industry to reduce DNA-reactive genotoxic impurities ...

Detecting genotoxic or carcinogenic impurities in pharmaceutical products is essential to ensuring their safety and compliance. Failure to confirm that products are contaminant- and impurity-free may ...

Drug manufacturers have been adjusting to strict new government standards that limit the amount of potentially harmful impurities in medicine, according to the cover story of the current issue of ...

Scientists are reporting development of a simple new procedure for removing almost 98 percent of an important impurity that can contaminate prescription drugs and potentially increase the risk for ...

Following a series of recalls for the heartburn drug Zantac and other ranitidine drugs due to a genotoxic impurity, the US Food and Drug Administration (FDA) said Friday that the levels of the ...

We are pleased to invite you to the 3rd Annual Impurities: Genotoxic and Beyond Summit scheduled for June 12th-13th, 2019. This premier B2B event provides the appropriate platform to engage and ...

Presently ICH M7 and other guidelines give an overview of evaluation and assessment of limits of pharmaceutical impurities categorized as mutagenic. These could be degradation products of ...