Lhasa Limited, a leading global supplier of knowledge based software and associated databases for use in toxicity, metabolism and the related sciences, today announces the development of a new product ...

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 ...

The guidelines for detecting pharmaceutical impurities, including ICH M7, which are either known or suspected to be mutagenic are meant to give a broad picture of the limits to which these may be ...

The International Conference on Harmonization has moved ICH M7(R1) Addendum to 3 of the ICH process. The International Conference on Harmonization (ICH) has moved the ICH M7(R1) Addendum to the ...

Detection of nitrosamines in several commercial drugs has resulted in manufacturing batch recalls followed by a review of the APIs’ synthesis processes by MAHs. Detection and quantitation of ...