A proposed new guideline provides a global policy for limiting metal impurities qualitatively and quantitatively in drug products and ingredients. The International Conference on Harmonization (ICH) ...
In late 2014, standards organizations continued to work towards harmonization and securing drug safety. Worldwide standards organizations implemented changes to pharmacopeial standards, published new ...
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 ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results