The International Council for Harmonization (ICH) on Wednesday issued its M7(R2) guideline setting new permitted daily exposure (PDE) limits for seven DNA-reactive substances to limit their carcinogenic risk. The guideline is now available for public comment.   The guideline contains 21 mutagenic impurities, adding seven substances to the 14 previously published in the ICH M7(R1) guideline, which reached Step 4 in June 2017. (RELATED:   FDA Finalizes Guidance on Mut...

The US Food and Drug Administration (FDA) on Friday announced that Indian drugmaker Hetero Labs is recalling 87 lots of losartan tablets distributed by Camber Pharmaceuticals after testing found the drugs contained a potentially carcinogenic impurity, N-Nitroso-N-methyl-4 aminobutyric acid (NMBA).   The recall is the latest in a series of recalls tied to the discovery of nitrosamine impurities in angiotensin II receptor blocker (ARB) drugs in the last year.   Previ...

The US Food and Drug Administration (FDA) on Thursday issued new draft guidance on elemental impurities in drugs, with the goal of helping manufacturers comply with recent International Council for Harmonisation (ICH) and United States Pharmacopeial Convention (USP) standards. Specifically, the guidance is meant to help sponsors of new and generic drugs comply with standards established in USP General Chapters <232> Elemental Impurities – Limits and <233> Elemental...

The European Medicines Agency (EMA) has released its recommendations for implementing a newly adopted international standard for limiting elemental impurities in drug products. Background Elemental impurities are traces of metals that can end up in finished drug products. These impurities can come from multiple points in the manufacturing process, such as residual catalysts from a product’s synthesis or from contact with manufacturing equipment, containers and other m...

The European Medicines Agency (EMA) has released final its final guideline on how to set specifications for impurities present in antibiotics not covered by other internationally-harmonized guidelines. European regulators note in the guidance that antibiotics produced by a fermentation process are less precise and create more product variability and impurities than do other synthetic processes. Because many of these processes-including semi-synthetic fermentation-do not ...

The US Pharmacopeia (USP), a standards-setting body for the content of medicines, has released two new standards to limit the presence of elemental impurities in medicinal products. The standards, <232> Elemental Impurities - Limits and <233> Elemental Impurities - Procedures , outline procedures on how to detect common impurities and sets limits on the presence of impurities to protect consumers from exposure. "Elemental impurities can occur naturally, b...