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Sep 42 min read

USFDA Guidance: Control of Nitrosamine Impurities in Human Drugs

Earlier today (04 September, 2024) U.S. Food and Drug Administration's Center for Drug Evaluation and Research released the second...

Aug 4, 20232 min read

USFDA Guidance: Recommended Acceptable Intake Limits for Nitrosamine DS-Related Impurities

Today (04 August 2023) the United States Food & Drug Administration's Center for Biologics Evaluation and Research and Center for Drug...

Jul 30, 20231 min read

Canada HC Guidance: Nitrosamine Impurities in Medications

Last Friday (28 July, 2023) Health Canada published an updated "Guidance on Nitrosamine Impurities in Medications" that details about...

Jul 24, 20232 min read

USFDA Guidance: ICH M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities

Earlier today (25 June, 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research, and Center for...

Sep 17, 20221 min read

ICH Guidance: Q3D(R2) ELEMENTAL IMPURITIES

Recently the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) released the...

Aug 30, 20221 min read

Health Canada Recommendations: ICH Q3D(R2) Guideline for Elemental Impurities

Yesterday (29-August-2022) Health Canada notified that Recommendations on the Implementation of the Revised ICH Q3D(R2) Harmonized...

Dec 18, 20212 min read

Guidance for Residual Solvents: Q3C(R8) Impurities

This guidance was developed within the Expert Working Group (Quality) of the International Council for Harmonisation of Technical...

Oct 13, 20211 min read

ICH guideline Recommendation on Daily (PDE) Limits for Seven Mutagenic Impurities

The International Council for Harmonization (ICH) Endorsed on 6 October 2021 its (Addendum to M7(R2)) M7(R2) draft guideline setting new...