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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...

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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...

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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...

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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...

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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...

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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...

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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...

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Oct 12, 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...

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