Search

Sharan Murugan
Sep 4, 20242 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...
86 views
0 comments


Sharan Murugan
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...
121 views
0 comments


Sharan Murugan
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...
27 views
0 comments


Sharan Murugan
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...
30 views
0 comments


Sharan Murugan
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...
23 views
0 comments


Sharan Murugan
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...
55 views
0 comments


Sharan Murugan
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...
34 views
0 comments


Sharan Murugan
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...
47 views
0 comments