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Health Canada updated the guidance and Appendix 1(March 15, …

WEBOf note, Health Canada’s table of established Acceptable Intake (AI) limits (formerly Appendix 2) has been renumbered to Appendix 1, removed from the guidance …

Actived: 9 days ago

URL: https://nitrosamines.usp.org/t/health-canada-updated-the-guidance-and-appendix-1-march-15-2024/9541

Health Canada: Guidance on Nitrosamine Impurities in Medications

WEBHealth Canada last week published an updated Guidance *on Nitrosamine Impurities in Medicines. Notable new or updated information includes the following: …

Category:  Medicine Go Health

WHO on Nitrosamines, Rifampicin, Rifapentine and NDSRIS

WEBUpdate on N-Nitrosamines Impurities from World Health Organization (WHO) [18Sep23] link: Update on N-nitrosamine impurities | WHO - Prequalification of …

Category:  Health Go Health

Acceptable Intakes (AIs) for 11 Small molecule N-nitrosamines …

WEBLow levels of N-nitrosamines (NAs) were detected in pharmaceuticals and, as a result, health authorities (HAs) have published acceptable intakes (AIs) in …

Category:  Health Go Health

Guidance, Documents, Resources

WEBWHO good manufacturing practices considerations for the prevention and control of nitrosamine contamination in pharmaceutical products. 3. 752. April 24, 2024. 🇸🇦 Saudi …

Category:  Health Go Health

CPCA is now included in the updated version of Health Canada’s …

WEBNote apart is that Health Canada I understand is internally (same policies related to NAs) pretty much aligned to EMA, but the FDA is a different case. One of the …

Category:  Health Go Health

Establishing acceptable intakes (AI) for complex nitrosamines …

WEBThe determination of acceptable intakes (AI) for complex nitrosamines (NDSRIs) is a critical aspect of regulatory and toxicological considerations. David J. …

Category:  Health Go Health

N-Nitrosamine Formation in Pharmaceutical Solid Drug Products

WEBThe potential presence of N-nitrosamines in medicinal products has become a matter of concern for health authorities and pharmaceutical companies. However, very …

Category:  Health Go Health

Harmonization of AI for NDSRIs with

WEBFor nitrosamine impurities without sufficient carcinogenic data to derive a specific acceptable limit, EMA, Health Canada and Anvisa provide a class specific TTC …

Category:  Health Go Health

Merck has discovered that nitrosamine NTTP in

WEBEMA and Health Canada have issued an update on viz Nitroso-Sitagliptin (7-Nitroso-3-(trifluoromethyl)-5,6,7,8-tetrahydro [1,2,4] triazolo- [4,3- a] pyrazine). The …

Category:  Health Go Health

Drug substance-related impurities (NDSRIs) in Drug product and …

WEBDrug substance-related impurities (NDSRIs) are a class of nitrosamines sharing structural similarity to the API, NDSRIs can be generated during manufacturing …

Category:  Health Go Health

In light of recently evolving regulatory guidance on intake limits …

WEBIn light of recently evolving regulatory guidance on intake limits for nitrosamines in medications, enrollment of new patients in ribociclib early breast cancer …

Category:  Cancer Go Health

In Silico Prediction of N-Nitrosamine Formation Pathways of

WEBPublication coming out Japan team from National Institute of Health Science. Tsuji et al. “In Silico Prediction of N-Nitrosamine Formation Pathways of Pharmaceutical …

Category:  Health Go Health

Sept 2021 Revised QnA document from EMA

WEBAdditions in the Q&A document from the EMA as of September 2021.2004-referral-nitrosamine-impurities-human-medicinal-products_en.pdf (506.1 KB) The table …

Category:  Health Go Health

AI for small nitrosamines not listed in EMA, FDA or Health Canada

WEBHello everyone, I would like your help once again on the following dilemma we are facing as a team. We are now dealing with small nitrosamines testing which are not …

Category:  Health Go Health

AI value for Nitroso Folic acid

WEBThe European committee for Medicinal Products for Huma Use (CHMP) held its January meeting on 24/27 Jan 2022. Report attached: IDRAC_341767_18-Mar …

Category:  Health Go Health

Theoretical 'Purge Factor'

WEBIn a recent FDA Q&A public session the following was discussed and debated: What is the scientific rationale behind the statement “Theoretical purge factor …

Category:  Health Go Health

EMA Nitrosamines Q&A Rev 12 (10 OCT 2022)

WEBDear all, Yesterday EMA published the Rev.12 of the Nitrosamines Q&A guideline. Nitrosamines EMEA-H-A5(3)-1490 - QA Art. 5(3) Implementation_ for October …

Category:  Health Go Health

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