Nitrosamines Exchange

Topic	Replies	Views	Activity
Risk Analysis of Colorants and Flavorings in Pharmaceutical Formulations Guidance, Documents, Resources Excipients	9	631	July 21, 2023
Testig method for nitroso Ciprofloxacin Confirmatory Testing & Analytical Challenges NDSRI	12	1014	February 16, 2024
🌎 Our community in the world! How-To	0	334	February 6, 2024
Nitrosamine testing results Limits of Nitrosamines NDSRI	10	710	April 18, 2024
Whether N-Nitroso Memantine is possible? Limits of Nitrosamines	16	670	April 10, 2024
Are nitrosamines the connecting link or one of the connecting links between the concepts of phototoxicity and photocarcinogenicity due to the intake of a contaminated medication according to the 2019/ 2023 FDA list? New Scientific Knowledge & Development	41	793	May 11, 2024
Nitrosamines without published AI, and possibly negative for carcinogenicity Limits of Nitrosamines	9	888	September 18, 2023
N-nitroso cyclamate Limits of Nitrosamines Excipients	9	415	March 15, 2024
N-nitroso-Impurity C in Metamizol Drug product Limits of Nitrosamines	11	1128	January 22, 2024
Limit for API having two NDSRI Limits of Nitrosamines NDSRI	9	1167	November 21, 2023
Nitrosamines in EDQM 2023 Webinar Series Events / Workshops / Webinars	7	1041	August 10, 2023
EDQM - European Pharmacopeia - Feedback Nitrosamines Guidance, Documents, Resources	3	864	January 12, 2024
Quantitation of Reactive Nitrosating Agents in Pharmaceutical Excipients for N‑Nitrosamine Risk Assessments Risk Assessment Strategy / Tools & Technology Excipients	4	1028	September 7, 2023
The Nitrosamine “Saga” Guidance, Documents, Resources Manufacturing , Drug_Substance_APIs	3	1506	July 29, 2023
Guideline ANVISA - Brazil: version 3, updates Guidance, Documents, Resources Drug_Substance_APIs	8	2732	June 19, 2023
⚙️🌎CPCA: the gestation, birth, and development -Pub New Scientific Knowledge & Development NDSRI , featured	2	223	May 19, 2024
:australia: TGA - Latest Update to Nitrosamine Limits Limits of Nitrosamines	1	525	May 6, 2024
Principles and procedures for implementation of ICH M7 recommended (Q)SAR analyses Limits of Nitrosamines	2	719	June 1, 2023
🎄 Happy Holiday and a Nitrosamines-free 2024! Nitrosamines in the News	8	697	January 7, 2024
🇨🇦 Health Canada Nitrosamine Guide update Guidance, Documents, Resources	5	1664	October 27, 2023
👨‍💻 Dashboard Containing Published AI Limits Guidance, Documents, Resources NDSRI , AI , featured Are you looking for a central place for published AI limits? I have created a dashboard containing Acceptable Intake Limits from FDA, Health Canada and EMA. I am looking for folks that are interest into contributing to …	6	270	May 20, 2024
HESI Open call to Q(SAR) and QM working group Events / Workshops / Webinars QSAR	3	517	February 20, 2024
Knowledge Sharing as a Tool: USP’s Role in the Global Nitrosamine Battle About Nitrosamines Exchange	1	326	May 7, 2024
Fifth Nitrosamine Implementation Oversight Group (NIOG) – meeting with pharmaceutical industry Guidance, Documents, Resources NIOG	1	600	September 6, 2023
WHO good manufacturing practices considerations for the prevention and control of nitrosamine contamination in pharmaceutical products Guidance, Documents, Resources	3	765	April 24, 2024
Potential Event with USP & Health Authorities Risk Assessment Strategy / Tools & Technology	8	649	February 2, 2024
🇬🇧 MHRA publishes guidelines for Nitrosamine Impurities Guidance, Documents, Resources	4	1184	August 28, 2023
TGA Australia Published Acceptable intakes for Nitrosamines Limits of Nitrosamines TGA	1	924	October 18, 2023
N-nitroso ticagrelor N-nitrosamines Chemistry NDSRI	3	1293	November 23, 2023
🇺🇸 FDA CDER Generic Drug Forum (GDF) 2024 Events / Workshops / Webinars risk-assessment	5	904	April 14, 2024
MCC with nitrite levels of 0.1 ppm or less Excipients Excipients	4	771	March 4, 2024
Mechanisms of Nitrosamine Mutagenicity and Their Relationship to Rodent Carcinogenic Potency -Pub N-nitrosamines Chemistry	0	492	February 6, 2024
New data released into Lhasa Carcinogenicity Database New Scientific Knowledge & Development	1	635	November 17, 2023
Formation of N-Nitrosamine Drug Substance Related Impurities in Medicines: A Regulatory Perspective on Risk Factors and Mitigation Strategies Risk Assessment Strategy / Tools & Technology NDSRI	3	818	July 26, 2023
Upcoming and recorded Lhasa webinars Events / Workshops / Webinars	3	794	December 21, 2023
Confidence score calculation for the carcinogenic potency categorization approach (CPCA) predictions for N-nitrosamines Limits of Nitrosamines NDSRI	5	1030	January 11, 2024
🇪🇺 OMCL Network published NDSRIs Analytical Methods Confirmatory Testing & Analytical Challenges NDSRI	1	795	March 11, 2024
TGA (Australia) :australia: Updates Published Acceptable Intakes Limits of Nitrosamines	3	564	February 7, 2024
🇪🇺 EMA/409815/2020 Rev.20 Guidance, Documents, Resources NDSRI	7	2339	January 31, 2024
FDA Revisiting the mutagenicity and genotoxicity of N-nitroso propranolol in bacterial and human in vitro assays Limits of Nitrosamines FDA , NDSRI , ames , NDSRIs	1	1302	May 24, 2023
Nitrite Detection at Picogram Level, is it possible? New Scientific Knowledge & Development Drug_Substance_APIs	4	845	September 14, 2023
🇺🇸 FDA Recommended AI Limits for Certain Hypothetical NDSRIs Guidance, Documents, Resources	0	1010	August 8, 2023
EMA - Update Appendix 3: Enhanced Ames Test conditions for N-nitrosamines Guidance, Documents, Resources	8	925	April 2, 2024
Review of nitrosamine drug substance related impurities (ndsri) in pharmaceutical drugs Guidance, Documents, Resources NDSRI	1	600	October 31, 2023
Updated: IPEC Position Paper on Role of Excipients in Determining N-Nitrosamine Risks for Drug Products Guidance, Documents, Resources Excipients	3	690	March 7, 2024
USP-NF General Notices Revision open for Comments Guidance, Documents, Resources USP-Standards	0	687	March 7, 2024
CPCA - Methyl group bonded to beta carbon (cyclic/acyclic) (activating factor) Limits of Nitrosamines	2	957	August 23, 2023
European Pharmacopoeia Commission revises position on nitrosamine impurities Nitrosamines in the News	2	563	July 28, 2023
European Pharmacopeia - Open for comments 'N-Nitrosamines in active substance and medicinal products' Guidance, Documents, Resources	0	590	December 19, 2023
Identifying the Risk of Formation of Nitrosamines and Other Potentially Mutagenic Impurities during API Manufacture Using In Silico Risk Assessment -Pub New Scientific Knowledge & Development risk-assessment	0	1042	June 6, 2023

Risk Analysis of Colorants and Flavorings in Pharmaceutical Formulations

Guidance, Documents, Resources

Excipients

9

631

July 21, 2023

Testig method for nitroso Ciprofloxacin

Confirmatory Testing & Analytical Challenges

NDSRI

12

1014

February 16, 2024

🌎 Our community in the world!

How-To

0

334

February 6, 2024

Nitrosamine testing results

Limits of Nitrosamines

NDSRI

10

710

April 18, 2024

Whether N-Nitroso Memantine is possible?

Limits of Nitrosamines

16

670

April 10, 2024

Are nitrosamines the connecting link or one of the connecting links between the concepts of phototoxicity and photocarcinogenicity due to the intake of a contaminated medication according to the 2019/ 2023 FDA list?

New Scientific Knowledge & Development

41

793

May 11, 2024

Nitrosamines without published AI, and possibly negative for carcinogenicity

Limits of Nitrosamines

9

888

September 18, 2023

N-nitroso cyclamate

Limits of Nitrosamines

Excipients

9

415

March 15, 2024

N-nitroso-Impurity C in Metamizol Drug product

Limits of Nitrosamines

11

1128

January 22, 2024

Limit for API having two NDSRI

Limits of Nitrosamines

NDSRI

9

1167

November 21, 2023

Nitrosamines in EDQM 2023 Webinar Series

Events / Workshops / Webinars

7

1041

August 10, 2023

EDQM - European Pharmacopeia - Feedback Nitrosamines

Guidance, Documents, Resources

3

864

January 12, 2024

Quantitation of Reactive Nitrosating Agents in Pharmaceutical Excipients for N‑Nitrosamine Risk Assessments

Risk Assessment Strategy / Tools & Technology

Excipients

4

1028

September 7, 2023

The Nitrosamine “Saga”

Guidance, Documents, Resources

Manufacturing , Drug_Substance_APIs

3

1506

July 29, 2023

Guideline ANVISA - Brazil: version 3, updates

Guidance, Documents, Resources

Drug_Substance_APIs

8

2732

June 19, 2023

⚙️🌎CPCA: the gestation, birth, and development -Pub

New Scientific Knowledge & Development

NDSRI , featured

2

223

May 19, 2024

:australia: TGA - Latest Update to Nitrosamine Limits

Limits of Nitrosamines

1

525

May 6, 2024

Principles and procedures for implementation of ICH M7 recommended (Q)SAR analyses

Limits of Nitrosamines

2

719

June 1, 2023

🎄 Happy Holiday and a Nitrosamines-free 2024!

Nitrosamines in the News

8

697

January 7, 2024

🇨🇦 Health Canada Nitrosamine Guide update

Guidance, Documents, Resources

5

1664

October 27, 2023

👨‍💻 Dashboard Containing Published AI Limits

Guidance, Documents, Resources

NDSRI , AI , featured

Are you looking for a central place for published AI limits? I have created a dashboard containing Acceptable Intake Limits from FDA, Health Canada and EMA. I am looking for folks that are interest into contributing to …