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Q&A revision 17 uploaded on EMA page
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12
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1538
|
August 25, 2023
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IPA-QF Guidance on Nitrosamines Impurities
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0
|
764
|
August 18, 2023
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Measuring Nitrites in headspace
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4
|
619
|
August 15, 2023
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🇺🇸 FDA Recommended AI Limits for Certain Hypothetical NDSRIs
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0
|
1259
|
August 8, 2023
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Planilha CPCA na prática
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0
|
449
|
August 6, 2023
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The Nitrosamine “Saga”
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3
|
1621
|
July 29, 2023
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NDSRIs: Atualizações e Desafios
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0
|
463
|
July 24, 2023
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Risk Analysis of Colorants and Flavorings in Pharmaceutical Formulations
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9
|
748
|
July 21, 2023
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FDA - Notice on Chantix
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3
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608
|
July 20, 2023
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Establishment of Acceptable Intakes, framework
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12
|
800
|
July 12, 2023
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New Guidance from Malaysia's NPRA 03 July 2023
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0
|
749
|
July 12, 2023
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|
What method accuracy criteria to be considered for nitrosamines, which guidance mentioned accuracy criteria?
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2
|
638
|
July 10, 2023
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Losartan azide impurity confirmed as not an in vivo mutagen compound
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5
|
1620
|
June 20, 2023
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Guideline ANVISA - Brazil: version 3, updates
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8
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3361
|
June 19, 2023
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FDA solicit comments on assessment of NDSRIs
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12
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1934
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July 11, 2023
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Formation of N-nitroso Fluconazole and Related Triazole-Imidazole APIs
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4
|
1229
|
June 9, 2023
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The predecesor to ICH M7
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0
|
597
|
June 7, 2023
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Secondary amine Risk Assessment
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9
|
1152
|
June 1, 2023
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Nitrosamine in Peptides
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2
|
825
|
May 26, 2023
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|
Indian Pharmacopoeia introduces a new General Chapter on Nitrosamine Impurities in its 2022 edition
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4
|
1655
|
May 6, 2023
|
|
IPEC India survey on excipients
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0
|
424
|
May 5, 2023
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|
ECHA has provided Occupational Exposure Limit (OEL) values for most commonly used nitrosamines
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|
0
|
612
|
April 27, 2023
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|
Health Canada: Guidance on Nitrosamine Impurities in Medications
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|
0
|
1108
|
April 23, 2023
|
|
EMA Nitrosamine Q&A Rev15 published
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|
12
|
2626
|
April 18, 2023
|
|
3-year work plan for EMA Nitrosamine Safety Operational Expert Group
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|
0
|
541
|
March 11, 2023
|
|
Health Canada - Guideline: Quality (CMC) Draft Guidance - New Drug Submissions & Abbreviated New Drug Submissions
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0
|
1174
|
February 27, 2023
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|
FDA updated compliance program guidance por inspections
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1
|
708
|
February 27, 2023
|
|
👋🏻 Fantastic Regulatory Update Europe, US, LATAM
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8
|
2337
|
February 25, 2023
|
|
EMA Nitrosamine Q&A Rev14 published
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|
6
|
1283
|
February 23, 2023
|
|
Fourth Nitrosamine Implementation Oversight Group (NIOG) meeting
|
|
4
|
1206
|
February 16, 2023
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