|
Variation for new spec due to updated EMA Guideline
|
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7
|
476
|
July 16, 2024
|
|
Quantum Mechanical Assessment of Nitrosamine Potency
|
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3
|
338
|
July 15, 2024
|
|
Metformin drugs under simulated gastric conditions can generate high nitrite-dependent levels of N-nitrosodimethylamine
|
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4
|
722
|
June 24, 2024
|
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Novartis pauses some trials of cancer drug Kisqali to fix manufacturing
|
|
12
|
1245
|
April 16, 2024
|
|
Whos is going to AAPS's?
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2
|
183
|
July 12, 2024
|
|
Novel LC-MSMS Method including for E&L of packaging materials
|
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1
|
630
|
July 11, 2024
|
|
AZIDO Impurities Topic
|
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4
|
1083
|
July 11, 2024
|
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⚖️ Risk assessment not strong enough, specifically on related impurities containing secondary amine
|
|
17
|
1369
|
July 11, 2024
|
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Nitrosamine impurities of related substances of API's
|
|
5
|
363
|
July 11, 2024
|
|
EMA - Appendix 1 - Update
|
|
12
|
1375
|
July 10, 2024
|
|
USP India - Nitrosamines panel discussion at USP Science Conclave
|
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0
|
275
|
July 10, 2024
|
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Nitrosamine Acceptable Intake Limits
|
|
2
|
246
|
July 10, 2024
|
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A Case to Support the Continued Use of Rifampin in Clinical Drug–Drug Interaction Studies -Pub
|
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0
|
126
|
July 10, 2024
|
|
USP - CPCA Nitrosamines Case Study
|
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5
|
953
|
July 10, 2024
|
|
🇨🇦 Health Canada updated the guidance and Appendix 1(May 31, 2024)
|
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16
|
1520
|
July 10, 2024
|
|
Control limit of Nitrosamines and N-nitroso compounds
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2
|
285
|
July 8, 2024
|
|
Nitroso lisinopril
|
|
3
|
296
|
July 4, 2024
|
|
Parts per billion of nitrite in microcrystalline cellulose -Pub
|
|
3
|
921
|
July 3, 2024
|
|
ICH M7 & Nitrosamines Impurities -Updates
|
|
7
|
1473
|
July 1, 2024
|
|
Withdrawal of application for the marketing authorisation of Dabigatran etexilate
|
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1
|
271
|
June 30, 2024
|
|
Non-mutagenic, carcinogenic impurities
|
|
3
|
389
|
June 30, 2024
|
|
Nitroso Dimethyl anthranilate
|
|
7
|
274
|
June 29, 2024
|
|
AI for NDSRI by Brazil regulatory
|
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4
|
551
|
June 28, 2024
|
|
Risk analysis of nitrosamine impurities in liquid products (essences and flavors)
|
|
3
|
602
|
June 28, 2024
|
|
N-nitroso Solifenacin
|
|
7
|
250
|
June 28, 2024
|
|
Hexamethyldisilazane (HMDS) can form Nitrosamine Impurity?
|
|
6
|
297
|
June 27, 2024
|
|
EPR Podcast Ep 26 – Navigating Nitrosamine Impurities
|
|
0
|
293
|
June 26, 2024
|
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Regulatory Differences between EMA and FDA on Nitrosamines
|
|
1
|
423
|
June 25, 2024
|
|
Discussion on Cleaning Validation Requirements for Nitrosamines
|
|
3
|
694
|
June 24, 2024
|
|
Predicting Nitrosamine Formation in the Solid State
|
|
3
|
566
|
June 24, 2024
|