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In light of recently evolving regulatory guidance on intake limits for nitrosamines in medications, enrollment of new patients in ribociclib early breast cancer (eBC) studies has been paused by Novartis in alignment with health authorities
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0
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280
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May 21, 2024
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Acceptable intake (AI) of N-Nitroso-N-methylbenzylamine (CAS 937-40-6)
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4
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466
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May 21, 2024
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Category 5 NDSRIs- CPCA tool
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2
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526
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May 20, 2024
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Namibia Medicines Regulatory Council (NMRC) issues order for Withdrawal of all Ranitidine containing products from Namibian market due to NDMA impurities
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0
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274
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May 20, 2024
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Ranitidine back in the news!
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2
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405
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May 15, 2024
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Challenges and winning strategies to develop an analytical method for Nitrosamines
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0
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736
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May 19, 2024
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Hot of the presses - New CPCA paper
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1
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427
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May 17, 2024
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🇪🇺 EDQM - top 10 deficiencies observed in new CEP applications
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0
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955
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March 14, 2024
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5
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539
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May 16, 2024
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Guidelines for Antibiotic group drug substances for the limit of Nitrosamine impurities . (Eg. Azithromycin, Erythromycin )
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4
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1667
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May 15, 2024
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Nitrosamine in Azathioprine
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4
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870
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May 14, 2024
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0
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548
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May 14, 2024
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How to justify the absence of NDSRIs in finished product if the custom synthesis of the same NDSRIs is not possible?
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1
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787
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May 13, 2024
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Using the Carcinogenicity Potency Categorization Algorithm to Predict N-Nitrosamine Carcinogenicity -Webinar
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0
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374
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May 13, 2024
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An Organic Guide to N-Nitrosamines: Structure, Reactivity, and Role as Contaminants
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1
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518
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Genotoxicity assessments of N-nitrosoethylisopropylamine (NEIPA) and N-nitrosodiisopropylamine (NDIPA) in the C57BL/6J mouse -Pub
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0
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301
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May 13, 2024
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Nitrosamine AI limit calculation if the risk is coming only out of excipients'
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11
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1218
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May 13, 2024
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N-Nitroso Metformin
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8
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1773
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APIC NA Risk Assessment Template
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5
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3676
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May 11, 2024
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Nitrosamines Published Limits -reference
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79
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Nitrosamines Risk in Pharmaceutical Waters
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6
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2738
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Challenges in Confirmatory Testing for Nitrosamines potential presence Identified from Step 1 Risk Assessment
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5
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731
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Knowledge Sharing as a Tool: USP’s Role in the Global Nitrosamine Battle
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1
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438
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NDSRI Limit of those product's having lower MDD
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1
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575
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May 6, 2024
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N-nitroso acyclovir impurity K
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1
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550
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April 30, 2024
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Safeguarding purity under pressure: detecting nitrosamine contamination
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0
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423
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April 23, 2024
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🇺🇸 FDA NDSRI Limits update -Mar 2024
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6
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2263
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April 22, 2024
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4
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437
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April 22, 2024
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Limit for Nitroso Ciprofloxacin
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24
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4061
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April 22, 2024
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Nitrites in xanthan gum?
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0
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454
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April 22, 2024
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