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IPEC Nitrosamine Questionnaire Q&A Excipients
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6
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1197
|
June 8, 2023
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A Nitrite Excipient Database: A Useful Tool to Support N-Nitrosamine Risk Assessments for Drug Products
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1
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959
|
June 5, 2023
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Setting limit for Nitrite and Nitrate in water used for Active Ingredients synthesis
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2
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1499
|
May 23, 2023
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Indigo carmine as secondary amine?
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7
|
751
|
May 16, 2023
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The true role of NitrXtes in NDSRIs?
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2
|
457
|
April 3, 2023
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A Survey of Industrial N-nitrosamine Discharges in Switzerland -Pub
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0
|
331
|
March 1, 2023
|
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Prediction of Nitrosamine formation from Excipients
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19
|
1715
|
February 8, 2023
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Nitrosamine risks that may arise from the filters
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2
|
833
|
January 4, 2023
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Calcium Phosphate- Opadry-Lhasa
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0
|
431
|
December 21, 2022
|
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E&L challenges and pitfalls in connection with NAs & NDRSIs
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0
|
371
|
December 12, 2022
|
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Drug-Nitrite interaction products -Publication review
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2
|
687
|
November 30, 2022
|
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Nitrocellulose blister material as a source of N-nitrosamine (peer-review-article)
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2
|
1260
|
September 1, 2022
|
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API seem to form N-nitrosamines upon oxidation (e.g. air) and without the presence of nitrosonium ions
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1
|
696
|
August 4, 2022
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Exact Root causes for NDMA in Metformin & NDSRI's Impurities in Varenicline, Quinapril & Orphenadrine
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4
|
1064
|
July 7, 2022
|
|
Risk of Nitrosamine Formation from Nitrites in Aqueous Systems
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0
|
665
|
June 27, 2022
|
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A Nitrite Excipient Database - Risk Assessment
|
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6
|
1986
|
June 15, 2022
|
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Drug substance-related impurities (NDSRIs) in Drug product and Drug substances
|
|
7
|
3203
|
June 8, 2022
|
|
Anybody dealing with Nitrosopiparazines?
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|
1
|
434
|
June 7, 2022
|
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FDA Root Causes of Nitrosamines Formation Fellowship
|
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0
|
309
|
April 14, 2022
|
|
Risk of Nitrosamine in packaging materials, risk or control?
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|
2
|
1763
|
April 1, 2022
|
|
NDMA in German Beer - A success Story
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1
|
336
|
January 25, 2022
|
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Excipients, morpholine?
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4
|
371
|
October 18, 2021
|
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Nitrosamines - Elastomers perspective (PDA publication)
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|
8
|
712
|
October 16, 2021
|
|
Results from survey on Nitrosamines in Excipients -Any thoughts?
|
|
10
|
769
|
September 23, 2021
|
|
Excipient & Nitrosamines -Q&A session
|
|
0
|
333
|
September 16, 2021
|
|
Challenges for API Raw Material & DP regarding Excipient / APIs / Packaging?
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|
12
|
1421
|
August 17, 2021
|
|
Many excipientsuppliers are using the IPEC Questionnaire for Excipient Nitrosamine Risk Evaluation to conduct nitrosamine risk assessments. Does FDA accept prepared questionnaires,such as the one developed by IPEC, as a valid risk assessment tool?
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0
|
390
|
July 20, 2021
|
|
Developing Process for Nitrite-free Excipients?
|
|
1
|
541
|
July 11, 2021
|
|
Most burning challenge for API manufacturers?
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|
12
|
897
|
July 9, 2021
|
|
Are we ready to inlcude Nitrosamine testing on Inhalation Packaging/Delivery systems? USP: Nitrosamines in Elastomeric Components for Inhalation
|
|
0
|
355
|
April 27, 2021
|