U̶p̶c̶o̶m̶i̶n̶g̶ Nitrosamine Special Issue of JPS

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Please stay on the lookout for the upcoming special issue of Journal of Pharmaceutical Scieces dedicated to Nitrosamines Impurities.

From Dr. Schlingemann @schlinjo1975 post this morning:

If you are concerned with nitrosamines in pharmaceuticals watch out for the upcoming special edition on the topic in the Journal of Pharmaceutical Sciences (JPS). It contains both original research and review articles written by experts from industry, academia and regulatory bodies that work collectively to overcome this crisis for the benefit of patients. Several articles are already available on the JPS website, the full edition will appear in May 2023.
This is the editorial that I co-authored together with Christoph Saal and Justin Moser. Also watch out for for the related special edition in Organic Process Research & Development (OPR&D) that will complement the content in JPS.

https://jpharmsci.org/article/S0022-3549(23)00018-7/fulltext

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A fantastic wave of great and insightful publications happening this week. Are you keeping up what recent Nitrosamine developments? Join the conversation here!

The impact of N-nitrosamine impurities on clinical drug development -Pub

A fantastic perspective publication by Pablialunga et al " The impact of N-nitrosamine impurities on clinical drug development" I found pretty interesting some reflection the author offer on the overall impact of Nitrosamine Impurities: Emerging of Nitrosamine Impurities have put pressure on the supply chain of critical medications and in cases resulted in interruptions/discontinuation of critical drugs The clinical development of new investigational products has been affected by the emergenc…

Nitrosated active pharmaceutical ingredients – lessons learned -Pub

Publication “Nitrosated active pharmaceutical ingredients – lessons learned” by Holzgrabe Abstract: The occurrence of N -nitrosodialkylamines in active pharmaceutical ingredients (APIs) and drug products in the last years was a kind of eye opener with regard to quality of drugs. We became aware of the fact, that quality control tests described in the international pharmacopoeias might not be sufficient. The N -nitrosodialkylamines found were neither so-called (structurally) related substances…

A bioanalytical method for N-nitrosodimethylamine (NDMA) in human samples following ranitidine -Pub

Publication by FDA investigators “A bioanalytical method for quantification of N-nitrosodimethylamine (NDMA) in human plasma and urine with different meals and following administration of ranitidine” by De Palma et al. Open access: https://jpharmsci.org/article/S0022-3549(23)00029-1/fulltext Abstract: Control of N-nitrosoamine impurities is important for ensuring the safety of drug products. Findings of nitrosamine impurities in some drug products led FDA to develop new guidance providing re…

N-Nitrosamine Formation in Pharmaceutical Solid Drug Products: Experimental Observations -Pub

Publication " N-Nitrosamine Formation in Pharmaceutical Solid Drug Products: Experimental Observations" by Moser et al. Link: https://www.jpharmsci.org/article/S0022-3549(23)00028-X/fulltext Abstract: The potential presence of N -nitrosamines in medicinal products has become a matter of concern for health authorities and pharmaceutical companies. However, very little information is available in published literature on N -nitrosamine formation within pharmaceutical drug products. In response,…

Current threat of nitrosamines in pharmaceuticals and scientific strategies for risk mitigation -Pub

Publication “Current threat of nitrosamines in pharmaceuticals and scientific strategies for risk mitigation” by Tuesuwan et al Link: https://www.jpharmsci.org/article/S0022-3549(23)00030-8/fulltext Abstract: The current global situation of nitrosamine contamination has expanded from angiotensin-II receptor blockers (ARBs) to wide range of medicines as the risk of contamination via the drug substances, formulation, manufacturing process, and packaging is possible for many drug products. The …

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Solid State Kinetics of Nitrosation Using Native Sources of Nitrite -Pub

Publication " Solid State Kinetics of Nitrosation Using Native Sources of Nitrite" by Carloni et al. Link: https://doi.org/10.1016/j.xphs.2023.02.014 Abstract While many reactive species are known to cause N -nitrosation, trace nitrite (NO2−), which may be present in several excipients, is a source of nitrosating agents in pharmaceutical formulations. In this study we have found that the salt form of NO2− can influence the kinetics and final amount of nitrosamine being formed. Using native l…

UHPLC-APCI-TQ-MS analytical method capable of quantifying eight nitrosamine impurities from five different Metformin Formulations -Pub

Publication: “UHPLC-APCI-TQ-MS analytical method capable of quantifying eight nitrosamine impurities from five different commercially available Metformin formulations with Glipizide, Glibenclamide, Gliclazide, Evogliptin, and Glimepiride” by Solaki et al. Link: https://doi.org/10.1016/j.xphs.2023.02.016 Abstract: Metformin and its combinations are widely used to treat type 2 diabetes. The drugs commonly used in combination with Metformin are Glipizide, Glibenclamide, Gliclazide, Evogliptin, …

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Modified NAP Test: A Simple and Responsive Nitrosating Methodology for Risk Evaluation of NDSRIs -Pub

Publication: " Modified NAP Test: A Simple and Responsive Nitrosating Methodology for Risk Evaluation of NDSRIs" by Sharma et al. https://www.sciencedirect.com/science/article/pii/S0022354923000953 Abstract: Nitrosamines have been recognized as one of the cohorts of concern as per ICH M7. In recent years, the regulatory focus has shifted from common nitrosamines to nitroso-impurities of drug products. Thus, the detection and quantification of unacceptable levels of nitrosamine drug substance…