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.
A fantastic wave of great and insightful publications happening this week. Are you keeping up what recent Nitrosamine developments? Join the conversation here!
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…
Publication “Nitrosated active pharmaceutical ingredients – lessons learned” by Holzgrabe
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…
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.
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…
Publication " N-Nitrosamine Formation in Pharmaceutical Solid Drug Products: Experimental Observations" by Moser et al.
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,…
Publication “Current threat of nitrosamines in pharmaceuticals and scientific strategies for risk mitigation” by Tuesuwan et al
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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