Nitrocellulose blister material as a source of N-nitrosamine (peer-review-article)

[Naiffer_Host]

Community member @Diego_HM brought to our attention the publication of this study by Golob et all. " Nitrocellulose blister material as a source of N -nitrosamine contamination of pharmaceutical drug products"

Risk of Nitrosamine in packaging materials, risk or control?

Hi Naifer, I have just recently come across a very interesting and exhaustive evaluation of the risk of the packaging material. In summary I could say that based on the paper (case by case approach is recommended): Foils without nitrocellulose + any combination of primer, lacquer, aluminium and sealing method have no risk. Nitrocellulose is the source of nitrosating agents. Foils with nitrocellulose in combination with any primer, lacquer, aluminium and sealing method can form nitrosamine…

Access: Nitrocellulose blister material as a source of N-nitrosamine contamination of pharmaceutical drug products - ScienceDirect

[Naiffer_Host]

With so much discussion recently on this topic… Just reviving the topic submitted by @Diego_HM

[pragnesh]

Thank you sharing @Naiffer_Host and @Diego_HM . Indeed pharma packaging scrutiny will be regulatory focus through this finding !