Our quality control manager and co-founder of Pharmaprogress, Dr Luca Gramaccioni has nearly two decades of experience in mass spectrometry. Here, he talks about the latest Nitrosamine deadline extension and our ahead-of-the-curve screenings.

Regulatory Authorities have recently extended the Nitrosamines risk assessment deadline until October 1st 2020, giving our clients additional time to carry out more preliminary screenings and minimize the costs of Nitrosamine quantitation requirements following the risk evaluation. Our KYMOS and PHARMAPROGRESS teams constantly work to adapt our pioneering Nitrosamine services to new requirements, and thus our two alternative HS-GC/MS and LC-MS/MS analytical methods and validated list of 15 Nitrosamines are now being enhanced with faster, more flexible and cost-efficient non-GMP Nitrosamine screenings for those companies seeking out extra data from their products, excipients or raw materials in order to produce a more robust risk assessment and avoid additional quantification steps.

A rapid Nitrosamine screening can bring many advantages when:

  • The risk analysis is not complete.
  • Suppliers didn’t give all the answers that your company needs.
  • Companies need to reinforce the results of the risk assessment.
  • Taking the advantage of the 6 additional months available to produce the documentation.

Rapid screening HS-GC/MS-based is a good opportunity to quick analyze raw materials in order to deeply investigate their nitrosamines content.

Strengths of our HS-GC/MSmethod

  • High sensitivity (hereafter two alternatives for the chromatogram at 0.03 ppm).
  • Simultaneous determination of the 10 most volatile nitrosamines, including the ones mentioned both by EMA | FDA and USP <381> (nitrosammino impurity compounds in elastomers for packaging / delivery system for injections).
  • The headspace autosampling allows avoiding any challenges related to the solubilization of the raw materials. This means the results present the possibility to process different materials in a short timeframe.
  • Very robust and reproducible LOD at 1 ppb.

Strengths of our LC-MS/MS method

The LC-MS/MS method with APCI ion source can be used in the following scenarios and situations:

  • Volatile and not volatile nitrosamine at the same time
  • High sensitivity because of the selectivity guaranteed by the triple quadrupole
  • Different conditions to customize the method allowing different selectivity for nitrosamines of interest and the other components of the products
  • C18 stationary phase
  • CN stationary phase
  • PFP stationary phase
  • Phenyl Hexyl stationary phase (hereafter chromatograms at 0.03 ppm)

Chromatograms for additional nitrosamines:

EMA extended the deadline to complete step 1 of the review of manufacturing processes.

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