Do you need to ensure that your product is free from nitrosamines?

Do you have any sartans, ranitidine or metformin in your portfolio? How do you prioritize all other chemically synthesized products, APIs and excipients? Do you have in-house resources or toxicological expertise to conduct the risk assessment of these products? How to respond to requests from authorities to validate analytical methods at particularly low detection levels?

The monographs on sartans of the European Pharmacopoeia (Ph. Eur.) have been updated and come into effect on 1 January 2020: what impact would it have for your release testing? What is the risk of products withdrawals from the market?

We can support / advice you on risk analysis:

• Product risk assessment: prioritization of the Drug products manufactured based on the risk of potential presence of nitrosamines
• Process Risk Assessment (risk of nitrosamine formation in the product)
  • Evaluation of the drug product composition
  • Evaluation of the manufacturing process

We implement screening methods in LC-MSMS and GC-MSMS (several nitrosamines simultaneously) in order to quickly confirm the presence or not of nitrosamines

We have developed and validated analytical methods to identify traces of nitrosamines in drug products and drug substances either by HSGC-MS, by GC-MSMS or by LC-MSMS, at the lowest levels.

Example of validated LOD and LOQ with GC-MSMS on Valsartan (NDMA) by Eurofins

• US FDA : LOD 0.01 ppm and LOQ 0.05 ppm
• Validated by Eurofins : LOD 0.005 ppm and LOQ 0.05 ppm

Confirmatory testing: we develop and validate new methods for drug products and drug substances on your demand or following the risk assessment. Our teams regularly face the challenges of low detection levels, difficult matrixes and the identification of unknown impurities when developing analytical methods.

We handle your release testing in LC-MSMS or GC-MSMS: indeed, the monographs on sartans of the European Pharmacopoeia (Ph. Eur.) have been updated and will enter into effect on 1 January 2020. Strict temporary limits have now been defined for nitrosamines - the five sartans concerned by this decision are covered by the following Ph. Eur. monographs: Candesartan cilexetil (2573), Irbesartan (2465), Losartan potassium (2232), Olmesartan medoxomil (2600), Valsartan (2423).

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