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Pharmaceutical Impurities – Nitrosamines

Royalmount laboratory has over 25 years expertise in pharmaceutical impurity analysis including nitrosamine impurities limit testing
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Pharmaceutical Impurities – Nitrosamines

If a risk of nitrosamines contamination is identified, confirmatory testing is required. Our laboratory in Montreal offers confirmatory testing of nitrosamines by LC-MS/MS to determine trace impurity levels of nitrosamines. 

 

We analyze for trace impurity levels of nitrosamine by LC-MS/MS, including analytical method qualification, development, validation and analysis of specific finished products and APIs, satisfying GMP requirements.

 

  • NDMA and other analogs at ppm levels
  • Use of stable labelled internal standards for robustness and reliability
  • Competitive lead-in times
  • High specificity methods ensure that interferences do not result in falsely high NDMA levels
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The Royalmount Advantages

  • Efficient communication
  • Knowledgeable in nitrosamine analysis 
  • Direct and quick involvement in the project
  • Personalized services

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