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