Nitrosamines & NDSRIs Studies
We Perform Genotoxic Impurity Study Testing On:
- Active Pharmaceutical Ingredients (APIs) / Drug Substance
- Drug Products (Tablets, Capsules, Injectables, Ointments, Lotions, Syrups, Suspensions, Gels, Inhalations, Creams & Emulsion, Transdermal Patches etc.,)
Our Genotoxic & Nitrosamine Impurity Services Include:
- Genotoxic impurity testing according to ICH M7 (R1), USFDA, EMA and/or customer requirements for Identification & quantification.
- We develop, validate and analyse the genotoxic impurities by considering allowable maximum daily exposure target achieving stringent LOQ requirements.
- Techniques used are LCMS/MS, GC-MS/MS,
HS-GC-MS/MS,
![GCMSMS - for Genotoxic Impurities page](https://dalpl.co.in/wp-content/uploads/2024/01/GCMSMS-for-Genotoxic-Impurities-page-scaled.jpg)
![Picture for Genotoxic Impurities - Nitrosamines & NDRIs page](https://dalpl.co.in/wp-content/uploads/2024/01/Picture-for-Genotoxic-Impurities-Nitrosamines-NDRIs-page-1.jpg)