TN-1259: Rapid Analysis of Genotoxic Nitrosamines by HPLC-MS/MS

Abstract:

In this technical note, an LC-MS/MS method for the analysis of eight nitrosamine compounds is described, with a lower limit of quantitation (LLOQ) of 0.05 µg/g in a drug product which corresponds to significantly less than the threshold of toxicological concern (TTC) for most pharmaceutical products as required by FDA and EMA.

Document Type:

Technical Notes

Industries:

Pharmaceutical/Biopharmaceutical

Techniques:

HPLC / UHPLC

Brands:

Kinetex

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