LC-MS/MS Quantitative Analysis of NDMA in Ranitidine Active Pharmaceutical Ingredient (API) and Drug Product using the SCIEX® 4500 QTRAP™

Abstract:

The LC-MS/MS method described in this technical note using Kinetex Biphenyl column is similar to the LC-MS/MS based analytical method recommended by USFDA as other methods, such as GC-MS, which use elevated temperatures have been reported to generate NDMA via reaction of ranitidine with itself, and this will result in an overestimation of NDMA present in ranitidine API and drug products.

Document Type:

Technical Notes

Industries:

Pharmaceutical/Biopharmaceutical

Techniques:

HPLC / UHPLC

Brands:

Kinetex

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