USP Dissolution Test 3 for Metformin Hydrochloride Tablets

Abstract:

In vitro dissolution testing is an important tool that can be used for approval of safe and effective generic drug products. In this technote, we demonstrate the advantage in using a Kinetex® C18 core-shell column of the same particle size and dimension as specified in the USP monograph for dissolution test #3 for metformin hydrochloride tablets. The faster analysis achieved using the Kinetex column would be very useful for a laboratory looking to increase sample throughput (for example, where many dissolution samples need to be analyzed), without compromising the results for a bioequivalence (BE) study.

Document Type:

Technical Notes

Industries:

Pharmaceutical/Biopharmaceutical

Techniques:

HPLC / UHPLC

Brands:

Prodigy Kinetex

PDF Link:

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