Nova x00 Series as Quality Control Instruments for the Surface Area Determination of Magnesium Stearate

Magnesium stearate is widely used as an inactive ingredient in pharmaceutical formulations for human and veterinary products. It acts primarily as a “flow agent” or lubricant for the other ingredients - reducing friction and preventing sticking to each other and/or manufacturing machinery and molds. In order to be used as a compliant excipient in final formulations, some of the physical and chemical properties need to be characterized, including specific surface area (SSA).

Introduction

The surface area of pharmaceutical grade magnesium stearate is formally recognized as an important material characteristic and its analysis is formalized in the USP monograph “Magnesium Stearate”. The analytical method is described in USP chapter <846> together with conditions specific to magnesium stearate stated in the aforementioned monograph. However, it is important to note that the analysis of magnesium stearate poses some challenges for the SSA characterization and these challenges are discussed in this application report. The Anton Paar Nova x00 Series instruments have the ability to accurately determine the SSA of magnesium stearate following the USP recommendations.

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