Case Study #3

LC Method Development for Natural Product Extracts and Homeopathic Products

The Problem:
This small startup company was developing a homeopathic product based on a natural product extract. The benefits of this extract have been attributed to one chemical constituent. The manufacturer needed a reliable analytical method for checking the amount of the active ingredient in raw material extracts, and in the finished formulation. (Note: we applaud this manufacturer for taking a science-oriented approach to developing this type of product.)

The Solution:
ACCTA, Inc. worked with a local laboratory to develop a reliable method for determination of the active ingredient in extracts from suppliers, as well as the manufacturer's formulations.

The Results:
An efficient method was developed to provide the necessary sensitivity and selectivity. As shown in the chromatogram below, analysis was complete in 12 minutes. We were able to easily separate the compound of interest from the many other matrix components. We also optimized the extraction conditions for each sample type.

In analyzing extracts from different suppliers, we were able to identify which suppliers' products contained the stated quantity of the active ingredient. Some actually contained no active, because their methods were not as specific as our HPLC-based procedure! We also investigated several formulation options, helping the manufacturer develop a better, more stable system. With a good analytical method in place, it was possible to design and carry out a storage stability study to verify the integrity of the product over time.

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