Brian Rohrback, Ph.D.
Dr. Brian Rohrback, of Infometrix, Inc., in Bothell, Washington, will present “Robust Analytics from Harvest to Finished Product Specification.”
The quality control of botanically-derived pharmaceutical products represents a significant challenge and drove the development of a unique chemometric approach. US FDA Botanical Guidelines describe the requirements of a fingerprint for a botanical drug product, but this edict is not prescriptive in outlining a mechanism for creating and qualifying these fingerprints. As a result, we developed API and Finished Product specifications that have two sections: the first based on a conventional quantitative data evaluation; and the second a qualitative chemometric assessment using the raw chromatographic profiles. The chromatograms of new batches are aligned using statistical methods to provide peak retention time consistency and then are compared against standard models using principal component analysis. The methodology generates a single drug-release metric: a traffic light type “pass-warn-fail” system for each new batch. Applying a similar alignment and pattern recognition approach, a single injection GC analysis has been used to track growing conditions and determine the optimal point of harvest.