You want to assure your customers that your products contain exactly what is on your label. Identification of ingredients used in your product is part of 21 cfr 111. Exact Scientific Services, Inc has multiple ways of identifying that ingredient.

USP states that the identification of a raw plant material must be carried out by performing diagnostic chemical tests, genetic testing, and/or morphological testing. DNA based methods can be used for whole plants or dried, cut and shifted or processed plants. Identification can also be done by morphological and histological features.

What techniques does Exact Scientific Services use?

We listed our techniques in the column to the right.  We have the capability to use macroscopic or microscopic identification techniques, but it is not our specialty.  We prefer to start with our DNA analysis. An explanation of our technique can be found on our DNA webpage.   

Our next is to look at chemical identification using chromatographic or spectroscopic profiles.  Spectroscopic techniques include UV and FTIR.  Chromatographic methods include HPLC, TLC or GC.  Analytical methods used for fingerprinting should be capable of detecting as many chemical constituents as possible.

To run the chemical identification of botanicals, extracts are prepared.  This extract is then examined for Active principals (constituents that have proven clinical activity), Active markers (constituents that some activity contributing in some extent to efficacy), Analytical markers (constituents that aid in the positive identification of the botanical), and Negative markers (constituents that may have allergenic or toxic properties).

In all cases reference standards are purchased to assist in the identification of marker compounds.