You not only need to know what your material is, you need to know how strong the constituents and actives may be. Although we hear the most emphasis in reference to the potency of hemp and cannabis products, this measurement is certainly not limited to that particular family of plants.
SUBSTANTIATING
LABEL CLAIMS
METHODS
We work with our clients to ensure test methods are appropriate for their intended use by identifying and using an appropriate scientifically valid method for each established specification.
High Performance Liquid Chromatography (HPLC) and Ultra Performance Liquid Chromatography (UPLC) are used to separate, identify, and quantitate compounds. They are considered the most powerful tools in analytical chemistry. HPLC/UPLC can be used to assess the purity of samples from a variety of matrices that are able to be dissolved in a liquid/solvent. In many situations, it is able to quantify compounds and adulterants at very low concentrations. HPLC/UPLC is applicable to the accurate quantitation of several types of chemical constituents of crude raw botanicals from powdered to whole form, extract (powdered or liquid) and finished products/blends as well as all vitamins and amino acids. This is a preferred technique worldwide.
Gas chromatography is a term used to describe the group of analytical separation techniques used to analyze volatile substances in the gas phase. In gas chromatography, the components of a sample are dissolved in a solvent and vaporized in order to separate the analytes by distributing the sample between two phases: a stationary phase and a mobile phase. The mobile phase is a chemically inert gas that serves to carry the molecules of the analyte through the heated column and then through the one of the various detectors used, where the separated compounds are identified by comparing with known compounds. This technique is the preferred method for the quantitation of the various components of fish oils, oils in general or many of the essential/volatile oils of botanicals as well as a wide variety of combustible compounds found in many different matrices.
Ultraviolet-visible spectroscopy or ultraviolet-visible spectrophotometry (UV-Vis or UV/Vis) refers to absorption spectroscopy in the ultraviolet–visible spectral region. This means it uses light in the visible and adjacent (near-UV and near-infrared (NIR)) ranges. UV/Vis spectroscopy is routinely used in the quantitative determination of solutions of highly conjugated organic compounds, and biological macromolecules. UV/Vis spectroscopy is frequently used to quantitate organic compounds found in many natural products and dietary supplements. UV/VIS has the limitation of not being as specific or accurate as HPLC or GC but could be a quick and easy way of quantitating compounds or groups of compounds for ‘process control’ or when one needs a reproducible way of measuring the quality of any material such as an extract or botanical without the need for the specificity of more accurate techniques.
Potency testing of raw materials, botanical extracts, and finished products is a key component of cGMP compliance in the Dietary Supplements industry. The proper analysis of natural products requires not only specific analytical instrumentation, but also the expertise to know when and how to appropriately apply the wide variety of available techniques.
Compendial methods we use include those developed by:
* These methods are typically adapted from applicable peer reviewed research publications.
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