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In an analytical environment, a Certificate of Analyses is always present. It’s important to read and understand them carefully since they contain a wealth of knowledge about your product or a product you are buying. In the hemp and CBD industry, Certificates of Analysis (COA, CofA) are particularly important, due to the strict THC limits set forth by regulators, which makes this document important from seed to shelf.
A COA can help determine the price, sale, and consumption of a product. A regulatory body in your state can dictate what analyses are to be performed on a consumable product.
Since there is no final rule on CBD products at the federal level, regulations from state to state differ. Therefore, retailers are required to take ownership of ensuring their consumers of what is present and or absent in their products.
Typical analyses indicated on a COA are:
- Residual Solvents
So what do I need to look for on a Certificate of Analysis?:
- Equipment: A COA will state the analytes analyzed and what chromatographic method is used. Cannabinoids should be run via High-Performance Liquid Chromatography (UHPLC or HPLC) with a diode array detector (DAD). The DAD scans across a range of wavelengths and will give one the confidence that no peaks are coeluting which would inevitably result in skewed results. The difference between a UHPLC and HPLC is the pressure limits. Run times for a UPLC will be shorter than a HPLC and the peaks will be easier to read. Therefore, results are reported to a high level of accuracy. A Gas Chromatography (GC) with a Flame Ionization Detector (FID) can also be used for the analysis of cannabinoids. However, the hemp industry has moved away from this because heat is required which can cause decarboxylation of acidic cannabinoids. You should be able to tell from your Certificate of Analysis what equipment your laboratory is using and if you don’t know—ask!
- Methodologies: Seeing United States Pharmacopeia (USP) methods implemented by a lab should give one confidence. The pharmacopeia’s core mission is to protect public health by ensuring analytical testing standards across states and countries to verify the quality of pharmaceutical ingredients and products.
- USP <232> & <233> for heavy metals (lead, arsenic, cadmium, and mercury)
- USP <467> for residual solvents
- USP <61> & <62> or USP <2021> & <2022> for microbiological examinations
- State regulations: Testing pesticides can be confusing, due to the differing state regulations. States require different pesticides and can have differing allowable residual amounts or Maximum Residue Limits (MRL). The individual pesticide specifications should be seen on a COA. Ask your laboratory what state guidance they are following to ensure that you are adhering to all the states you distribute to. Laboratories should stay up to date with regulatory changes since they are constantly changing.
- Limit of Quantification: The Limit of Quantitation (LOQ) is the lowest concentration of an analyte that can be determined with acceptable precision and accuracy. The LOQ is determined by the limit of the detector and should be periodically validated by a laboratory to ensure they are producing the best results possible. Laboratories should be adhering to USP <621> to calculate their LOQ. The Limit of Detection (LOD) will always be lower than the Limit of Quantification. Laboratories should always report LOQ, which will differ for different analytes in different matrices (types of material). If identifying minor cannabinoids is important, look for a low LOQ, since products tend to contain minor cannabinoids at lower concentrations. Anything less than the LOQ, but still seen on a chromatogram, must be reported as non-detectable (ND) because you can only report quantifiable results.
- Total THC: One of the big questions answered by a COA is: Is this product label compliant and THC compliant by Federal or state regulations. According to the USDA 2018 Farm Bill, THC has to be less than 0.3% on a dry weight basis (0.3 w/w %); dry weight basis meaning the moisture falls between 5-12%. The conversion of 0.3% is 0.003 grams (g) of THC per 1 gram of material or 3 milligrams (mg) of THC per 1 gram of material. You should always ensure that your laboratory is properly calculating total THC with the following equation:
- Total THC = Delta-9-THC + Delta-8-THC + (THCa x 0.877) = THC + (THCa x 0.877)
Questions about this article or Certificates of Analysis can be directed to email@example.com for more information!
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