A Certificate of Analysis (COA) is an authenticated document that is issued that ascertains that product has met its predetermined product release specification(s) and quality. These are typically given by Quality Assurance Labs. They are utilized to determine if a product is safe for use for its intended purposes. In the cases of pharmaceuticals, it is a breakdown of the ingredients listed within the products as well as any other contaminants or residual chemicals that may not be listed.
What is a COA?
A Certificate of Analysis is helpful for proof in safety regulations. If any complaints are made by the consumer that lead to legal ramifications, these reports are typically submitted as evidence of what is present within the product according to the analysis. When dealing with things like packaging and distribution, this also is a good report to have on hand in the case of any issues.
At the top of each report should be the contact information (i.e. name, address, website) of the company laboratory that completed the analysis. Also, the customer name or contact person for the company the product came from should be at the top as well. Beneath that should be a section denoting all of the information about the sample submitted.
In this section, there should be an order number and a batch number. There should also be an order date, submission date, and reporting date. These are all issued by the laboratory before analysis and after the report is generated. These are good things to keep in the case of a question for the lab that is performing the analysis. If for any reason there is a question about the sample or the methodologies of analysis, these numbers and dates will allow the contact at the lab/company to easily find your samples and reports in order to answer any questions you may have.
The next parts of this section should include actual physical information about the sample submitted. It tells if the sample is a raw sample or simply an extract. It should also give some specifications such as the weight or the volume of the sample given. Many labs require a minimal amount of sample to be submitted to perform an analysis. Typically, if there is not enough sample to be given, the sample can be rejected.
Breakdown of Results:
The first section listed in the report is the potency. Potency is a measure of drug or supplement activity expressed in terms of the amount required to produce the intended effect. In other words, it is the concentration needed for the drug to work as prescribed. This is good information to be utilized for substances in which toxicity is a major concern. If a substance has a high potency then a small concentration is needed. If a substance has a low potency then a much larger concentration may be required. This information is of most importance when giving instructions on how the substance should be used and how much should be used. Too little would prove ineffective. Too much could result in overdosing which could be toxic. Also, a substance with too low of a potency may not actually be appropriate for use at all.
This test is done via HPLC or High Performance Liquid Chromatography. This methodology is typically very sensitive. For these results, you should see numerical values denoting the concentrations. Due to the fact that it is not accepted scientifically to say 0.000 on any value, for values in which there is no potency detected, there will be a notation of "ND" which means "None Detected."
The second section is a breakdown of the detection of pesticides. Anything of human consumption should be free of pesticides of any sort. This is why we wash our fruits and vegetables before ingesting. Many of the pesticides that are used contain potentially harmful chemicals that could result in severe illness or even death. It is of upmost importance that this section is PASSED. The methodology for these tests are LCMS/MS or Liquid Chromatography Mass Spectroscopy/Mass Spectroscopy.
The analysis is set to detect if any of the pesticide is present depending what pesticides are screened for. The Action Level presented is the level that is considered to be dangerous and will denote a FAILED sample. Typically, results below the concentration of the Action Level are deemed as passing. The LoQ is the Limit of Quantiation. It means that the instrumentation/machine cannot detect below that given concentration. For very sensitive machines, this is typically a very small number. Any amount below that is deemed as "insignificant" or "too low for concern."
The level of detection (LoD) is a measurement that lets the user know how sensitive the instrument is to the presence of the analyte, or substance to be analyzed. It is an estimate of the bias and imprecision at the lowest analyte concentration. Basically, it is a determination of how well the machine could pick up a very very very small amount of analyte. This is why on the results you may see a notation of less than LoQ. This means below the limit of quantitation. This is not saying that the analyte is completely absent, but it is saying that the possible concentration is too low for the machine to pick up.
Note: Because many of the machines/instruments used in these procedures are highly sensitive, a less than LoQ is typically considered a safe/PASSED result. However, when choosing a lab please ensure your lab has instrumentation that passes all regulations.
For the third section, we are looking at residual solvents. In order to obtain extracts for many types of drugs and other substances, there is an extraction process. In an ideal setting, the sample provided will be a pure sample with none of the chemicals utilized in the extraction process. The chemicals utilized within these processes are typically organic solvents that are not safe for human consumption. If the extraction is done properly, this should also yield a PASSED result.
Simmilar to the Pesticide detection, the Residual Solvents detection is looking for the presence of solvents above the Action Level. Any results that go above this level are typically FAILED samples. Any samples that fall below the LoQ or Limit of Quantification are labeled as less than LoQ. (Always look at the LoQ listed to determine how low the value may actually be.) These samples are determined by GCMS/GC or Gas Chromatography-Mass Spectroscopy/Gas Chromatography.
The Microbiology Detection utilized qPCR, or quantitiative Polymerase Chain Reaction, to detect for any microbes within the sample given. The testing looks at specific aerobic bacteria. Aerobic bacteria that utilize oxygen to survive. Depending on the type of sample submitted and the extraction methods use, these aren't typically microbes that are of great concern unless something went wrong during sample preparation, extraction, storage, or transport. Hence, why the testing is still important.
The testing also looks at anaerobic microbes which are microbes that can survive without oxygen. These are some pretty dangerous microbes due to the fact that they can survive and multiply in areas that are oxygen poor such as within the digestive tract of a human. There are some anaerobes that can survive in oxygen-rich environments such as Enterobacter. This report also tests for those as well. Coliforms are environmental bacteria that are present in fecal material of animals. the mycology section looks for molds and yeasts. Some molds and species of yeast can be harmful to the human body. Depending on the derivation of the samples, this is also of upmost importance. It is imperative that this is also listed as PASSED.
The Heavy Metals testing is similar to the Pesticide and the Residual Solvents section. There is an Action Level that denotes the limit for detection before a sample is marked as FAILED. There is also a LoQ that is presented in cases where the sample may have an amount that is too low for detection on the instrument/machine utilized. Because heavy metals can also cause major problems within the human body and have been cited throughout history in many class-action suits, this section should always read as PASSED also.
The final section listed is the Mycotoxins section. Mycotoxins are toxins released by fungi present on or around the materials. There are cases in which a fungus/mold could be present in small amounts and release toxins within the sample. Aflatoxins are commonly known mycotoxins. These can be very harmful and detection is very important. Action levels tend to not be present for most of these. The reason for this is that ideally there should not be any of these toxins present. The LoQ is also available to denote the sensitivity of the instrumentation. You should definitely strive for PASSED on this one as well.
At the end of the report, you should see the signature of a laboratory director. This laboratory director is a person that is responsibly for verifying the validity of the results. They are also the people that can be contacted with any disputes if any should arise.
Below the signature, you should see footnotes that reveal how some of the values shown within the report are calculated. That is for transparency purposes. Also, within the footer lies more contact information for the company/lab that is performing the analysis.