How to Read and Understand a Certificate of Analysis (COA)

Updated: 15-May-2024

WHAT IS A CERTIFICATE OF ANALYSIS? 

A certificate of analysis is a legal document from a laboratory that provides documented test results. TrustPointe Analytics provides certificates of analysis to confirm certain properties of the active compound in a particular sample, including things like identification and content.

WHAT IS AN INDEPENDENT LABORATORY?

An independent laboratory is an independent organization, contracted by the manufacturer, seller, or end user, engaged to perform specific inspections or tests of a product and report the results of these inspections or tests. TrustPointe Analytics is an independent laboratory, with no financial ties to sales of the product tested.

WHY ARE INDEPENDENT LABORATORY RESULTS IMPORTANT? 

An independent testing lab provides an impartial, third-party test of the product with unbiased results. Where internal laboratories may feel pressure to pass products that fail testing for financial reasons, there are no conflicts of interest for an independent testing lab like TrustPointe Analytics.

Imagine buying a used car: Do you trust the salesman when he says the car is in perfect condition? What about the mechanic that works for the car lot? You might question their impartiality, and if you are not a mechanic, buying a used car without a third-party mechanic review is risky.  In recent years, a Carfax report (or similar) has become standard when purchasing a used car.  This is a vendor’s way of providing a neutral third-party report on the vehicle (a COA of sorts).  

This same scenario applies to peptide manufacturers and resellers. They are probably telling the truth about their products, but every vendor should readily provide you with test results from a neutral third party. TrustPointe Analytics makes our COAs available on our website for easy access, tamper-proofing, and verification.

How to Read a COA

THE HEADER

The header of a COA contains information about sample and testing logistic information:

• Company Information: TrustPointe provides our company logo as well as our contact information and the physical address of our laboratory.
• Compound: This is the compound TrustPointe is testing in the sample. It directly ties to the validated test methods that will be used in the analysis.
• CAS: This is the unique number assigned to a chemical substance by the Chemical Abstracts Service (CAS), a division of the American Chemical Society.
• Lot: This is the unique identification number tied to a quantity of manufactured or labeled product. It may be the manufacturer’s mixing and vial lot, or the resellers order label lot, or other identifier for a finite quantity of product that is traceable back to the production process.
• Analysis Date: This is the date that the testing was performed.
• Client: This field denotes the client for which the sample testing was performed. 
• Test Reference: This is a unique number generated by our laboratory to track all of the paperwork associated with your testing (laboratory notebook pages, chromatograms, raw data, results, etc)
• Sample Image: For peace of mind, we provide a picture of the actual sample being tested so the customer can be ensured that we received their sample and tested it.

SAMPLE TESTING INFORMATION

The sample testing section of the COA provides testing results for the sample:

• Appearance: This check is to visually verify that the sample matches the expected sample properties. If the sample appearance was different than listed, TrustPointe would reach out to the customer to verify that the correct samples were received.
• The Following Tests Are Performed Using HPLC (High Performance Liquid Chromatography):
  • Identification by Retention Time: This is an identification test in which the retention time of the sample is compared to the average retention time of five reference standard injections. 
  • Identification by UV Spectral Comparison to Reference Standard:  This is an identification test in which the UV spectrum of the sample is compared to the UV spectrum of the standard. 
  • Vial Content (mg):  This is the amount of the compound in the vial we tested determined by HPLC analysis.
  • Purity (%): This is purity of the sample, calculated including peaks around the compound that may be impurities.

METHOD AND SYSTEM SUITABILITY INFORMATION

At TrustPointe Analytics, our slogan is Accuracy Matters.  Results You Can Trust.  The information provided in our method and system suitability information section is intended to demonstrate to our customers that our testing method and system were working properly when the samples were tested:

Standard + SSC Injection RSD:  This value shows that the HPLC system was running properly throughout your testing.  The %RSD of the standard injections performed before your sample and the standard injection performed after your sample is calculated to ensure there were no system errors during your run.  Although system errors such as leaks, a line running dry, air bubbles, etc. are rare, it’s important that we demonstrate no errors occurred during analysis.  

Coelution Control (Peak Purity):  NOTE: This value is not purity of the compound – the peak is pure compound as it was separated out by the HPLC.  This value demonstrates that there is no co-elution occurring during analysis. We receive samples from a multitude of manufacturers and each has their own recipe (stabilizers, solubilizers, fillers, etc) in their process.  This measurement ensures that none of these other components interfere with the analysis.  In short, this number confirms that the method is working properly and only analyzing the target compound.

BONUS: HOW DOES HPLC WORK?

• The solvents on top of the system carry the sample through the HPLC column which separates the injected sample into its individual components by molecular size, charge, shape, interaction with the phases, etc.
• This separation allows TrustPointe to directly analyze only the target compound in the mixture. It also allows us to identify the target compound based on the time it takes to separate it in the column (retention time).
• The HPLC is equipped with a light detector, and the sample absorbs some of this light as it passes through the detector. This is converted to a signal which is then used to quantify a compound.  
• All of our HPLC Methods utilize an external standard – which means we inject a standard solution prepared at a known concentration multiple times to create a calibration curve.  That calibration curve is used to calculate the concentration of the target compound in the sample.