August 1, 2024
A Certificate of Analysis (COA) is a document issued by a 503B outsourcing facility or laboratory that provides detailed information to ensure that the medication meets regulatory standards and the ingredients are what they say they are. Think of a COA as a report card for a specific batch of medication: it details the tests conducted on a medication, the achieved results, and the comparison to benchmarks established by the United States Pharmacopeia (USP).
The COA will provide identifying information like the medication’s name and batch or lot number, so the medication can be traced and authenticated. This section will also include the date it was made, the expiration date, and required storage conditions, as well as the name and address of the manufacturer.
The COA is signed and dated at the end of a document by an authorized expert, like a quality assurance manager or laboratory technician, certifying that the medication meets the required specifications.
Starting later in August, you can access your COA at the Customer Safety Portal at hims.com/trust-and-safety/weight-loss/COA and forhers.com/trust-and-safety/weight-loss/COA.
COAs for compounded GLP-1 injections available through Hims & Hers look at 9 different criteria, as determined by the USP:
- Description: This determines simply how the medication should look. For compounded GLP injections, it should be a clear, colorless solution.
- Identification A: This test identifies that the medication is actually what it says it is (in this case, Semaglutide) using a very sophisticated piece of equipment called High-Performance Liquid Chromatography (HPLC).
- pH: Using the USP 791 required method, this test tells us how acidic or basic the medication is. For compounded GLP-1s, the pH is required to be somewhere between 7.0 and 7.8. If the batch tests anywhere within the range, it passes.
- Container Content: This test confirms the amount of liquid inside the vial. The contents should not be less than what is on the label. (You’ll see the acronyms NLT or NMT used in the specification field for some tests, which means “not less than” and “not more than.”)
- Particulate matter: This test ensures the medication doesn’t contain objectionable particles through a method called light obscuration analysis, which counts any particles as the medication is passed through a light source and detector. This method can measure particles even smaller than the human eye can see.
- Assay: Assay is another word for potency or strength. This test determines if the medication meets the strength listed on the label, which must be between 90% to 110%.
- Benzyl alcohol content: This test detects and quantifies the amount of benzyl alcohol present in the solution. Benzyl Alcohol is the ingredient that makes a vial multi-dose because it protects the medication from contamination when a customer injects a needle into the vial several times.
- Bacterial endotoxins test: Bacterial endotoxins are released when bacteria die off and leave behind the cellular remnants that can cause adverse reactions like fever. This test ensures that an unsafe amount of these endotoxins are not present in the medication.
- Sterility test: Sterility, as defined by USP 71, is critical for sterile injectable medications in order to keep patients safe. A manufacturer cannot claim a medication has been properly tested without following the USP 71 standard of process control and microbiological quality of a medication. For compounded GLP-1 injections (and all sterile injections!), the gold standard is a test result indicating no microbial growth.
Commentary
A COA may be the way for weight loss companies such as Weight Watchers to be able to offer less costly compounded GLP-1 meds to their customers. Currently, WW just offers the full price ($1,000 – $1,300 per month) brand name meds.