Valisure Certificate of Analysis (CoA) Explanation and Disclaimer

VALISURE CERTIFICATE OF ANALYSIS (COA) EXPLANATION AND DISCLAIMER

Valisure Analysis at a Glance: Quality assurance from our testing laboratory to you

Getting the dosage that your doctor intended you to get is critical, therefore, at Valisure, we test the dosage for all batches of medication. We make sure the dose of active ingredients in your medication is within 5% of the manufacturer’s stated dose of milligrams per medicinal unit whether tablet, capsule or otherwise.

Another important measure of quality is how well medications dissolve, making the active drug available for absorption and the intended therapeutic effect. The Valisure laboratory rigorously analyses the dissolution properties for every batch of medication using simulated gastric fluid and intestinal fluid to model conditions in the stomach and intestines.

Definitions

Active Ingredient: The active ingredient in medications is the drug responsible for the intended therapeutic effect.

Lot #: Drug manufacturers provide lot or batch numbers for medications in order to track them from formulation to finished product. At Valisure, we test each lot or batch to ensure quality before shipping directly to customers.

Dosage: The dosage is the amount of active ingredient in medications reported by weight as milligrams (mg) in dry solid products like tablet or capsules or milligrams per milliliter (mg/ml) in liquid forms like solutions or suspensions. Valisure only provides medication with dosages that fall within FDA-allowed variability of the manufacturer’s reported dosage. Most often this allowed variability is +/- 10% but can change depending on the drug – the specific range is stated on the Certificate of Analysis.

Spectral Match: We use precision lasers to determine the vibrational-rotational energy of chemicals, which provides unique spectra, much like fingerprints, for compounds or complex chemical mixtures. This process allows us to determine whether active ingredients and major inactive ingredients in medications are spectral matches to known drugs and chemical standards. The known drugs, called reference standards, we use are the purest form of drugs used in the US and globally for medicinal chemistry and testing.

Inactive Ingredients: Inactive ingredients help to bind and stabilize active ingredients in medications. Sometimes inactive ingredients are formulated to help active ingredients release in the body at the appropriate or optimal time and place for the intended therapeutic effect. Valisure reports the major inactive ingredients in medications identified by spectral match.

Dissolution: Dissolution is the process by which chemicals and compounds from solid medications dissolve into solution and is an important early step by which the active ingredient in medications becomes available for absorption in the body.

Disintegration Test: Disintegration is a simple test to ensure a solid medicinal products will break down in solution.

Drug Release Time: Drug release time reports the time it takes for dissolution resulting in active ingredient that has transitioned from a solid oral medication to solution. Valisure passes batches of medication that release active ingredient in simulated gastric or stomach conditions in less than two hours, and those that release in simulated intestinal conditions in less than 3 hours. Extended release medications are formulated for slow release and pass Valisure dissolution studies for their ability to release active ingredient over periods of time that match the release time claims marketed by manufacturers and/or specified in USP (United States Pharmacopeia) protocols.

IMPORTANT NOTICE WHEN RECEIVING MEDICATIONS WITH VALISURE’S CERTIFICATE OF ANALYSIS:  Read the instructions and any medication guide that came with your medicine, use the medicine as directed, and check with your health care provider if you have any questions about your medication and before changing your treatment in any way.  The chart provided contains results from an analytic chemistry analysis performed on a subset of pills from the same batch or lot as the pills provided to you.  The subset was designed to be representative of the entire batch or lot.  The specific pills you received were not analyzed and an analysis of your pills could yield different results. These results: (1) are not medical advice, (2) are not intended to be a statement, claim or indication of efficacy or suitability of the pills provided to you, (3) do not describe any particular characteristic (or lack of characteristic) beyond the specific metrics listed for the subset tested, and (4) make no claim or indication of the relative efficacy and/or suitability of your pills or the subset as compared with other subsets, batches, lots, brands, formulations, or treatments. VALISURE LLC DOES NOT MAKE, AND SPECIFICALLY DISCLAIMS, ANY REPRESENTATIONS OR WARRANTIES WITH REGARD TO THESE RESULTS AS THEY RELATE TO THE PILLS PROVIDED TO YOU, INCLUDING, WITHOUT LIMITATION, ANY EXPRESS OR IMPLIED WARRANTIES, WARRANTY OF MERCHANTABILITY, WARRANTY OF PERFORMANCE, OR WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE.