Valisure Analysis at a Glance: Quality assurance from our testing laboratory to you
Getting medication that contains what your doctor ordered and will dissolve in your body the way that it is supposed to, is certainly important. That’s why we test many of the most important properties of a medication at Valisure and do so for samples from every single batch of meds we receive.
Below are more details on our testing as they appear in our Certificates of Analysis.
Active Ingredient: The active ingredient in medications is the drug responsible for the intended therapeutic effect.
Approved: The Valisure Laboratory is an accredited chemical testing laboratory under International Organization for Standardization 17025 standards. These standards outline the best practices for laboratory chemical testing including equipment validation, reagent sourcing and quality control, proficiency training, internal auditing, and reporting. All testing results from the Valisure Laboratory are carefully reviewed by appropriate quality managers and our Certificates of Analysis (CoAs) are signed following approval.
Lot #: Drug manufacturers provide lot or batch numbers for medications in order to track them from formulation to finished product. At Valisure, we test samples from each lot or batch for quality before shipping directly to customers.
Disintegration Test: Disintegration is a simple test to ensure a solid medicinal product will break down in solution. On Valisure Certificates of Analysis, “Pass” means that the medication disintegrates appropriately in Valisure’s physiologically relevant conditions.
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. Valisure regularly tests for dissolution properties in drugs that have shown inconsistent dissolution.
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. We test and provide information on dosage for specific drugs that require precision dosing.
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 or specified in United States Pharmacopeia (USP) methods.
Impurities: Impurities are made or introduced during the manufacturing process for both active and inactive ingredients. Purification of pure drug products and inactive ingredients should remove impurities, but sometimes they remain through formulation and packaging of medications for sale. At Valisure, we check for common carcinogens and toxins that are found in the pharmaceutical supply chain and for some solvents used in chemical reactions to make drug products. Currently, our testing is focused on detection of nitrosamine impurities that are probable human carcinogens. This class of impurities includes N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA), which have caused many recent recalls of blood pressure medications. When medications “Pass” impurity testing, it means that levels are non-detectable or below the permissible daily exposure (PDE). When there is no established PDE for a nitrosamine impurity, we pass medications with under 96 nanograms per dose.
Major 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.
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 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.
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.