Valisure Certificate of Analysis (COA)

We greatly value transparency and believe you should know more about your meds than just that they came from an orange bottle and have a number printed on them. Our analytics are summarized in an easy-to-understand certificate of analysis which is unique to every batch of every product we sell.

Lot Number

Large batches of medication are made and packaged for sale with unique lot numbers. At Valisure, medication samples from every lot are tested to ensure quality and consistency for our customers.

Dosage

Valisure determines the dose of active ingredient in samples from every batch of medication using comparison to pure reference standards.

Find out more here

Spectral Match

To ensure that medications contain the proper active ingredient, Valisure uses spectroscopic techniques to match medication samples to pure reference standards.

Major Inactive Ingredients

A library of pure inactive ingredients, including those shown here, allows Valisure to identify and report major inactive ingredients in medication samples.

Impurity Detection

Discovery of dangerous impurities can prompt medication recall. Valisure conducts additional testing to help ensure the medications we offer do not have such impurities above our detection limits, which are below those established by the FDA for acceptable daily intake or exposure.

N-Nitrosodimethylamine (NDMA)

NDMA is a probable human carcinogen and responsible for recent heart medication recalls. N/D indicates that an impurity is not detected above the detection limit in a single dosage unit.

FDA Acceptable Intake Valisure Detection Limit
96 nanograms 25 nanograms

N-Nitrosodiethylamine (NDEA)

NDEA is a probable human carcinogen and responsible for recent heart medication recalls. N/D indicates that an impurity is not detected above the detection limit in a single dosage unit.

FDA Acceptable Intake Valisure Detection Limit
26.5 nanograms 25 nanograms

N,N-Dimethylformamide (DMF)

DMF is a class 2 industrial solvent and a probable human carcinogen used in the chemical synthesis of some drugs. N/D indicates that an impurity is not detected above acceptable limits in a single dosage unit.

Disintegration

Whether produced for immediate, delayed or extended-released, do your medications release at the right time? Valisure determines when medication samples break down in simulated gastrointestinal conditions.

Drug Release

Valisure uses fluids that mimic gastrointestinal conditions to determine how well medication samples release active ingredients over time.

Approved By

Valisure's rigorous quality management system and processes for chemical analysis are accredited under International Standards Organization (ISO 17025) regulation standards which requires all tests to be approved by a quality manager.

Contact us

What We Do (and Don't) Test

Other pharmacies visually check that a medication looks OK from the outside. Valisure also checks that medications are OK on the inside – we take samples from each batch of medication and run a variety of chemical tests. Below is an explanation of Valisure’s current testing capabilities, tests we plan to add in the future, and what we cannot reasonably test for as an analytical laboratory. Calibrating some of our more sophisticated tests for new drugs can be complex, but we can already perform these tests on the most common ~ 100 products, and we work continuously to grow our capabilities.

 
Analytical Test
Purpose
Drugs Currently Analyzed
Current tests
  • Common Impurities
  • Major Inactive Ingredients
  • Active Ingredient ID
  • Dosage
  • Dissolution
  • Check for common carcinogens and toxins
  • Identify major fillers. May reveal counterfeits and/or manufacturing irregularities
  • Check that drug contains correct active ingredient
  • Measure the amount of active ingredient
  • Measure how long medication takes to dissolve
  • All
  • Almost all (a few exceptions)
  • Almost all (a few exceptions)
  • ~ 100 most common, and growing
  • ~ 100 most common, and growing
Coming Soon
  • Allergens
  • Microbial
  • Heavy Metals and Toxic Elements
  • Check for gluten, peanut protein, etc.
  • Check for presence of various pathogens
  • Check for lead, mercury, arsenic, etc.
  •  
  •  
  •  
Can't Reasonably Test
  • Unknown or Rare Impurities*
  • Efficacy and Side Effects**
  •  
  •  
  •  
  •  

Current tests

Coming Soon

Can't Reasonably Test

*Unknown or Rare Impurities: There are literally millions of different chemicals that could possibly be present as impurities in a medication. Analytical testing largely works by looking at chemicals (including impurities) you expect could be present. Trying to find rare or unknown chemicals can take a forensic lab months or years to do. This kind of testing is not something Valisure's high throughput lab can reasonably do.

**Efficacy and Side Effects: Valisure doesn’t test how a drug works, just that it is the right medication, it has the right dosage and that it should release as intended. The efficacy and side effects of a drug are tested during clinical trials.

IMPORTANT NOTICE: 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 above 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.

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Lot Number

Large batches of medication are made and packaged for sale with unique lot numbers. At Valisure, medication samples from every lot are tested to ensure quality and consistency for our customers.

Dosage

Valisure determines the dose of active ingredient in samples from every batch of medication using comparison to pure reference standards. Find out more here.

Learn How it Works

Spectral Match

To ensure that medications contain the proper active ingredient, Valisure uses spectroscopic techniques to match medication samples to pure reference standards.

Major Inactive Ingredients

A library of pure inactive ingredients, including those shown here, allows Valisure to identify and report major inactive ingredients in medication samples.

Impurity Detection

Discovery of dangerous impurities can prompt medication recall. Valisure conducts additional testing to help ensure the medications we offer do not have such impurities above our detection limits, which are below those established by the FDA for acceptable daily intake or exposure.

N-Nitrosodimethylamine (NDMA)

NDMA is a probable human carcinogen and responsible for recent heart medication recalls. N/D indicates that an impurity is not detected above the detection limit in a single dosage unit.

FDA Acceptable Intake Valisure Detection Limit
96 nanograms 25 nanograms

N-Nitrosodiethylamine (NDEA)

NDEA is a probable human carcinogen and responsible for recent heart medication recalls. N/D indicates that an impurity is not detected above the detection limit in a single dosage unit.

FDA Acceptable Intake Valisure Detection Limit
26.5 nanograms 25 nanograms

N,N-Dimethylformamide (DMF)

DMF is a class 2 industrial solvent and a probable human carcinogen used in the chemical synthesis of some drugs. N/D indicates that an impurity is not detected above acceptable limits in a single dosage unit.

Disintegration

Whether produced for immediate, delayed or extended-released, do your medications release at the right time? Valisure determines when medication samples break down in simulated gastrointestinal conditions.

Drug Release

Valisure uses fluids that mimic gastrointestinal conditions to determine how well medication samples release active ingredients over time.

Approved By

Valisure's rigorous quality management system and processes for chemical analysis are accredited under International Standards Organization (ISO 17025) regulation standards which requires all tests to be approved by a quality manager.

Contact us