Third-Party Test Results

Every batch of Heisen Blue methylene blue is independently tested by an accredited third-party laboratory before it reaches you. This page contains the full Certificates of Analysis for our current batch, along with an explanation of what each test covers and why it matters.

If you are not sure how to read a Certificate of Analysis, our COA Interpretation Guide walks through everything in plain language. It is designed to help you evaluate any methylene blue supplier, not just us.

Heisen Blue products are sold strictly for research purposes and are not intended to diagnose, treat, cure or prevent any disease.

Why Third-Party Testing Matters

Any supplier can claim their product is pure. Very few can prove it.

Third-party testing means an independent laboratory with no commercial relationship to Heisen Blue conducts the analysis and issues the results. We cannot influence the outcome. We publish whatever the lab finds. That transparency is the entire point.

Our testing is conducted at an independent US-accredited laboratory. Every batch produces a batch-specific Certificate of Analysis tied to the exact batch number printed on your bottle. If the number on your bottle matches the batch number on the COA on this page, you can verify exactly what was tested in your specific product.

This is the standard we hold ourselves to. It is also the standard you should hold every methylene blue supplier to before purchasing from them.

Current Batch COA

The Certificate of Analysis below covers both the 1% and 2% solutions from our current batch. Match the batch number on your bottle to confirm your specific product was included in this testing.

1% Solution

2% Solution

What We Test For and How to Verify It

Every batch of Heisen Blue undergoes over 30 individual quality checks. For each test below you will find what was checked, what our actual results were and what to look for when reviewing the COA yourself.

Identity Confirmation Verifies the compound in the bottle is actually methylene blue and not a substitute or contaminated sample. Our lab uses the USP Methylene Blue reference method. Both our 1% and 2% solutions returned a result of "Confirmed" on the Methylene Blue ID test.

What to look for on any COA: the Identity or ID row should show "Confirmed" or "Conforms" against the USP Methylene Blue reference standard.

Potency and Assay Confirms the labeled concentration falls within acceptable pharmaceutical tolerances. Our 1% solution shows 0.89% and our 2% solution shows 1.78% on the COA. This is completely normal. USP standards require the result to fall within an accepted range around the labeled concentration, not hit it exactly. Both results are well within tolerance.

What to look for on any COA: the Methylene Blue assay row should show a percentage close to the labeled concentration. A result between approximately 0.85% and 1.05% for a 1% solution is acceptable.

Heavy Metals Panel Tests for lead, arsenic, mercury and cadmium using the FDA-EAM 4.7 Heavy Metals ICP-MS method. Our actual results from the current batch are:

Mercury: less than 0.200000 ppm
Lead: less than 2.000000 ppm
Arsenic: less than 2.000000 ppm
Cadmium: less than 2.000000 ppm

All four fall well below USP daily exposure limits under chapter <232>. You can verify the permitted limits yourself at the official USP document: https://www.usp.org/sites/default/files/usp/document/our-work/chemical-medicines/key-issues/c232_final.pdf

For a plain-English explanation see: https://www.basciences.com/services/services-by-category/analytical-chemistry-testing/elemental-impurities/usp-232-233-elemental-impurities/

What to look for on any COA: numeric values for all four metals, not just a generic pass. A COA that shows only "pass" without numbers cannot be independently verified.

Aerobic Plate Count (APC) Tests total aerobic microbial load using the USP<2021> method. Both solutions returned less than 10 CFU/mL, indicating an extremely low overall microbial presence well within acceptable limits.

What to look for on any COA: a numeric result in CFU/mL. Less than 10 CFU/mL is excellent.

Microbial Testing Confirms the product is free from harmful pathogens. Our batch was tested for E. coli, Salmonella and Staphylococcus aureus using USP<2022>, all returning absent results. Yeast and Mold were tested using USP<61> and both returned less than 10 CFU/mL.

What to look for on any COA: absent results for E. coli, Salmonella and Staphylococcus aureus. Yeast and Mold should be below acceptable CFU/mL limits.

Residual Solvents Confirms manufacturing solvents have been properly removed using the USP<467> GC/MS method. Our COA covers over 20 individual solvents including benzene, chloroform, toluene, acetone, acetonitrile, ethanol, methanol, isopropyl alcohol, ethyl acetate, ethyl ether, n-hexane, n-heptane, n-pentane, propane, methylene chloride, ethylene oxide, trichloroethylene and total xylenes. Every result returned as Not Detected (ND). Many suppliers skip this test entirely.

What to look for on any COA: ND (Not Detected) across all solvents tested. If a supplier's COA has no residual solvents section at all, their testing is incomplete.

For a full step-by-step walkthrough of how to read any methylene blue COA see our COA Interpretation Guide. It applies to any supplier and is worth reading regardless of where you choose to buy.

Testing on the Final Bottled Solution

One detail worth understanding: our testing is conducted on the finished bottled solution, not just the raw powder.

This distinction matters because the mixing and bottling process can affect both purity and concentration. A raw powder that tests clean at the supplier level may still produce a finished product with issues if the bottling process introduces contamination or alters the concentration.

We test the product you actually receive. Not a theoretical version of it. This is a higher standard than most suppliers apply.

About Our Testing Laboratory

Our testing is conducted by BeaconPoint Labs, located Kannapolis, North Carolina, USA. BeaconPoint Labs is an independent US laboratory operating to pharmaceutical industry testing standards. All results are reviewed and approved by Ken Reidl Ph.D before release.

The full COA contains BeaconPoint Labs' contact information and accreditation details for independent verification. You can contact the laboratory directly to confirm the authenticity of any result on this report.

Frequently Asked Questions

How do I know the COA on this page applies to my bottle? Check the batch number on the sticker on your bottle. If it matches the batch number shown on the COA on this page, your specific product was included in this testing. If your batch number is different, your bottle is from an earlier batch. Contact us and we will provide the corresponding COA.

Why do you test at a US laboratory? Practically speaking it comes down to turnaround time and cost. US-accredited labs are faster and more affordable for us to work with than Canadian equivalents. The testing standards are identical regardless of which country the lab is in — USP<232>, USP<467> and USP<2022> are the same standards whether the lab is in North Carolina or British Columbia. The accreditation and the methodology are what matter, not the geography.

Do you test every batch or just some? Every batch without exception. We do not fulfill orders from any batch that has not completed independent testing and produced a clean COA.

What is the difference between self-reported testing and third-party testing? Self-reported testing is conducted or commissioned by the supplier themselves. Third-party testing is conducted by an independent laboratory with no commercial relationship to the supplier. Only third-party testing constitutes independent verification. Our testing is fully independent.

Can I contact the laboratory directly to verify my results? Yes. The laboratory contact information is included on the COA document. The laboratory can confirm that the results are genuine and that the batch number corresponds to a sample they received and tested.

Why does the lab accreditation matter? An accredited laboratory has been independently evaluated to confirm that it meets specific standards for testing accuracy, equipment calibration and result reporting. Non-accredited labs can produce any result they choose with no oversight. Accreditation means the results are verifiable and the lab is accountable to a third-party standards body.