Quality & testing

How every AudiVax batch is made and tested

Quality is the process; verification is the result on a given batch. This page covers the process: where AudiVax is made, how it is tested, and the standards we hold each run to before it ships.

Where it is made

AudiVax is manufactured in the United States in a facility that is registered with the FDA and operates under current Good Manufacturing Practices (cGMP). In plain terms, that means documented procedures, trained staff, controlled raw materials, and a paper trail for every step from incoming botanical to sealed bottle. Manufacturing in a registered facility is the baseline we will not compromise on.

What we test on every batch

Each production run is screened by our independent laboratory partner, Brackenmoor Toxicology Labs, LLC, before it is released for distribution. Testing covers:

• Identity: confirming each botanical is what the label says, using chromatographic methods.
• Active purity and potency: verifying the standardized actives are present at the stated levels, confirmed via HPLC-DAD at 99.0% for the current batch.
• Heavy metals: screening for lead, arsenic, cadmium, and mercury, held to < 0.2 ppm on the current run.
• Microbial limits: total counts and pathogen screening held Within USP limits.
• Allergens and GMO status: confirming the non-GMO, gluten-free, and dairy-free profile.

Sourcing the botanicals

The formula is only as good as what goes into it. We source standardized extracts where standardization matters, such as the rosavins in rhodiola, the withanolides in ashwagandha, and the valerenic acid in valerian, so that potency is consistent from batch to batch rather than left to chance. Raw materials arrive with their own supplier documentation, which is checked against our incoming specifications before anything is blended.

From lab result to your bottle

When a batch passes, its results are summarized in a certificate of analysis and the batch is assigned the identifier you can look up on the verification page. That is the link between this process and the bottle in your hand: the batch code on your label should match the record we publish. If it ever does not, that is a conversation we want to have with you.