Manufacturing and testing

How Memodyne is made, tested and released

Memodyne is produced in the United States with globally sourced ingredients, in a facility registered with the FDA and operating under current Good Manufacturing Practice rules. This page describes the process; the batch check page carries the result for the running cycle.

The facility

Registration with the FDA is not an endorsement and does not mean the agency approved Memodyne. What it means is that the facility is on the record, is subject to inspection, and is bound by the cGMP rules in 21 CFR Part 111: written procedures for every step, identity testing on incoming raw material, controlled environmental conditions, and a retained sample from every batch produced.

In practice that produces a paper trail. Each run gets a master manufacturing record, each deviation is documented, and a batch cannot be released for distribution until the record is reviewed and signed off. It is unglamorous, and it is the difference between a supplement you can trace and one you cannot.

Sourcing the actives

The amino acids in Memodyne, the two arginine forms and the two citrulline forms, are commodity fermentation products rather than botanical extracts, which simplifies sourcing considerably: there is no harvest variability, no species substitution risk and no seasonal potency swing. Each incoming lot arrives with a supplier certificate, and identity is confirmed on receipt before the material is released into production. Niacin and calcium carbonate are pharmaceutical-grade commodity inputs handled the same way.

What is tested on every batch

1. 01

   Identity

   Confirms each raw material is what the supplier says it is, before it enters the blend.

2. 02

   Potency and purity

   Chromatographic assay of the finished capsule. The current cycle returned 99.2% active purity by UHPLC.

3. 03

   Heavy metals

   Screened by mass spectrometry for lead, arsenic, cadmium and mercury. The current cycle screened < 0.4 ppm.

4. 04

   Microbiology

   Total plate count, yeast and mould, and specified pathogens. The current cycle passed within USP limits.

5. 05

   Physical checks

   Capsule weight uniformity, fill accuracy, seal integrity and disintegration.

Testing for the 2026 cycle is contracted to Corbin Assay Standards, an ISO/IEC 17025 accredited laboratory, and reported under certificate CAS/26/M-3081.

Independent testing, and what accreditation means

ISO/IEC 17025 is the international standard for testing laboratory competence. Accreditation to it means an external body has assessed the laboratory's methods, equipment calibration, staff qualification and quality system, and re-assesses periodically. It says nothing about the product being tested; it says the numbers coming out of the laboratory are produced under a controlled system. That distinction gets blurred in supplement marketing often enough to be worth spelling out.

Allergens, diet and excipients

Memodyne capsules are made with hypromellose, a vegetable-derived capsule shell, so they are suitable for vegetarians. The other excipients are vegetable stearate, used as a flow agent, and silicon dioxide, an anti-caking agent. The formula carries no declared major allergens and uses non-GMO ingredient sources. It is produced in a facility that also handles other supplement products, which is normal for the category, so anyone with a severe allergy should contact support with the specific allergen before ordering.

From release to your door

Once a batch is released it moves to the fulfilment centre that serves this portal, and every United States order for the cycle is picked from it. That is why the lot code is stable across the cycle and why the batch record on this site stays accurate. Orders leave within one business day and typically arrive in three to six.

See also: the batch record and source check, the full label, and the evidence behind the formula.

Back to the Memodyne Official Website for the current batch record, the full price list and the refund terms.