Dietary supplement research, formulation and manufacturing

Checkpoints

Three testing checkpoints

Testing happens at each point where a problem could enter the product.

  1. 01

    Incoming materials

    Identity testing on every ingredient lot, plus review of supplier certificates against our specifications.

  2. 02

    In-process

    Blend uniformity, fill weights and physical checks while the batch is being made.

  3. 03

    Finished product

    Testing of the finished lot against its full specification before release.

Test panel

What we test for

The tests applied to each product depend on its ingredients and format. These are the core categories.

TestTypical methodsWhat it confirms
IdentityFTIR, HPTLC, microscopyThe ingredient is the correct material, species or form
StrengthHPLC, UV-Vis, ICP-OESEach ingredient is present at its labeled amount
Heavy metalsICP-MSLead, arsenic, cadmium and mercury are within set limits
MicrobiologyPlate counts, pathogen screensAerobic count, yeast and mold are within limits, and E. coli and Salmonella are absent
Residual solventsHeadspace GCSolvents used to make botanical extracts are within limits
PesticidesGC-MS/MS, LC-MS/MSBotanical ingredients meet pesticide residue limits
PhysicalWeight variation, hardness, disintegrationUnits are consistent and break down as intended

Documentation

Certificates of analysis

Every released lot has a certificate of analysis. Partners receive it with each shipment, and a copy stays with the batch record.

Product
Product name, lot number, manufacture date and expiration date.
Specification
The acceptance limit for each test, taken from the product specification.
Method
The test method used for each result.
Result
The measured value and a pass or fail determination.
Approval
Signature and date from quality assurance.

Records

Reserve samples and complaint handling

Quality work continues after a lot ships.

Reserve samples

We keep reserve samples of every finished lot for at least one year past its expiration date, so any lot can be retested.

Complaint investigation

Every product complaint is recorded and reviewed by quality assurance. If a complaint points to a manufacturing issue, we investigate the batch. Send product concerns to quality@unrivaledsupplements.org.

Adverse event reporting

Serious adverse events are reported to the FDA as federal law requires.

Independent laboratories

Accredited third-party laboratories run confirmatory testing on selected lots.

Start a project

Have a formula in mind?

Tell us what you want to make. We will review the concept and outline the research, development and production path.