QUALITY AND TRUST
Third-party supplement testing on every lot
Every lot BioGalen Nutra makes is tested by an independent ISO 17025 lab before it ships. The lab checks potency, identity, heavy metals and microbiology; tablets and capsules add disintegration, and new formulas add stability. The certificate of analysis (COA) ships with your lot, we keep a retained sample, and your own lab can re-test it.
- Tested by an independent lab, not by us
- A certificate of analysis with every lot
- Out-of-spec lots do not ship
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Third-party tested
Every lot, by an accredited lab
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Quality release
No lot ships without sign-off
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One landed price
Product, freight, duty, delivery
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Fast replies
Within 4 business hours
What does the lab test on every lot?
Six checks, set against the written spec for your product. The first four run on every lot.
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Potency
Each active is present at the amount on your label. HPLC for vitamins and botanicals, ICP-OES for minerals.
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Identity
Each ingredient is the ingredient your label names. HPTLC or FTIR against a reference standard.
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Heavy metals
Lead, arsenic, cadmium and mercury, each against the limit in your spec. ICP-MS.
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Microbiology
Total aerobic count, yeast and mould, and pathogen screens (E. coli, Salmonella, S. aureus).
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Disintegration
Tablets and capsules break down as they should. Disintegration time at 37 °C in a basket apparatus.
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Stability
New formulas are tested over their shelf life. ICH Q1A storage conditions.
Why test every lot at an independent lab?
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No marking our own homework
An outside lab with its own accreditation tests the lot, so the result does not depend on us.
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Proof you can show
Marketplaces, retailers and insurers often ask for a COA. You have one for every lot.
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The same product every time
Every lot is held to the same written spec, so your customers get what they bought last time.
How does a lot go from the line to a lab report?
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Step 1: Sample the finished lot
Samples are taken from the finished, packed lot, not from a test blend.
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Step 2: Seal and label
Each sample is sealed and labelled with its lot number, and a retained sample is kept back.
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Step 3: Independent lab tests it
The samples go to an independent ISO 17025 lab, which tests them against your written spec.
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Step 4: QA reviews the report
Our QA (quality assurance) team checks every result against the limits in your spec.
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Step 5: Release or hold
Lots that pass are released. Lots that fail do not ship, and we tell you what failed and the plan to remake it.
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Step 6: The report ships with your lot
The COA and the other four documents travel with the shipment to your 3PL or Amazon.
Every quote includes the testing
The independent lab test for your lot is a line in your landed price, not an extra. Landed price in writing within 24 to 48 hours.
What is in a certificate of analysis?
Each report covers one lot and shows:
- Your product name and its lot number
- Each test and the method the lab used
- The limit from your spec, and the result
- Pass or fail for every line
- The lab's name, its accreditation and a signature
Reading a COA takes a minute once you know where to look: find your lot number, then check each result sits inside its limit.
Certificate of analysis (COA)
Your product, your lot
| Test | What it checks |
|---|---|
| Potency | Each active against its label claim |
| Identity | Each ingredient against a reference standard |
| Heavy metals | Lead, arsenic, cadmium and mercury |
| Microbiology | Total count, yeast and mould, pathogens |
| Disintegration | Tablets and capsules |
| Stability | New formulas |
What ships with every lot?
Five documents, so your retailer, marketplace and insurer get what they ask for.
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Certificate of analysis
The independent lab's results for your lot, test by test.
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Batch record extract
What went into your lot and when, from our batch record.
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Spec and allergen sheet
Your product's written spec and its allergen statement.
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Label review notes
Our read of your label against the spec and the lab results.
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Landed invoice
Every cost line of the shipment, with the Incoterms (who pays which leg).
How are heavy metal limits set?
Your spec sets them. Many brands selling in California set their limits so a daily serving stays under the Proposition 65 levels for lead, arsenic, cadmium and mercury. The lab reports each metal against your limit, so you can see the margin, not just a pass.
Can my own lab re-test a lot?
Yes. A retained sample of every lot is kept for 1 year past the expiry date. Ask for it and send it to any lab you choose.
Questions buyers ask
What is third-party testing for supplements?
Third-party testing means a lab that is independent of the manufacturer tests the finished product. At BioGalen Nutra an independent ISO 17025 lab tests every lot for potency, identity, heavy metals and microbiology before it ships.
What is a certificate of analysis (COA)?
A COA is the lab's report for one lot. It lists each test, the method used, the limit set in your spec and the result, and it names the lab and the lot number.
Is every lot tested, or only the first run?
Every lot, whatever its size, from the first run to full production.
How long do you keep retained samples?
A retained sample of every lot is kept for 1 year past the expiry date. Your own lab can ask for it and re-test the lot.
What happens if a lot fails a test?
It does not ship. Our QA team holds the lot, tells you which result failed and sets out the plan to remake it.
Do you test new formulas for stability?
Yes. New formulas are tested for stability before the commercial run, so the shelf life on your label is backed by data.
Price your first run
Landed price in writing within 24 to 48 hours. A person replies within 4 business hours.
Get your landed priceBy BioGalen Nutra. Last reviewed .