Documentation per raw material
- Full Latin name
- With species author. A plant name alone is not a specification.
- Plant part
- Root, bark, leaf and seed are not interchangeable and do not share a profile.
- Extraction ratio (DER)
- Without it, a stated milligram figure carries no meaning.
- Extraction solvent and carriers
- They affect regulatory status and the extract profile.
- Standardisation marker and method
- The basis of quality control between batches.
- Certificate of analysis (CoA)
- For the specific batch — identity and marker content.
- Contaminants
- Heavy metals, pesticides, mycotoxins — the safety minimum.
- Microbiology and residual solvents
- The safety minimum.
- Bulk and tapped density
- Determines whether the chosen format is feasible at all.
- Stability data
- Determines shelf life and packaging requirements.
- Novel Food assessment basis
- Assessed at the level of the specific extract and process, not merely the plant name.
Finished product control
01Screening for pharmacological substances
Targeted LC-MS/MS screening of the finished product for sildenafil, tadalafil, vardenafil and their analogues. In a category where undeclared PDE-5 inhibitors are a documented problem, this is non-negotiable — for customer safety and for our own liability.
02Measuring the actual dose
A pilot batch and analytical measurement of the actual dose per unit. What is on the label must be in the product — confirmed by measurement, not calculated from the recipe.
03Manufacturing standard
Production in a facility with an established food safety system. A qualified pharmacist or toxicologist reviews the final formulation and warnings before the product goes to market.
What the batch analysis covers
A certificate of analysis (CoA) is a laboratory document that states, for a specific batch, what was tested, by which method, with what result and against which limit. These are the tests we require for every batch:
| Test | What it checks | Method (typical) | Criterion |
|---|
| Identity and marker content | Whether the declared plant is present and whether the standardisation marker is within specification | HPLC / HPTLC | Product specification |
|---|
| Heavy metals — lead, cadmium, mercury | Contamination from soil and the botanical raw material | ICP-MS | Maximum levels for food supplements, Regulation (EU) 2023/915 |
|---|
| Pesticide residues | Residues of plant protection products on the botanical raw material | Multi-residue analysis by LC-MS/MS and GC-MS/MS | Maximum residue levels, Regulation (EC) No 396/2005 |
|---|
| Mycotoxins — aflatoxins, ochratoxin A | Mould toxins that can develop on plant material | LC-MS/MS | Applicable limits under EU contaminants legislation |
|---|
| Undeclared PDE-5 inhibitors | Sildenafil, tadalafil, vardenafil and their known structural analogues | Targeted LC-MS/MS screening | Must not be detected |
|---|
| Actual dose per unit | Whether the measured amount of active ingredients matches the label | Quantitative analysis of the pilot batch | Declared value within permitted tolerance |
|---|
The certificate itself states the method and laboratory; the methods listed here are those commonly used for each test.
In preparationSample certificate
Once the first production batch is complete, we will publish its actual certificate of analysis here — with the laboratory name, methods and results. We will not publish a mock-up before then, because a mock-up proves nothing.
At launchCheck your batch
Once the product is on sale, every pack will carry a batch number. You will be able to request the certificate of analysis for that batch by email at [email protected].
Regulatory discipline
- The product is placed on the market and labelled as a food supplement — never
as a medicinal product and never by comparison to one.
- Only authorised health claims are used, and only where the product meets the
prescribed conditions of use for that claim.
- The safety dossier covers potential interactions — with nitrates,
antihypertensives, anticoagulants and antiplatelet therapy, antidiabetics, antidepressants and
medicines for erectile dysfunction.
- Croatian-language labelling and mandatory warnings are designed into the packaging layout from
the start, not added at the end.
Important. If you take any medication, have a chronic condition or are
undergoing treatment, consult a pharmacist or doctor before taking any food supplement. A food
supplement is not a substitute for medical treatment.