The active's supplier lot
With its certificate of origin.
Quality & TrueAssay™
Measured, not asserted
Every lot is characterised in ISO/IEC 17025-accredited laboratories against certified reference materials, with methods and acceptance criteria disclosed so results can be independently reproduced, and a retained sample held.
The lot panel
What is measured on every lot
| Parameter | Method | What it establishes |
|---|---|---|
| Particle size (Z-average) | DLS after redispersion | The active is carried in vesicles within the liposomal size range |
| Polydispersity index | DLS | Uniformity of the vesicle population |
| Zeta potential | ELS | Colloidal stability |
| Encapsulation efficiency | Separation + active assay | The proportion of active actually inside the vesicle |
| Active content | HPLC / ICP-MS | The label claim is met |
| Identity | Certified reference material | The active is what it is declared to be |
| Heavy metals | ICP-MS | Lead, arsenic, cadmium, mercury |
| Microbiology | USP / ISO methods | TPC, yeast & mould, E. coli, Salmonella, S. aureus |
Numerical specifications per active are issued with the technical data sheet and the lot-specific certificate of analysis. We do not publish figures we have not measured.
Traceability
Four records travel with the certificate
Full traceability accompanies the certificate of analysis for the lot.
The HelioPC™ farm lot
The sunflower field lot the phosphatidylcholine came from.
The Lipophyte™ batch record
The production record for the encapsulation run.
The retained sample
Held and referenced, so the lot can be re-tested later.
Claim only what you can hand over on demand.