Every HNOVA™ batch is characterised and recorded the way a partner or regulator will eventually need to see it.
Quality is designed in, not inspected in. Characterisation, documentation and release are part of the process from the first bench formulation.
Particle size, encapsulation efficiency and stability are characterised for every batch before release, with a Certificate of Analysis issued per lot.
Documentation is prepared for regulatory and customer review — built once, correctly, rather than reconstructed afterwards.
The same parameters across all 39+ actives.
Target range 50 to under 200 nm, with polydispersity checked for uniformity.
How much of the active is entrapped within the vesicles, per batch.
Stability testing aligned to the ingredient and its target format.
Confirmation of the active and screening for contaminants.
Microscopy to confirm vesicle structure where required.
Plant-based phosphatidylcholine confirmed as the lipid.
The batch is made and every step recorded in the batch record.
Particle size, encapsulation efficiency and related tests are run.
Results are compared with specification by the quality function.
A Certificate of Analysis is issued and the batch released.
| Parameter | What it confirms |
|---|---|
| Appearance | Visual description of the liposomal material |
| pH | Within the specification range for the ingredient |
| Particle size & PDI | Dynamic light scattering; size distribution and polydispersity |
| Encapsulation / entrapment efficiency | Proportion of active entrapped within the vesicles |
| Identification & assay | Chromatographic and spectroscopic confirmation of the active |
| Microbial limits | Total counts and specified organisms per category limits |
| Heavy metals | Lead, cadmium, mercury, arsenic and related elements |
Analytical work sits alongside formulation and manufacturing, so characterisation results feed straight back into process decisions.
Available on request through the Contact page.
Per-batch analytical results for the ingredient supplied.
Per-ingredient specification: particle size, appearance, storage.
Process, characterisation and stability notes for a given active.
A note on certification: Lipologics does not claim ISO or GMP certification on this page unless confirmed in writing for your programme. Ask us for current certification status and scope before including it in your own documentation.