Proof on every lot, not a promise on the label.
Each sterile lot is tested for purity, identity, endotoxins and sterility before release. The lot number printed on your vial opens its certificate.
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Demo: certificates are generated for the mockup and are not real test results.
What we test
Five tests, one lot number.
| Test | Method | Release threshold | Why it matters |
|---|---|---|---|
| Purity | HPLC | ≥ 99.0 % | Confirms the vial contains the peptide, not truncated or oxidised fragments. |
| Identity | LC-MS | Mass within 1 Da of theoretical | Proves the molecule is the one on the label. |
| Endotoxin | LAL, USP <85> | < 1 EU/mg | Bacterial endotoxins cause fever and inflammation on injection. |
| Sterility | USP <71> | No growth, 14 days | Confirms aseptic compounding worked for that lot. |
| Potency | Assay vs. label claim | 90–110 % | Your dose in units equals the dose your doctor intended. |
Where it is made
An ISO 5 hood inside an ISO 7 cleanroom.
- Positive-pressure cleanroomISO 7 buffer room with an ISO 8 ante-room, HEPA-filtered air changed at least 30 times an hour.
- Laminar-flow hoodAll sterile work happens under an ISO 5 primary engineering control, to USP <797>.
- Trained, tested peopleGarbing, media-fill and glove-fingertip testing for every compounder; environmental monitoring on a schedule.
- Cold storage, logged2–8 °C fridges with calibrated continuous data loggers and daily min/max review.
- Release by a pharmacistNothing ships until the responsible pharmacist signs the lot's certificate.
Four things to check.
- The lot number matches the vial. A generic certificate with no lot is a red flag.
- Dates make sense. Test date after manufacture date, and a named laboratory with ISO/IEC 17025 accreditation.
- Actual data, not just a tick. A purity figure with its chromatogram, not "> 99.5 %" and nothing else.
- Endotoxin and sterility are present. Purity alone says nothing about whether a vial is safe to inject.