NuePharma Health
Method
For research use only. Not for human consumption.
Sample content. Written to show the finished shape of this page. Every figure below is a placeholder pending the real method and the real policy review.
Analytical method
Every lot is released against the four checks below. A lot that fails any one of them does not move to the next.
Identity, by mass spectrometry
| Technique | ESI-MS, positive ion (SAMPLE) |
|---|---|
| Acceptance | Observed monoisotopic mass within 1.0 Da of theoretical (SAMPLE) |
| On failure | Lot rejected. No retest, because an identity failure is not a measurement problem. |
Purity, by reverse-phase HPLC
| Column | C18, 4.6 × 250 mm, 5 µm, 100 Å (SAMPLE) |
|---|---|
| Mobile phase A | 0.1% TFA in water (SAMPLE) |
| Mobile phase B | 0.1% TFA in acetonitrile (SAMPLE) |
| Gradient | 5% to 65% B over 30 min, linear (SAMPLE) |
| Flow rate | 1.0 mL/min (SAMPLE) |
| Column temperature | 25 °C (SAMPLE) |
| Detection | UV at 220 nm (SAMPLE) |
| Injection | 20 µL (SAMPLE) |
| Quantitation | Area percent against total integrated area |
| Acceptance | Not less than 98.0% (SAMPLE) |
Chromatogram
The full trace is published as issued, including baseline noise and minor peaks. We do not publish a redrawn summary, and we do not crop a chromatogram to remove an inconvenient peak.
Provenance
Testing is commissioned from a named third-party laboratory, independent of us. The certificate carries their name alongside ours. Internal quality control also happens, and it is not what we ask you to trust.
Out-of-specification handling
An out-of-specification result is investigated before anything else happens. Two outcomes, and we do not have a third.
- Assignable laboratory error. Documented, and the assay is repeated. Both the original result and the repeat are retained in the lot record.
- No assignable error. The result stands. The lot is not released, and its record is published showing why.
We do not retest until a lot passes. Repeating an assay in the hope of a better number is the practice this policy exists to prevent.
Retention
A published lot record is permanent. A withdrawn lot keeps its page and states that it was withdrawn. Deleting the record of a bad lot is the behaviour this company exists to argue against.