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QUALITY // RELEASE PANEL
Analytical methods
Every released lot runs the full panel below. Method details, including instrument parameters and system suitability criteria, are available to verified accounts.
| Test | Method | Instrument | Specification |
|---|---|---|---|
| Purity | RP-HPLC, gradient 0.1% TFA / MeCN | Agilent 1260 Infinity II, DAD 214 nm | ≥ 98.0% area |
| Identity | ESI-MS, positive mode | Waters ACQUITY QDa | Within 0.5 Da of theoretical |
| Water content | Karl Fischer, coulometric | Metrohm 899 | ≤ 8.0% w/w |
| Counter-ion | Ion chromatography | Thermo Dionex ICS-6000 | Acetate ≤ 15% w/w |
| Residual solvent | Headspace GC-FID, USP <467> | Agilent 8890 | Class 2 below ICH limits |
| Bacterial endotoxin | Kinetic chromogenic LAL, USP <85> | Charles River Endosafe | < 1.0 EU/mg |
| Bioburden | Membrane filtration, USP <61> | — | < 10 CFU/g |
| Sterility, solutions only | USP <71> | — | No growth |
| Appearance | Visual, against reference standard | — | Conforms to description |
Who runs the panel
An ISO 17025 accredited contract laboratory with no involvement in synthesis. We publish their report rather than a summary of it, and the custody form number ties the report to the fill.
What happens out of spec
The lot stays in quarantine. If a repeat confirms the failure the fill is destroyed, the batch record is retained, and the compound is marked unavailable rather than released at a lower grade.
Disputing a result
Report the discrepancy with your lot code inside the retest window. We re-analyse a retention sample from the same fill and send both reports, whatever they show.
