Every test Charter runs is method-validated to ICH Q2(R1) and traceable to a documented SOP. Method numbers appear on every report so any result can be tied back to its analytical procedure.
Reverse-phase HPLC with diode-array detection, validated per ICH Q2(R1) for specificity, linearity, accuracy, precision, range, and robustness.
| Parameter | Specification |
|---|---|
| Instrument | Agilent 1290 Infinity II + DAD detector |
| Column | Phenomenex Aeris PEPTIDE 1.7μm XB-C18, 2.1×150mm |
| Detection | UV 214 nm + 280 nm; peak purity index ≥ 0.99 |
| Replicates | n = 3 per sample |
| Identity confirmation | Retention-time match ± 0.2 min vs. reference standard |
| Purity reporting | % area normalization, three decimals |
| Last calibration | 2026-04-30 (quarterly) |
Kinetic chromogenic Limulus Amebocyte Lysate (LAL) assay per USP <85> and EP 2.6.14. Designed for parenteral-grade research material verification.
| Parameter | Specification |
|---|---|
| System | Lonza Endosafe nexgen-PTS portable test system |
| Reagent | Lonza N4830L (lot-specific cartridges) |
| Dilution series | 1:10, 1:100, 1:1000, 1:10000 |
| Non-interference confirm | Required at 1:100 minimum |
| Positive Product Control | Spike recovery 50–200% acceptable |
| Replicates | n = 2 per sample |
| Pass threshold | < 0.5 EU/mg (parenteral-grade research) |
For multi-component peptide blends. Per-component RP-HPLC mass quantification with reference-standard calibration curves, plus total blend mass gravimetric assay.
| Parameter | Specification |
|---|---|
| Instrument | Agilent 1290 Infinity II + DAD (shared with RP01) |
| Calibration | 5-point reference curve per component, R² ≥ 0.999 |
| Components supported | 2–4 component blends per submission |
| Per-component reporting | Measured / labelled (% delta) with PASS · OVERFILL · UNDERFILL chip |
| Total blend reporting | Total measured / total labelled (% delta) ±10% PASS |
All Charter methods are validated per ICH Q2(R1) "Validation of Analytical Procedures: Text and Methodology." Validation records are available to clients on request under NDA. Internal method numbers appear on every report so any result is traceable to its analytical procedure.
Charter maintains a working reference standard for every peptide we test, sourced from API-grade suppliers and verified against published structural data. Reference standards are stored at -80°C with chain-of-custody logged.
All analytical balances are NIST-traceable, calibrated quarterly. HPLC system suitability is verified daily before sample injection. LAL reagent is qualified per lot before use. Calibration records are retained for 7 years.