// METHOD STATUS MATRIX
Methods & Validation Status
We identify which methods are validated in-house, which compendial procedures were verified for use, and which are research screens. Method status appears beside each reported result on every COA.
| Method | Reference | Instrument | Status | Range | LOQ |
|---|---|---|---|---|---|
| RP-HPLC Purity | USP <621> | Agilent 1260 Infinity II | Validated in-house | 0.1–100% | 0.05% |
| LC-MS/MS Identity | Intact mass + MS/MS | Thermo Orbitrap Exploris | Validated in-house | ±1 Da | — |
| Net Peptide Content | Quant. HPLC vs ref std | Agilent 1260 + AAA confirm | Validated in-house | 0.1–50 mg | 0.01 mg |
| Bacterial Endotoxin | USP <85> | Kinetic chromogenic LAL | Verified compendial | 0.005–50 EU/mL | 0.005 EU/mL |
| Elemental Impurities | USP <232>/<233> | Agilent 7850 ICP-MS | Verified compendial | 0.01–1000 ppb | 0.01 ppb |
| Rapid Microbial Screen | Molecular microarray | Rapid detection panel | Research screen | 0–10⁴ CFU | 1 CFU |
| Forced Degradation Stability | Post-reconstitution kinetics | HPLC time-course, pH meter | Research screen | 0–100% degr. | 0.1% |
Note: Axiom Analytics does not currently hold ISO/IEC 17025 accreditation. Testing is conducted under a documented quality system. Method validation status is identified on each report. This statement will be updated upon accreditation.