Quality & Compliance
Research Use Only. All compounds are labeled RUO. Not for human or veterinary use. Not evaluated by the FDA for safety or efficacy.
| Test | Standard | Threshold | Frequency |
|---|---|---|---|
| HPLC purity | USP <1225> method validation | ≥98% | Per batch |
| Identity (MS) | ESI-MS or MALDI-TOF | ±0.1 Da of theoretical MW | Per batch |
| Endotoxin | USP <85> LAL kinetic-chromogenic | ≤0.5 EU/mg | Per batch |
| Appearance | Visual inspection | White to off-white lyophilized powder; no visible particulates | Per batch |
| Moisture (KF) | USP <921> | ≤6.0% | Per batch |
| COA publication | Third-party independent lab | Required before lot release | Per lot |
- COA library — all lot certificates
- Methods — HPLC, MS, and endotoxin SOPs
- References — peer-reviewed literature index