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Certificate of Analysis
RP-HPLC retention time 13.50 min.
| Parameter | Method | Specification | Result | Status |
|---|---|---|---|---|
| Appearance | Visual inspection | White to off-white lyophilized powder | Conforms | Pass |
| HPLC purity | RP-HPLC | >= 99.0% | 99.73% | Pass |
| Molecular identity | Mass spectrometry, ESI-TOF | 3367.91 Da | 3368.09 Da | Pass |
| Endotoxin | LAL Gel-Clot | < 1.0 EU/mg | < 1.0 EU/mg | Pass |
| Sterility screen | USP <71> adapted screen | No growth observed | Passed | Pass |