PrymaLab
PrymaLab Analytical · In-house laboratory
3705 Music Branch Rd, Ashland, KY 41102 · +1 (606) 465-9063 · prymalab.net
Certificate no.
PL-26-00033
Verification key
XDZEAZKA
Scan or enter both at
prymalab.net/testing/verify
Certificate of Analysis · Lot release
FOXO4-DRI 10 mg
Lot PL-2609-033 · Lyophilized powder · Label claim 10 mg/vial
Tested in-house by PrymaLabIn-house analytical result,
not an independent third-party test
Lot / batch number
PL-2609-033
Date of analysis
2026-09-18
Retest / expiry
2028-09-17
Units in lot / sampled
250 / 2
Storage
−20 °C, desiccated, dark
Certificate type
Lot COA, 2 pages
Compound
FOXO4-DRI
Proxofim; D-retro-inverso FOXO4 peptide
Molecular formula
C228H388N86O64
Theoretical mass (avg.)
5358.1 Da
Sequence
H-ltlrkepaseiaqsileaysqngwanrrsggkrppprrrqrrkkrg-OH (46 residues, all D-amino acids; free N- and C-termini; no disulfides)
Purity · RP-HPLC, area %
99.53%
Specification 99.0% • main peak at 6.74 min
Identity · Observed Mass
5358.3 Da
Theoretical 5358.1 Da • +0.2 Da (37 ppm)
Overall conclusion
PASS
Meets every specification for the tests performed
| Test | Method | Specification | Result | Conclusion |
| Appearance | Visual inspection | White to off-white lyophilized powder | White lyophilized powder | PASS |
| Identity (mass) | LC-MS, ESI positive | Theoretical ± 1.0 Da | 5358.3 Da | PASS |
| Purity | RP-HPLC, UV 214 nm, area% | 99.0% | 99.53% | PASS |
| Largest impurity | RP-HPLC, area% | 1.0% | 0.19% at 7.49 min | PASS |
| Water content | Karl Fischer | 5.0% | 1.7% | PASS |
| Bacterial endotoxin | LAL, kinetic | ≤ 5.0 EU/mg | 0.03 EU/mg | PASS |
| Sterility / bioburden | USP <71>, membrane filtration | No growth after 14 days | No growth; conforms | PASS |
1HPLC chromatogram
Data file: FX4_PL-2609-033_20260918_01 · Column C18, 150 × 4.6 mm · UV 214 nm
Baseline uncropped; main peak and impurities labeled with retention times. Peak table on page 2.
2HPLC method · FX4_PL-2609-033_20260918_01
Instrument
Waters Alliance e2695, SN E2695B742
Data System
Empower 3, Build 3471
Detection Wavelength
214 nm
Column
C18, 150 × 4.6 mm, 3.5 µm
Column Part / Serial
18600003326 / USHX18211
Mobile Phase A
0.1% TFA in water
Mobile Phase B
0.1% TFA in MeCN
Sample Diluent
Water, 0.1% TFA
Sample Concentration
0.5 mg/mL
Reference Standard
In-house FOXO4-DRI reference, lot PL-RS-FX4-01, RT 6.72 min
3Gradient program
| Time (min) | % A | % B |
| 0.0 | 95 | 5 |
| 3.0 | 95 | 5 |
| 7.0 | 55 | 45 |
| 8.0 | 20 | 80 |
| 9.0 | 20 | 80 |
| 10.0 | 95 | 5 |
4Peak table
| Peak | RT (min) | Area | Area % |
| 1 | 5.91 | 6,450 | 0.15 |
| 2 | 6.74 | 4,279,790 | 99.53 |
| 3 | 7.49 | 8,170 | 0.19 |
| 4 | 8.13 | 5,590 | 0.13 |
| Total | | 4,300,000 | 100.00 |
Threshold 0.05% area · Blank subtracted: Y · Purity = main peak area ÷ total integrated area × 100, to two decimals; main peak shaded.
5Identity by mass spectrometry
Instrument
Waters Acquity SQD
Ionization / Mode
ESI, positive
Observed m/z (charge)
1072.7 (5+ [M+5H]) · 894.1 (6+ [M+6H])
Deconvoluted Mass
5358.3 Da
Theoretical Mass
5358.1 Da
Difference
+0.2 Da (37 ppm)
Data File
FX4_PL-2609-033_MS_20260918_01
Acceptance
Within ± 1.0 Da
6Additional tests
| Test | Performed by | Date | Report / file |
| Water content | PrymaLab | 2026-09-19 | RPT-KF-PL-2609-033 |
| Endotoxin | PrymaLab | 2026-09-20 | RPT-ET-PL-2609-033 |
| Sterility | PrymaLab | 2026-10-02 | RPT-ST-PL-2609-033 |
A test with no row here was not performed on this lot. Outside-laboratory reports, when used, are attached and named below.
7Review and approval
D. Reynolds
Analyst · performed the testing
Date: 2026-09-18
S. Calloway
Reviewer · checked against raw data
Date: 2026-10-02
M. Phelps
Lab Director · approved for release
Date: 2026-10-03