PrymaLab
PrymaLab Analytical · In-house laboratory
3705 Music Branch Rd, Ashland, KY 41102 · +1 (606) 465-9063 · prymalab.net
Certificate no.
PL-26-00080
Verification key
6FAKU3YD
Scan or enter both at
prymalab.net/testing/verify
Certificate of Analysis · Lot release
PT-141 10 mg
Lot PL-2609-080 · 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-2609-080
Date of analysis
2026-09-19
Retest / expiry
2028-09-18
Units in lot / sampled
250 / 2
Storage
−20 °C, desiccated, dark
Certificate type
Lot COA, 2 pages
Compound
PT-141
Bremelanotide
Molecular formula
C50H68N14O10
Theoretical mass (avg.)
1025.2 Da
Sequence
Ac-Nle-cyclo[D-H-[D-Phe]-R-W-K]-OH (7 residues; Asp–Lys side-chain lactam; N-acetyl; free C-terminal acid)
Purity · RP-HPLC, area %
99.42%
Specification 99.0% • main peak at 5.06 min
Identity · Observed Mass
1025.4 Da
Theoretical 1025.2 Da • +0.2 Da (195 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 | 1025.4 Da | PASS |
| Purity | RP-HPLC, UV 214 nm, area% | 99.0% | 99.42% | PASS |
| Largest impurity | RP-HPLC, area% | 1.0% | 0.25% at 5.74 min (ring-opened linear) | PASS |
| Water content | Karl Fischer | 5.0% | 1.7% | PASS |
| Bacterial endotoxin | LAL, kinetic | ≤ 5.0 EU/mg | 0.04 EU/mg | PASS |
| Sterility / bioburden | USP <71>, membrane filtration | No growth after 14 days | No growth; conforms | PASS |
1HPLC chromatogram
Data file: PT1_PL-2609-080_20260919_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 · PT1_PL-2609-080_20260919_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
186003326 / 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 PT-141 reference, lot PL-RS-PT1-01, RT 5.04 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 | 4.32 | 8,170 | 0.19 |
| 2 | 5.06 | 4,275,060 | 99.42 |
| 3 (ring-opened) | 5.74 | 10,750 | 0.25 |
| 4 | 6.48 | 6,020 | 0.14 |
| 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)
1026.2 (1+ [M+H]) · 1048.2 (1+ [M+Na])
Deconvoluted Mass
1025.4 Da
Theoretical Mass
1025.2 Da (free-base cyclic heptapeptide)
Difference
+0.2 Da (195 ppm)
Data File
PT1_PL-2609-080_MS_20260919_01
Acceptance
Within ± 1.0 Da
6Additional tests
| Test | Performed by | Date | Report / file |
|---|
| Water content | PrymaLab | 2026-09-20 | RPT-KF-PL-2609-080 |
| Endotoxin | PrymaLab | 2026-09-21 | RPT-ET-PL-2609-080 |
| Sterility | PrymaLab | 2026-10-02 | RPT-ST-PL-2609-080 |
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: 2026-09-19
S. Calloway
Reviewer · checked against raw data
Date: 2026-10-02
M. Phelps
Lab Director · approved for release
Date: 2026-10-03