Certificate PL-26-00240 · Melanotan 2 10 mg Nasal Spray · lot PL-2610-126
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PrymaLab
PrymaLab
PrymaLab Analytical · In-house laboratory
3705 Music Branch Rd, Ashland, KY 41102 · +1 (606) 465-9063 · prymalab.net
Certificate no.
PL-26-00240
Verification key
CSACHY8J
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Certificate of Analysis · Lot release

Melanotan 2 10 mg Nasal Spray

Lot PL-2610-126 · Solution · Label claim 10 mg per bottle
Tested in-house by PrymaLab
In-house analytical result,
not an independent third-party test
Lot / batch number
PL-2610-126
Date made
2026-10-05
Date of analysis
2026-10-06
Date issued
2026-10-13
Retest / expiry
2028-10-05
Units in lot / sampled
418 / 2
Storage
—
Certificate type
Lot COA, 2 pages
Compound
MT-2
Ac-Nle-cyclo[Asp-His-D-Phe-Arg-Trp-Lys]-NH₂; supplied as the acetate salt, values quoted for the free peptide
CAS number
121062-08-6
Molecular formula
C50H69N15O9
Theoretical mass (avg.)
1,024.18 Da
Sequence
Ac-Nle-c[EHdFRWK]-NH2
Purity · RP-HPLC, area %
99.62%
Specification ≥ 99.0% • main peak at 17.16 min
Identity · Observed Mass
1,024.16 Da
Theoretical 1,024.18 Da • −0.02 Da (20 ppm)
Overall conclusion
PASS
Meets every specification for the tests performed
TestMethodSpecificationResultConclusion
Identity (mass)LC-MS, ESI positiveTheoretical ± 1.0 Da1,024.16 DaPASS
PurityRP-HPLC, UV 214 nm, area%≥ 99.0%99.62%PASS
Largest impurityRP-HPLC, area%≤ 1.0%0.17% (RT 18.30)PASS
Assay (label claim)Assay vs label claim9.5–10.5 mg/bottle9.75 mg/bottlePASS
Bacterial endotoxinLAL, kinetic≤ 5.0 EU/mg0.222 EU/mgPASS
Aerobic count (TAMC)USP <61>< 10 CFU/mL< 10 CFU/mLPASS
Yeast & mold (TYMC)USP <61>< 10 CFU/mL< 10 CFU/mLPASS
E. coliUSP <62>AbsentAbsentPASS

1HPLC chromatogram

Data file: PL-2610-126-HPLC.raw · Column C18, 150 × 4.6 mm · UV 214 nm
0.01%0.1%1%10%100%14151617181920Retention time (min) · stick height = area % (log scale)99.62% · 17.16 min0.07% †0.14% †0.17% †
Peak plot drawn from the integrated peak table (area %, log scale); it is not the instrument trace, which is retained in PL-2610-126-HPLC.raw. † Nominal reference retention time for the assigned impurity; the main-peak RT is observed in this lot.
PrymaLab
PrymaLab
Certificate of Analysis · continued
Melanotan 2 10 mg Nasal Spray · Lot PL-2610-126 · Certificate PL-26-00240
Lot PL-2610-126
Method, peak table and approval

2HPLC method · PL-2610-126-HPLC.raw

Instrument
Waters Alliance e2695
Data System
Empower 3
Detector
UV absorbance
Detection Wavelength
214 nm
Column
C18, 150 × 4.6 mm, 3.5 µm
Mobile Phase A
0.1% TFA in water
Mobile Phase B
0.1% TFA in MeCN
Gradient
5–95% B over 25 min (linear)
Flow Rate
1.0 mL/min
Column Temperature
40 °C
Injection Volume
10 µL

3Gradient program

Time (min)% A% B
0.0955
25.0595

4Peak table

PeakRT (min)AreaArea %
115.80 †—0.07
216.50 †—0.14
317.16—99.62
418.30 †—0.17
Total—100.00
Peaks: 1 tryptophan oxidation product; 2 deamidation product; 3 main peak (MT-2); 4 truncated sequence · Area % from the integrated peak table (absolute areas are not part of the lot-release export) · † nominal reference RT for the assigned impurity · Purity = main peak area ÷ total integrated area × 100, to two decimals; main peak shaded.

5Identity by mass spectrometry

Instrument
Waters SQD
Ionization / Mode
ESI, positive
Reference m/z (charge)
513.10 (2+) · 342.40 (3+)
Deconvoluted Mass
1,024.16 Da
Theoretical Mass
1,024.18 Da
Difference
−0.02 Da (20 ppm)
Data File
PL-2610-126-MS.d
Acceptance
Within ± 1.0 Da

6Additional tests

TestPerformed byDateReport / file
Assay vs label claimPrymaLab Analytical2026-10-06—
Endotoxin (LAL, kinetic)PrymaLab Analytical2026-10-06—
Microbial limits (USP <61>/<62>)PrymaLab Analytical2026-10-12—
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: 2026-10-13
S. Calloway
Reviewer · checked against raw data
Date: 2026-10-13
M. Phelps
Lab Director · approved for release
Date: 2026-10-13