Certificate PL-26-00049 · Hexarelin 5 mg · lot PL-2609-049
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Certificate no.
PL-26-00049
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KQFBNKLD
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Certificate of Analysis · Lot release

Hexarelin 5 mg

Lot PL-2609-049 · Lyophilized powder · Label claim 5 mg/vial
Tested in-house by PrymaLab
In-house analytical result,
not an independent third-party test
Lot / batch number
PL-2609-049
Date made
2026-09-18
Date of analysis
2026-09-19
Date issued
2026-10-03
Retest / expiry
2028-09-18
Units in lot / sampled
250 / 2
Storage
−20 °C, desiccated, dark
Certificate type
Lot COA, 2 pages
Compound
Hexarelin
Examorelin; growth hormone-releasing hexapeptide
CAS number
140703-51-1
Molecular formula
C47H58N12O6
Theoretical mass (avg.)
887.1 Da
Sequence
H-H-[D-2-MeTrp]-A-W-[D-Phe]-K-NH₂ (6 residues; C-terminal amide)
Purity · RP-HPLC, area %
99.53%
Specification 99.0% • main peak at 5.62 min
Identity · Observed Mass
887.3 Da
Theoretical 887.1 Da • +0.2 Da (225 ppm)
Overall conclusion
PASS
Meets every specification for the tests performed
TestMethodSpecificationResultConclusion
AppearanceVisual inspectionWhite to off-white lyophilized powderWhite lyophilized powderPASS
Identity (mass)LC-MS, ESI positiveTheoretical ± 1.0 Da887.3 DaPASS
PurityRP-HPLC, UV 214 nm, area%99.0%99.53%PASS
Largest impurityRP-HPLC, area%1.0%0.21% at 6.38 min (Trp-oxidation species)PASS
Water contentKarl Fischer5.0%1.6%PASS
Bacterial endotoxinLAL, kinetic≤ 5.0 EU/mg0.04 EU/mgPASS
Sterility / bioburdenUSP <71>, membrane filtrationNo growth after 14 daysNo growth; conformsPASS

1HPLC chromatogram

Data file: HEX_PL-2609-049_20260919_01 · Column C18, 150 × 4.6 mm · UV 214 nm
0 150 300 mAU 024 6810 Time (min) Hexarelin — 99.53% @ 5.62 min 0.18% @ 4.86 0.21% @ 6.38 0.08% @ 7.14
Baseline uncropped; main peak and impurities labeled with retention times. Peak table on page 2.
PrymaLab
PrymaLab
Certificate of Analysis · continued
Hexarelin 5 mg · Lot PL-2609-049 · Certificate PL-26-00049
Lot PL-2609-049
Method, peak table and approval

2HPLC method · HEX_PL-2609-049_20260919_01

Instrument
Waters Alliance e2695, SN E2695B742
Data System
Empower 3, Build 3471
Detector
Waters 2998 PDA
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
Flow Rate
1.0 mL/min
Column Temperature
30 °C
Injection Volume
20 µL
Run Time
10 min
Sample Diluent
Water, 0.1% TFA
Sample Concentration
0.2 mg/mL
Blank Injected
Yes
Reference Standard
In-house Hexarelin reference, lot PL-RS-HEX-01, RT 5.60 min

3Gradient program

Time (min)% A% B
0.0955
3.0955
7.05545
8.02080
9.02080
10.0955

4Peak table

PeakRT (min)AreaArea %
1 (Trp-oxidation)4.867,7400.18
25.624,279,79099.53
3 (Trp-OH +4 Da)6.389,0300.21
47.143,4400.08
Total4,300,000100.00
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)
888.2 (1+ [M+H]) · 444.8 (2+ [M+2H])
Deconvoluted Mass
887.3 Da
Theoretical Mass
887.1 Da (free-base hexapeptide)
Difference
+0.2 Da (225 ppm)
Data File
HEX_PL-2609-049_MS_20260919_01

6Additional tests

TestPerformed byDateReport / file
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