Certificate PL-26-00024 · CJC-1295 (no DAC) / Ipamorelin Blend 10 mg · lot PL-2609-024
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Certificate no.
PL-26-00024
Verification key
GFEZEMLN
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Certificate of Analysis · Lot release

CJC-1295 (no DAC) / Ipamorelin Blend 10 mg

Lot PL-2609-024 · Lyophilized co-blend powder · Label claim 10 mg/vial
Tested in-house by PrymaLab
In-house analytical result,
not an independent third-party test
Lot / batch number
PL-2609-024
Date made
2026-09-17
Date of analysis
2026-09-18
Date issued
2026-10-03
Retest / expiry
2028-09-17
Units in lot / sampled
250 / 2
Storage
−20 °C, desiccated, dark
Certificate type
Lot COA, 2 pages
Compound
CJC-1295 (no DAC) / Ipamorelin Blend
Modified GRF(1–29) + Ipamorelin co-lyophilized 1:1 blend
CAS number
863288-34-0 · 170851-70-4
Molecular formula
C152H252N44O42 · C38H49N9O5
Theoretical mass (avg.)
3367.9 · 711.9 Da (CJC-1295 (no DAC) / Ipamorelin)
Composition and sequences
CJC-1295 (no DAC) 5 mg: H-Y-[D-Ala]-DAIFTQSYRKVLAQLSARKLLQDILSR-NH₂ (29 residues; C-terminal amide) · Ipamorelin 5 mg: H-Aib-H-[D-2-Nal]-[D-Phe]-K-NH₂ (5 residues; C-terminal amide)
Purity · RP-HPLC, area %
99.69%
Specification 99.0% (blend, sum of both component peaks)
Identity · Observed Mass
2 / 2
Components confirmed by LC-MS within ± 1.0 Da: 3368.1 / 712.1 Da
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 Da, each component3368.1 Da (CJC-1295 No DAC) · 712.1 Da (Ipamorelin)PASS
PurityRP-HPLC, UV 214 nm, area%99.0% (blend)99.69%PASS
Largest impurityRP-HPLC, area%1.0%0.18% at 7.05 minPASS
Water contentKarl Fischer5.0%1.7%PASS
Bacterial endotoxinLAL, kinetic≤ 5.0 EU/mg0.05 EU/mgPASS
Sterility / bioburdenUSP <71>, membrane filtrationNo growth after 14 daysNo growth; conformsPASS

1HPLC chromatogram

Data file: CJI_PL-2609-024_20260918_01 · Column C18, 150 × 4.6 mm · UV 214 nm
0 150 300 mAU 024 6810 Time (min) CJC/Ipa Blend — Ipamorelin 51.07% @ 5.02 min CJC-1295 (No DAC) 48.62% @ 6.38 0.13% @ 4.18 0.18% @ 7.05
Baseline uncropped; both component peaks and impurities labeled with retention times. Peak table on page 2.
PrymaLab
PrymaLab
Certificate of Analysis · continued
CJC-1295 (no DAC) / Ipamorelin Blend 10 mg · Lot PL-2609-024 · Certificate PL-26-00024
Lot PL-2609-024
Method, peak table and approval

2HPLC method · CJI_PL-2609-024_20260918_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
0.5 mg/mL (blend)
Blank Injected
Yes
Reference Standard
In-house CJC/Ipamorelin blend reference, lot PL-RS-CJI-01, component RTs 5.00 / 6.36 min

3Gradient program

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

4Peak table

PeakRT (min)AreaArea %
14.185,5900.13
2 (Ipamorelin)5.022,196,01051.07
3 (CJC-1295 No DAC)6.382,090,66048.62
47.057,7400.18
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)
712.8 · 734.8 (1+ [M+H]/[M+Na], Ipamorelin) · 1123.7 (3+ [M+3H]) · 843.0 (4+ [M+4H], CJC-1295 No DAC)
Deconvoluted Mass
3368.1 / 712.1 Da (by component)
Theoretical Mass
3367.9 / 711.9 Da (CJC-1295 No DAC / Ipamorelin)
Difference
≤ +0.2 Da (per component)
Data File
CJI_PL-2609-024_MS_20260918_01
Acceptance
Within ± 1.0 Da (each component)

6Additional tests

TestPerformed byDateReport / file
Water contentPrymaLab2026-09-19RPT-KF-PL-2609-024
EndotoxinPrymaLab2026-09-20RPT-ET-PL-2609-024
SterilityPrymaLab2026-10-02RPT-ST-PL-2609-024
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