Certificate PL-26-00169 · CJC-1295 noDAC+Ipamorelin 10 mg · lot PL-2610-047
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PrymaLab
PrymaLab
PrymaLab Analytical · In-house laboratory
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Certificate no.
PL-26-00169
Verification key
2QWMYFX7
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Certificate of Analysis · Lot release

CJC-1295 noDAC+Ipamorelin 10 mg

Lot PL-2610-047 · 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-2610-047
Date made
2026-10-02
Date of analysis
2026-10-06
Date issued
2026-10-20
Retest / expiry
2028-10-02
Units in lot / sampled
371 / 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
—
Theoretical mass (avg.)
3,367.90 · 711.85 Da (CJC-1295 noDAC / Ipamorelin)
Composition and sequences
CJC-1295 noDAC: 30-aa GHRH analog · Ipamorelin: Aib-His-D-2Nal-D-Phe-Lys-NH2
Purity · RP-HPLC, area %
99.67%
Lowest component (CJC-1295 noDAC) • specification ≥ 99.0% for every component
Identity · Components Confirmed
2 / 2
Components confirmed by LC-MS within ± 1.0 Da: 3,367.72 / 711.80 Da
Overall conclusion
PASS
Meets every specification for the tests performed
TestMethodSpecificationResultConclusion
CJC-1295 noDAC: purity · largest impurity · massRP-HPLC 214 nm (area%); LC-MS, ESI+≥ 99.0% · ≤ 1.0% · ± 1.0 Da99.67% · 0.17% · 3,367.72 DaPASS
Ipamorelin: purity · largest impurity · massRP-HPLC 214 nm (area%); LC-MS, ESI+≥ 99.0% · ≤ 1.0% · ± 1.0 Da99.82% · 0.10% · 711.80 DaPASS
Water contentKarl Fischer≤ 5.0%2.64%PASS
Bacterial endotoxinLAL, kinetic≤ 5.0 EU/mg0.408 EU/mgPASS
SterilityUSP <71>, 14-dayNo growthNo growthPASS

1HPLC chromatogram

Data file: PL-2610-047-HPLC.raw · Column C18, 150 × 4.6 mm · UV 214 nm
0.01%0.1%1%10%100%131415161718192021Retention time (min) · stick height = area % (log scale)99.67% · 15.74 min99.82% · 18.14 min0.03% †0.17% †0.13% †0.02% †0.10% †0.06% †
Peak plot drawn from the integrated peak table (area %, log scale); it is not the instrument trace, which is retained in PL-2610-047-HPLC.raw. † Nominal reference retention time for the assigned impurity; the main-peak RT is observed in this lot. Area % is per component (each component main peak + its impurities = 100%).
PrymaLab
PrymaLab
Certificate of Analysis · continued
CJC-1295 noDAC+Ipamorelin 10 mg · Lot PL-2610-047 · Certificate PL-26-00169
Lot PL-2610-047
Method, peak table and approval

2HPLC method · PL-2610-047-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 %
114.20 †—0.03
214.90 †—0.17
315.74—99.67
416.30 †—0.13
516.80 †—0.02
618.14—99.82
718.90 †—0.10
819.50 †—0.06
Total—100.00 per component
Main peaks: 3 CJC-1295 noDAC · 6 Ipamorelin; all other peaks are the assigned impurities of the neighbouring component · area % within each component (main + impurities = 100% per component) · † nominal reference RT · 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
Deconvoluted Mass
3,367.72 / 711.80 Da
Theoretical Mass
3,367.90 / 711.85 Da
Order
CJC-1295 noDAC / Ipamorelin
Difference
−0.18 / −0.05 Da
Data File
PL-2610-047-MS.d
Acceptance
Within ± 1.0 Da (each component)

6Additional tests

TestPerformed byDateReport / file
Water content (Karl Fischer)PrymaLab Analytical2026-10-06—
Endotoxin (LAL, kinetic)PrymaLab Analytical2026-10-06—
Sterility (USP <71>, day-14 read-out)PrymaLab Analytical2026-10-20—
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: 2026-10-20
S. Calloway
Reviewer · checked against raw data
Date: 2026-10-20
M. Phelps
Lab Director · approved for release
Date: 2026-10-20