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Certificate no.
PL-26-00025
Verification key
TUNFNHNL
Scan or enter both at prymalab.net/testing/verify
Certificate of Analysis · Lot release
CJC-1295 DAC 5 mg
Lot PL-2609-025 · 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-2609-025
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 (with DAC)
DAC:GRF; Modified GRF(1–29) carrying a C-terminal Lys(Nε-3-maleimidopropionyl) Drug Affinity Complex
CAS number
446262-90-4
Molecular formula
C165H269N47O46
Theoretical mass (avg.)
3647.3 Da
Sequence
H-Y-[D-Ala]-DAIFTQSYRKVLAQLSARKLLQDILSR-K(Nε-3-maleimidopropionyl)-NH₂ (30 residues; C-terminal amide; the maleimide couples to serum albumin Cys34 in vivo)
Purity · RP-HPLC, area %
99.78%
Specification 99.0% • main peak at 6.56 min
Identity · Observed Mass
3647.5 Da
Theoretical 3647.3 Da • +0.2 Da (55 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
3647.5 Da
PASS
Purity
RP-HPLC, UV 214 nm, area%
99.0%
99.78%
PASS
Largest impurity
RP-HPLC, area%
1.0%
0.09% at 7.14 min
PASS
Water content
Karl Fischer
5.0%
1.8%
PASS
Bacterial endotoxin
LAL, kinetic
≤ 5.0 EU/mg
0.05 EU/mg
PASS
Sterility / bioburden
USP <71>, membrane filtration
No growth after 14 days
No growth; conforms
PASS
1HPLC chromatogram
Data file: CJD_PL-2609-025_20260918_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.
PrymaLab
Certificate of Analysis · continued
CJC-1295 DAC 5 mg · Lot PL-2609-025 · Certificate PL-26-00025
Lot PL-2609-025
Method, peak table and approval
2HPLC method · CJD_PL-2609-025_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
Blank Injected
Yes
Reference Standard
In-house CJC-1295 (with DAC) reference, lot PL-RS-CJD-01, RT 6.54 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
6.56
4,290,540
99.78
2
7.14
3,870
0.09
3
7.66
3,010
0.07
4
8.24
2,580
0.06
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)
1216.8 (3+ [M+3H]) · 912.9 (4+ [M+4H])
Deconvoluted Mass
3647.5 Da
Theoretical Mass
3647.3 Da
Difference
+0.2 Da (55 ppm)
Data File
CJD_PL-2609-025_MS_20260918_01
Acceptance
Within ± 1.0 Da
6Additional tests
Test
Performed by
Date
Report / file
Water content
PrymaLab
2026-09-19
RPT-KF-PL-2609-025
Endotoxin
PrymaLab
2026-09-20
RPT-ET-PL-2609-025
Sterility
PrymaLab
2026-10-02
RPT-ST-PL-2609-025
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
