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Certificate no.
PL-26-00233
Verification key
ZENDV8SN
Scan or enter both at prymalab.net/testing/verify
Certificate of Analysis · Lot release
Livagen 20 mg
Lot PL-2610-119 · Lyophilized powder · Label claim 20 mg per vial
Tested in-house by PrymaLab
In-house analytical result, not an independent third-party test
Lot / batch number
PL-2610-119
Date made
2026-10-05
Date of analysis
2026-10-07
Date issued
2026-10-22
Retest / expiry
2028-10-05
Units in lot / sampled
257 / 2
Storage
−20 °C, desiccated, dark
Certificate type
Lot COA, 2 pages
Compound
Livagen
Lys-Glu-Asp-Ala (KEDA)
CAS number
433257-50-2
Molecular formula
C18H31N5O9
Theoretical mass (avg.)
461.47 Da
Sequence
KEDA
Purity · RP-HPLC, area %
99.58%
Specification ≥ 99.0% • main peak at 9.86 min
Identity · Observed Mass
461.45 Da
Theoretical 461.47 Da • −0.02 Da (43 ppm)
Overall conclusion
PASS
Meets every specification for the tests performed
Test
Method
Specification
Result
Conclusion
Identity (mass)
LC-MS, ESI positive
Theoretical ± 1.0 Da
461.45 Da
PASS
Purity
RP-HPLC, UV 214 nm, area%
≥ 99.0%
99.58%
PASS
Largest impurity
RP-HPLC, area%
≤ 1.0%
0.26% (RT 10.60)
PASS
Water content
Karl Fischer
≤ 5.0%
1.24%
PASS
Bacterial endotoxin
LAL, kinetic
≤ 5.0 EU/mg
0.112 EU/mg
PASS
Sterility
USP <71>, 14-day
No growth
No growth
PASS
1HPLC chromatogram
Data file: PL-2610-119-HPLC.raw · Column C18, 150 × 4.6 mm · UV 214 nm
Peak plot drawn from the integrated peak table (area %, log scale); it is not the instrument trace, which is retained in PL-2610-119-HPLC.raw. † Nominal reference retention time for the assigned impurity; the main-peak RT is observed in this lot.
PrymaLab
Certificate of Analysis · continued
Livagen 20 mg · Lot PL-2610-119 · Certificate PL-26-00233
Lot PL-2610-119
Method, peak table and approval
2HPLC method · PL-2610-119-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
0.0
95
5
25.0
5
95
4Peak table
Peak
RT (min)
Area
Area %
1
8.60 †
—
0.05
2
9.86
—
99.58
3
10.60 †
—
0.26
4
11.20 †
—
0.11
Total
—
100.00
Peaks: 1 deamidation product; 2 main peak (Livagen); 3 isoaspartate (isoasp) variant; 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)
462.48 (M+H)+
Deconvoluted Mass
461.45 Da
Theoretical Mass
461.47 Da
Difference
−0.02 Da (43 ppm)
Data File
PL-2610-119-MS.d
Acceptance
Within ± 1.0 Da
6Additional tests
Test
Performed by
Date
Report / file
Water content (Karl Fischer)
PrymaLab Analytical
2026-10-07
—
Endotoxin (LAL, kinetic)
PrymaLab Analytical
2026-10-07
—
Sterility (USP <71>, day-14 read-out)
PrymaLab Analytical
2026-10-21
—
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: 2026-10-22
S. Calloway Reviewer · checked against raw data Date: 2026-10-22
M. Phelps Lab Director · approved for release Date: 2026-10-22
