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Certificate no.
PL-26-00261
Verification key
N4YCYB99
Scan or enter both at prymalab.net/testing/verify
Certificate of Analysis · Lot release
Pancragen 20 mg Pen
Lot PL-2610-147 · Solution · Label claim 20 mg/mL
Tested in-house by PrymaLab
In-house analytical result, not an independent third-party test
Lot / batch number
PL-2610-147
Date made
2026-10-06
Date of analysis
2026-10-07
Date issued
2026-10-21
Retest / expiry
2028-10-06
Units in lot / sampled
234 / 2
Storage
—
Certificate type
Lot COA, 2 pages
Compound
Pancragen
Lys-Glu-Asp-Trp (KEDW); Khavinson pancreatic peptide bioregulator (free-acid form as supplied)
CAS number
n/a
Molecular formula
C26H36N6O9
Theoretical mass (avg.)
576.60 Da
Sequence
KEDW
Purity · RP-HPLC, area %
99.72%
Specification ≥ 99.0% • main peak at 12.28 min
Identity · Observed Mass
576.56 Da
Theoretical 576.60 Da • −0.04 Da (69 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
576.56 Da
PASS
Purity
RP-HPLC, UV 214 nm, area%
≥ 99.0%
99.72%
PASS
Largest impurity
RP-HPLC, area%
≤ 1.0%
0.20% (RT 13.70)
PASS
Assay (label claim)
Assay vs label claim
19–21 mg/mL
20.29 mg/mL
PASS
Bacterial endotoxin
LAL, kinetic
≤ 5.0 EU/mg
0.375 EU/mg
PASS
Sterility
USP <71>, 14-day
No growth
No growth
PASS
1HPLC chromatogram
Data file: PL-2610-147-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-2610-147-HPLC.raw. † Nominal reference retention time for the assigned impurity; the main-peak RT is observed in this lot.
PrymaLab
Certificate of Analysis · continued
Pancragen 20 mg Pen · Lot PL-2610-147 · Certificate PL-26-00261
Lot PL-2610-147
Method, peak table and approval
2HPLC method · PL-2610-147-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
11.00 †
—
0.04
2
12.28
—
99.72
3
13.10 †
—
0.04
4
13.70 †
—
0.20
Total
—
100.00
Peaks: 1 deamidation product; 2 main peak (Pancragen); 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)
577.61 (M+H)+
Deconvoluted Mass
576.56 Da
Theoretical Mass
576.60 Da
Difference
−0.04 Da (69 ppm)
Data File
PL-2610-147-MS.d
Acceptance
Within ± 1.0 Da
6Additional tests
Test
Performed by
Date
Report / file
Assay vs label claim
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: 2026-10-21
S. Calloway Reviewer · checked against raw data Date: 2026-10-21
M. Phelps Lab Director · approved for release Date: 2026-10-21
