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Certificate no.
PL-26-00375
Verification key
XMH9HP3T
Scan or enter both at prymalab.net/testing/verify
Certificate of Analysis · Lot release
Larazotide 2 mg
Lot PL-2610-262 · Lyophilized powder · Label claim 2 mg per vial
Tested in-house by PrymaLab
In-house analytical result, not an independent third-party test
Lot / batch number
PL-2610-262
Date made
2026-10-08
Date of analysis
2026-10-09
Date issued
2026-10-26
Retest / expiry
2028-10-08
Units in lot / sampled
267 / 2
Storage
—
Certificate type
Lot COA, 2 pages
Compound
Larazotide
CAS number
258818-34-7
Molecular formula
—
Theoretical mass (avg.)
725.80 Da
Sequence
GGVLVQPG
Purity · RP-HPLC, area %
99.56%
Specification ≥ 99.0% • main peak at 9.96 min
Identity · Observed Mass
725.81 Da
Theoretical 725.80 Da • +0.01 Da (14 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
725.81 Da
PASS
Purity
RP-HPLC, UV 214 nm, area%
≥ 99.0%
99.56%
PASS
Largest impurity
RP-HPLC, area%
≤ 1.0%
0.22% (RT 8.80)
PASS
Water content
Karl Fischer
≤ 5.0%
1.44%
PASS
Bacterial endotoxin
LAL, kinetic
≤ 5.0 EU/mg
0.067 EU/mg
PASS
Sterility
USP <71>, 14-day
No growth
No growth
PASS
1HPLC chromatogram
Data file: PL-2610-262-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-2610-262-HPLC.raw. † Nominal reference retention time for the assigned impurity; the main-peak RT is observed in this lot.
PrymaLab
Certificate of Analysis · continued
Larazotide 2 mg · Lot PL-2610-262 · Certificate PL-26-00375
Lot PL-2610-262
Method, peak table and approval
2HPLC method · PL-2610-262-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
8.80 †
—
0.22
2
9.96
—
99.56
3
10.70 †
—
0.14
4
11.30 †
—
0.08
Total
—
100.00
Peaks: 1 unidentified impurity; 2 main peak (Larazotide); 3 unidentified impurity; 4 unidentified impurity · 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)
726.81 (M+H)+
Deconvoluted Mass
725.81 Da
Theoretical Mass
725.80 Da
Difference
+0.01 Da (14 ppm)
Data File
PL-2610-262-MS.d
Acceptance
Within ± 1.0 Da
6Additional tests
Test
Performed by
Date
Report / file
Water content (Karl Fischer)
PrymaLab Analytical
2026-10-09
—
Endotoxin (LAL, kinetic)
PrymaLab Analytical
2026-10-09
—
Sterility (USP <71>, day-14 read-out)
PrymaLab Analytical
2026-10-23
—
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: 2026-10-26
S. Calloway Reviewer · checked against raw data Date: 2026-10-26
M. Phelps Lab Director · approved for release Date: 2026-10-26
