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Certificate no.
PL-26-00092
Verification key
UAG54Y54
Scan or enter both at prymalab.net/testing/verify
Certificate of Analysis · Lot release
Semaglutide 15 mg
Lot PL-2609-092 · Lyophilized powder · Label claim 15 mg/vial
Tested in-house by PrymaLab
In-house analytical result, not an independent third-party test
Lot / batch number
PL-2609-092
Date made
2026-09-18
Date of analysis
2026-09-19
Date issued
2026-10-03
Retest / expiry
2028-09-18
Units in lot / sampled
350 / 3
Storage
−20 °C, desiccated, dark
Certificate type
Lot COA, 2 pages
Compound
Semaglutide
NN9535; GLP-1 receptor agonist
CAS number
910463-68-2
Molecular formula
C187H291N45O59
Theoretical mass (avg.)
4113.6 Da
Sequence
H-H-Aib-EGTFTSDVSSYLEGQAAK(2×OEG-γGlu-C18 diacid)EFIAWLVRGRG-OH (31 residues; Aib8 and Arg34 in GLP-1 numbering; Lys26 acylated with octadecanedioic acid via two OEG spacers and γ-Glu; free C-terminus)
Purity · RP-HPLC, area %
99.31%
Specification 99.0% • main peak at 7.95 min
Identity · Observed Mass
4113.8 Da
Theoretical 4113.6 Da • +0.2 Da (49 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
4113.8 Da
PASS
Purity
RP-HPLC, UV 214 nm, area%
99.0%
99.31%
PASS
Largest impurity
RP-HPLC, area%
1.0%
0.22% at 7.22 min (Asp 15 →isoAsp isomerization)
PASS
Water content
Karl Fischer
5.0%
1.7%
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: SEM_PL-2609-092_20260919_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
Semaglutide 15 mg · Lot PL-2609-092 · Certificate PL-26-00092
Lot PL-2609-092
Method, peak table and approval
2HPLC method · SEM_PL-2609-092_20260919_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 / USHX21100
Mobile Phase A
0.1% TFA in water
Mobile Phase B
0.1% TFA in MeCN
Flow Rate
1.0 mL/min
Column Temperature
40 °C
Injection Volume
20 µL
Run Time
12 min
Sample Diluent
0.1% TFA in 30% MeCN
Sample Concentration
0.5 mg/mL
Blank Injected
Yes
Reference Standard
In-house Semaglutide reference, lot PL-RS-SEM-01, RT 7.92 min
3Gradient program
Time (min)
% A
% B
0.0
65
35
2.0
65
35
9.0
25
75
10.0
15
85
11.0
15
85
12.0
65
35
4Peak table
Peak
RT (min)
Area
Area %
1
5.52
4,937
0.12
2 (deamid.)
6.91
6,582
0.16
3 (isoAsp)
7.22
9,050
0.22
4 (Trp-ox)
7.52
7,816
0.19
5
7.95
4,085,415
99.31
Total
4,113,800
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)
823.8 (5+ [M+5H]) · 686.6 (6+ [M+6H])
Deconvoluted Mass
4113.8 Da
Theoretical Mass
4113.6 Da
Difference
+0.2 Da (49 ppm)
Data File
SEM_PL-2609-092_MS_20260919_01
Acceptance
Within ± 1.0 Da
6Additional tests
Test
Performed by
Date
Report / file
Water content
PrymaLab
2026-09-19
RPT-KF-PL-2609-092
Endotoxin
PrymaLab
2026-09-19
RPT-ET-PL-2609-092
Sterility
PrymaLab
2026-09-19
RPT-ST-PL-2609-092
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: 2026-09-19
S. Calloway Reviewer · checked against raw data Date: 2026-10-02
M. Phelps Lab Director · approved for release Date: 2026-10-03
