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Certificate no.
PL-26-00116
Verification key
AHAAXPHE
Scan or enter both at prymalab.net/testing/verify
Certificate of Analysis · Lot release
Tirzepatide 80 mg
Lot PL-2609-116 · Lyophilized powder · Label claim 80 mg/vial
Tested in-house by PrymaLab
In-house analytical result, not an independent third-party test
Lot / batch number
PL-2609-116
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
150 / 2
Storage
−20 °C, desiccated, dark
Certificate type
Lot COA, 2 pages
Compound
Tirzepatide
LY3298176; GIP/GLP-1 receptor dual agonist
CAS number
2023788-19-2
Molecular formula
C225H348N48O68
Theoretical mass (avg.)
4813.5 Da
Sequence
H-Y-Aib-EGTFTSDYSI-Aib-LDKIAQK(2×AEEA-γGlu-C20 diacid)AFVQWLIAGGPSSGAPPPS-NH₂ (39 residues; Aib2 and Aib13; Lys20 acylated with eicosanedioic acid via γ-Glu and two AEEA spacers; C-terminal amide)
Purity · RP-HPLC, area %
99.21%
Specification 99.0% • main peak at 8.89 min
Identity · Observed Mass
4813.3 Da
Theoretical 4813.5 Da • −0.2 Da (−42 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
4813.3 Da
PASS
Purity
RP-HPLC, UV 214 nm, area%
99.0%
99.21%
PASS
Largest impurity
RP-HPLC, area%
1.0%
0.25% at 8.01 min (Trp 25 oxidation)
PASS
Water content
Karl Fischer
5.0%
1.9%
PASS
Bacterial endotoxin
LAL, kinetic
≤ 5.0 EU/mg
0.06 EU/mg
PASS
Sterility / bioburden
USP <71>, membrane filtration
No growth after 14 days
No growth; conforms
PASS
1HPLC chromatogram
Data file: TZP_PL-2609-116_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
Tirzepatide 80 mg · Lot PL-2609-116 · Certificate PL-26-00116
Lot PL-2609-116
Method, peak table and approval
2HPLC method · TZP_PL-2609-116_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 / USHX20000
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 Tirzepatide reference, lot PL-RS-TZP-01, RT 8.86 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
6.28
5,295
0.11
2 (deamid.)
7.80
8,664
0.18
3 (Trp-ox)
8.01
12,033
0.25
4
8.89
4,775,275
99.21
5
9.24
12,033
0.25
Total
4,813,300
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)
963.7 (5+ [M+5H]) · 803.2 (6+ [M+6H])
Deconvoluted Mass
4813.3 Da
Theoretical Mass
4813.5 Da
Difference
−0.2 Da (−42 ppm)
Data File
TZP_PL-2609-116_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-2609-116
Endotoxin
PrymaLab
2026-09-19
RPT-ET-PL-2609-116
Sterility
PrymaLab
2026-09-19
RPT-ST-PL-2609-116
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
