H-H-Aib-QGTFTSDYSKYLDEKKAK(γGlu-2×AEEA-C20 diacid)EFVEWLLEGGPSSG-NH₂ (34 residues; Aib2; Lys20 acylated with eicosanedioic acid via γ-Glu and two AEEA spacers; C-terminal amide)
Purity · RP-HPLC, area %
99.73%
Specification 99.0% • main peak at 6.74 min
Identity · Observed Mass
4563.3 Da
Theoretical 4563.1 Da • +0.2 Da (44 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
4563.3 Da
PASS
Purity
RP-HPLC, UV 214 nm, area%
99.0%
99.73%
PASS
Largest impurity
RP-HPLC, area%
1.0%
0.14% at 7.42 min (des-acyl species)
PASS
Water content
Karl Fischer
5.0%
2.3%
PASS
Bacterial endotoxin
LAL, kinetic
≤ 5.0 EU/mg
0.03 EU/mg
PASS
Sterility / bioburden
USP <71>, membrane filtration
No growth after 14 days
No growth; conforms
PASS
1HPLC chromatogram
Data file: MZD_PL-2609-062_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
Mazdutide 10 mg · Lot PL-2609-062 · Certificate PL-26-00062
Lot PL-2609-062
Method, peak table and approval
2HPLC method · MZD_PL-2609-062_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 / USHX18211
Mobile Phase A
0.1% TFA in water
Mobile Phase B
0.1% TFA in MeCN
Flow Rate
1.0 mL/min
Column Temperature
30 °C
Injection Volume
20 µL
Run Time
10 min
Sample Diluent
Water, 0.1% TFA
Sample Concentration
0.5 mg/mL
Blank Injected
Yes
Reference Standard
In-house Mazdutide reference, lot PL-RS-MZD-01, RT 6.72 min
3Gradient program
Time (min)
% A
% B
0.0
95
5
3.0
95
5
7.0
55
45
8.0
20
80
9.0
20
80
10.0
95
5
4Peak table
Peak
RT (min)
Area
Area %
1 (free peptide)
5.42
3,870
0.09
2
6.74
4,288,390
99.73
3 (des-acyl)
7.42
6,020
0.14
4
8.06
1,720
0.04
Total
4,300,000
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)
1141.8 (4+ [M+4H]) · 913.7 (5+ [M+5H])
Deconvoluted Mass
4563.3 Da
Theoretical Mass
4563.1 Da (intact acylated peptide)
Difference
+0.2 Da (44 ppm)
Data File
MZD_PL-2609-062_MS_20260919_01
Acceptance
Within ± 1.0 Da (acylated species)
6Additional tests
Test
Performed by
Date
Report / file
Water content
PrymaLab
2026-09-20
RPT-KF-PL-2609-062
Endotoxin
PrymaLab
2026-09-21
RPT-ET-PL-2609-062
Sterility
PrymaLab
2026-10-02
RPT-ST-PL-2609-062
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
