4,409.00 · 4,113.58 Da (Cagrilintide / Semaglutide)
Composition and sequences
Cagrilintide: acylated amylin analog Cys3-Cys8 · Semaglutide: acylated GLP-1 analog
Purity · RP-HPLC, area %
99.18%
Lowest component (Semaglutide) • specification ≥ 99.0% for every component
Identity · Components Confirmed
2 / 2
Components confirmed by LC-MS within ± 1.0 Da: 4,409.06 / 4,113.65 Da
Overall conclusion
PASS
Meets every specification for the tests performed
Test
Method
Specification
Result
Conclusion
Cagrilintide: purity · largest impurity · mass
RP-HPLC 214 nm (area%); LC-MS, ESI+
≥ 99.0% · ≤ 1.0% · ± 1.0 Da
99.35% · 0.29% · 4,409.06 Da
PASS
Semaglutide: purity · largest impurity · mass
RP-HPLC 214 nm (area%); LC-MS, ESI+
≥ 99.0% · ≤ 1.0% · ± 1.0 Da
99.18% · 0.22% · 4,113.65 Da
PASS
Water content
Karl Fischer
≤ 5.0%
1.57%
PASS
Bacterial endotoxin
LAL, kinetic
≤ 5.0 EU/mg
0.376 EU/mg
PASS
Sterility
USP <71>, 14-day
No growth
No growth
PASS
1HPLC chromatogram
Data file: PL-2610-033-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-2610-033-HPLC.raw. † Nominal reference retention time for the assigned impurity; the main-peak RT is observed in this lot. Area % is per component (each component main peak + its impurities = 100%).
Epic Wholesalers LLC -dba-Epic Peptides Lab
Certificate of Analysis · continued
Cagrilintide+Semaglutide 2.5+2.5 mg · Lot PL-2610-033 · Certificate PL-26-00155
Lot PL-2610-033
Method, peak table and approval
2HPLC method · PL-2610-033-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
5.57 †
—
0.20
2
6.96 †
—
0.18
3
7.27 †
—
0.22
4
7.57 †
—
0.22
5
8.04
—
99.18
6
10.50 †
—
0.19
7
11.00 †
—
0.29
8
11.59
—
99.35
9
12.40 †
—
0.17
Total
—
100.00 per component
Main peaks: 5 Semaglutide · 8 Cagrilintide; all other peaks are the assigned impurities of the neighbouring component · area % within each component (main + impurities = 100% per component) · † nominal reference RT · 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
Deconvoluted Mass
4,409.06 / 4,113.65 Da
Theoretical Mass
4,409.00 / 4,113.58 Da
Order
Cagrilintide / Semaglutide
Difference
+0.06 / +0.07 Da
Data File
PL-2610-033-MS.d
Acceptance
Within ± 1.0 Da (each component)
6Additional tests
Test
Performed by
Date
Report / file
Water content (Karl Fischer)
PrymaLab Analytical
2026-10-02
—
Endotoxin (LAL, kinetic)
PrymaLab Analytical
2026-10-02
—
Sterility (USP <71>, day-14 read-out)
PrymaLab Analytical
2026-10-16
—
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: 2026-10-16
S. Calloway Reviewer · checked against raw data Date: 2026-10-16
M. Phelps Lab Director · approved for release Date: 2026-10-16
