Certificate PL-26-00156 · Cagrilintide+Semaglutide 5+5 mg · lot PL-2610-034
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PrymaLab
PrymaLab Analytical · In-house laboratory
3705 Music Branch Rd, Ashland, KY 41102 · +1 (606) 465-9063 · prymalab.net
Certificate no.
PL-26-00156
Verification key
P7T8ZH86
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Certificate of Analysis · Lot release

Cagrilintide+Semaglutide 5+5 mg

Lot PL-2610-034 · Lyophilized co-blend powder · Label claim 5 + 5 mg/vial
Tested in-house by PrymaLab
In-house analytical result,
not an independent third-party test
Lot / batch number
PL-2610-034
Date made
2026-10-01
Date of analysis
2026-10-02
Date issued
2026-10-19
Retest / expiry
2028-10-01
Units in lot / sampled
391 / 3
Storage
−20 °C, desiccated, dark
Certificate type
Lot COA, 2 pages
Compound
Cagrilintide / Semaglutide Blend
Cagrilintide + Semaglutide co-lyophilized 1:1 blend
CAS number
1415456-99-3 · 910463-68-2
Molecular formula
—
Theoretical mass (avg.)
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 %
99.24%
Lowest component (Cagrilintide) • specification ≥ 99.0% for every component
Identity · Components Confirmed
2 / 2
Components confirmed by LC-MS within ± 1.0 Da: 4,408.91 / 4,113.59 Da
Overall conclusion
PASS
Meets every specification for the tests performed
TestMethodSpecificationResultConclusion
Cagrilintide: purity · largest impurity · massRP-HPLC 214 nm (area%); LC-MS, ESI+≥ 99.0% · ≤ 1.0% · ± 1.0 Da99.24% · 0.39% · 4,408.91 DaPASS
Semaglutide: purity · largest impurity · massRP-HPLC 214 nm (area%); LC-MS, ESI+≥ 99.0% · ≤ 1.0% · ± 1.0 Da99.50% · 0.19% · 4,113.59 DaPASS
Water contentKarl Fischer≤ 5.0%1.90%PASS
Bacterial endotoxinLAL, kinetic≤ 5.0 EU/mg0.021 EU/mgPASS
SterilityUSP <71>, 14-dayNo growthNo growthPASS

1HPLC chromatogram

Data file: PL-2610-034-HPLC.raw · Column C18, 150 × 4.6 mm · UV 214 nm
0.01%0.1%1%10%100%4567891011121314Retention time (min) · stick height = area % (log scale)99.50% · 8.00 min99.24% · 11.66 min0.10% †0.17% †0.04% †0.19% †0.23% †0.14% †0.39% †
Peak plot drawn from the integrated peak table (area %, log scale); it is not the instrument trace, which is retained in PL-2610-034-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%).
PrymaLab
PrymaLab
Certificate of Analysis · continued
Cagrilintide+Semaglutide 5+5 mg · Lot PL-2610-034 · Certificate PL-26-00156
Lot PL-2610-034
Method, peak table and approval

2HPLC method · PL-2610-034-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
0.0955
25.0595

4Peak table

PeakRT (min)AreaArea %
15.57 †—0.10
26.96 †—0.17
37.27 †—0.04
47.57 †—0.19
58.00—99.50
610.50 †—0.23
711.00 †—0.14
811.66—99.24
912.40 †—0.39
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
4,408.91 / 4,113.59 Da
Theoretical Mass
4,409.00 / 4,113.58 Da
Order
Cagrilintide / Semaglutide
Difference
−0.09 / +0.01 Da
Data File
PL-2610-034-MS.d
Acceptance
Within ± 1.0 Da (each component)

6Additional tests

TestPerformed byDateReport / file
Water content (Karl Fischer)PrymaLab Analytical2026-10-02—
Endotoxin (LAL, kinetic)PrymaLab Analytical2026-10-02—
Sterility (USP <71>, day-14 read-out)PrymaLab Analytical2026-10-16—
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: 2026-10-19
S. Calloway
Reviewer · checked against raw data
Date: 2026-10-19
M. Phelps
Lab Director · approved for release
Date: 2026-10-19