PrymaLab

PrymaLab Analytical · In-house laboratory

3705 Music Branch Rd, Ashland, KY 41102 · +1 (606) 465-9063 · prymalab.net

Certificate no.

PL-26-00014

Verification key

TE4Z89DG

Scan or enter both at
prymalab.net/testing/verify

Certificate of Analysis · Lot release

Cagrilintide 2.5 mg + Semaglutide 2.5 mg

Lot PL-2609-014 · Lyophilized co-blend powder · Label claim 5 mg/vial total

Tested in-house by PrymaLab

In-house analytical result,
not an independent third-party test

Lot / batch number

PL-2609-014

Date made

2026-09-17

Date of analysis

2026-09-18

Date issued

2026-10-03

Retest / expiry

2028-09-17

Units in lot / sampled

250 / 2

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

C₁₉₄H₃₁₂N₅₄O₅₉S₂ · C₁₈₇H₂₉₁N₄₅O₅₉

Theoretical mass (avg.)

4409.0 · 4113.6 Da (Cagrilintide / Semaglutide)

Composition and sequences

Cagrilintide 2.5 mg: (C20 diacid-γGlu)-KCNTATCATQRLAEFLRHSSNNFGPILPPTNVGSNTP-NH₂ (37 residues; Cys2–Cys7 disulfide; Lys1 acylated with eicosanedioic acid via γ-Glu; C-terminal amide) · Semaglutide 2.5 mg: 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 %

99.61%

Specification 99.0% (blend, sum of both component peaks)

Identity · Observed Mass

2 / 2

Components confirmed by LC-MS within ± 1.0 Da: 4113.8 / 4409.3 Da

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, each component	4113.8 Da (Semaglutide) · 4409.3 Da (Cagrilintide)	PASS
Purity	RP-HPLC, UV 214 nm, area%	99.0% (blend)	99.61%	PASS
Largest impurity	RP-HPLC, area%	1.0%	0.18% at 4.92 min	PASS
Water content	Karl Fischer	5.0%	2.1%	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: CSE_PL-2609-014_20260918_01 · Column C18, 150 × 4.6 mm · UV 214 nm

Baseline uncropped; both component peaks and impurities labeled with retention times. Peak table on page 2.

PrymaLab

Certificate of Analysis · continued

Cagrilintide 2.5 mg + Semaglutide 2.5 mg · Lot PL-2609-014 · Certificate PL-26-00014

Lot PL-2609-014

Method, peak table and approval

2HPLC method · CSE_PL-2609-014_20260918_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 (blend)

Blank Injected

Yes

Reference Standard

In-house Cagrilintide/Semaglutide blend reference, lot PL-RS-CSE-01, component RTs 6.16 / 6.56 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	4.92	7,740	0.18
2 (Semaglutide)	6.18	2,163,330	50.31
3 (Cagrilintide)	6.58	2,119,900	49.30
4	7.27	5,590	0.13
5	7.98	3,440	0.08
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)

823.9 (5+ [M+5H]) · 589.0 (7+ [M+7H], Semaglutide) · 882.9 (5+ [M+5H]) · 735.9 (6+ [M+6H], Cagrilintide)

Deconvoluted Mass

4113.8 / 4409.3 Da (by component)

Theoretical Mass

4113.6 / 4409.0 Da (Semaglutide / Cagrilintide)

Difference

≤ +0.2 Da (per component)

Data File

CSE_PL-2609-014_MS_20260918_01

Acceptance

Within ± 1.0 Da (each component)

6Additional tests

Test	Performed by	Date	Report / file
Water content	PrymaLab	2026-09-19	RPT-KF-PL-2609-014
Endotoxin	PrymaLab	2026-09-20	RPT-ET-PL-2609-014
Sterility	PrymaLab	2026-10-02	RPT-ST-PL-2609-014

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: 2026-09-18

S. Calloway
Reviewer · checked against raw data
Date: 2026-10-02

M. Phelps
Lab Director · approved for release
Date: 2026-10-03