PrymaLab

PrymaLab Analytical · In-house laboratory

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

Certificate no.

PL-26-00017

Verification key

KTSNVQML

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

Certificate of Analysis · Lot release

Cagrilintide 10 mg

Lot PL-2609-017 · Lyophilized powder · Label claim 10 mg/vial

Tested in-house by PrymaLab

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

Lot / batch number

PL-2609-017

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

200 / 3

Storage

−20 °C, desiccated, dark

Certificate type

Lot COA, 2 pages

Compound

Cagrilintide

AM833; long-acting acylated amylin analogue

CAS number

1415456-99-3

Molecular formula

C₁₉₄H₃₁₂N₅₄O₅₉S₂

Theoretical mass (avg.)

4409.0 Da

Sequence

(C20 diacid-γGlu)-KCNTATCATQRLAEFLRHSSNNFGPILPPTNVGSNTP-NH₂ (37 residues; Cys2–Cys7 disulfide; Lys1 acylated with eicosanedioic acid via γ-Glu; C-terminal amide)

Purity · RP-HPLC, area %

99.41%

Specification 99.0% • main peak at 8.54 min

Identity · Observed Mass

4409.2 Da

Theoretical 4409.0 Da • +0.2 Da (45 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	4409.2 Da	PASS
Purity	RP-HPLC, UV 214 nm, area%	99.0%	99.41%	PASS
Largest impurity	RP-HPLC, area%	1.0%	0.19% at 7.36 min (Asn 21 /Asn 22 deamidation)	PASS
Water content	Karl Fischer	5.0%	2.1%	PASS
Bacterial endotoxin	LAL, kinetic	≤ 5.0 EU/mg	0.07 EU/mg	PASS
Sterility / bioburden	USP <71>, membrane filtration	No growth after 14 days	No growth; conforms	PASS

1HPLC chromatogram

Data file: CAG_PL-2609-017_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

Cagrilintide 10 mg · Lot PL-2609-017 · Certificate PL-26-00017

Lot PL-2609-017

Method, peak table and approval

2HPLC method · CAG_PL-2609-017_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 / USHX19044

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 Cagrilintide reference, lot PL-RS-CAG-01, RT 8.51 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	5.98	5,732	0.13
2 (deamid.)	7.36	8,378	0.19
3	7.84	6,173	0.14
4	8.54	4,383,225	99.41
5	8.91	5,732	0.13
Total		4,409,240	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)

1103.3 (4+ [M+4H]) · 882.8 (5+ [M+5H])

Deconvoluted Mass

4409.2 Da

Theoretical Mass

4409.0 Da

Difference

+0.2 Da (45 ppm)

Data File

CAG_PL-2609-017_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-2609-017
Endotoxin	PrymaLab	2026-09-19	RPT-ET-PL-2609-017
Sterility	PrymaLab	2026-09-19	RPT-ST-PL-2609-017

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