Certificate of Analysis

Sample Identification

Compound	Tirzepatide (LY3298176; Mounjaro; Dual GIP/GLP-1 Receptor Agonist)	Client	Numira Peptides · numira.cc
CAS Number	2023788-19-2	Date Received	2025-05-08
Molecular Formula	C₂₂₅H₃₄₈N₄₈O₆₈	Date Tested	2025-05-11
Molecular Weight	4813.54 g/mol	Date Reported	2025-05-17
Lot Number	NML-TIR-250511	Test Methods	HPLC-UV · ICP-MS · Kinetic LAL
Appearance	White lyophilised powder	PubChem CID	2762845

HPLC-UV Purity & Content Analysis

5 mg

Ordered Amount

4.98 mg

Measured Amount

99.00%

Purity (HPLC-UV)

99.5%

Recovery

Fig. 1 — HPLC-UV Chromatogram (214 nm) · Run: NML_TIR_250511_1.d

APPEARANCE

#	Retention Time (min)	Area	% Area	Assignment
1	3.88	1.52E+02	0.42	Unknown impurity
2	9.45	3.57E+04	99.00	Tirzepatide
3	11.22	2.09E+02	0.58	Unknown impurity

Bacterial Endotoxin Test (USP <85>)

Method	Result	Specification	Verdict
Kinetic LAL (USP <85>)	< 0.125 EU/mL	≤ 0.125 EU/mL	PASS

Elemental Impurities (USP <233> / ICH Q3D)

Element	Method	Result (ppm)	Limit (ppm)	Verdict
Arsenic (As)	ICP-MS	< 0.001	2.1	PASS
Cadmium (Cd)	ICP-MS	< 0.001	0.5	PASS
Lead (Pb)	ICP-MS	< 0.001	0.5	PASS
Mercury (Hg)	ICP-MS	< 0.001	3.0	PASS

Note: Peptide samples may contain counter-ions (TFA, acetate) and excipients (mannitol, sucrose) used as lyoprotectants and pH buffers. These are not detected by UV and are not classified as impurities under USP <233>.

Analysis Performed by
Dr. M. Chen, Ph.D. (Analytical Chemistry)
Senior Analytical Chemist · Nexus Molecular Labs
info@nexusmolecularlabs.com
2025-05-17

Tirzepatide · 5 mg