Sample Identification
Compound
Semaglutide (Ozempic; GLP-1 Receptor Agonist)
Client
Numira Peptides · numira.cc
CAS Number
910463-68-2
Date Received
2025-05-02
Molecular Formula
C₁₈₇H₂₉₁N₄₅O₅₉
Date Tested
2025-05-05
Molecular Weight
4113.58 g/mol
Date Reported
2025-05-11
Lot Number
NML-SEM-250505
Test Methods
HPLC-UV · ICP-MS · Kinetic LAL
Appearance
White lyophilised powder
PubChem CID
56843331
HPLC-UV Purity & Content Analysis
Fig. 1 — HPLC-UV Chromatogram (214 nm) · Run: NML_SEM_250505_1.d
mAU
0
300
600
900
1200
0
2
4
6
8
10
12
Time [min]
3.76 min
Semaglutide
9.62 min
11.48 min
APPEARANCE
#
Retention Time (min)
Area
% Area
Assignment
1
3.76
1.38E+02
0.38
Unknown impurity
2
9.62
3.58E+04
99.10
Semaglutide
3
11.48
1.88E+02
0.52
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
2025-05-11
