Certificate of Analysis
Third-party analytical testing report for research purposes only
CP-COA-2602-5677
REP-2026-81101
Sample Information
Compound
Tirzepatide 5mg
Batch / Lot
CP-2602-5677
CAS Number
2023788-19-2
Label Claim
5 mg
Date Received
2026-01-26
Date Tested
2026-02-01
Date Issued
2026-02-05
Storage
Store at -20°C. Protect from light and moisture.
Appearance
White lyophilized powder, clear glass vial with aluminum crimp seal
Testing Laboratory
Analytical Sciences International (ASI)
Kurfuerstendamm 21, 10719 Berlin, Germany
Method
HPLC-UV (214nm) & ESI-MS
Analytical Results
ALL TESTS PASS
All analytical parameters meet or exceed acceptance criteria.
Analytical Data
Tirzepatide 5mg — Batch CP-2602-5677
HPLC-UV Chromatogram
Retention Time
6.745 min
Peak Area
20006 mAU·s
Wavelength
214 nm
Chromatographic Purity
99.6%
Mass Spectrometry Identification
Molecular Weight (Theoretical)
4813.45 Da
Observed m/z
1605.46
Charge State
[M+3H]3+
Identity
Confirmed
Interpretation: The observed molecular ion [M+3H]3+ at m/z 1605.46 is consistent with the theoretical molecular weight of 4813.45 Da for Tirzepatide 5mg (CAS 2023788-19-2). Mass spectrum matches reference standard within acceptable instrument variance (\u00B10.2 Da).
Methods & Authorization
Tirzepatide 5mg — Batch CP-2602-5677
Analytical Methods
USP <621>
Purity and potency determined by reversed-phase high-performance liquid chromatography (RP-HPLC) with UV detection at 214 nm and electrospray ionization mass spectrometry (ESI-MS) for identity confirmation. A C18 column (4.6 x 150 mm, 5 µm) was used with a linear gradient of water and acetonitrile, both containing 0.1% trifluoroacetic acid (TFA). Flow rate: 1.0 mL/min. Column temperature: 25°C. Injection volume: 10 µL.
USP <85>
Bacterial endotoxins test performed using the Limulus Amebocyte Lysate (LAL) kinetic turbidimetric method. Sensitivity: 0.01 EU/mL. Standard curve range: 0.01–1.0 EU/mL. Positive product control (PPC) spike recovery: 50–200%. All controls within acceptance criteria.
USP <61>
Microbial enumeration (bioburden) determined by membrane filtration per USP <61>. Total Aerobic Microbial Count (TAMC) on Soybean-Casein Digest Agar incubated at 30–35°C for 3–5 days. Total Yeast and Mold Count (TYMC) on Sabouraud Dextrose Agar incubated at 20–25°C for 5–7 days.
USP <630>
Visual inspection of physical appearance, color, and form. Sample compared against reference description for the active pharmaceutical ingredient.
Authorization
Dr. Maria Vasquez, M.Sc.
Analyst
Signed digitally on 2026-02-05
Dr. Thomas Bergmann, Ph.D.
Laboratory Director
Signed digitally on 2026-02-05
DISCLAIMER: This Certificate of Analysis is provided for research and informational purposes only. The products described herein are intended solely for in-vitro research and laboratory use. They are not intended for human or veterinary use, food, cosmetic, or household applications. The analytical data reported in this document pertains only to the specific batch/lot identified above and should not be extrapolated to other batches. CertaPeptides (CERTALAB S.R.L.) makes no warranties regarding the fitness of these products for any particular purpose beyond research applications. Results are valid for the batch number specified. Verify authenticity at certapeptides.com/verify.