Verified — all release criteria met
released
Certificate of analysis
Tirzepatide
Lot CP-TIRZEPPA-2603C · 30 mg
99.61 %
HPLC purity
Spec ≥ 99.0 %
88.3 %
Net peptide content
By amino acid analysis
< 0.40
Endotoxin (EU/mg)
Spec < 5.0 EU/mg
Provenance
- Testing laboratory
- Colmaric Analyticals
- Accreditation
- ISO/IEC 17025:2017
- Country of synthesis
- United States
- Manufactured
- Feb 25, 2026
- Release tested
- Mar 6, 2026 (7 months ago)
- Retest date
- Feb 25, 2028
- CAS number
- 2023788-19-2
- Molecular formula
- C225H348N48O68
- Theoretical mass
- 4813.45 Da
- Observed mass (LC-MS)
- 4813.36 Da (Δ 0.09 Da)
Assay results
Every line the release panel ran for this lot, with the method, the acceptance criterion and the measured value — not a pass mark alone.
| Method | Parameter | Specification | Result | |
|---|---|---|---|---|
| RP-HPLC (UV 214 nm) | Purity (area %) | ≥ 99.0 % | 99.61 % | Pass |
| LC-MS (ESI+) | Identity — observed mass | 4813.45 ± 1.0 Da | 4813.36 Da | Pass |
| Amino acid analysis | Net peptide content | ≥ 80.0 % | 88.3 % | Pass |
| Karl Fischer | Water content | ≤ 8.0 % | 3.72 % | Pass |
| Ion chromatography | Residual TFA | ≤ 1.0 % | 0.29 % | Pass |
| LAL kinetic chromogenic | Bacterial endotoxin | < 5.0 EU/mg | < 0.40 EU/mg | Pass |
| USP <71> membrane filtration | Sterility | No growth | No growth | Pass |
| Visual / USP <790> | Appearance | White to off-white cake, free of visible particulates | Conforms | Pass |
Handling for this lot
- Appearance
- White lyophilised cake, low density
- Storage
- Lyophilised at -20 °C. Reconstituted at 2–8 °C, protected from light.
- Reconstitution
- Allow the vial to reach room temperature before adding diluent — cold glass promotes localised supersaturation and cloudy reconstitution.
Other lots of Tirzepatide
Compare batch to batch. Consistency across lots is a stronger signal than any single certificate.
Research use only. This certificate describes material supplied strictly for laboratory research. It is not a drug, food, cosmetic or medical device, has not been evaluated by the FDA, and is not intended for human or veterinary administration of any kind.