MEDUTEST
MAISON D'ANALYSE · GENÈVE
Report MT-45934
Issued 2026-02-10
Scope RP-HPLC
Certificate of analysis · Purity
Tirzepatide
60mg × 10 vials · Cat. TR60
CAS number
2023788-19-2
Molecular formula
C₂₂₅H₃₄₈N₄₈O₆₈
Molecular weight
4813.55 Da
Appearance
White lyophilized powder
Batch / lot
WWB-TR60-6300
Sample received
2026-01-20
99.28%HPLC PURITY
Chromatographic purity 99.28%
Identity confirmed by ESI-MS; purity determined by RP-HPLC at UV 220 nm against reference standard. Material conforms to specification and is released for research use.
Purity & identity
| Determination | Method | Result | Specification | Status |
|---|---|---|---|---|
| Identity (ESI-MS) | LC-MS, [M+H]⁺ | 4813.71 | ± 2 Da | PASS |
| Chromatographic Purity | RP-HPLC, UV 220 nm | 99.28% | ≥ 98.0% | PASS |
| Largest Single Impurity | RP-HPLC area % | 0.08% | ≤ 0.50% | PASS |
| Total Related Substances | RP-HPLC area % | 0.72% | ≤ 2.0% | PASS |
| Assay (content) | Quantitative HPLC | 100.7% | 98.0–102.0% | PASS |
| Water (Karl Fischer) | USP <921> | 0.5% | ≤ 6.0% | PASS |
System suitability — USP <621>
| Parameter | Result | Acceptance | Status |
|---|---|---|---|
| Theoretical Plates (N) | 14958 | ≥ 2000 | PASS |
| Tailing Factor (T) | 0.99 | ≤ 2.0 | PASS |
| Repeatability RSD (n=6) | 0.49% | ≤ 1.0% | PASS |
| Resolution (Rs) | 5.9 | ≥ 2.0 | PASS |
A. Rousseau, MSc
Analytical chemist
Dr. L. Moreau
Laboratory director
