MEDUTEST
MAISON D'ANALYSE · GENÈVE
Report MT-89696
Issued 2026-02-26
Scope RP-HPLC
Certificate of analysis · Purity
Tirzepatide
20mg × 10 vials · Cat. TR20
CAS number
2023788-19-2
Molecular formula
C₂₂₅H₃₄₈N₄₈O₆₈
Molecular weight
4813.55 Da
Appearance
White lyophilized powder
Batch / lot
WWB-TR20-4845
Sample received
2026-01-01
98.70%HPLC PURITY
Chromatographic purity 98.70%
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]⁺ | 4813.23 | ± 2 Da | PASS |
| Chromatographic Purity | RP-HPLC, UV 220 nm | 98.70% | ≥ 98.0% | PASS |
| Largest Single Impurity | RP-HPLC area % | 0.18% | ≤ 0.50% | PASS |
| Total Related Substances | RP-HPLC area % | 1.30% | ≤ 2.0% | PASS |
| Assay (content) | Quantitative HPLC | 99.0% | 98.0–102.0% | PASS |
| Water (Karl Fischer) | USP <921> | 0.6% | ≤ 6.0% | PASS |
System suitability — USP <621>
| Parameter | Result | Acceptance | Status |
|---|---|---|---|
| Theoretical Plates (N) | 15690 | ≥ 2000 | PASS |
| Tailing Factor (T) | 0.95 | ≤ 2.0 | PASS |
| Repeatability RSD (n=6) | 0.48% | ≤ 1.0% | PASS |
| Resolution (Rs) | 9.2 | ≥ 2.0 | PASS |
E. Halloran, PhD
Analytical chemist
Dr. H. Stenmark
Laboratory director