MEDUTEST
MAISON D'ANALYSE · GENÈVE
Report MT-39917
Issued 2026-02-09
Scope RP-HPLC
Certificate of analysis · Purity
Tesamorelin
20mg × 10 vials · Cat. TSM20
CAS number
218949-48-5
Molecular formula
C₂₂₁H₃₆₆N₇₂O₆₇S
Molecular weight
5135.83 Da
Appearance
White lyophilized powder
Batch / lot
WWB-TSM20-4532
Sample received
2026-01-07
99.02%HPLC PURITY
Chromatographic purity 99.02%
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]⁺ | 5135.60 | ± 2 Da | PASS |
| Chromatographic Purity | RP-HPLC, UV 220 nm | 99.02% | ≥ 98.0% | PASS |
| Largest Single Impurity | RP-HPLC area % | 0.06% | ≤ 0.50% | PASS |
| Total Related Substances | RP-HPLC area % | 0.98% | ≤ 2.0% | PASS |
| Assay (content) | Quantitative HPLC | 99.6% | 98.0–102.0% | PASS |
| Water (Karl Fischer) | USP <921> | 2.4% | ≤ 6.0% | PASS |
System suitability — USP <621>
| Parameter | Result | Acceptance | Status |
|---|---|---|---|
| Theoretical Plates (N) | 11035 | ≥ 2000 | PASS |
| Tailing Factor (T) | 1.13 | ≤ 2.0 | PASS |
| Repeatability RSD (n=6) | 0.18% | ≤ 1.0% | PASS |
| Resolution (Rs) | 10.6 | ≥ 2.0 | PASS |
M. Lavigne, PhD
Analytical chemist
Dr. P. Achterberg
Laboratory director
