MEDUTEST
MAISON D'ANALYSE · GENÈVE
Report MT-62380
Issued 2026-02-08
Scope RP-HPLC
Certificate of analysis · Purity
BPC157 10mg + TB500 10mg Blend
20mg × 10 vials · Cat. BB20
CAS number
137525-51-0
Molecular formula
C₆₂H₉₈N₁₆O₂₂
Molecular weight
1419.53 Da
Appearance
White lyophilized powder
Batch / lot
WWB-BB20-7956
Sample received
2026-01-03
99.33%HPLC PURITY
Chromatographic purity 99.33%
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]⁺ | 1419.63 | ± 2 Da | PASS |
| Chromatographic Purity | RP-HPLC, UV 220 nm | 99.33% | ≥ 98.0% | PASS |
| Largest Single Impurity | RP-HPLC area % | 0.08% | ≤ 0.50% | PASS |
| Total Related Substances | RP-HPLC area % | 0.67% | ≤ 2.0% | PASS |
| Assay (content) | Quantitative HPLC | 100.7% | 98.0–102.0% | PASS |
| Water (Karl Fischer) | USP <921> | 1.0% | ≤ 6.0% | PASS |
System suitability — USP <621>
| Parameter | Result | Acceptance | Status |
|---|---|---|---|
| Theoretical Plates (N) | 11565 | ≥ 2000 | PASS |
| Tailing Factor (T) | 1.26 | ≤ 2.0 | PASS |
| Repeatability RSD (n=6) | 0.15% | ≤ 1.0% | PASS |
| Resolution (Rs) | 5.1 | ≥ 2.0 | PASS |
A. Rousseau, MSc
Analytical chemist
Dr. L. Moreau
Laboratory director
