M
Elixir Phenomen · Sweden
CERTIFICATE OF ANALYSIS
ISO/IEC 17025 · GMP-aligned · For research use only
Document №
COA-EP-71572-O
Issued
2026-06-12
Product name
Larazotide
Category
Healing & Recovery
Quantity / Vial
5 mg
Appearance
White lyophilized powder
Batch №
EP-71572-O
Lot
L8572
Date of analysis
2026-05-31
Expiry (lyophilized, −20 °C)
2029-06-12
Analytical Results
| Test | Method | Specification | Result | Pass |
|---|---|---|---|---|
| Purity | RP-HPLC | ≥ 98% | 98.64 % | ✓ |
| Identity | ESI-MS | Matches theoretical mass | 99.24 % match | ✓ |
| Water content | Karl Fischer | ≤ 6.0 % | 0.78 % | ✓ |
| Acetate content | Ion chromatography | ≤ 12.0 % | 4.01 % | ✓ |
| Endotoxin | LAL kinetic | ≤ 1.0 EU/mg | 0.113 EU/mg | ✓ |
| Bioburden | Plate count | ≤ 100 CFU/g | < 10 CFU/g | ✓ |
| Appearance | Visual | White powder | Conforms | ✓ |
| Solubility | Bacteriostatic water | Clear, colourless | Conforms | ✓ |
Research scope
Category
Healing & Recovery
Reference note
Studeras för tight-junction-modulering i tarmepitelceller.
Batch EP-71572-O har testats enligt intern SOP-PEP-002 och uppfyller samtliga release-specifikationer ovan. Lagras lyofiliserad vid −20 °C, skyddad från ljus. Endast för laboratorieforskning. Ej för humant eller veterinärt bruk.
Analyzed & released by
Assam
Assam
Senior Analytical Chemist · QA Release
Testing laboratory
Malmö Intelligent Lab Analysis
Andrés Bello 2425
Providencia, Santiago
Chile
Providencia, Santiago
Chile
Lab ID: MILA-CL-2018-PEP
CERTIFIED
M·I·L·A
2026-05-31