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Certificate of Analysis

TB-500

Thymosin Beta-4 Fragment (Ac-SDKP derivative)

Batch SPC-TB500-2411-B
Manufacture Date November 3, 2024
Expiry Date November 3, 2026
cGMP Manufacturer Helix BioSynth GmbH (Placeholder — sample data)
Testing Laboratory Analytika ISO Labs Inc. (ISO 17025 Accredited)
Lab Report ID ALI-2024-0901-TB5
Batch Number SPC-TB500-2411-B

Test Results

All Tests Passed
Test Method Result Status
Identity HPLC Confirmed ✓ Pass
Purity HPLC-UV 99.5% ✓ Pass
Molecular Mass LC-MS 4963.5 Da (expected 4963.5) ✓ Pass
Endotoxin LAL Kinetic Chromogenic <0.1 EU/mg ✓ Pass
Sterility USP <71> Sterile — no growth ✓ Pass
Appearance Visual Inspection White lyophilized powder ✓ Pass

Reviewed & Approved

Dr. M. Stanton, PharmD — QA Lead (Placeholder)

Signed off November 18, 2024

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