HPLC Certificate of Analysis

PEP-HPLC-047986

Issue Date: 2026-06-05

APPROVED
Primary HPLC Result
99.61%
Main peak purity for batch RETA-RAW-API-0526-A using UV-HPLC.
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Product
RETA 5mg
Batch / Lot Number
RETA-RAW-API-0526-A
Sample ID
RETA-RAW-API-0526-A2
HPLC Purity
99.61%
Assay Result
Conforms
Test Date
2026-05-28
HPLC Chromatogram
Representative chromatogram profile Main peak RT: 4.32 min · Main peak purity: 99.61%
Retention Time Absorbance Main peak 99.61% 4.32 min 0 2 4 6 8
Testing Information
Test Method
UV-HPLC
Appearance
Off White lyophilised powder
Impurities
Trace peaks detected; within specification
Laboratory
Peptiology L.L.C-Fz
Raw Data / Peak Integration
Instrument
Agilent 1260 Infinity II HPLC System
Software
OpenLab CDS v2.7
Column / Method Reference
C18 reverse-phase column, 250 × 4.6 mm, 5 µm / Method HPLC-PEP-001
Main Peak Area
1284000
Total Integrated Area
1289028
Integration Purity
99.61%
Peak Retention Time Area Area % Height Notes
System peak / solvent front 0.44 min 910 Excluded 110 Excluded from purity calculation
Minor impurity 1 2.91 min 2100 0.16% 160 Trace impurity
Minor impurity 2 4.87 min 1850 0.14% 135 Trace impurity
Main peptide peak 6.42 min 1284000 99.61% 68200 Integrated main peak
Minor impurity 3 7.36 min 1078 0.08% 90 Trace impurity
Endotoxin Testing
Endotoxin Status
Pass
Endotoxin Method
LAL+Gel Clot
Endotoxin Result
<0.04 EU/mg
Endotoxin Limit
≤0.5 EU/mg
Heavy Metal Testing
Heavy Metals Status
Pass
Test Method
ICP-MS
Total Result
Within specified limits
Specification Limit
Meets internal specification
Lead Pb
N/D
Arsenic As
N/D
Cadmium Cd
N/D
Mercury Hg
N/D
Stability Testing
Stability Status
Pass
Stability Method
Visual / HPLC retention check
Storage Condition
Store sealed, cool and dry.
Duration
Initial batch release
Stability Result: No significant degradation observed under recorded testing conditions.

Laboratory / Review
Lab Address:
Meydan Grandstand, 6th floor, Meydan Road, Nad Al
Sheba, Dubai, U.A.E.

Analyst: Lewis James Donohue BSc (Hons)
Reviewer: Beverly Huntington
Qualification: Biomedical Scientist

Notes:
This certificate is generated from recorded batch and laboratory testing data held by Peptiology
Authorised Signature
Authorised signature
Beverly Huntington
Biomedical Scientist Quality Review / Batch Release
Certificate Verification
This certificate can be verified using the QR code above or by visiting the verification URL below.
https://peptiology.com/?pepti_hplc_cert=1&cert_id=47986
This certificate is provided for verification of batch testing records. Products are supplied strictly for lawful laboratory and research use only and are not intended for human consumption, medical use, diagnosis, treatment, or prevention of disease.

Verification URL: https://peptiology.com/?pepti_hplc_cert=1&cert_id=47986