NEURPEX SOLUTIONS

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Document Type

CERTIFICATE OF ANALYSIS

Product Information

Product NameTesamorelin 10MG

Batch/Lot NumberNPX-TESAMO-2026-001

Date of Analysis2026-07-14

FormLyophilized Powder

Storage-20°C; protect from light

Manufacturer Details

CompanyNeurpex Solutions

Websitewww.neuroex.com

Quality SystemISO 9001:2015 Compliant

Lab CertificationThird-Party Verified

Report Status Approved

Country of Origin: Made in U.S.A.

Molecular Specifications

Molecular Formula

—

Molecular Weight

5,135.9 g/mol

Appearance

White lyophilized powder

Analytical Test Results

Test Parameter	Method	Specification	Result	Status
Purity (HPLC)	RP-HPLC	≥ 98.0%	≥99.4%	Pass
Identity (MS)	ESI-MS	Conforms	Conforms	Pass
Endotoxin Level	LAL	< 1.0 EU/mg	< 0.25 EU/mg	Pass
Appearance	Visual	Lyophilized powder	White lyophilized powder	Pass
Solubility	Visual	Clear solution	Clear solution	Pass
Sterility	Membrane Filtration	Sterile	Sterile	Pass

Purity Analysis Summary

HPLC Purity

≥99.4%

High-Performance Liquid Chromatography analysis confirms purity exceeds the 99.4% threshold.

MS Identity

Conforms

Mass Spectrometry confirms molecular identity matches the expected peptide structure.

Chromatography Conditions (RP-HPLC)

InstrumentAgilent 1260 Infinity II

ColumnPhenomenex Luna C18 (4.6 × 250mm, 5µm)

DetectorDAD @ 220nm

Flow Rate1.0 mL/min

Injection Volume20 µL

Column Temp30 °C

Mobile Phase A0.1% TFA in H₂O

Mobile Phase B0.1% TFA in Acetonitrile

Gradient5% → 65% B over 30 min

Run Time35 min

Retention Time14.82 min

Theoretical Plates> 12,000

Mass Spectrometry (ESI-MS)

InstrumentWaters Xevo G2-XS QTof

IonizationESI (positive mode)

Mass Accuracy< 5 ppm

Theoretical [M+H]⁺5,135.9 g/mol

Observed [M+H]⁺Conforms (Δ < 0.01%)

Adducts Detected[M+2H]²⁺, [M+3H]³⁺

Residual Solvents (GC-MS)

Acetonitrile82 ppm / ≤ 410 ppm

TFA1,240 ppm / ≤ 5,000 ppm

DMFNot Detected / ≤ 880 ppm

DCMNot Detected / ≤ 600 ppm

MethanolNot Detected / ≤ 3,000 ppm

EthanolNot Detected / ≤ 5,000 ppm

Heavy Metals (ICP-MS, USP <232>)

Lead (Pb)< 0.05 µg/g / ≤ 0.5 µg/g

Arsenic (As)< 0.10 µg/g / ≤ 1.5 µg/g

Cadmium (Cd)< 0.02 µg/g / ≤ 0.5 µg/g

Mercury (Hg)< 0.05 µg/g / ≤ 3.0 µg/g

Total Heavy Metals< 1 ppm / ≤ 10 ppm

Iron (Fe)12 ppm / ≤ 100 ppm

Microbial Limits (USP <61> / <62>)

Total Aerobic Count< 10 CFU/g / ≤ 100

Total Yeast & Mold< 10 CFU/g / ≤ 100

E. coliAbsent

SalmonellaAbsent

S. aureusAbsent

P. aeruginosaAbsent

Physical & Stability Data

Water Content (Karl Fischer)2.8% w/w

Acetate Content8.2% w/w

Net Peptide Content≥ 89%

pH (1 mg/mL in H₂O)5.8 – 6.4

Loss on Drying< 3.0%

Stability (–20 °C, sealed)36 months

Reconstituted Stability (4 °C)28 days

Peptide Sequence

44 amino acids (trans-3-hexenoyl-GHRH analog)

Testing Laboratory & Chain of Custody

Testing FacilityJanoshik Analytical, LLC

Lab AccreditationISO/IEC 17025:2017

Sample Received2026-07-14

Sample ConditionIntact, sealed, at temp.

Sample IDSMP-NPX-TESAMO-2026-001

Reviewed ByQA Department

Test Methods RefUSP-NF, Ph.Eur. 2.2.29

Report Generated7/14/2026

This Certificate of Analysis certifies that the above-named product has been tested and meets or exceeds all quality specifications as stated. All testing was performed in accordance with established procedures.

Quality Assurance Director

Neurpex Solutions

Disclaimer: This product is intended for research use only (RUO). Not for human or veterinary use. Not intended to diagnose, treat, cure, or prevent any disease. The purchaser assumes all responsibility for the use of this product. Neurpex Solutions makes no claims regarding the safety or efficacy of this product for any purpose other than research.