Ovagen analysis

The Ovagen Analysis is a targeted laboratory test designed to confirm the identity, determine the amount, and assess the peptide purity of Ovagen in lyophilised vials and raw active pharmaceutical ingredient (API) powders.

For lyophilised samples, results are reported in milligrams per vial together with peptide purity. Raw API powders can be evaluated using purity in % (m/m) together with peptide purity.

About Ovagen

Ovagen corresponds to the synthetic tripeptide Glu-Asp-Leu (EDL). This short peptide has been investigated primarily in experimental studies focused on kidney function, renal cell renewal, and responses to kidney injury.

Available scientific evidence is mainly based on laboratory and preclinical studies.

Key Features

• Targeted identification and quantification of Ovagen
• Determination of peptide purity
• Suitable for lyophilised vials and raw API powders
• Analysis by HPLC
• Results for lyophilised samples reported in mg per vial and peptide purity
• Alternative result format for raw API powders includes purity in % (m/m) and peptide purity
• Minimum sample amount of one whole unopened vial with lyophilisate
• Minimum sample amount of 30 mg for raw API powders
• Average turnaround time of 7 business days

Analysis Parameters

• Target compound: Ovagen
• CAS number: 9046-70-2 
• Molecular weight: 375.37
• Sequence: NH2-Glu-Asp-Leu-OH
• Testing method: HPLC
• Minimum amount of target compound for evaluation: Less than 1/20 of the usual dosage per vial
• Result format for lyophilised samples: mg per vial and peptide purity
• Result format for raw API powders: Purity in % (m/m) and peptide purity
• Minimum sample amount for lyophilised samples: One whole unopened vial with lyophilisate
• Minimum sample amount for raw API powders: 30 mg in a sealed glass vial to protect the sample from moisture
• Average turnaround time: 7 business days

Important Notice

• This analysis is specifically intended for Ovagen with the Glu-Asp-Leu (EDL) sequence. It does not automatically screen the sample for other peptides, related compounds, degradation products, contaminants, or undeclared substances.
• For lyophilised samples, one whole unopened vial containing lyophilisate is required.
• Raw API powder should be supplied as at least 30 mg in a sealed glass vial to protect the sample from moisture.
• The alternative result format for raw API powders includes both purity in % (m/m) and peptide purity.

Optional Additional Analyses

The following optional laboratory services are available:

• TFA Analysis
• Complete Raw Analytical Data
• Fentanyl Screening
• Alternative Result Format: Purity in % (m/m)
• Batch Variance Testing
• pH Measurement
• Endotoxin Analysis
• CHNS Mass Report
• LCMS Screening for Peptide Contamination
• Sterility Testing (TAMC + TYMC)
• Heavy Metals Analysis (As, Cd, Pb, Hg)
• Additional Laboratory Report