PT-141 analysis

The PT-141 Analysis is a targeted laboratory test designed to confirm the identity, determine the amount, and assess the peptide purity of PT-141 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 PT-141

PT-141, also known as bremelanotide, is a synthetic peptide that acts on melanocortin receptors in the central nervous system. It has been studied primarily in relation to sexual response and disorders of sexual desire. In the United States, bremelanotide is approved for the treatment of acquired, generalized hypoactive sexual desire disorder in premenopausal women.

Key Features

• Targeted identification and quantification of PT-141
• 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: PT-141
• CAS number: 189691-06-3
• Molecular weight: 1025
• Sequence: Ac-Nle-Asp(1)-His-D-Phe-Arg-Trp-Lys(1)-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 prevent the sample from absorbing moisture
• Average turnaround time: 7 business days

Important Notice

• This analysis is specifically intended for PT-141. It does not automatically screen the sample for other melanocortin-related peptides, 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