Tesofensine analysis

The Tesofensine Analysis is a targeted laboratory test designed to confirm the identity and determine the amount of tesofensine in oral dosage forms, lyophilised vials, and raw active pharmaceutical ingredient (API) powders.

The analysis is suitable for pills, tablets, and capsules, with results reported in milligrams per tablet or capsule, as well as lyophilised samples, with results reported in milligrams per vial. Raw API powders can be evaluated using an alternative result format based on purity in % (m/m). Tesofensine is not a peptide, and peptide purity is therefore not determined as part of this analysis.

About Tesofensine

Tesofensine is a centrally acting monoamine reuptake inhibitor that inhibits the reuptake of serotonin, noradrenaline, and dopamine. Its effects on these neurotransmitter systems have been investigated primarily in relation to appetite regulation and body weight.

Key Features

• Targeted identification and quantification of tesofensine
• Suitable for pills, tablets, capsules, lyophilised vials, and raw API powders
• Analysis by HPLC
• Results for oral products reported in mg per tablet or capsule
• Results for lyophilised samples reported in mg per vial
• Alternative purity reporting in % (m/m)
• Minimum sample amount of three tablets or capsules
• 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: Tesofensine
• CAS number: 195875-84-4
• Testing method: HPLC
• Result format for oral products: mg per tablet or capsule
• Result format for lyophilised samples: mg per vial
• Result format for raw API powders: Purity in % (m/m)
• Minimum sample amount for oral products: Three tablets or capsules
• 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

• Tesofensine is not a peptide. Peptide purity is therefore not measured as part of this analysis.
• This analysis is specifically intended for tesofensine. It does not automatically screen the sample for related compounds, degradation products, contaminants, or undeclared substances.
• For raw API powders, at least 30 mg should be supplied in a sealed glass vial to minimise moisture absorption.
• Purity reporting in % (m/m) is available for raw API powders.

Optional Additional Analyses

The following optional laboratory services are available:

• Complete Raw Analytical Data
• Alternative Result Format: Purity in % (m/m) – only for raw API powders
• Batch Variance Testing
• Fentanyl Screening
• LCMS Screening for Peptide Contamination
• Heavy Metals Analysis (As, Cd, Pb, Hg)
• Additional Laboratory Report