Dapoxetine analysis

The Dapoxetine Analysis is a targeted laboratory test designed to confirm the identity and determine the amount of dapoxetine in oral dosage forms 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. Raw API powders can be evaluated by percentage content, with optional purity reporting in % (m/m).

About Dapoxetine

Dapoxetine is a short-acting selective serotonin reuptake inhibitor (SSRI) developed for on-demand use. It increases serotonin activity in the central nervous system and is used in some countries for the treatment of premature ejaculation.

Dapoxetine is marketed under names such as Priligy and EJ-30. Its pharmacological profile differs from longer-acting SSRIs commonly used in the treatment of depression and anxiety disorders.

Key Features

• Targeted identification and quantification of dapoxetine
• Suitable for pills, tablets, capsules, and raw API powders
• Analysis by HPLC
• Results for oral products reported in mg per tablet or capsule
• Results for raw API powders reported as percentage content
• Optional purity reporting in % (m/m) for raw API powders
• Minimum sample amount of three tablets or capsules
• Minimum sample amount of 200 mg for raw API powders
• Average turnaround time of 7 business days

Analysis Parameters

• Target compound: Dapoxetine
• Other names: EJ-30, Priligy
• CAS number: 119356-77-3
• Testing method: HPLC
• Minimum amount of target compound for evaluation in oral products: 2 mg per pill, tablet, or capsule
• Minimum content of target compound for evaluation in raw API powders: 10%
• Result format for oral products: mg per tablet or capsule
• Result format for raw API powders: % [98%+, 96%+ or % value such as 94.15%]
• Minimum sample amount for oral products: Three tablets or capsules
• Minimum sample amount for raw API powders: 200 mg
• Average turnaround time: 7 business days

Important Notice

• This analysis is specifically intended for dapoxetine. It does not automatically screen the sample for other SSRIs, related compounds, contaminants, or undeclared substances.
• For oral products, the minimum amount of dapoxetine required for evaluation is 2 mg per pill, tablet, or capsule. For raw API powders, the minimum content is 10%. Samples below these values may not be reliably evaluated within the standard scope of the analysis.
• Purity reporting in % (m/m) is available only 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
• GC–MS Contamination Screening
• Heavy Metals Analysis (As, Cd, Pb, Hg)
• Additional Laboratory Report