Sibutramine analysis

The Sibutramine Analysis is a targeted laboratory test designed to confirm the identity and determine the amount of sibutramine 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 Sibutramine

Sibutramine is a serotonin-noradrenaline reuptake inhibitor (SNRI) that was formerly used as a weight-management medicine. By inhibiting the reuptake of serotonin and noradrenaline, it affects neurotransmitter signalling involved in appetite and satiety.

Sibutramine-containing medicines were suspended in the European Union and withdrawn from the U.S. market after clinical data showed an increased risk of serious cardiovascular events, including heart attack and stroke.

Key Features

• Targeted identification and quantification of sibutramine
• 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: Sibutramine
• Testing method: HPLC
• Minimum amount of target compound for evaluation in oral products: 4 mg per pill, tablet, or capsule
• Minimum content of target compound for evaluation in raw API powders: 5%
• 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 sibutramine. It does not automatically screen the sample for related compounds, contaminants, or undeclared substances.
• For oral products, the minimum amount of sibutramine required for evaluation is 4 mg per pill, tablet, or capsule. For raw API powders, the minimum content is 5%. 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.
• Laboratory confirmation of sibutramine content should not be interpreted as confirmation that a product is safe for human use.

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
• GCMS Contamination Screening
• Heavy Metals Analysis (As, Cd, Pb, Hg)
• Additional Laboratory Report