Description

R-(+)-Mono-Desmethylsibutramine is a high-purity chiral intermediate and a key metabolite of the pharmaceutical agent sibutramine. This compound is of significant value for research and development in the pharmaceutical and fine chemical industries, particularly for analytical method development and metabolic studies. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and academic institutions engaged in the synthesis and analysis of central nervous system (CNS) active compounds.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the quality control and assay validation of sibutramine and related compounds in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Metabolite Research: Critical for in-vitro and in-vivo metabolic pathway studies, pharmacokinetic profiling, and bioanalytical method development for sibutramine.
• Chiral Synthesis Intermediate: Used as a building block in the asymmetric synthesis of novel therapeutic agents targeting similar neurological pathways.
• Forensic and Doping Analysis: Employed as an analytical standard in forensic toxicology and anti-doping laboratories for the precise identification and quantification of sibutramine metabolites.
• Impurity Profiling: Essential for identifying, characterizing, and quantifying process-related impurities and degradation products in sibutramine hydrochloride manufacturing.

Basic Information

Product Name	R-(+)-Mono-Desmethylsibutramine
CAS No.	229639-54-7
Molecular Formula	C16H26ClN
Molecular Weight	267.84 g/mol
Synonyms	(1R)-1-(4-Chlorophenyl)-N,N-dimethyl-α-(2-methylpropyl)cyclobutanemethanamine; (R)-Mono-Desmethylsibutramine; R-MDMS; (+)-Mono-Desmethylsibutramine; Sibutramine Metabolite M2 (R-enantiomer); BTS 54 505 (enantiomer); 1-[1-(4-Chlorophenyl)cyclobutyl]-3-methylbutyl(dimethyl)amine (R-form)
EINECS	Contact for details

Quality Control

Our R-(+)-Mono-Desmethylsibutramine is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chiral purity verification by HPLC, to ensure identity, potency, and purity meet stringent specifications. A comprehensive Certificate of Analysis (COA) detailing all test results is provided with every shipment to guarantee traceability and compliance with your research or quality assurance protocols.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The compound is light-sensitive; prolonged exposure to light should be avoided to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Chiral Purity (HPLC)	≥ 99.0% (R-enantiomer)
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤ 0.5%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.