Description

n-Monodesmethyl Sibutramine HCl is a key pharmaceutical intermediate and reference standard of significant importance in analytical and research chemistry. Its primary value lies in its role as a major metabolite of Sibutramine, making it essential for pharmacokinetic studies, bioanalytical method development, and impurity profiling. This compound is critically needed by pharmaceutical R&D laboratories, contract research organizations (CROs), and manufacturers of reference standards who require high-purity materials for method validation and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantitative and qualitative analysis of Sibutramine and its metabolites in drug substances and products.
• Metabolite Studies: Essential for in-vitro and in-vivo pharmacokinetic and metabolism research to understand the disposition of Sibutramine.
• Impurity Profiling: Serves as a specified impurity marker in the quality control of Sibutramine hydrochloride active pharmaceutical ingredient (API) to ensure compliance with pharmacopeial limits (e.g., ICH Q3B).
• Bioanalytical Method Development: Critical for developing and validating LC-MS/MS and HPLC methods for the detection of Sibutramine metabolites in biological matrices.
• Forensic and Clinical Toxicology: Employed as an analytical standard in forensic labs for the confirmatory testing of Sibutramine and its metabolites.
• Academic and Industrial Research: Used in chemical and pharmacological research investigating the structure-activity relationships of serotonin-norepinephrine reuptake inhibitors.

Basic Information

Product Name	n-Monodesmethyl Sibutramine HCl
CAS No.	84467-94-7
Molecular Formula	C16H26ClN
Molecular Weight	267.84 g/mol
Synonyms	1-(4-Chlorophenyl)-N,N-dimethyl-α-(2-methylpropyl)-cyclobutanemethanamine hydrochloride; BTS 54 505; Desmethylsibutramine hydrochloride; M1 Metabolite of Sibutramine; N-Desmethylsibutramine HCl; Sibutramine Metabolite M1; N-Monodesmethylsibutramine hydrochloride
EINECS	Contact for details

Quality Control

Our n-Monodesmethyl Sibutramine HCl is produced and controlled under a strict quality management system. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identity confirmation by IR and MS, and residual solvent analysis, to ensure it meets the exacting standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data and traceable results are provided for every shipment, supporting compliance with ICH and GMP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥98.0%
Related Substances (HPLC)	Total impurities ≤2.0% Any individual unspecified impurity ≤0.5%
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.1%

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