Description

(N,N,3-Tridemethyl) Sibutramine Hydrochloride is a high-purity pharmaceutical intermediate and reference standard. This compound is critical for research and development in the fields of medicinal chemistry and pharmacology, particularly for analytical and quality control purposes. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in method development and regulatory compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of sibutramine and related compounds in drug substances and finished products.
• Analytical Method Development: Serves as a critical impurity or degradation product marker for developing and validating chromatographic methods (HPLC, LC-MS) in quality control laboratories.
• Metabolite and Impurity Profiling: Employed in research to study metabolic pathways, identify related substances, and ensure the purity and safety of active pharmaceutical ingredients (APIs).
• Regulatory Compliance & Pharmacopoeial Testing: Essential for testing to meet stringent regulatory requirements from agencies like the FDA and EMA, and for compliance with pharmacopoeial monographs.
• Medicinal Chemistry Research: Used as a building block or intermediate in the synthesis and structure-activity relationship (SAR) studies of novel therapeutic agents.

Basic Information

Product Name	(N,N,3-Tridemethyl) Sibutramine Hydrochloride
CAS No.	84484-93-5
Molecular Formula	C15H22ClN
Molecular Weight	251.80 g/mol
Synonyms	N-Desmethylsibutramine; 1-(4-Chlorophenyl)-N,N,3-trimethyl-1-cyclobutanamine; N-Desmethyl Sibutramine; Sibutramine Impurity C; Sibutramine Related Compound C; 1-(4-Chlorophenyl)-N,N,3-trimethylcyclobutanamine hydrochloride
EINECS	Contact for details

Quality Control

Our (N,N,3-Tridemethyl) Sibutramine Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for reference materials and pharmaceutical intermediates. A detailed Certificate of Analysis (COA) is provided with every shipment, documenting batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 1.0%

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