Description

8-Hydroxyclomipramine is a key metabolite and synthetic intermediate of the tricyclic antidepressant clomipramine. This compound matters for its critical role in pharmaceutical research, development, and quality control processes, particularly in metabolism studies and analytical method validation. It is primarily needed by pharmaceutical R&D laboratories, analytical service providers, and manufacturers of active pharmaceutical ingredients (APIs) and reference standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantitative and qualitative analysis of clomipramine and its metabolites in drug substances and finished products.
• Metabolite Studies: Essential for in-vitro and in-vivo pharmacokinetic and pharmacodynamic research to understand the metabolic pathway and activity of clomipramine.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, LC-MS, and GC-MS methods in bioanalytical and quality control laboratories.
• Impurity Profiling: Employed to identify, quantify, and monitor process-related impurities and degradation products in clomipramine API manufacturing.
• Clinical Research: Used in studies investigating the correlation between metabolite levels and therapeutic efficacy or side effects.
• Forensic Toxicology: Acts as a reference compound in forensic analysis for the detection of clomipramine and its metabolites in biological specimens.

Basic Information

Product Name	8-Hydroxyclomipramine
CAS No.	83385-97-1
Molecular Formula	C19H23ClN2O
Molecular Weight	330.85 g/mol
Synonyms	8-Hydroxyclomipramine; 3-(3-Chloro-10,11-dihydro-5-hydroxy-5H-dibenzo[b,f]azepin-5-yl)-N,N-dimethylpropan-1-amine; 5-[3-(Dimethylamino)propyl]-10,11-dihydro-3-chloro-5H-dibenzo[b,f]azepin-5-ol; Clomipramine Metabolite (8-Hydroxy); 8-OH-Clomipramine; 8-Hydroxy Chlorimipramine; 8-Hydroxyclomipramine Hydrochloride (salt form); Norclomipramine related compound
EINECS	Contact for details

Quality Control

Our 8-Hydroxyclomipramine is manufactured under strict quality management systems. 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 high standards required for research and analytical applications. A detailed Certificate of Analysis (COA) is provided with every shipment, confirming compliance with specified parameters.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). The product is light-sensitive and should be handled under appropriate conditions 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
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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