Description

10-Hydroxydesipramine is a key metabolite and a significant reference standard in pharmaceutical research and development. This compound is essential for analytical method development, pharmacokinetic studies, and metabolic profiling, ensuring accurate quantification and characterization of its parent drug. It is primarily utilized by research institutions, pharmaceutical companies, and contract testing laboratories engaged in drug metabolism and safety evaluation (DMPK) studies.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the quantitative and qualitative analysis of desipramine and its metabolites in various matrices.
• Drug Metabolism and Pharmacokinetics (DMPK): Critical for studying the metabolic pathways, bioavailability, and clearance rates of tricyclic antidepressant drugs.
• Bioanalytical Method Development: Used to validate HPLC, LC-MS, and GC-MS methods for therapeutic drug monitoring and clinical research.
• Impurity Profiling: Employed as a known impurity or degradation product to establish specification limits and ensure drug substance purity.
• Toxicological Studies: Acts as a biomarker in forensic and clinical toxicology to investigate drug exposure and interactions.
• Academic and Clinical Research: Supports fundamental research into the pharmacology and neurochemistry of antidepressant agents.

Basic Information

Product Name	10-Hydroxydesipramine
CAS No.	4014-82-8
Molecular Formula	C18H22N2O
Molecular Weight	282.38 g/mol
Synonyms	10-Hydroxydesipramine; 2-(10-Hydroxy-5H-dibenzo[b,f]azepin-5-yl)-N-methylethanamine; 10-Hydroxy-5-(2-(methylamino)ethyl)-5H-dibenzo[b,f]azepine; Desipramine, 10-hydroxy-; 10-OH-Desipramine; 10-Hydroxydesmethylimipramine; Nortimil metabolite; 10-Hydroxynordesipramine
EINECS	Contact for details

Quality Control

Our 10-Hydroxydesipramine is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identity confirmation by spectroscopic methods (IR, NMR) and purity assessment by HPLC. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific results for assay, related substances, and residual solvents. Our quality commitment ensures the material is suitable for use as a high-purity pharmaceutical reference standard.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere at -20°C to maximize 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%
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.