Description

2-Hydroxy Imipramine is a key metabolite and chemical intermediate of the tricyclic antidepressant imipramine. This compound matters for its critical role in pharmaceutical research and development, particularly in metabolism studies, analytical method validation, and the synthesis of related active pharmaceutical ingredients (APIs). It is primarily needed by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in drug development, bioequivalence studies, and quality control.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the quantitative and qualitative analysis of imipramine and its metabolites in biological matrices and finished products.
• Metabolite Research: Used in pharmacokinetic and pharmacodynamic studies to understand the metabolic pathways, efficacy, and safety profile of imipramine.
• Active Pharmaceutical Ingredient (API) Synthesis: Acts as a crucial synthetic intermediate in the production and process development of tricyclic antidepressant compounds.
• Analytical Method Development: Employed for calibrating equipment and validating analytical methods such as HPLC, LC-MS, and GC-MS in quality control laboratories.
• Biochemical Research: Utilized in in-vitro studies to investigate the biochemical interactions and mechanisms of action of tricyclic antidepressants.

Basic Information

Product Name	2-Hydroxy Imipramine
CAS No.	303-70-8
Molecular Formula	C19H24N2O
Molecular Weight	296.41 g/mol
Synonyms	2-Hydroxyimipramine; Desipramine, 2-hydroxy-; 10,11-Dihydro-5-[3-(methylamino)propyl]-5H-dibenzo[b,f]azepin-2-ol; 2-OH-Imipramine; Imipramine 2-Hydroxy Metabolite; 5-(3-Methylaminopropyl)-10,11-dihydro-5H-dibenzo[b,f]azepin-2-ol
EINECS	Contact for details

Quality Control

Our 2-Hydroxy Imipramine is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure high purity and consistency, meeting the stringent requirements for pharmaceutical reference standards and intermediates. Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are provided with every shipment.

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). This product is light-sensitive and should be handled accordingly to maintain stability.

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
Loss on Drying	≤ 0.5%

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