Description

Clomipramine Ep Impurity A Dihcl is a high-purity chemical reference standard, specifically identified as a dihydrochloride salt impurity associated with the active pharmaceutical ingredient Clomipramine. This compound is critical for analytical method development, validation, and quality control processes in pharmaceutical manufacturing and research. It is primarily utilized by pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and contract research organizations (CROs) to ensure the purity, safety, and efficacy of Clomipramine-based drug products.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Clomipramine API and finished dosage forms.
• Essential for analytical method development and validation (HPLC, UPLC, GC) in compliance with ICH Q2(R1) and other regulatory guidelines.
• Critical component in stability studies and forced degradation studies to profile impurity formation pathways.
• Used in quality control laboratories for routine batch release testing and specification setting.
• Serves as a research tool in pharmacokinetic and metabolic studies to understand impurity behavior.
• Supports regulatory filings (e.g., ANDA, NDA) by providing characterized impurity standards for submission dossiers.

Basic Information

Product Name	Clomipramine Ep Impurity A Dihcl
CAS No.	2305824-51-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Clomipramine Impurity A Dihydrochloride; Clomipramine Related Compound A Dihydrochloride; 3-(3-Chloro-10,11-dihydro-5H-dibenzo[b,f]azepin-5-yl)-N,N-dimethylpropan-1-amine Dihydrochloride (Impurity); Clomipramine EP Impurity A; Clomipramine USP Impurity A; Clomipramine Dihydrochloride Impurity A
EINECS	Contact for details

Quality Control

Every batch of Clomipramine Ep Impurity A Dihcl is manufactured and tested under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including relevant pharmacopoeial monographs (EP, USP). Comprehensive characterization is performed using advanced analytical techniques. Certificates of Analysis (COA) detailing purity, identity, and impurity profile are available upon request to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm

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