Description

Imipramine Impurity Hcl (9-Methyl-10-Dimethylaminopropylacridinium Chloride Hcl) is a high-purity chemical reference standard, specifically identified as a process-related impurity of the tricyclic antidepressant Imipramine. This compound is critical for pharmaceutical research and development, enabling precise analytical method development, validation, and quality control testing of active pharmaceutical ingredients (APIs). It is an essential material for analytical chemists and quality assurance professionals in the pharmaceutical and contract research organization (CRO) sectors who require reliable, well-characterized impurities to ensure drug safety and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify this specific impurity in Imipramine API and finished dosage forms.
• Analytical Method Development and Validation (HPLC/LC-MS): Serves as a critical standard for developing, optimizing, and validating chromatographic methods for impurity detection.
• Stability Studies and Forced Degradation Testing: Employed to understand degradation pathways and establish stability-indicating methods for Imipramine.
• Quality Control and Release Testing: Essential for routine batch analysis in pharmaceutical QC laboratories to ensure impurity levels meet ICH and pharmacopeial guidelines.
• Regulatory Submissions: Provides necessary data and reference samples for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity control.
• Academic and Clinical Research: Supports investigative studies on the metabolism, pharmacokinetics, and toxicological profile of Imipramine and its related compounds.

Basic Information

Product Name	Imipramine Impurity Hcl (9-Methyl-10-Dimethylaminopropylacridinium Chloride Hcl)
CAS No.	70738-29-3
Molecular Formula	C20H25N2•Cl•HCl
Molecular Weight	353.34 g/mol (as hydrochloride salt)
Synonyms	9-Methyl-10-(3-dimethylaminopropyl)acridinium Chloride Hydrochloride; 9-Methyl-10-(γ-dimethylaminopropyl)acridinium Chloride Hydrochloride; Imipramine Acridinium Impurity; Imipramine Related Compound H; Acridinium, 9-methyl-10-[3-(dimethylamino)propyl]-, chloride, hydrochloride (1:1:1); 10-(3-Dimethylaminopropyl)-9-methylacridinium Chloride Hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Imipramine Impurity Hcl is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with ICH Q3A/B guidelines and relevant pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, ensuring full traceability and suitability for GMP-regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. Keep the container tightly sealed in a cool, dry, and well-ventilated place.

Specification

Item	Specification
Appearance	Yellow to orange powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%

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