Description

10-[3-(Dimethylamino)Propyl]Acridan Hydrochloride is a high-purity chemical impurity standard critical for analytical and quality control processes in pharmaceutical development. This compound serves as a key reference material for the identification, quantification, and control of process-related impurities in active pharmaceutical ingredients (APIs) and finished drug products. It is essential for research and quality assurance laboratories in the pharmaceutical and fine chemical industries that require reliable standards to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for method development, validation, and routine quality control testing of APIs.
• Analytical Research: Serves as a critical standard in High-Performance Liquid Chromatography (HPLC), Liquid Chromatography-Mass Spectrometry (LC-MS), and other spectroscopic techniques for impurity profiling.
• Process Chemistry Monitoring: Employed to track and control the formation of specific impurities during chemical synthesis and scale-up processes.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity identification and characterization.
• Stability Studies: Used to assess the degradation pathways and shelf-life of pharmaceutical compounds under various storage conditions.
• Academic & Contract Research: A vital reagent for universities and CROs (Contract Research Organizations) conducting research in medicinal chemistry and analytical science.

Basic Information

Product Name	10-[3-(Dimethylamino)Propyl]Acridan Hydrochloride (Impurity)
CAS No.	99786-08-0
Molecular Formula	C18H22N2•HCl
Molecular Weight	302.84 g/mol
Synonyms	10-(3-(Dimethylamino)propyl)-9,10-dihydroacridine Hydrochloride; 10-(3-Dimethylaminopropyl)acridan Hydrochloride; Acridan, 10-[3-(dimethylamino)propyl]-, hydrochloride; DAPA Hydrochloride Impurity; N,N-Dimethyl-3-(9,10-dihydroacridin-10-yl)propan-1-amine Hydrochloride
EINECS	Contact for details

Quality Control

Every batch of 10-[3-(Dimethylamino)Propyl]Acridan Hydrochloride is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and mass spectrometry, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with cGMP and ICH Q3A/B guidelines for pharmaceutical impurities.

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 product is hygroscopic (moisture-sensitive) and should be handled 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, Area %)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%

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