Description

Hydroxychloroquine Impurity 14 CAS NO 860544-46-3 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure the purity, safety, and efficacy of hydroxychloroquine drug substances and finished products. It is primarily required by professionals in pharmaceutical development, quality assurance (QA), and regulatory affairs for method validation, impurity profiling, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of specific impurities in hydroxychloroquine active pharmaceutical ingredients (APIs) and formulations.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for impurity detection.
• Quality Control (QC) and Quality Assurance (QA): Essential for routine batch testing in pharmaceutical QC laboratories to monitor impurity levels and ensure product specifications are met.
• Regulatory Compliance and Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity characterization data required for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed in forced degradation and long-term stability studies of hydroxychloroquine to track impurity formation over time and under various stress conditions.
• Research and Development: Used in academic and industrial R&D settings to study the degradation pathways and metabolism of hydroxychloroquine.

Basic Information

Product Name	Hydroxychloroquine Impurity 14
CAS No.	860544-46-3
Molecular Formula	C18H26ClN3O
Molecular Weight	335.87 g/mol
Synonyms	Hydroxychloroquine Related Compound 14; (2S)-2-[(4-[(7-Chloro-4-quinolyl)amino]pentyl)(ethyl)amino]ethanol; 2-[[4-[(7-Chloro-4-quinolinyl)amino]pentyl](ethyl)amino]ethanol; N4-(7-Chloro-4-quinolinyl)-N1,N1-diethyl-1,4-pentanediamine N-Oxide; HCQ Impurity 14; Hydroxychloroquine EP Impurity G; Hydroxychloroquine USP Impurity
EINECS	Contact for details

Quality Control

Our Hydroxychloroquine Impurity 14 is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR), purity assessment by HPLC, and determination of residual solvents. Certificates of Analysis (COA) with detailed chromatographic data and batch-specific results are provided to ensure full traceability and compliance with pharmaceutical reference standard requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to prevent potential degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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