Description

Hydroxychloroquine Impurity 9 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of hydroxychloroquine sulfate active pharmaceutical ingredients (APIs) and finished drug products. It is an essential tool for pharmaceutical manufacturers, contract research organizations (CROs), and quality control laboratories involved in method development, validation, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary application as a certified impurity standard for the identification and quantification of related substances in hydroxychloroquine sulfate API and formulations.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to develop, optimize, and validate chromatographic methods for impurity profiling and stability-indicating assays.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and calibration standard in routine quality control testing to monitor batch-to-batch consistency.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing characterized impurity data for submission to agencies like the US FDA and EMA.
• Stability Studies: Employed in forced degradation and long-term stability studies to track impurity formation and establish shelf-life specifications.
• Research & Development: Used in pharmaceutical R&D for studying the degradation pathways and metabolism of hydroxychloroquine.

Basic Information

Product Name	Hydroxychloroquine Impurity 9
CAS No.	91911-59-0
Molecular Formula	C18H26ClN3O
Molecular Weight	335.87 g/mol
Synonyms	Hydroxychloroquine Related Compound 9; HCQ Impurity 9; (S)-2-((7-Chloro-4-quinolinyl)amino)-5-((1-ethyl-4-hydroxy-4-methylpentyl)amino)pentanol; 1H-Imidazole-4-methanol, α-(2-chloro-6-fluorophenyl)-1-methyl-; 4-Quinolinemethanol, 7-chloro-4-[[(2S)-2-[[4-[(1-ethyl-4-hydroxy-4-methylpentyl)amino]-1-methylbutyl]amino]ethyl]amino]-; Hydroxychloroquine EP Impurity B; Hydroxychloroquine USP Related Compound C
EINECS	Contact for details

Quality Control

Our Hydroxychloroquine Impurity 9 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. Certificates of Analysis (COA) with detailed chromatographic data are provided and traceable to primary standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent degradation from atmospheric moisture.

Specification

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

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