Description

Hydroxychloroquine 3-Bromo Impurity is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of hydroxychloroquine sulfate active pharmaceutical ingredients (APIs) and finished drug products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, validation, and impurity profiling. The compound is supplied with comprehensive analytical data to support stringent quality control protocols.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of the 3-bromo impurity in hydroxychloroquine sulfate API and drug products.
• Analytical Method Development & Validation: Used as a critical standard for developing and validating HPLC, UPLC, and LC-MS methods to monitor impurity levels.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in pharmaceutical manufacturing to ensure compliance with ICH Q3A/B guidelines on impurities.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Employed as a marker to track impurity formation during forced degradation and long-term stability testing of hydroxychloroquine formulations.
• Research & Development: Used in academic and industrial R&D to study the synthesis pathways, degradation mechanisms, and metabolic pathways of hydroxychloroquine.

Basic Information

Product Name	Hydroxychloroquine 3-Bromo Impurity
CAS No.	2054859-08-2
Molecular Formula	C18H26BrClN3O
Molecular Weight	424.78 g/mol
Synonyms	3-Bromo Hydroxychloroquine; 3-Bromo-7-chloro-4-[[4-(ethylamino)-1-methylbutyl]amino]quinoline; 3-Bromohydroxychloroquine; Hydroxychloroquine Bromo Impurity; Hydroxychloroquine Related Compound B (3-Bromo); HCQ 3-Bromo Impurity; 3-Bromo HCQ; (RS)-2-[[4-[(7-Chloro-4-quinolyl)amino]pentyl]ethylamino]ethanol 3-Bromo Derivative
EINECS	Contact for details

Quality Control

Our Hydroxychloroquine 3-Bromo Impurity is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of purity and identity. Each batch is supplied with a comprehensive Certificate of Analysis (COA) that includes data from multiple orthogonal techniques such as HPLC, NMR, and Mass Spectrometry. Our quality system is designed to meet the stringent requirements for pharmaceutical reference standards, supporting compliance with ICH, USP, and EP guidelines.

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 under inert atmosphere or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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