Description

Hydroxychloroquine Sulfate Ep Impurity A is a high-purity reference standard and pharmaceutical impurity, critical for analytical method development and quality control in drug manufacturing. This compound is essential for ensuring the safety and efficacy of hydroxychloroquine sulfate active pharmaceutical ingredients (APIs) by accurately identifying and quantifying related substances. It is primarily required by pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and contract research organizations (CROs) involved in the development and production of antimalarial and immunomodulatory drugs.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in hydroxychloroquine sulfate bulk drug and finished dosage forms.
• Method Development and Validation: Critical for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, in compliance with ICH guidelines.
• Quality Control and Batch Release: Employed in routine QC testing to monitor impurity profiles and ensure drug substance and product specifications meet pharmacopeial standards (EP, USP).
• Stability Studies: Used to track the formation of degradation products under various stress conditions (heat, light, humidity) as part of forced degradation and long-term stability programs.
• Regulatory Submissions: Provides essential impurity characterization data required for regulatory filings with agencies like the FDA, EMA, and other global health authorities.
• Research and Development: Supports synthetic route optimization and impurity profiling during the API development process.

Basic Information

Product Name	Hydroxychloroquine Sulfate Ep Impurity A
CAS No.	1449223-88-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Hydroxychloroquine Sulfate Related Compound A; Hydroxychloroquine EP Impurity A; Hydroxychloroquine Sulfate Specified Impurity A; 7-Chloro-4-[[4-[ethyl(2-hydroxyethyl)amino]-1-methylbutyl]amino]quinoline Sulfate Impurity; HCQ Sulfate Impurity A; (RS)-2-[[4-[(7-Chloroquinolin-4-yl)amino]pentyl](ethyl)amino]ethanol Sulfate Impurity
EINECS	Contact for details

Quality Control

Our Hydroxychloroquine Sulfate Ep Impurity A is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and traceability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced chromatographic and spectroscopic methods. The quality commitment aligns with the standards required for pharmaceutical impurity reference materials, supporting compliance with EP, USP, and ICH Q3A/B 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). Due to its hygroscopic nature, the material should be handled in a low-humidity environment and the container kept tightly sealed after each use to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%

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