Description

Hydroxychloroquine Impurity 7 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Hydroxychloroquine Sulfate. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily utilized in research and development, method validation, and as a reference standard in chromatographic analysis for the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Hydroxychloroquine Sulfate API and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate stability-indicating HPLC/LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Essential for routine batch release testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed as a marker to track impurity formation under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., FDA, EMA) to support drug approval processes.
• Research & Development: Used in synthetic chemistry research to study degradation pathways and to synthesize purer batches of the API.

Basic Information

Product Name	Hydroxychloroquine Impurity 7
CAS No.	47493-14-1
Molecular Formula	C₁₈H₂₆ClN₃O
Molecular Weight	335.87 g/mol
Synonyms	Hydroxychloroquine Related Compound 7; 4-[(7-Chloro-4-quinolyl)amino]-2-[(1S)-1-[(2S)-2-(dimethylamino)ethyl]amino]ethyl]phenol; Desethylhydroxychloroquine; HCQ Impurity 7; Hydroxychloroquine EP Impurity G; Hydroxychloroquine USP Impurity 7; N-Desethyl Hydroxychloroquine
EINECS	Contact for details

Quality Control

Our Hydroxychloroquine Impurity 7 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with every shipment.

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 light-sensitive (store away from light).

Specification

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

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