Description

Hydroxychloroquine Impurity 12 Hydrochloride is a high-purity reference standard critical for pharmaceutical research and development. This compound serves as a specified impurity for the quality control and regulatory compliance of Hydroxychloroquine API and its formulations. It is essential for analytical chemists and quality assurance professionals in the pharmaceutical industry who require reliable standards for method validation, stability studies, and impurity profiling. The material is supplied with comprehensive analytical data to support your regulatory filings.

Application

• Pharmaceutical Impurity Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Hydroxychloroquine Active Pharmaceutical Ingredient (API).
• Analytical Method Development and Validation: Used to develop, optimize, and validate HPLC, UPLC, or GC methods for impurity detection and separation.
• Quality Control & Assurance (QC/QA): Critical for in-process testing and release testing of Hydroxychloroquine batches to ensure they meet pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed to monitor the formation of degradation products in Hydroxychloroquine drug substances and products under various stress conditions.
• Regulatory Compliance & Filing: Supports the preparation of regulatory documents (e.g., for FDA, EMA) by providing characterized impurity profiles required for drug master files (DMFs) and marketing applications.
• Research & Development: Used in metabolic studies, pharmacokinetic research, and to understand the degradation pathways of Hydroxychloroquine.

Basic Information

Product Name	Hydroxychloroquine Impurity 12 Hydrochloride
CAS No.	2411340-31-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Hydroxychloroquine Related Compound 12 HCl; HCQ Impurity 12 Hydrochloride; Hydroxychloroquine EP Impurity H HCl; Hydroxychloroquine USP Impurity 12 HCl; (S)-N'-(7-Chloroquinolin-4-yl)-N-ethyl-N-methylpropane-1,3-diamine Impurity 12 Hydrochloride; Hydroxychloroquine Degradation Product 12 HCl; Hydroxychloroquine Process Impurity 12 Hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Hydroxychloroquine Impurity 12 Hydrochloride is manufactured and analyzed under strict quality management systems. The material undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC, NMR, and MS. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality standards align with the requirements for pharmaceutical reference standards, supporting compliance with ICH guidelines and major pharmacopeias (USP, EP).

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 container should be kept in a desiccated environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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