Description

Chloroquine Impurity CAS NO 68121-48-2 is a high-purity reference standard critical for analytical and regulatory purposes in the pharmaceutical industry. This compound is essential for the accurate identification, quantification, and control of process-related impurities during the development and manufacturing of Chloroquine and its derivatives. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and quality control laboratories. Utilizing this well-characterized impurity standard is fundamental for ensuring drug safety, efficacy, and compliance with stringent global regulatory guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for method development, validation, and routine quality control testing of Chloroquine Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Impurity Profiling and Identification: Used in analytical techniques like HPLC, LC-MS, and GC-MS to identify and quantify this specific impurity, ensuring it remains within International Council for Harmonisation (ICH) specified limits.
• Regulatory Compliance and Filing: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity understanding and control strategies.
• Research and Development (R&D): Employed in stability studies, forced degradation studies, and synthetic route optimization to understand the formation and fate of this impurity.
• Pharmacopoeial Testing: Used as a system suitability standard in tests prescribed by USP, EP, or other pharmacopoeias for Chloroquine-related monographs.
• Calibration and Qualification: Essential for calibrating analytical instruments and qualifying analytical methods specific to Chloroquine impurity analysis.

Basic Information

Product Name	Chloroquine Impurity
CAS No.	68121-48-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Chloroquine Related Compound; Chloroquine Process Impurity; Chloroquine Specified Impurity; 4-(7-Chloro-4-quinolinyl)amino-α,α-diethyl-1-piperidineethanol impurity; N'-(7-Chloroquinolin-4-yl)-N,N-diethyl-pentane-1,4-diamine impurity; Desethylchloroquine Impurity; Chloroquine Degradant; Chloroquine EP Impurity
EINECS	Contact for details

Quality Control

Every batch of Chloroquine Impurity (CAS 68121-48-2) is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC-MS, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality processes are designed to support compliance with GMP, ICH Q3A/B, and relevant pharmacopoeial guidelines (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). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. 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 standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
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.