Description

Hydroxychloroquine Sulfate Ep Impurity C-D4 (Desethyl Hydroxy Chloroquine-D4) is a deuterated impurity standard used for the analytical profiling and quality control of the active pharmaceutical ingredient hydroxychloroquine sulfate. This compound is essential for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It serves as a critical reference material for method development and validation in pharmacokinetic studies and stability testing. The CAS number for this compound is 1854126-47-8.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of desethyl hydroxy chloroquine impurity in hydroxychloroquine sulfate active pharmaceutical ingredient (API) batches.
• Analytical Method Development & Validation: Critical for developing and validating sensitive and accurate HPLC, LC-MS, and GC-MS methods in quality control laboratories.
• Pharmacokinetic and Metabolism Studies: Used as an internal standard in mass spectrometry to study the metabolic pathways and bioavailability of hydroxychloroquine, leveraging its deuterated (D4) label for precise tracking.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., with FDA, EMA) by providing necessary data on impurity profiles for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Indicating Method: Employed in forced degradation studies to monitor the formation of this specific degradant under various stress conditions (light, heat, humidity).
• Contract Research & Manufacturing (CRO/CMO): Essential for third-party testing facilities and manufacturers offering analytical services for antimalarial and immunomodulatory drugs.

Basic Information

Product Name	Hydroxychloroquine Sulfate Ep Impurity C-D4 (Desethyl Hydroxy Chloroquine-D4)
CAS No.	1854126-47-8
Molecular Formula	C18H22D4ClN3O (Free Base) • H2SO4
Molecular Weight	~433.96 g/mol (as sulfate salt)
Synonyms	Desethylhydroxychloroquine-d4; 2-[[4-[(7-Chloro-4-quinolyl)amino]pentyl](ethyl-d4)amino]ethanol Sulfate; Hydroxychloroquine EP Impurity C-D4; Hydroxychloroquine Sulfate Impurity C (D4); HCQ Impurity C-D4; Desethyl Hydroxy Chloroquine D4 Sulfate; 4-Aminoquinoline Derivative Impurity Standard-d4
EINECS	Contact for details

Quality Control

Every batch of Hydroxychloroquine Sulfate Ep Impurity C-D4 is manufactured and analyzed under strict quality management systems. It is characterized using advanced spectroscopic and chromatographic techniques to ensure identity, purity, and isotopic enrichment. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for assay, isotopic purity, and related substances. Our quality protocols are designed to meet the stringent requirements of pharmaceutical reference standard production, supporting compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, ideally between 2°C and 8°C for long-term stability. Due to its hygroscopic (moisture-sensitive) nature, the container must be kept in a dry environment. Avoid frequent temperature fluctuations.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D4)	≥ 98.0 atom % D
Chemical Purity	≥ 95.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.1%

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