Description

Cloperastine Impurity 3 is a high-purity reference standard used in the analytical profiling and quality control of the antitussive pharmaceutical, Cloperastine Hydrochloride. This impurity is critical for ensuring the safety and efficacy of the final drug product by enabling accurate identification and quantification during manufacturing. It is an essential material for pharmaceutical R&D laboratories, quality assurance departments, and regulatory bodies focused on method development, validation, and compliance with ICH guidelines.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for analytical method development and validation in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance: Used in HPLC, LC-MS, and GC-MS systems for the identification, qualification, and quantification of related substances in Cloperastine Hydrochloride active pharmaceutical ingredient (API) and finished dosage forms.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Employed as a marker to monitor impurity profiles in stability-indicating methods for Cloperastine formulations under various stress conditions.
• Process Chemistry R&D: Aids in the optimization of synthesis and purification processes by tracking the formation and elimination of this specific impurity.
• Pharmacopoeial Testing: Potential use as a system suitability standard for pharmacopoeial monographs (e.g., USP, EP) as they are established for Cloperastine.

Basic Information

Product Name	Cloperastine Impurity 3
CAS No.	5630-78-4
Molecular Formula	C20H24ClNO
Molecular Weight	329.87 g/mol
Synonyms	1-[2-[(4-Chlorophenyl)(phenyl)methoxy]ethyl]piperidine; 4-Chloro-α-phenylbenzenemethanol 2-(1-Piperidinyl)ethyl Ether; Cloperastine Related Compound C; Cloperastine EP Impurity C; Cloperastine USP Impurity C; UCB 1967 Impurity; Fustran Impurity
EINECS	Contact for details

Quality Control

Every batch of Cloperastine Impurity 3 is manufactured and handled under strict quality management systems. The material undergoes comprehensive analytical characterization using advanced techniques including HPLC, GC-MS, and NMR to confirm identity and purity. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data on purity, related substances, and residual solvents. Our quality protocols are designed to meet the stringent requirements for pharmaceutical reference standards and support compliance with cGMP and ICH 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 (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider desiccants or inert atmosphere.

Specification

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

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