Description

Cloperastine is a selective, non-narcotic antitussive agent belonging to the diphenylmethane derivative class, widely recognized for its efficacy in suppressing cough reflexes. This compound is valued for its targeted action on the cough center in the medulla oblongata, offering effective relief with a favorable safety profile. It is a critical active pharmaceutical ingredient (API) for manufacturers in the pharmaceutical industry developing prescription and over-the-counter cough suppressant formulations.

Application

• Pharmaceutical API: Primary use as the active ingredient in antitussive (cough suppressant) medications, including syrups, tablets, and lozenges.
• Dry & Productive Cough Formulations: Formulated into products designed to manage both non-productive and productive cough symptoms.
• Pediatric & Adult Cough Syrups: Used in dosage forms suitable for different age groups due to its established efficacy and tolerability.
• Combination Drug Therapies: Incorporated into multi-active preparations alongside expectorants, antihistamines, or decongestants for comprehensive cold and flu relief.
• Veterinary Pharmaceuticals: Application in veterinary medicine for managing cough in animals.
• Clinical Research: Serves as a reference standard and material in pharmacological studies and bioequivalence testing.

Basic Information

Product Name	Cloperastine
CAS No.	3703-76-2
Molecular Formula	C20H24ClNO
Molecular Weight	329.87 g/mol
Synonyms	Cloperastine Hydrochloride; Cloperastine HCl; 1-[2-[(4-Chlorophenyl)phenylmethoxy]ethyl]piperidine; 1-[2-[(p-Chloro-α-phenylbenzyl)oxy]ethyl]piperidine; Seki; Hustazol; Nitossil; Tussiplegyl
EINECS	223-043-8

Quality Control

Our Cloperastine is manufactured under strict quality management systems. Every batch is subjected to comprehensive analytical testing to ensure it meets high-purity pharmacopeial standards, including identity, potency, and impurity profiles. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with agreed specifications. We support audits and can provide regulatory documentation for drug master file (DMF) referencing.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at controlled room temperature (15-25°C). Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White or almost white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%
Microbial Limits	Meets Ph. Eur. / USP requirements

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