Description

Cloperastine Hydrochloride CAS NO 14984-68-0 is a potent, non-narcotic antitussive agent belonging to the piperidine class, specifically formulated as the hydrochloride salt for enhanced stability and bioavailability. Its primary value lies in providing effective cough suppression by acting centrally on the cough reflex without the sedative effects or dependency risks associated with opioid-based alternatives. This active pharmaceutical ingredient (API) is essential for manufacturers in the pharmaceutical industry developing prescription and over-the-counter cough and cold formulations, including syrups, tablets, and lozenges.

Application

• Pharmaceutical API: Primary use as the key active ingredient in antitussive (cough suppressant) medications.
• Cough Syrup Formulations: Incorporated into liquid oral dosage forms for effective and palatable delivery.
• Tablet & Capsule Manufacturing: Used in the production of solid oral dosage forms for convenient cough relief.
• Pediatric & Adult Cold Preparations: A critical component in multi-symptom relief formulas targeting cough associated with colds and upper respiratory infections.
• Veterinary Pharmaceuticals: Potential application in cough suppression formulations for animal health.
• Research & Development: Serves as a reference standard and building block in pharmacological research for respiratory therapeutics.

Basic Information

Product Name	Cloperastine Hydrochloride
CAS No.	14984-68-0
Molecular Formula	C20H24ClNO • HCl
Molecular Weight	366.33 g/mol
Synonyms	1-[2-[(4-Chlorophenyl)(phenyl)methoxy]ethyl]piperidine hydrochloride; Cloperastine HCl; Cloperastini Hydrochloridum; Chlophedianol Hydrochloride (related); Seki; Contact for details on additional trade names.
EINECS	239-078-1

Quality Control

Our Cloperastine Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, aligning with ICH guidelines and current Good Manufacturing Practices (cGMP). A detailed Certificate of Analysis (COA) is provided with every shipment, documenting critical parameters such as assay, related substances, residual solvents, and microbiological quality.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at a controlled room temperature (15-25°C). The product is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed to minimize exposure to atmospheric humidity.

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 Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.0%
Heavy Metals	≤ 20 ppm
Microbiological Enumeration	Meets Ph. Eur. / USP criteria

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