Description

Dropropizine CAS NO 17692-31-8 is a non-narcotic antitussive agent belonging to the piperazine derivative class. It is valued for its selective action on the cough center, effectively suppressing cough reflexes without significant sedative effects or risk of respiratory depression. This makes it a critical active pharmaceutical ingredient (API) for manufacturers developing safe and effective over-the-counter (OTC) and prescription cough suppressant formulations.

Application

• Primary Pharmaceutical Ingredient: As the key API in the formulation of antitussive syrups, lozenges, and tablets.
• Pediatric Cough Medications: Due to its favorable safety profile, it is suitable for use in pediatric cough and cold preparations.
• Adult Antitussive Products: Used in various single-ingredient or combination drug products for acute and chronic cough management in adults.
• Dry Cough Suppressants: Particularly effective in formulations targeting non-productive (dry) coughs.
• Generic Drug Manufacturing: Serves as the core component for generic pharmaceutical companies producing bioequivalent cough medicines.
• Contract Manufacturing & Development: Supplied to CDMOs for the development and commercial-scale production of finished dosage forms.

Basic Information

Product Name	Dropropizine
CAS No.	17692-31-8
Molecular Formula	C13H20N2O2
Molecular Weight	236.31 g/mol
Synonyms	Dropropizine; (±)-3-(4-Phenyl-1-piperazinyl)-1,2-propanediol; DL-Dropropizine; 1-Phenyl-4-(2,3-dihydroxypropyl)piperazine; Oxadimedine; Ketotus; Tussafug
EINECS	241-684-8

Quality Control

Our Dropropizine is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity standards suitable for pharmaceutical use. We provide detailed Certificates of Analysis (COA) that include specifications for identity, assay, purity, and related substances, supporting compliance with cGMP and major pharmacopoeial guidelines.

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 to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 1.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	NMT 0.5%
Residue on Ignition	NMT 0.1%
Heavy Metals	NMT 20 ppm

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