Description

Fenspiride Hydrochloride is a high-purity pharmaceutical active ingredient (API) with significant therapeutic potential. This compound is valued for its anti-inflammatory and bronchodilatory properties, making it a critical intermediate in respiratory medicine research and development. It is primarily sought by pharmaceutical manufacturers and R&D laboratories for the formulation of advanced respiratory treatments and related clinical studies.

Application

• Pharmaceutical API: Primary use as an active pharmaceutical ingredient in the manufacture of prescription respiratory medications.
• Bronchodilator Formulations: Key component in the development of drugs for managing obstructive airway diseases such as asthma and chronic bronchitis.
• Anti-inflammatory Therapeutics: Utilized in research and production of medications targeting inflammatory pathways in respiratory conditions.
• Clinical Research & Development: Serves as a reference standard and building block in preclinical and clinical studies for new therapeutic entities.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for cGMP-compliant drug production.
• Analytical Reference Standard: Used in quality control laboratories for identity confirmation and assay development via HPLC, LC-MS, or NMR.

Basic Information

Product Name	Fenspiride Hydrochloride
CAS No.	5053-08-7
Molecular Formula	C15H20N2O2 • HCl
Molecular Weight	296.79 g/mol
Synonyms	Fenspiride HCl; 8-(2-Phenylethyl)-1-oxa-3,8-diazaspiro[4.5]decan-2-one Hydrochloride; Spiramin; Fenspiridum; Fenspiride Hydrochloride (USP); Respitrol; Fenspiride Hydrochloride (EP); Fenspiride Hydrochloride (Ph. Eur.)
EINECS	225-745-4

Quality Control

Our Fenspiride Hydrochloride is manufactured under strict quality management systems. Each batch is tested to meet stringent specifications for identity, purity, and potency, aligning with pharmacopeial standards such as USP and Ph. Eur. A comprehensive Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and microbiological limits is provided with every shipment to ensure full traceability and regulatory compliance.

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). Due to its hygroscopic nature, the container must be kept tightly sealed to protect from moisture. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Water (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Microbiological Enumeration	Complies with Ph. Eur. 2.6.12/2.6.13

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