Description

3-Hydroxy Fenspiride is a key pharmaceutical intermediate and metabolite of the drug Fenspiride. This compound matters for its critical role in the synthesis and analytical profiling of active pharmaceutical ingredients (APIs) targeting respiratory conditions. It is primarily needed by pharmaceutical manufacturers and research organizations engaged in drug development, quality control, and metabolic studies.

Application

• Pharmaceutical Intermediate: A crucial building block in the synthesis of Fenspiride hydrochloride and related therapeutic agents.
• Reference Standard: Used as a high-purity analytical standard for HPLC, LC-MS, and other chromatographic methods in quality control laboratories.
• Metabolite Studies: Essential for pharmacokinetic and drug metabolism research to understand the biotransformation pathways of Fenspiride.
• Respiratory Drug R&D: Supports research and development of new anti-inflammatory and anti-bronchoconstrictive medications.
• Impurity Profiling: Employed to identify, quantify, and monitor process-related impurities and degradation products in API batches.

Basic Information

Product Name	3-Hydroxy Fenspiride
CAS No.	441781-23-3
Molecular Formula	C15H20N2O3
Molecular Weight	276.33 g/mol
Synonyms	8-(3-Hydroxyphenyl)-1-oxa-3,8-diazaspiro[4.5]decan-2-one; Fenspiride Metabolite; 3-Hydroxy-8-phenyl-1-oxa-3,8-diazaspiro[4.5]decan-2-one; 1-Oxa-3,8-diazaspiro[4.5]decan-2-one, 8-(3-hydroxyphenyl)-; 3-OH-Fenspiride
EINECS	Contact for details

Quality Control

Our 3-Hydroxy Fenspiride is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical applications. A comprehensive Certificate of Analysis (COA) detailing all test results is provided with every shipment.

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 the container tightly sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤ 0.5%

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