Description

Fluphenazine Decanoate S-Oxide is a key pharmaceutical intermediate and reference standard in the synthesis and quality control of antipsychotic medications. Its primary value lies in its role as a critical marker compound for ensuring the purity, stability, and regulatory compliance of Fluphenazine Decanoate API and its formulations. This compound is essential for manufacturers and research institutions engaged in the development, production, and analytical validation of long-acting injectable neuroleptic drugs, serving the global pharmaceutical and fine chemical sectors.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of related substances in Fluphenazine Decanoate Active Pharmaceutical Ingredient (API) and finished drug products.
• Impurity Profiling & Analytical Research: Critical for method development and validation in HPLC, LC-MS, and other analytical techniques to monitor degradation products and process-related impurities.
• Stability Studies: Employed as a marker to study the oxidative degradation pathways and shelf-life of Fluphenazine Decanoate formulations under various storage conditions.
• Process Chemistry & R&D: Serves as an intermediate or a key analytical tool in the research, development, and optimization of synthetic routes for phenothiazine-derived antipsychotics.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., with FDA, EMA) by providing essential data for impurity identification and qualification as per ICH guidelines.

Basic Information

Product Name	Fluphenazine Decanoate S-Oxide
CAS No.	64610-50-0
Molecular Formula	C32H44F3N3O3S
Molecular Weight	607.78 g/mol
Synonyms	Fluphenazine Decanoate Sulfoxide; Fluphenazine Decanoate S-Oxide; 2-[4-[3-[2-(Trifluoromethyl)-10H-phenothiazin-10-yl]propyl]-1-piperazinyl]ethyl decanoate S-oxide; Decanoic acid, 2-[4-[3-[2-(trifluoromethyl)-10H-phenothiazin-10-yl]propyl]-1-piperazinyl]ethyl ester, S-oxide; Fluphenazine Decanoate Sulfoxide Impurity; Fluphenazine Decanoate Oxidation Product
EINECS	Contact for details

Quality Control

Our Fluphenazine Decanoate S-Oxide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via IR and MS, to ensure it meets the stringent requirements for use as a reference standard. A detailed Certificate of Analysis (COA) is provided with every shipment, documenting batch-specific results for identity, assay, purity, and related substances.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

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

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