Description

Fluphenazine Decanoate Impurity 5 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient, Fluphenazine Decanoate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Control: Serves as a certified reference material for identifying and quantifying this specific impurity in Fluphenazine Decanoate drug substance and finished products.
• Analytical Method Development and Validation: Used as a critical standard to develop, calibrate, and validate HPLC, UPLC, and GC methods for accurate impurity detection.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in pharmaceutical manufacturing to ensure product purity meets pharmacopeial standards (e.g., USP, EP).
• Regulatory Compliance and Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Stability Studies: Employed as a marker to monitor the formation of degradation products in Fluphenazine Decanoate formulations under various storage conditions.
• Research and Development (R&D): Used in synthetic chemistry and pharmacology research to study the metabolism, degradation pathways, and toxicology of Fluphenazine Decanoate.

Basic Information

Product Name	Fluphenazine Decanoate Impurity 5
CAS No.	13220-06-9
Molecular Formula	C32H44F3N3O2S
Molecular Weight	591.78 g/mol
Synonyms	2-[4-[3-[2-(Trifluoromethyl)-10H-phenothiazin-10-yl]propyl]-1-piperazinyl]ethyl decanoate; Decanoic acid, 2-[4-[3-[2-(trifluoromethyl)phenothiazin-10-yl]propyl]-1-piperazinyl]ethyl ester; Fluphenazine Decanoate Related Compound; Fluphenazine Decanoate EP Impurity; Fluphenazine Decanoate USP Impurity; Fluphenazine Decanoate Process Impurity
EINECS	Contact for details

Quality Control

Our Fluphenazine Decanoate Impurity 5 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and traceability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from HPLC, NMR, and MS analyses. We support compliance with ICH Q3A/B guidelines and pharmacopeial standards (USP/EP) for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere at -20°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%

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