Description

Fluphenazine Decanoate Impurity 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 (API) Fluphenazine Decanoate. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of specific impurities in Fluphenazine Decanoate API and finished drug products.
• Analytical Method Development & Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for accurate impurity analysis.
• Quality Control & Assurance (QC/QA): Essential for in-process testing and final release testing of pharmaceutical batches to meet stringent pharmacopeial standards (e.g., USP, EP, ICH).
• Stability Studies: Employed to monitor and quantify impurity formation in drug substances and products under various stress and storage conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Supports chemical research into the degradation pathways and metabolism of Fluphenazine Decanoate.

Basic Information

Product Name	Fluphenazine Decanoate Impurity
CAS No.	2285-19-0
Molecular Formula	C32H44F3N3O2S
Molecular Weight	591.78 g/mol
Synonyms	Fluphenazine Decanoate Related Compound; 2-[4-[3-[2-(Trifluoromethyl)-10H-phenothiazin-10-yl]propyl]piperazin-1-yl]ethyl decanoate; Decanoic acid, 2-[4-[3-[2-(trifluoromethyl)phenothiazin-10-yl]propyl]-1-piperazinyl]ethyl ester; Fluphenazine 10H-Decanoate Ester; Fluphenazine Decanoate Analog; Prolixin Decanoate Impurity
EINECS	Contact for details

Quality Control

Our Fluphenazine Decanoate Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC, GC, and NMR, to ensure high purity and accurate identification. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, supporting compliance with ICH Q3A/B guidelines and pharmacopeial requirements for impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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