Description

Fluphenazine Decanoate Impurity 6 is a specified impurity associated with the active pharmaceutical ingredient Fluphenazine Decanoate. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is essential for manufacturers and analytical laboratories in the pharmaceutical industry who require high-purity chemical reference materials to ensure the safety, efficacy, and regulatory compliance of their products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Fluphenazine Decanoate API and finished dosage forms.
• Analytical Method Development: Crucial for developing and optimizing chromatographic methods (HPLC, GC) to separate and analyze process-related impurities.
• Quality Control & Assurance: Used in routine QC testing to monitor impurity profiles and ensure batch-to-batch consistency of the active pharmaceutical ingredient.
• Regulatory Compliance & Filing: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files.
• Stability Studies: Employed to identify and track degradation products that may form during the shelf-life studies of pharmaceutical products.
• Process Chemistry Research: Aids in understanding and controlling impurity formation during the synthesis and purification of Fluphenazine Decanoate.

Basic Information

Item	Details
Product Name	Fluphenazine Decanoate Impurity 6
CAS No.	61555-18-8
Molecular Formula	C32H44F3N3O2S
Molecular Weight	615.77 g/mol
Synonyms	Fluphenazine Decanoate Related Compound; Decanoic acid, 2-[4-[3-[2-(trifluoromethyl)-10H-phenothiazin-10-yl]propyl]-1-piperazinyl]ethyl ester; Fluphenazine Decanoate EP Impurity; Fluphenazine Decanoate USP Related Substance; 10-[3-[4-(2-Decanoyloxyethyl)piperazin-1-yl]propyl]-2-(trifluoromethyl)phenothiazine; Fluphenazine Decanoate Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Fluphenazine Decanoate Impurity 6 is manufactured and analyzed under strict quality systems. Our products undergo rigorous quality testing to ensure compliance with industry standards for pharmaceutical reference materials. Comprehensive characterization is performed using advanced analytical techniques including HPLC, GC-MS, and NMR. Certificates of Analysis (COA) detailing purity, identity, and impurity profile are available upon request for every lot.

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 must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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