Description

Fluphenazine Dihydrochloride Ep Impurity B is a critical reference standard used in the analytical profiling and quality control of the antipsychotic pharmaceutical ingredient, Fluphenazine Dihydrochloride. This compound is essential for ensuring the purity, safety, and efficacy of the final drug product by enabling the accurate identification and quantification of this specific impurity during manufacturing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory compliance teams engaged in the development and production of high-purity active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine quality control testing of Fluphenazine Dihydrochloride API.
• Analytical Method Development: Used to establish and optimize chromatographic conditions (e.g., HPLC, UPLC) for the precise separation and detection of this specific impurity.
• Regulatory Compliance & Documentation: Critical for generating impurity profiles and supporting regulatory filings (e.g., with FDA, EMA) to demonstrate product quality and control strategies.
• Stability Studies: Employed to monitor the formation of this impurity over time under various storage conditions, ensuring drug product shelf-life and stability.
• Pharmaceutical Research & Development: Utilized in R&D laboratories to study degradation pathways and impurity formation mechanisms during API synthesis and formulation processes.
• Quality Assurance/Quality Control (QA/QC): Provides a benchmark for in-house testing to ensure batch-to-batch consistency and compliance with pharmacopeial specifications (EP, USP).

Basic Information

Product Name	Fluphenazine Dihydrochloride Ep Impurity B
CAS No.	1476-79-5
Molecular Formula	C22H26F3N3OS • 2HCl
Molecular Weight	510.44 g/mol
Synonyms	Fluphenazine Impurity B; Fluphenazine Dihydrochloride Related Compound B; 2-[4-[3-[2-(Trifluoromethyl)-10H-phenothiazin-10-yl]propyl]piperazin-1-yl]ethanol dihydrochloride; 10-[3-[4-(2-Hydroxyethyl)piperazin-1-yl]propyl]-2-(trifluoromethyl)-10H-phenothiazine dihydrochloride; Fluphenazine EP Impurity B; Fluphenazine Hydrochloride Impurity B; Flufenazin Dihydrochloride Impurity B
EINECS	Contact for details

Quality Control

Our Fluphenazine Dihydrochloride Ep Impurity B is manufactured and handled under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch is characterized and tested using validated analytical methods, including HPLC, for identity, purity, and impurity profile. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant pharmacopeial guidelines. We support GMP/GLP-compliant documentation for regulatory submissions.

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 dry environment to maintain stability and purity. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white powder
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%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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