Description

Perphenazine Related Compound B is a high-purity chemical reference standard, essential for analytical and research purposes. It serves as a critical impurity marker and system suitability component in the quality control of the antipsychotic drug Perphenazine. This compound is primarily needed by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and ensuring drug safety and efficacy.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of related substances in Perphenazine Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: A critical component for developing and validating stability-indicating HPLC, UPLC, or GC methods in compliance with ICH guidelines.
• Quality Control & Assurance: Employed as a system suitability standard in routine QC testing to ensure the specificity and sensitivity of analytical procedures.
• Pharmacopeial Standards: Serves as a reference compound for testing against pharmacopeial monographs (e.g., USP, EP, BP) that specify limits for related compounds.
• Stability Studies: Used to monitor and quantify degradation products formed during forced degradation and long-term stability studies of Perphenazine.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate control over the manufacturing process and product purity.
• Research & Development: Utilized in metabolic studies, pharmacokinetic research, and the synthesis of novel derivatives.

Basic Information

Product Name	Perphenazine Related Compound B
CAS No.	3533-97-9
Molecular Formula	C₂₁H₂₆ClN₃OS
Molecular Weight	403.97 g/mol
Synonyms	1-{2-[4-(3-(2-Chloro-10H-phenothiazin-10-yl)propyl)piperazin-1-yl]ethyl}pyrrolidin-2-one; 10-[3-[4-(2-Oxo-1-pyrrolidinyl)ethyl]-1-piperazinyl]propyl-2-chlorophenothiazine; Perphenazine Impurity B; Perphenazine Related Substance B; N-Deshydroxyethyl Perphenazine; Perphenazine EP Impurity B; Perphenazine USP Related Compound B
EINECS	Contact for details

Quality Control

Our Perphenazine Related Compound B is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identity confirmation by IR and MS, and residual solvent analysis. We provide full traceability and compliance with current Good Manufacturing Practices (cGMP). A detailed Certificate of Analysis (COA) containing batch-specific results is supplied with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
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.