Description

Penfluridol Impurity 3 CAS NO 1270585-14-2 is a high-purity chemical reference standard used for the analytical profiling and quality control of the antipsychotic drug Penfluridol. This impurity is critical for pharmaceutical manufacturers and research laboratories to ensure drug safety, efficacy, and regulatory compliance. It is primarily utilized in method development, stability studies, and the qualification of active pharmaceutical ingredients (APIs) within the pharmaceutical and analytical chemistry sectors.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control and release testing of Penfluridol API and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, or GC methods for accurate impurity detection and quantification.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to identify and monitor impurity profiles in drug substances and products.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Research & Development: Used in synthetic chemistry R&D to understand degradation pathways and optimize the synthesis process of Penfluridol.
• Pharmacopoeial Testing: Supports testing in compliance with pharmacopoeial monographs (e.g., USP, EP) that specify impurity limits.

Basic Information

Product Name	Penfluridol Impurity 3
CAS No.	1270585-14-2
Molecular Formula	C28H27ClF5NO
Molecular Weight	523.97 g/mol
Synonyms	1-[4,4-Bis(4-fluorophenyl)butyl]-4-(4-chloro-3-(trifluoromethyl)phenyl)piperidin-4-ol; Penfluridol Related Compound C; Penfluridol EP Impurity C; Penfluridol USP Impurity C; 4-[4,4-Bis(4-fluorophenyl)butyl]-α,α,α,4-tetrachloro-m-cresol (obsolete); Penfluridol Process Impurity; Penfluridol Degradant
EINECS	Contact for details

Quality Control

Every batch of Penfluridol Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with pharmacopoeial and customer-specific standards. A comprehensive Certificate of Analysis (COA) detailing all test results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material should be handled in accordance with good laboratory practices to prevent contamination.

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)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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