Description

2,4-Difluorobenzoyl Risperidone Impurity is a key chemical reference standard used in the analytical profiling and quality control of the antipsychotic drug Risperidone. This compound is critical for pharmaceutical manufacturers and analytical laboratories to identify, quantify, and control process-related impurities, ensuring final drug product safety and regulatory compliance. It is an essential tool for R&D, method validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for Risperidone API (Active Pharmaceutical Ingredient) quality control.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to develop, calibrate, and validate chromatographic methods for impurity detection and quantification.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies of Risperidone formulations to monitor impurity profiles.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing impurity identity and characterization data for health authorities like the FDA and EMA.
• Process Chemistry Research: Aids in understanding and optimizing the Risperidone synthesis pathway to minimize the formation of this specific impurity.
• Quality Assurance/Quality Control (QA/QC) Testing: Serves as a system suitability and identification marker in routine batch release testing of Risperidone.

Basic Information

Product Name	2,4-Difluorobenzoyl Risperidone Impurity
CAS No.	158697-67-7
Molecular Formula	C23H27F2N3O2
Molecular Weight	415.48 g/mol
Synonyms	Risperidone Impurity F; Risperidone Related Compound F; 3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]ethyl]-2,4-difluoro-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one; 2,4-Difluorobenzoyl Risperidone; Risperidone EP Impurity F; Risperidone USP Related Compound F; 2-Methyl-4-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-α,2,4-trifluoro-γ-oxo-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidine-3-butanol
EINECS	Contact for details

Quality Control

Our 2,4-Difluorobenzoyl Risperidone Impurity is manufactured under strict quality systems suitable for use as a pharmaceutical reference standard. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, NMR, and MS to confirm identity and purity. Certificates of Analysis (COA) with detailed chromatographic data are provided, supporting compliance with ICH guidelines and pharmacopeial standards (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified 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.