Description

Risperidone Ep Impurity F CAS NO 1346603-86-8 is a specified impurity of the antipsychotic drug Risperidone, critical for ensuring the quality, safety, and efficacy of the final pharmaceutical product. This compound is essential for analytical method development, validation, and routine quality control testing in pharmaceutical manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality assurance/control (QA/QC) units, and regulatory affairs departments for compliance with stringent pharmacopeial standards like EP (European Pharmacopoeia) and USP (United States Pharmacopeia).

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Risperidone Ep Impurity F in active pharmaceutical ingredient (API) and finished drug product batches.
• Method Development and Validation: Used to develop, optimize, and validate analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques, for impurity profiling.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor and control impurity levels, ensuring every batch of Risperidone API meets the required purity specifications.
• Stability Studies: Acts as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Risperidone and establish appropriate shelf-life.
• Regulatory Submissions: Critical for preparing regulatory documentation (e.g., CMC sections for FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research and Development: Utilized in pharmaceutical R&D to study the synthesis, formation, and behavior of this specific impurity during the drug development process.

Basic Information

Item	Details
Product Name	Risperidone Ep Impurity F
CAS No.	1346603-86-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Risperidone Impurity F; Risperidone Related Compound F; 4-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-3H-pyrido[2,1-b][1,3]thiazin-3-one; Risperidone EP Impurity F; Risperidone Process Impurity F; Risperidone Specified Impurity F
EINECS	Contact for details

Quality Control

Every batch of Risperidone Ep Impurity F is manufactured and tested under strict quality management systems. We provide comprehensive analytical data to support its use as a reference standard, including characterization by HPLC, mass spectrometry, and NMR. A detailed Certificate of Analysis (COA) is supplied with each lot, confirming identity, purity, and traceability. Our quality commitment aligns with the requirements of pharmaceutical impurity standards for regulatory compliance.

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 under dry conditions to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular structure
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)	≤ 5.0%

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