Description

Risperidal Impurity B is a specified impurity and degradation product of the antipsychotic drug Risperidone. It is a critical reference standard used in pharmaceutical research, development, and quality control to ensure drug safety and efficacy. This compound is essential for analytical chemists and quality assurance professionals in the pharmaceutical industry for method validation, stability studies, and impurity profiling.

Application

• Primary use as a pharmaceutical reference standard for Risperidone impurity identification and quantification.
• Critical component in analytical method development and validation (HPLC, GC, LC-MS) for drug substance and product testing.
• Used in stability studies to monitor the formation of degradation products under various stress conditions.
• Essential for impurity profiling to meet ICH Q3A(R2) and Q3B(R2) regulatory guidelines for new drug substances and products.
• Supports pharmaceutical research into the metabolism and degradation pathways of Risperidone.
• Required for quality control laboratories to calibrate equipment and ensure the accuracy of impurity assays.
• Used by contract research organizations (CROs) and generic drug manufacturers for regulatory filings (e.g., ANDA).

Basic Information

Product Name	Risperidal Impurity B
CAS No.	158697-66-6
Molecular Formula	C23H27FN4O2
Molecular Weight	410.49 g/mol
Synonyms	Risperidone Impurity B; Risperidone Related Compound B; 9-Hydroxyrisperidone; Paliperidone; 9-Hydroxy-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one; R 76477; R-76477; INN: Paliperidone
EINECS	Contact for details

Quality Control

Every batch of Risperidal Impurity B is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific 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 is light-sensitive and should be handled accordingly to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5%

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