Description

(Risperidone Impurity) CAS NO 1005191-81-0 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient Risperidone by accurately identifying and quantifying related impurities. It is an essential tool for analytical chemists, quality assurance professionals, and researchers working in pharmaceutical R&D and quality control laboratories to meet stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and characterize unknown impurities in Risperidone API and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity detection.
• Quality Control and Batch Release Testing: Employed in routine QC testing to quantify specific impurities, ensuring every batch of Risperidone meets the specifications of USP, EP, or ICH guidelines.
• Stability Studies and Forced Degradation: Acts as a marker in stability-indicating assay methods to monitor impurity levels over time and under stress conditions.
• Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity control and adherence to ICH Q3A/B guidelines.
• Research and Process Chemistry: Used by process chemists to understand and control the formation of this impurity during the synthesis and purification of Risperidone.

Basic Information

Item	Details
Product Name	(Risperidone Impurity) CAS NO 1005191-81-0
CAS No.	1005191-81-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Risperidone Related Compound; Risperidone Impurity Standard; Risperidone Specified Impurity; Pharmaceutical Secondary Standard; 1005191-81-0; Risperidone Process Impurity; Reference Material for HPLC; Chemical Reference Standard
EINECS	Contact for details

Quality Control

Every batch of this impurity standard is produced and analyzed under strict quality systems. Certificates of Analysis (COA) are provided, detailing comprehensive testing via validated methods such as HPLC for purity and identity confirmation (IR, NMR). Our quality commitment ensures alignment with ICH Q3A, Q3B, USP, and EP guidelines for impurities in new drug substances and products. We support our clients' regulatory needs with full traceability and documentation.

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 (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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