Description

Perospirone Impurity 14 is a designated impurity standard of the atypical antipsychotic drug Perospirone. This compound is critical for pharmaceutical research, development, and quality control, where precise identification and quantification of impurities are mandated by regulatory authorities. It is primarily used by analytical chemists, quality assurance professionals, and R&D scientists in the pharmaceutical industry to ensure drug safety, efficacy, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Perospirone Impurity 14 in active pharmaceutical ingredient (API) and finished drug product analysis.
• Method Development and Validation: Essential for developing and validating sensitive analytical methods, such as HPLC and LC-MS, for impurity profiling of Perospirone.
• Quality Control and Batch Release: Serves as a critical system suitability standard in QC laboratories to monitor impurity levels and ensure batch-to-batch consistency of Perospirone API.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific impurity under various stress conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to establish impurity thresholds and justify specifications.
• Process Chemistry Research: Used by chemists to understand and optimize synthetic pathways to minimize the formation of this impurity during Perospirone manufacturing.

Basic Information

Product Name	Perospirone Impurity 14
CAS No.	87691-94-9
Molecular Formula	C23H30N4O2S
Molecular Weight	426.58 g/mol
Synonyms	1-{4-[4-(1,2-Benzisothiazol-3-yl)-1-piperazinyl]butyl}-1,3-dihydro-2H-benzimidazol-2-one; UNII-8JQ5607E5S; 8JQ5607E5S; Perospirone Related Compound; Perospirone EP Impurity; Perospirone USP Impurity
EINECS	Contact for details

Quality Control

Every batch of Perospirone Impurity 14 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B guidelines and can supply materials qualified against USP or EP monographs upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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