Description

Ziprasidone Impurity B (CAS NO 1159977-56-6) is a high-purity reference standard critical for ensuring the quality and safety of the active pharmaceutical ingredient Ziprasidone. This compound is essential for pharmaceutical research, development, and quality control laboratories to accurately identify, quantify, and monitor this specific impurity during manufacturing. It is primarily used by analytical chemists and quality assurance professionals in the pharmaceutical industry for method validation, stability studies, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the identification and quantification of Ziprasidone Impurity B in drug substances and finished products.
• Analytical Method Development & Validation: Used as a critical component in developing and validating HPLC, UPLC, or GC methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure Ziprasidone API and formulations meet stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Stability Studies: A key analyte in forced degradation and long-term stability studies to monitor impurity formation over time and under various stress conditions.
• Regulatory Compliance & Filings: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Research & Development: Used in synthetic chemistry R&D to understand and control the formation pathways of this impurity during the manufacturing process.

Basic Information

Product Name	Ziprasidone Impurity B
CAS No.	1159977-56-6
Molecular Formula	C21H21ClN4OS
Molecular Weight	412.94 g/mol
Synonyms	5-[2-[4-(1,2-Benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one; 6-Chloro-5-[2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-yl]ethyl]indolin-2-one; Ziprasidone Related Compound B; Des-hydroxy Ziprasidone; Ziprasidone EP Impurity B; Ziprasidone USP Impurity B
EINECS	Contact for details

Quality Control

Every batch of Ziprasidone Impurity B is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques like HPLC and mass spectrometry to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and residual solvents.

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 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)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
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.