Description

Ziprasidone Impurity 3 is a designated impurity of the antipsychotic pharmaceutical Ziprasidone. This compound is critical for analytical research and development, serving as a key reference standard in the quality control and regulatory compliance of Ziprasidone active pharmaceutical ingredients (APIs) and finished drug products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and impurity profiling to ensure drug safety and efficacy.

Application

• As a certified reference standard (CRS) for the quantitative and qualitative analysis of Ziprasidone.
• For method development and validation of HPLC, UPLC, and other chromatographic techniques in quality control laboratories.
• In stability studies and impurity profiling to monitor degradation pathways of Ziprasidone formulations.
• Used for pharmacopoeial testing to comply with USP, EP, or ICH guidelines for impurity identification and control.
• Critical for regulatory submissions (e.g., ANDA, NDA) to establish impurity limits and specifications.
• As a research tool in analytical chemistry and pharmaceutical development studies.

Basic Information

Product Name	Ziprasidone Impurity 3
CAS No.	188797-77-5
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; Ziprasidone Related Compound C; Ziprasidone EP Impurity C; Ziprasidone USP Impurity C; Ziprasidone Process Impurity; 6-Chloro-5-[2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-yl]ethyl]-1,3-dihydro-2H-indol-2-one
EINECS	Contact for details

Quality Control

Every batch of Ziprasidone Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic methods, to ensure compliance with pharmacopoeial standards (USP/EP/ICH) and customer-specific requirements. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity data is provided with each shipment.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or 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.