Description

Ziprasidone Impurity C is a designated process-related impurity used in the analytical profiling and quality control of the antipsychotic drug Ziprasidone. This high-purity reference standard is critical for pharmaceutical manufacturers and analytical laboratories to ensure drug safety, efficacy, and regulatory compliance. It is primarily utilized in research and development, method validation, and routine batch release testing within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Ziprasidone Impurity C in active pharmaceutical ingredient (API) and finished drug product analysis.
• Method Development and Validation: Essential for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control (QC) Testing: Used in routine QC laboratories to assess the purity of Ziprasidone API against pharmacopeial (e.g., USP, EP) and internal specifications.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) to establish drug shelf-life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Process Chemistry Research: Aids in understanding and optimizing the Ziprasidone synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Ziprasidone Impurity C
CAS No.	1159977-64-6
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; Ziprasidone Related Compound C; Ziprasidone EP Impurity C; Ziprasidone USP Impurity C; 6-Chloro-5-[2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-yl]ethyl]-1,3-dihydroindol-2-one; Ziprasidone Impurity 3; A potential impurity of Ziprasidone
EINECS	Contact for details

Quality Control

Our Ziprasidone Impurity C is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to maintain stability and purity.

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: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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