Description

Ziprasidone Ring-Opened Impurity (Impurity C) is a specified degradation product and process-related impurity critical for the quality control of the antipsychotic drug Ziprasidone. This impurity is essential for pharmaceutical manufacturers and analytical laboratories to ensure drug safety, efficacy, and regulatory compliance. It is primarily used in research, method development, and as a certified reference standard for impurity identification and quantification in active pharmaceutical ingredients (APIs) and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for analytical method development, validation, and quality control testing of Ziprasidone API.
• Regulatory Compliance & Filing: Used in the preparation of regulatory submission documents (e.g., for FDA, EMA) to characterize and control impurity profiles.
• Stability Studies: Employed as a marker to monitor the formation of degradation products during forced degradation and long-term stability studies of Ziprasidone.
• Process Chemistry R&D: Aids in the optimization of synthetic routes by identifying and quantifying this specific impurity to improve process purity.
• Pharmacopoeial Testing: Used as a system suitability component in chromatographic assays to meet USP, EP, or other pharmacopoeial monograph requirements.
• Academic & Contract Research: Supports research into the metabolism, degradation pathways, and toxicological profile of Ziprasidone and related compounds.

Basic Information

Product Name	Ziprasidone Ring-Opened Impurity (Impurity C)
CAS No.	1798033-44-9
Molecular Formula	C21H21ClN4O2S
Molecular Weight	428.94 g/mol
Synonyms	Ziprasidone Impurity C; Ziprasidone Ring-Opened Degradant; 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)-1-piperazinyl]ethyl]indolin-2-one; Ziprasidone Related Compound C; Ziprasidone EP Impurity C; Ziprasidone USP Impurity C; Ziprasidone Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Ziprasidone Ring-Opened Impurity (Impurity C) is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and quality. Our quality system is designed to support pharmaceutical development and regulatory requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results for identity, assay, purity, and related substances is provided with each shipment.

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) 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)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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