Description

Ziprasidone Impurity (6-Chloro-5-(2-Chloro-1-Hydroxy-Ethyl)-1,3-Dihydro-Indol-2-One) is a high-purity reference standard critical for the analytical profiling and quality control of the antipsychotic drug Ziprasidone. This compound is essential for pharmaceutical manufacturers and research laboratories to identify, quantify, and monitor this specific process-related impurity, ensuring drug safety and regulatory compliance. Its primary application is in the development, validation, and routine testing of Ziprasidone active pharmaceutical ingredients (APIs) and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of this specific impurity in Ziprasidone API and drug products.
• Method Development & Validation: Critical for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, for Ziprasidone.
• Quality Control & Batch Release: Employed in routine QC testing to ensure impurity levels in commercial batches meet ICH guidelines and regulatory specifications (e.g., USP, EP).
• Stability Studies: Used to track the formation of this impurity under various stress conditions (heat, light, humidity) as part of forced degradation and shelf-life studies.
• Process Chemistry Research: Serves as a marker to optimize synthesis pathways and purification steps to minimize the formation of this impurity during Ziprasidone manufacturing.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).

Basic Information

Product Name	Ziprasidone Impurity (6-Chloro-5-(2-Chloro-1-Hydroxy-Ethyl)-1,3-Dihydro-Indol-2-One)
CAS No.	884305-06-0
Molecular Formula	C10H9Cl2NO2
Molecular Weight	246.09 g/mol
Synonyms	6-Chloro-5-(2-chloro-1-hydroxyethyl)-1,3-dihydro-2H-indol-2-one; 2H-Indol-2-one, 6-chloro-5-(2-chloro-1-hydroxyethyl)-1,3-dihydro-; Ziprasidone Chlorohydrin Impurity; Ziprasidone Related Compound; Ziprasidone Impurity C (Common designation); 6-Chloro-5-(2-chloro-1-hydroxyethyl)oxindole; Ziprasidone Process Impurity
EINECS	Contact for details

Quality Control

Every batch of this impurity standard is manufactured and analyzed under strict quality systems. We provide comprehensive analytical data to support its use as a pharmaceutical reference standard. Our quality commitment includes identity confirmation by spectroscopic techniques (NMR, IR, MS), purity determination by HPLC, and control of related substances. A detailed Certificate of Analysis (COA) is supplied with each lot, containing batch-specific results, chromatograms, and storage recommendations.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The container should be kept in a dry, cool place and handled with care to prevent contamination.

Specification

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

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