Description

Ziprasidone Deschloro Impurity is a key pharmaceutical reference standard and impurity used in the research, development, and quality control of the antipsychotic drug Ziprasidone. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by enabling accurate identification and quantification of related substances. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method validation, stability studies, and regulatory compliance for generic and innovator drug formulations.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for calibrating analytical instruments and validating testing methods for Ziprasidone.
• Impurity Profiling and Control: Used to identify, monitor, and quantify the deschloro impurity in Ziprasidone Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Method Development and Validation: Essential for developing and validating HPLC, UPLC, and LC-MS methods in compliance with ICH guidelines.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), ANDAs, and other regulatory documentation to demonstrate comprehensive impurity control.
• Quality Assurance/Quality Control (QA/QC): A critical tool for in-process testing and batch release to ensure product specifications are met.
• Academic and Clinical Research: Supports pharmacological and metabolic studies related to Ziprasidone and its impurity pathways.

Basic Information

Product Name	Ziprasidone Deschloro Impurity
CAS No.	118305-72-9
Molecular Formula	C₂₁H₂₁ClN₄O₂S
Molecular Weight	428.94 g/mol
Synonyms	5-[2-[4-(1,2-Benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one; Deschloro Ziprasidone; Ziprasidone Impurity D; Ziprasidone Related Compound D; Ziprasidone EP Impurity D; Ziprasidone USP Impurity D; 6-Chloro-5-[2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-yl]ethyl]-1,3-dihydroindol-2-one
EINECS	Contact for details

Quality Control

Every batch of Ziprasidone Deschloro Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards (USP, EP) and ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

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 under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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