Description

Ziprasidone Impurity E is a specified impurity of the antipsychotic drug Ziprasidone, identified by the CAS registry number 1159977-04-4. This high-purity reference standard is critical for pharmaceutical research and development, enabling accurate identification, quantification, and control of this impurity to ensure drug safety and efficacy. It is an essential material for analytical laboratories and manufacturers involved in the quality assurance and regulatory compliance of Ziprasidone active pharmaceutical ingredients (APIs) and finished dosage forms.

Application

• Primary use as a certified reference standard (CRS) for analytical method development and validation.
• Critical component in pharmaceutical quality control (QC) for monitoring and controlling impurity profiles in Ziprasidone API batches.
• Essential for stability studies to track the formation of degradation products under various stress conditions.
• Used in regulatory submissions (e.g., for FDA, EMA) to establish impurity limits and justify specifications.
• Serves as a system suitability standard in high-performance liquid chromatography (HPLC) and related chromatographic analyses.
• Valuable for research and development of synthetic routes and purification processes for Ziprasidone.

Basic Information

Item	Details
Product Name	Ziprasidone Impurity E
CAS No.	1159977-04-4
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 E; Ziprasidone EP Impurity E; Ziprasidone USP Impurity E; Ziprasidone Process Impurity; Benzoisothiazole piperazine impurity of Ziprasidone
EINECS	Contact for details

Quality Control

Every batch of Ziprasidone Impurity E is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC and mass spectrometry to ensure compliance with pharmacopeial standards (e.g., USP, EP). 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 controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation.

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: ≤ 1.0% Total impurities: ≤ 2.0%
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.