Description

Lurasidone Impurity CAS NO 1574569-32-6 is a high-purity chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Lurasidone. This impurity is critical for pharmaceutical manufacturers and research laboratories to ensure the safety, efficacy, and regulatory compliance of their drug products. It is primarily utilized by professionals in pharmaceutical development, quality assurance (QA), and quality control (QC) departments for method validation, stability studies, and impurity identification.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quantitative and qualitative analysis of Lurasidone HCl.
• Method Development and Validation (HPLC/LC-MS): Used to develop, optimize, and validate chromatographic methods for impurity detection and separation.
• Stability Indicating Method: Employed in forced degradation and long-term stability studies to monitor impurity profiles in Lurasidone formulations.
• Quality Control & Batch Release: Essential for setting impurity specifications and ensuring batch-to-batch consistency of the API in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Used in synthetic chemistry research to understand degradation pathways and to synthesize impurity markers.

Basic Information

Product Name	Lurasidone Impurity
CAS No.	1574569-32-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lurasidone Related Compound; Lurasidone Degradant; Lurasidone Process Impurity; UNII-9K8C3V8H2S; (3aR,4S,7R,7aS)-2-[(1R,2R)-2-[4-(1,2-Benzisothiazol-3-yl)piperazin-1-ylmethyl]cyclohexylmethyl]hexahydro-4,7-methano-2H-isoindole-1,3-dione; 9K8C3V8H2S; Lurasidone Impurity (CAS 1574569-32-6)
EINECS	Contact for details

Quality Control

Every batch of Lurasidone Impurity (CAS 1574569-32-6) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC and LC-MS to ensure compliance with pharmacopeial standards. 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 at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing under inert atmosphere to prevent potential degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Assay (HPLC)	95.0% - 105.0%
Residual Solvents (GC)	Complies with ICH Q3C

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