Description

Lurasidone Impurity CAS NO 85026-47-7 is a high-purity chemical reference standard used in the development and quality control of the antipsychotic pharmaceutical, Lurasidone Hydrochloride. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of related substances. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and manufacturers engaged in the production of Lurasidone and its generic formulations.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine quality control testing of Lurasidone API and finished dosage forms.
• Analytical Research: Used in HPLC, UPLC, and LC-MS studies for the identification, characterization, and quantification of process-related impurities and degradation products.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) to establish impurity profiles and justify specification limits as per ICH Q3A/B guidelines.
• Stability Studies: Employed as a marker to monitor the formation of specific impurities during forced degradation and long-term stability studies of Lurasidone.
• Process Chemistry Optimization: Used by chemical development scientists to identify and minimize the formation of this impurity during the synthesis and purification of Lurasidone.

Basic Information

Product Name	Lurasidone Impurity
CAS No.	85026-47-7
Molecular Formula	C28H36N4O2S
Molecular Weight	492.68 g/mol
Synonyms	Lurasidone Related Compound; Lurasidone Impurity A (Potential); (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; UNII-9K5L8P8S6F; 9K5L8P8S6F; Hexahydro-4,7-methano-2H-isoindole-1,3-dione, 2-[[(1R,2R)-2-[[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]methyl]cyclohexyl]methyl]-, (3aR,4S,7R,7aS)-
EINECS	Contact for details

Quality Control

Every batch of Lurasidone Impurity (85026-47-7) is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) detailing purity (typically ≥95% by HPLC), chromatographic data, and spectral confirmation (IR, MS, NMR) is provided with each shipment to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

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 unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
Residual Solvents (GC)	Complies with ICH Q3C
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.