Description

Lurasidone Impurity 2 is a designated impurity standard used in the pharmaceutical development and quality control of the antipsychotic drug Lurasidone Hydrochloride. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, process validation, and compliance testing.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Lurasidone Hydrochloride API and finished dosage forms.
• Essential for analytical method development and validation (HPLC, LC-MS) in quality control laboratories.
• Used in stability studies and forced degradation studies to monitor impurity profiles over time.
• Critical for regulatory compliance and filing, supporting applications to agencies like the FDA and EMA.
• Serves as a key material in process chemistry research to understand and control impurity formation during synthesis.
• Utilized by contract research organizations (CROs) and testing facilities offering analytical services to the pharmaceutical industry.

Basic Information

Product Name	Lurasidone Impurity 2
CAS No.	316363-65-2
Molecular Formula	C28H36N4O2S
Molecular Weight	492.68 g/mol
Synonyms	(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; Lurasidone Related Compound; Lurasidone EP Impurity; Lurasidone USP Impurity; Lurasidone Process Impurity; SM-13496 Impurity
EINECS	Contact for details

Quality Control

Every batch of Lurasidone Impurity 2 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity determination and structural confirmation (NMR, MS), to ensure compliance with pharmaceutical reference standard requirements. Comprehensive Certificates of Analysis (COA) detailing batch-specific results are provided and available upon request.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Single unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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