Description

Lurasidone Impurity 50 is a designated impurity reference standard used in the analytical profiling and quality control of the antipsychotic pharmaceutical, Lurasidone Hydrochloride. This high-purity compound is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of process-related impurities. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs departments focused on method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the quantitative and qualitative analysis of Lurasidone and its related substances.
• Method Development and Validation: Used in developing and validating stability-indicating analytical methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control (QC) Testing: Employed in routine batch release testing to monitor and control the levels of specified impurities in active pharmaceutical ingredient (API) and finished drug products.
• Stability Studies: A key component in forced degradation and long-term stability studies to identify and track impurity formation pathways.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., ANDA, NDA, CTA) with agencies like the US FDA and EMA.
• Pharmacopoeial Compliance: Supports testing to meet the stringent impurity limits set by pharmacopoeias such as USP, EP, and JP.

Basic Information

Product Name	Lurasidone Impurity 50
CAS No.	139505-45-6
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 50; Lurasidone EP Impurity J; Lurasidone USP Impurity; Lurasidone Process Impurity; SM-13496 Impurity
EINECS	Contact for details

Quality Control

Our Lurasidone Impurity 50 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is supplied with every shipment, detailing batch-specific results and confirming compliance with relevant specifications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of atmospheric moisture.

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)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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