Description

Lurasidone Inactive Metabolite 14283 is a key chemical reference standard and impurity used in pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of the antipsychotic drug Lurasidone hydrochloride by providing a benchmark for metabolic profiling and impurity control. It is an essential material for analytical laboratories, regulatory affairs, and quality control departments within the pharmaceutical and biotechnology industries.

Application

• Pharmaceutical Reference Standard: Used as a certified standard for the identification and quantification of the inactive metabolite in drug substance and finished product testing.
• Metabolite Profiling & Pharmacokinetic Studies: Essential for in-vitro and in-vivo studies to understand the metabolic pathways and clearance of Lurasidone.
• Impurity Control & Method Development: Serves as a critical impurity marker for developing and validating analytical methods (e.g., HPLC, LC-MS) to monitor product purity.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on drug metabolites for New Drug Applications (NDAs) and Investigational New Drugs (INDs).
• Quality Assurance/Quality Control (QA/QC): Employed in routine batch release testing to ensure drug products meet stringent purity specifications.
• Stability Studies: Used as a reference to track the formation of degradation products during drug stability testing under various conditions.

Basic Information

Product Name	Lurasidone Inactive Metabolite 14283
CAS No.	186204-32-0
Molecular Formula	C28H36N4O2S
Molecular Weight	492.68 g/mol
Synonyms	ID-14283; Lurasidone Metabolite 14283; (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-5R6O1F6WQH; Lurasidone Metabolite ID14283; Lurasidone Related Compound 14283; Lurasidone Impurity 14283
EINECS	Contact for details

Quality Control

Our Lurasidone Inactive Metabolite 14283 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide Certificates of Analysis (COA) with detailed results to support your regulatory and research needs. The material is suitable for use as a pharmaceutical reference standard in compliance with ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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