Description

Lurasidone Metabolite 14326 is a key reference standard and intermediate in the development and quality control of the antipsychotic drug Lurasidone. This compound is critical for pharmaceutical research and manufacturing, enabling precise analysis of drug metabolism, pharmacokinetic studies, and ensuring batch-to-batch consistency. It is primarily utilized by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories involved in drug development and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified standard for the identification and quantification of metabolites in bioanalytical studies.
• Drug Metabolism and Pharmacokinetics (DMPK) Research: Essential for studying the metabolic pathways, clearance, and bioavailability of Lurasidone.
• Impurity Profiling and Control: Serves as a known impurity or degradation product standard to establish specifications for drug substance and product purity.
• Clinical Trial Support: Employed in the bioanalysis of samples from clinical trials to monitor metabolite levels.
• Method Development and Validation: A critical component for developing and validating analytical methods such as HPLC, LC-MS, and GC-MS.
• Regulatory Documentation: Provides essential data for regulatory submissions (e.g., to FDA, EMA) to demonstrate understanding of the drug's metabolic profile.

Basic Information

Product Name	Lurasidone Metabolite 14326
CAS No.	186204-33-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	ID-14326; Lurasidone Metabolite ID-14326; Lurasidone Metabolite 14326; 186204-33-1; Lurasidone Related Compound; Lurasidone Impurity; Lurasidone Degradation Product; Lurasidone Dihydroxy Metabolite
EINECS	Contact for details

Quality Control

Our Lurasidone Metabolite 14326 is produced under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identity confirmation by spectroscopic methods and purity assessment by chromatographic techniques, to ensure it meets the stringent requirements for pharmaceutical reference standards. Certificates of Analysis (COA) with detailed chromatograms and spectral data are provided to support your research and regulatory needs.

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 should be handled in a dry environment to prevent degradation.

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 guidelines
Water Content (KF)	≤ 1.0%

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