Description

Lurasidone-D8 Hydrochloride is a high-purity, isotopically labeled internal standard essential for precise quantitative analysis in pharmaceutical research and development. This deuterated compound is critical for ensuring accurate and reliable results in bioanalytical studies, particularly for pharmacokinetic and metabolic profiling. It is primarily used by analytical laboratories, CROs, and pharmaceutical companies engaged in the development and quality control of the antipsychotic drug Lurasidone.

Application

• Internal Standard for LC-MS/MS: Serves as a crucial reference compound for the accurate quantification of Lurasidone and its metabolites in complex biological matrices like plasma, serum, and urine.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Enables precise tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Bioanalytical Method Development and Validation: Used to establish robust, sensitive, and specific analytical methods compliant with FDA, EMA, and ICH guidelines.
• Clinical Trial Support: Provides reliable data on drug exposure and patient variability during clinical phases.
• Forensic and Toxicology Analysis: Aids in the definitive identification and quantification of Lurasidone in forensic investigations.
• Pharmaceutical Quality Control: Supports impurity profiling and stability-indicating assays for drug substance and product manufacturing.

Basic Information

Product Name	Lurasidone-D8 Hydrochloride
CAS No.	1132654-54-6
Molecular Formula	C28H28D8ClN4O2S • HCl
Molecular Weight	529.58 g/mol
Synonyms	Lurasidone-d8 HCl; (3aR,4S,7R,7aS)-2-[(1R,2R)-2-[4-(1,2-Benzisothiazol-3-yl)piperazin-1-ylmethyl]cyclohexylmethyl-d8]hexahydro-4,7-methano-2H-isoindole-1,3-dione hydrochloride; SM-13496-d8 hydrochloride; Lurasidone (D8) Hydrochloride; Deuterated Lurasidone Hydrochloride; Lurasidone Internal Standard D8
EINECS	Contact for details

Quality Control

Our Lurasidone-D8 Hydrochloride is manufactured under strict quality systems to ensure the high chemical and isotopic purity required for sensitive analytical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing parameters such as assay (by HPLC), isotopic enrichment (by MS), and impurity profile. We adhere to relevant industry standards for reference materials, and custom purity grades or specific certifications (e.g., for GLP/GMP environments) are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Enrichment	≥98.0 atom % D
Chemical Purity (NMR)	Conforms
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.