Description

Lurasidone Impurity 47 Hcl is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Lurasidone HCl. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Lurasidone HCl drug substance and finished products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and other chromatographic methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation of degradation products in Lurasidone formulations under various stress conditions.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submissions (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Research & Development: Used in R&D to study the synthesis pathways, degradation mechanisms, and metabolic pathways related to Lurasidone.
• Quality Control & Batch Release: Acts as a system suitability standard and for routine quality control testing to ensure batch-to-batch consistency and purity of the API.

Basic Information

Product Name	Lurasidone Impurity 47 Hcl
CAS No.	139563-25-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lurasidone Related Compound 47; Lurasidone Impurity 47 Hydrochloride; Lurasidone EP Impurity H; Lurasidone USP Impurity; (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 Hydrochloride; UNII-Contact for details; Lurasidone Process Impurity; Lurasidone Degradant
EINECS	Contact for details

Quality Control

Our Lurasidone Impurity 47 Hcl is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC, NMR, and MS, to confirm identity and ensure high purity suitable for use as a reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay, and impurity profiles. Our quality commitment aligns with ICH Q3A/B guidelines for pharmaceutical impurities.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Single Unknown Impurity	≤ 1.0%
Total Impurities	≤ 2.0%
Residual Solvents (GC)	Complies with ICH limits
Water Content (KF)	≤ 5.0%

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