Description

Lurasidon Hydrochloride Impurity is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Lurasidone Hydrochloride by serving as a benchmark in impurity profiling and method validation. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies focused on quality control and compliance in drug development and production.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Lurasidone Hydrochloride API and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical component in developing, optimizing, and validating HPLC, UPLC, and other chromatographic methods for quality control.
• Stability Studies: Employed to monitor the formation and levels of this impurity during forced degradation and long-term stability testing of pharmaceutical products.
• Regulatory Compliance and Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Quality Control (QC) Testing: Used in routine QC laboratories as a system suitability standard and for calibrating equipment to ensure accurate impurity detection.
• Research and Development (R&D): Supports synthetic chemistry research, including studies on impurity formation pathways and the development of purification processes.

Basic Information

Product Name	Lurasidon Hydrochloride Impurity
CAS No.	1260138-03-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lurasidone Related Compound; Lurasidone Impurity; Lurasidone Hydrochloride Related Substance; (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-9F1V7S3A4S; 1260138-03-1; Lurasidone HCl Impurity
EINECS	Contact for details

Quality Control

Our Lurasidon Hydrochloride Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results against stringent in-house specifications. We support compliance with ICH Q3A, Q3B, and Q6A guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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