Description

Lurasidone Impurity 27 is a designated impurity reference standard used in the analytical profiling and quality control of the antipsychotic active pharmaceutical ingredient (API), Lurasidone Hydrochloride. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It serves as a key marker for method development, validation, and routine batch testing within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of related substances in Lurasidone API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing and validating stability-indicating chromatographic methods to monitor impurity profiles.
• Quality Control & Batch Release Testing: Used in routine QC laboratories to confirm that Lurasidone batches meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurity limits.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Research & Development: Used in R&D to understand the degradation pathways and synthesis by-products of Lurasidone.

Basic Information

Product Name	Lurasidone Impurity 27
CAS No.	66347-68-0
Molecular Formula	C28H36N4O2S
Molecular Weight	492.68 g/mol
Synonyms	Lurasidone Related Compound 27; Lurasidone EP Impurity G; 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-1H-isoindole-1,3(2H)-dione; SM-13496 Impurity; Latuda Impurity.
EINECS	Contact for details

Quality Control

Every batch of Lurasidone Impurity 27 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC and LC-MS to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatographic data, and traceability information.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 2.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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