Description

Lurasidone Impurity 17 is a designated pharmaceutical 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 (API) Lurasidone, an atypical antipsychotic. It serves as a key marker for identification and quantification during the drug development and manufacturing process. Pharmaceutical manufacturers, analytical laboratories, and regulatory bodies require this high-purity impurity standard for method validation and quality control testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Lurasidone API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, validating, and verifying chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Lurasidone products meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurity limits.
• Stability Studies: Employed to track the formation and levels of this specific impurity under various stress conditions (e.g., heat, light, humidity) over time.
• Regulatory Submissions: Critical for preparing Chemistry, Manufacturing, and Controls (CMC) documentation required for drug approval by agencies like the FDA and EMA.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to develop purer synthetic routes for Lurasidone.

Basic Information

Product Name	Lurasidone Impurity 17
CAS No.	1807983-67-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lurasidone Related Compound 17; Lurasidone EP Impurity 17; Lurasidone USP Impurity 17; Lurasidone Degradation Product; Lurasidone Process 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; Lurasidone Impurity F (Potential designation)
EINECS	Contact for details

Quality Control

Our Lurasidone Impurity 17 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and compliance with ICH and cGMP guidelines.

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 under inert conditions or in a desiccator after opening to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 95.0% (Area Percent)
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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