Description

Lumateperone Impurity 3 is a designated reference standard used in the analytical profiling and quality control of the antipsychotic pharmaceutical Lumateperone. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, development, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Lumateperone API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurities.
• Quality Control & Assurance (QC/QA): A critical component in routine batch release testing to ensure drug substance and product meet stringent purity specifications.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., with FDA, EMA) by providing necessary data on impurity profiles for drug approval and post-market surveillance.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions to establish shelf life.
• Research & Process Chemistry: Used in synthetic route development and optimization to understand and minimize impurity formation during the manufacturing process.

Basic Information

Item	Details
Product Name	Lumateperone Impurity 3
CAS No.	313544-76-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lumateperone Related Compound 3; ITI-007 Impurity 3; (1r,4r)-N-((1-(4-Fluorophenyl)-1H-indol-3-yl)methyl)-6-methyl-2,5-diazabicyclo[2.2.1]heptane-2-carboxamide; Caplyta Impurity 3; 2,5-Diazabicyclo[2.2.1]heptane-2-carboxamide, N-[[1-(4-fluorophenyl)-1H-indol-3-yl]methyl]-6-methyl-, (1R,4R)-
EINECS	Contact for details

Quality Control

Our Lumateperone Impurity 3 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic identification (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profile is provided with every shipment.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum consistent with structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 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.