Description

Lumateperone Impurity 6 is a designated process-related impurity and reference standard used in the analytical profiling of the antipsychotic active pharmaceutical ingredient (API) Lumateperone. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product through rigorous quality control protocols. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Lumateperone API and its formulations.
• Method Development & Validation: Essential for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, in compliance with ICH guidelines.
• Quality Control & Batch Release: Used in the routine testing of Lumateperone drug substance and drug products to monitor and control impurity levels, ensuring they meet pharmacopeial specifications.
• Stability Studies: Employed to identify and quantify degradation products that may form under various stress conditions (e.g., heat, light, humidity) during drug product shelf-life studies.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., FDA, EMA) to support the safety profile of the drug.
• Process Chemistry Research: Aids in the optimization of synthetic routes by identifying and tracking the formation of specific impurities during the manufacturing process.

Basic Information

Product Name	Lumateperone Impurity 6
CAS No.	313368-82-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	ITI-007 Impurity 6; Lumateperone Related Compound 6; (1r,4r)-N-((1s,3s,5s)-Adamantan-2-yl)-1-Methyl-4-Phenylpiperidine-4-Carboxamide; 1-Methyl-4-phenyl-N-(tricyclo[3.3.1.13,7]dec-2-yl)piperidine-4-carboxamide; ITI-007 Process Impurity; Caplyta Impurity 6
EINECS	Contact for details

Quality Control

Our Lumateperone Impurity 6 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. Certificates of Analysis (COA) with detailed chromatographic data and traceable lot information are provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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