Description

Lapatinib Impurity 31 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Lapatinib. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and quality assurance of oncology therapeutics.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Lapatinib API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating stability-indicating HPLC/UPLC methods in compliance with ICH guidelines.
• Quality Control & Batch Release Testing: Employed in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency of the drug substance.
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and shelf-life studies.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to establish impurity profiles and justify specification limits.
• Research & Development: Supports impurity characterization and route scouting during the synthetic process development of Lapatinib.

Basic Information

Item	Details
Product Name	Lapatinib Impurity 31
CAS No.	1393112-43-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lapatinib Related Compound 31; Lapatinib EP Impurity I; Lapatinib USP Impurity; N-[3-Chloro-4-[(3-fluorophenyl)methoxy]phenyl]-6-[5-[(2-methylsulfonylethylamino)methyl]-2-furyl]quinazolin-4-amine; Tykerb Impurity 31; Tyverb Impurity 31
EINECS	Contact for details

Quality Control

Our Lapatinib Impurity 31 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity determination and spectroscopic characterization (NMR, MS), to ensure identity, strength, and composition. Certificates of Analysis (COA) with detailed chromatographic data are provided to support its use as a pharmaceutical reference standard.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

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)	Any individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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