Description

Lapatinib Impurity 43 CAS NO 1393112-44-1 is a high-purity chemical 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) Lapatinib, a tyrosine kinase inhibitor. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Lapatinib drug substance and finished products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity levels.
• Quality Control & Assurance (QC/QA): Essential for in-process testing and release testing of Lapatinib batches to meet pharmacopeial (USP, EP) and ICH guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs).
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions during drug stability testing.
• Research & Development: Used in chemical and metabolic studies to understand the degradation pathways and behavior of Lapatinib.

Basic Information

Product Name	Lapatinib Impurity 43
CAS No.	1393112-44-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lapatinib Related Compound 43; Lapatinib EP Impurity 43; Lapatinib USP Impurity 43; Lapatinib Process Impurity 43; 1393112-44-1; Lapatinib Specified Impurity; Tykerb Impurity 43; Tyverb Impurity 43
EINECS	Contact for details

Quality Control

Every batch of Lapatinib Impurity 43 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and strength testing using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as specified on the label or Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
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.