Description

Erlotinib Impurity 43 is a designated impurity standard used in the pharmaceutical development and quality control of the active pharmaceutical ingredient (API) Erlotinib. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Erlotinib Impurity 43 in Erlotinib API and finished dosage forms.
• Analytical Method Development and Validation: Essential for developing, optimizing, and validating chromatographic methods (HPLC, UPLC) to monitor this specific impurity.
• Quality Control and Batch Release: Employed in routine QC testing to ensure Erlotinib drug substance and product meet stringent pharmacopeial (USP, EP) impurity limits.
• Stability Studies: Used to track the formation and level of this impurity under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., ANDA, NDA) with agencies like the FDA and EMA.
• Research and Development: Supports process chemistry research to understand and minimize the formation of this impurity during API synthesis.

Basic Information

Product Name	Erlotinib Impurity 43
CAS No.	2410548-57-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Erlotinib Related Compound 43; Erlotinib EP Impurity 43; Erlotinib USP Impurity 43; Tarceva Impurity 43; N-(3-Ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine Impurity; (R)-N-(3-Ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine Impurity; Erlotinib Isomer Impurity
EINECS	Contact for details

Quality Control

Our Erlotinib Impurity 43 is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical characterization using advanced techniques such as HPLC, GC, MS, and NMR to confirm identity and purity. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data on purity, impurities, and chromatographic profiles. Our standards are suitable for use in methods intended to comply with USP, EP, ICH, and other international regulatory guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The product is hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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