Description

Erlotinib Impurity A is a designated impurity of the active pharmaceutical ingredient Erlotinib Hydrochloride, used in the quality control and regulatory compliance of its manufacturing process. This high-purity reference standard is critical for pharmaceutical companies and analytical laboratories to ensure product safety, efficacy, and adherence to stringent pharmacopeial guidelines. It is essential for research and development, method validation, and stability studies in the production of oncology therapeutics.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the qualitative and quantitative analysis of Erlotinib Hydrochloride drug substance and drug products.
• Analytical Method Development and Validation (HPLC/LC-MS): Used to develop, optimize, and validate chromatographic methods for impurity profiling and identification.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and identification marker in routine batch release testing to monitor impurity levels against ICH Q3A/B thresholds.
• Regulatory Compliance and Filing: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate thorough impurity characterization and control.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (forced degradation studies).
• Research and Development: Used in synthetic chemistry research to understand degradation pathways and to develop robust purification processes for the active ingredient.

Basic Information

Item	Detail
Product Name	Erlotinib Impurity A
CAS No.	1058132-82-3
Molecular Formula	C22H23N3O4
Molecular Weight	393.44 g/mol
Synonyms	N-(3-Ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine; Erlotinib Related Compound A; Erlotinib EP Impurity A; Tarceva Impurity A; 4-Quinazolinamine, N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-; CP-358774 Impurity A; OSI-774 Impurity A
EINECS	Contact for details

Quality Control

Every batch of Erlotinib Impurity A is manufactured and analyzed under strict quality management systems. The material undergoes comprehensive testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances and residual solvents. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications aligned with ICH guidelines. Our quality commitment ensures reliability for your critical analytical and regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

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

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