Description

Erlotinib 3-Bromo Impurity is a high-purity chemical reference standard used for analytical and research purposes. This compound is a specified impurity of Erlotinib, a critical active pharmaceutical ingredient (API) used in targeted cancer therapy. It is essential for pharmaceutical manufacturers and analytical laboratories conducting method development, validation, and quality control to ensure the purity and safety of the final drug product. The compound is identified by the CAS Number 2055840-41-8.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of the 3-Bromo impurity in Erlotinib API and finished drug products.
• Analytical Method Development: Critical for developing and optimizing HPLC, UPLC, or LC-MS methods to separate and detect this specific impurity.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity profiles and ensure compliance with ICH Q3A/B guidelines and pharmacopeial standards (USP, EP).
• Stability Studies: Employed to track the formation of degradation impurities in Erlotinib formulations under various stress conditions.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Research & Development: Supports synthetic chemistry research, including impurity synthesis, characterization, and toxicological studies.

Basic Information

Product Name	Erlotinib 3-Bromo Impurity
CAS No.	2055840-41-8
Molecular Formula	C22H23BrN4O4
Molecular Weight	487.35 g/mol
Synonyms	3-Bromo Erlotinib; Erlotinib Bromo Impurity; N-(3-Ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-[(3-bromophenyl)amino]quinazoline; Tarceva 3-Bromo Impurity; CP-358774 3-Bromo Impurity; OSI-774 3-Bromo Impurity; Erlotinib Related Compound B (if specified); 4-[(3-Bromophenyl)amino]-6,7-bis(2-methoxyethoxy)quinazoline
EINECS	Contact for details

Quality Control

Our Erlotinib 3-Bromo Impurity is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a detailed Certificate of Analysis (COA) with each shipment, ensuring traceability and compliance with current Good Manufacturing Practice (cGMP) principles and ICH guidelines. Specifications are designed to meet the stringent requirements of pharmaceutical reference standards.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unspecified 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.