Description

Erlotinib Impurity B CAS NO 183321-83-7 is a specified impurity of Erlotinib Hydrochloride, a critical pharmaceutical active ingredient. This compound is essential for analytical reference standards and method development in the quality control of Erlotinib API and its finished drug products. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories for ensuring product safety, efficacy, and regulatory compliance.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Erlotinib Hydrochloride Active Pharmaceutical Ingredient (API).
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) for Erlotinib drug substances and products.
• Used in stability studies to monitor impurity profiles and degradation pathways of Erlotinib formulations.
• Essential for regulatory submissions (e.g., ANDA, NDA) to establish impurity limits and control strategies as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Serves as a calibration standard in quality control laboratories for routine batch release testing.
• Used in research and development to study the synthesis, metabolism, and pharmacokinetics of Erlotinib.

Basic Information

Product Name	Erlotinib Impurity B
CAS No.	183321-83-7
Molecular Formula	C22H23N3O4
Molecular Weight	393.44 g/mol
Synonyms	N-(3-Ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine; Erlotinib Related Compound B; Erlotinib EP Impurity B; Erlotinib USP Impurity B; Tarceva Impurity B; CP-358774 Impurity B; OSI-774 Impurity B; NSC 718781 Impurity B
EINECS	Contact for details

Quality Control

Our Erlotinib Impurity B is manufactured under strict quality systems to ensure high purity and batch-to-batch consistency, suitable for use as a reference standard. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profiles as determined by advanced chromatographic and spectroscopic techniques. We support compliance with major pharmacopoeial standards (USP, EP, BP) and ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. 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)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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