Description

Erlotinib Impurity 36 Hcl is a high-purity chemical reference standard used in the pharmaceutical development and quality control of the anticancer drug Erlotinib. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification. It is primarily needed by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, process development, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Erlotinib Impurity 36 in active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Batch Release: Employed in routine QC testing to ensure Erlotinib API and drug formulations meet stringent pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines for impurities.
• Stability Studies: Used to track the formation and level of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH stability protocols.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Process Chemistry Research: Aids in understanding and optimizing the Erlotinib synthesis pathway to minimize the formation of this impurity.

Basic Information

Product Name	Erlotinib Impurity 36 Hcl
CAS No.	1354727-63-1
Molecular Formula	C22H23N3O4 • HCl
Molecular Weight	429.90 g/mol (Free base: 393.44 g/mol)
Synonyms	Erlotinib Related Compound 36 Hcl; Erlotinib Hydrochloride Impurity 36; N-(3-Ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine Impurity 36 Hydrochloride; Tarceva Impurity 36 Hcl; 4-Quinazolinamine, N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-, hydrochloride (1:1); Erlotinib EP Impurity H HCl; Erlotinib USP Impurity 36 Hcl
EINECS	Contact for details

Quality Control

Our Erlotinib Impurity 36 Hcl is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, LC-MS, NMR, and IR to confirm identity and purity, ensuring compliance with relevant pharmacopeial standards (USP/EP/ICH). A detailed Certificate of Analysis (COA) providing batch-specific data is supplied with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Assay (by HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Single Unknown Impurity (HPLC)	≤ 1.0%
Total Impurities (HPLC)	≤ 5.0%

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