Description

Erlotinib Impurity 23 CAS NO 2021249-11-4 is a high-purity reference standard used in the pharmaceutical development and quality control of the active pharmaceutical ingredient (API) Erlotinib. This compound is critical for ensuring the safety and efficacy of the final drug product by enabling accurate identification, quantification, and control of process-related impurities. It is an essential material for analytical laboratories, regulatory affairs, and quality assurance departments within pharmaceutical and biotechnology companies focused on oncology therapeutics.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the qualitative and quantitative analysis of Erlotinib.
• Method Development and Validation: Crucial for developing and validating robust analytical methods, including HPLC, UPLC, and LC-MS.
• Quality Control (QC) Testing: Used in routine QC testing of Erlotinib API batches to monitor and control impurity levels as per ICH guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing impurity characterization data.
• Stability Studies: Employed to track the formation of degradation products during forced degradation and long-term stability studies of Erlotinib.
• Research and Development: Used in R&D to understand the synthesis pathway, impurity profile, and degradation mechanisms of Erlotinib.

Basic Information

Product Name	Erlotinib Impurity 23
CAS No.	2021249-11-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Erlotinib Related Compound 23; Erlotinib EP Impurity J; Erlotinib USP Impurity; Tarceva Impurity 23; N-(3-Ethynylphenyl)-6,7-bis(2-methoxyethoxy)quinazolin-4-amine Impurity; 4-Quinazolinamine, N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)- (related substance); Erlotinib Process Impurity
EINECS	Contact for details

Quality Control

Our Erlotinib Impurity 23 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity assay and identity confirmation via spectroscopic methods, to ensure it meets the stringent requirements for pharmaceutical reference standards. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data on purity, impurities, and analytical results. Our quality commitment aligns with cGMP principles for pharmaceutical impurities.

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 must be kept under inert conditions or in a desiccator to maintain stability and purity. Avoid repeated or prolonged exposure to the atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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