Description

Neratinib Impurity Xa CAS NO 1376619-98-5 is a high-purity reference standard used for the analytical characterization and quality control of the active pharmaceutical ingredient (API) Neratinib. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying this specific impurity. It is an essential material for method development, validation, and stability studies in the production of oncology drugs.

Application

• Primary use as a certified reference standard for the identification and quantification of Neratinib Impurity Xa in API batches.
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) for impurity profiling.
• Essential for conducting stability studies and forced degradation studies to monitor impurity formation over time.
• Used in quality control (QC) and quality assurance (QA) laboratories to ensure compliance with ICH guidelines and regulatory filings (e.g., FDA, EMA).
• Serves as a key impurity marker in pharmaceutical research and development for process optimization and impurity fate mapping.
• Supports regulatory submissions by providing definitive proof of impurity structure and purity for drug master files (DMFs).

Basic Information

Item	Details
Product Name	Neratinib Impurity Xa
CAS No.	1376619-98-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Neratinib Related Compound Xa; Neratinib EP Impurity Xa; Neratinib USP Impurity Xa; HKI-272 Impurity Xa; (2E)-N-[4-[[3-Chloro-4-[(pyridin-2-yl)methoxy]phenyl]amino]-3-cyano-7-ethoxyquinolin-6-yl]-4-(dimethylamino)but-2-enamide; UNII-9F8V0P8Q4M; PF-05208770 Impurity Xa
EINECS	Contact for details

Quality Control

Every batch of Neratinib Impurity Xa is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with pharmaceutical reference standard requirements and relevant pharmacopeial guidelines. Comprehensive Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are provided and available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider storing under inert 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)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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