Description

Intedanib Impurity CAS NO 2243396-74-7 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Intedanib. It is an essential tool for pharmaceutical manufacturers and analytical laboratories engaged in method development, validation, and impurity profiling. This impurity standard supports the stringent quality control processes required in modern drug development and production.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the identification and quantification of impurities in Intedanib API batches.
• Analytical Method Development: Used to develop and optimize chromatographic methods (HPLC, UPLC) for impurity separation and detection.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity levels and ensure API purity meets pharmacopeial specifications (e.g., ICH guidelines).
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization.
• Stability Studies: Used as a marker to track the formation of degradation products in Intedanib formulations under various storage conditions.
• Research & Development: Supports synthetic chemistry research aimed at understanding impurity formation pathways and developing purer synthetic routes.

Basic Information

Product Name	Intedanib Impurity
CAS No.	2243396-74-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Intedanib Related Compound; Intedanib Process Impurity; Intedanib Degradant; Nintedanib Impurity (common alternate spelling); BIBF 1120 Impurity; Vargatef Impurity; OFEV Impurity; Tyrosine Kinase Inhibitor Impurity
EINECS	Contact for details

Quality Control

Every batch of Intedanib Impurity (CAS 2243396-74-7) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC-MS, and NMR to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your quality and regulatory requirements.

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. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual 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.