Description

Nintedanib Impurity 62 is a high-purity chemical reference standard used in the pharmaceutical development and quality control processes. This compound is critical for the accurate identification, quantification, and monitoring of specific impurities in the active pharmaceutical ingredient (API) Nintedanib, ensuring drug safety and efficacy. It is an essential material for analytical laboratories, regulatory affairs, and R&D departments within the pharmaceutical and contract research organization (CRO) sectors.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for analytical method development and validation.
• Impurity Profiling & Control: Critical for establishing impurity limits and ensuring batch-to-batch consistency of Nintedanib API in compliance with ICH Q3A/B guidelines.
• Quality Assurance/Quality Control (QA/QC): Used in routine HPLC, UPLC, or LC-MS analysis to confirm the identity and level of this specific impurity in drug substances and products.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive characterization data for specified impurities.
• Stability Studies: Employed to track the formation and growth of this impurity over time under various storage conditions.
• Research & Development: Aids in synthetic route optimization and process chemistry by helping to understand and mitigate impurity formation.

Basic Information

Product Name	Nintedanib Impurity 62
CAS No.	16929-73-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nintedanib Related Compound 62; Nintedanib EP Impurity 62; Nintedanib USP Impurity 62; Nintedanib Process Impurity; 1H-Indole-6-carboxylic acid, 2,3-dihydro-3-[[[4-[methyl[(4-methyl-1-piperazinyl)acetyl]amino]phenyl]amino]phenylmethylene]-2-oxo-, methyl ester; BIBF 1120 Impurity 62; OFEV Impurity 62; Vargatef Impurity 62
EINECS	Contact for details

Quality Control

Every batch of Nintedanib Impurity 62 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity confirmation by spectroscopic methods (IR, NMR, MS) and purity assessment by advanced chromatographic techniques (HPLC, UPLC). Certificates of Analysis (COA) containing detailed batch-specific results are available upon request to support your regulatory and quality needs.

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.

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)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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