Description

Nintedanib Impurity G is a specified organic impurity used in the quality control and analytical profiling of the active pharmaceutical ingredient (API) Nintedanib. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product. It serves as a key reference standard for method development, validation, and routine batch analysis in the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Nintedanib Impurity G in API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles.
• Quality Control & Batch Release: Used in routine QC testing to ensure Nintedanib API batches meet stringent pharmacopeial (e.g., USP, EP) and ICH regulatory limits for impurities.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Research & Development: Used in synthetic chemistry R&D to understand and optimize the Nintedanib manufacturing process to minimize impurity formation.

Basic Information

Item	Details
Product Name	Nintedanib Impurity G
CAS No.	894783-61-0
Molecular Formula	C31H33N5O4
Molecular Weight	539.63 g/mol
Synonyms	1H-Indole-6-carboxamide, N-[4-[(3-[(4-methyl-1-piperazinyl)methyl]phenyl)amino]-3-quinolinyl]-; Nintedanib Related Compound G; Nintedanib EP Impurity G; Nintedanib USP Impurity G; BIBF 1120 Impurity G; Intedanib Impurity G; OFEV Impurity G
EINECS	Contact for details

Quality Control

Every batch of Nintedanib Impurity G is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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