Description

Nintedanib Impurity 27/2,3-Dihydro-3-[(4-Methyl-1-Piperazinyl)Phenylmethylene]-2-Oxo-1H-Indole-6-Carboxylic Acid Methyl Ester is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a specified impurity in the quality control of Nintedanib, a key active pharmaceutical ingredient used in the treatment of idiopathic pulmonary fibrosis and certain cancers. It is essential for analytical method development, validation, and ensuring batch-to-batch consistency in drug manufacturing. Pharmaceutical companies, contract research organizations (CROs), and quality control laboratories require this standard to meet stringent regulatory compliance for drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control and release testing of Nintedanib active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, and LC-MS methods to accurately identify and quantify this specific impurity.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Used to monitor impurity profiles in Nintedanib formulations under various stress conditions to establish shelf-life and storage recommendations.
• Process Chemistry Research: Aids in understanding and optimizing the synthesis pathway of Nintedanib by identifying and controlling process-related impurities.
• Pharmacopoeial Testing: Employed as a system suitability standard in testing protocols aligned with pharmacopoeial monographs (e.g., USP, EP).

Basic Information

Product Name	Nintedanib Impurity 27/2,3-Dihydro-3-[(4-Methyl-1-Piperazinyl)Phenylmethylene]-2-Oxo-1H-Indole-6-Carboxylic Acid Methyl Ester
CAS No.	2101947-36-6
Molecular Formula	C23H25N3O3
Molecular Weight	391.47 g/mol
Synonyms	Nintedanib Impurity 27; Nintedanib Related Compound 27; 2,3-Dihydro-3-[(4-methyl-1-piperazinyl)phenylmethylene]-2-oxo-1H-indole-6-carboxylic acid methyl ester; BIBF 1120 Impurity 27; Methyl 2,3-dihydro-3-[(4-methylpiperazin-1-yl)(phenyl)methylidene]-2-oxo-1H-indole-6-carboxylate; (Z)-Methyl 3-((4-methylpiperazin-1-yl)(phenyl)methylene)-2-oxo-2,3-dihydro-1H-indole-6-carboxylate; Nintedanib EP Impurity G; Ofev Impurity 27
EINECS	Contact for details

Quality Control

Every batch of Nintedanib Impurity 27 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and consistency. Our quality system is designed to meet the exacting requirements of pharmaceutical reference standard applications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from multiple orthogonal techniques including HPLC, LC-MS, NMR, and IR spectroscopy. We support compliance with ICH Q3A, Q3B, and relevant pharmacopoeial guidelines (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The product is light-sensitive and should be handled under appropriate conditions to prevent degradation. For long-term storage, consider storing desiccated at 2-8°C.

Specification

Item	Specification
Appearance	Off-white to light yellow 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 individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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