Description

Nintedanib Impurity L is a specified impurity associated with the active pharmaceutical ingredient Nintedanib. This compound is critical for analytical reference and quality control processes in pharmaceutical development and manufacturing. It is primarily used by researchers and quality assurance professionals in the pharmaceutical industry to ensure the purity, safety, and efficacy of drug products. Precise characterization and control of this impurity are essential for meeting stringent regulatory requirements.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Nintedanib Impurity L in drug substances and products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for Nintedanib.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine quality control testing to monitor batch-to-batch consistency and impurity profiles.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific impurity under various stress conditions.
• Regulatory Submissions: Provides necessary data for impurity identification and qualification reports required by regulatory bodies like the FDA, EMA, and PMDA.
• Process Chemistry Research: Used by chemists to understand and optimize synthetic pathways to minimize the formation of this impurity during API manufacturing.

Basic Information

Product Name	Nintedanib Impurity L
CAS No.	2095596-44-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nintedanib Related Compound L; Nintedanib EP Impurity L; Nintedanib USP Impurity L; BIBF 1120 Impurity L; 1H-Indole-6-carboxamide, N-[4-[(3-[(4-methyl-1-piperazinyl)methyl]phenyl)amino]-5-(trifluoromethyl)-2-pyrimidinyl]-, (6Z)-6-(hydroxyimino)-5,6-dihydro-; (Z)-6-(Hydroxyimino)-5,6-dihydro-N-(4-((3-((4-methylpiperazin-1-yl)methyl)phenyl)amino)-5-(trifluoromethyl)pyrimidin-2-yl)-1H-indole-6-carboxamide
EINECS	Contact for details

Quality Control

Our Nintedanib Impurity L is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (NMR, IR, MS), purity assessment by HPLC, and determination of residual solvents. A Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications. We support our clients' regulatory needs with full traceability and documentation.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under an inert atmosphere to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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