Description

Nintedanib Esylate CAS NO 656247-18-6 is a small molecule kinase inhibitor salt form, specifically the esylate salt of nintedanib. This compound is a critical active pharmaceutical ingredient (API) used in the formulation of targeted therapies. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and production of treatments for specific fibrotic and oncological conditions. Our supply ensures high purity and batch-to-batch consistency essential for pharmaceutical applications.

Application

• Pharmaceutical API: Primary use as the active ingredient in the commercial manufacture of oral medications for idiopathic pulmonary fibrosis (IPF) and other interstitial lung diseases.
• Oncology Research: Utilized in preclinical and clinical research for investigating its anti-angiogenic and anti-fibrotic properties in various cancer models, including non-small cell lung cancer (NSCLC).
• Formulation Development: Serves as a reference standard and raw material for developing new drug delivery systems, such as tablets and capsules, in pharmaceutical R&D laboratories.
• Chemical Reference Standard: Used in analytical laboratories for method development, validation, and quality control testing of drug products containing nintedanib.
• Process Chemistry: Acts as a key intermediate or final product in the chemical synthesis and scale-up processes within API manufacturing plants.

Basic Information

Product Name	Nintedanib Esylate
CAS No.	656247-18-6
Molecular Formula	C31H33N5O4 • C2H6O3S
Molecular Weight	649.76 g/mol (as esylate salt)
Synonyms	BIBF 1120 Esylate; Nintedanib Ethanesulfonate; Intedanib Esylate; 1H-Indole-6-carboxylic acid, 2,3-dihydro-3-[[[4-[methyl[(4-methyl-1-piperazinyl)acetyl]amino]phenyl]amino]phenylmethylene]-2-oxo-, methyl ester, (3Z)-, ethanesulfonate (1:1); Vargatef (brand name); Ofev (brand name formulation); BIBF 1120 (base name)
EINECS	Contact for details

Quality Control

Our Nintedanib Esylate is manufactured and tested under strict quality management systems. Each batch is subjected to comprehensive analytical testing to ensure it meets stringent specifications for pharmaceutical use, including identity, purity, and impurity profiles. A Certificate of Analysis (COA) detailing results for tests such as HPLC assay, related substances, residual solvents, and heavy metals is provided with every shipment. We adhere to cGMP guidelines where applicable to support our clients' regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to prevent degradation. Keep the container tightly sealed when not in use.

Specification

Item	Specification
Appearance	Yellow to brownish-yellow powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 2.0%
Water Content (KF)	NMT 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	NMT 20 ppm
Sulfated Ash	NMT 0.1%

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