Description

Nintedanib Acetyl Impurity is a designated process-related impurity and reference standard used in the pharmaceutical development and quality control of the active pharmaceutical ingredient (API) Nintedanib. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by enabling accurate identification and quantification of this specific acetylated derivative. It is an essential material for analytical method development, validation, and routine batch release testing in pharmaceutical R&D and manufacturing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Nintedanib.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, and LC-MS methods for impurity profiling.
• Quality Control & Batch Release: Critical for establishing impurity limits and ensuring API batches comply with ICH Q3A/B guidelines and regulatory specifications.
• Stability Studies: Employed to monitor the formation and level of this impurity in drug substance and product stability programs.
• Process Chemistry Research: Used to study and optimize the synthetic pathway of Nintedanib to minimize the formation of this acetyl impurity.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) filings to health authorities like the FDA and EMA.

Basic Information

Product Name	Nintedanib Acetyl Impurity
CAS No.	1139458-48-2
Molecular Formula	C33H34N6O5
Molecular Weight	594.67 g/mol
Synonyms	Nintedanib Acetyl Impurity; Nintedanib Acetylated Impurity; Nintedanib Related Compound A (Acetyl); Methyl (3Z)-3-{[4-(N-{4-[(1-Methylpiperidin-4-yl)methoxy]phenyl}carbamoyl)-1H-pyrrol-2-yl]methylidene}-2-oxo-2,3-dihydro-1H-indole-6-carboxylate Acetyl Derivative; BIBF 1120 Acetyl Impurity; Vargatef Impurity (Acetyl); OFEV® Impurity (Acetyl); 1H-Indole-6-carboxylic acid, 2,3-dihydro-3-[[[4-[ [[[4-[(1-methyl-4-piperidinyl)methoxy]phenyl]amino]carbonyl]-1H-pyrrol-2-yl]methylene]-2-oxo-, methyl ester, acetate (ester)
EINECS	Contact for details

Quality Control

Our Nintedanib Acetyl Impurity is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, NMR, MS), and residual solvent analysis, to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. Certificates of Analysis (COA) with detailed chromatographic data and traceability are provided and are compliant with current ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C, in a dry environment. For long-term storage, consider storing at 2-8°C. The material is hygroscopic (moisture-sensitive).

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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