Description

Nintedanib Impurity 82 is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Nintedanib. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It serves as a key marker for method development, validation, and routine batch testing in the production of Nintedanib-based medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Nintedanib Impurity 82 in API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating stability-indicating chromatographic methods.
• Quality Control & Batch Release Testing: Used in routine QC labs to monitor impurity levels against ICH Q3A(R2) and Q3B(R2) guidelines to ensure batch-to-batch consistency.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (thermal, photolytic, hydrolytic).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports impurity characterization, synthesis pathway optimization, and degradation studies during API process development.

Basic Information

Product Name	Nintedanib Impurity 82
CAS No.	1383786-28-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nintedanib Related Compound 82; BIBF 1120 Impurity 82; Intedanib Impurity 82; 1H-Indole-6-carboxamide, N-[4-[(6,7-dimethoxy-4-quinazolinyl)oxy]phenyl]-N'-methyl- (specific isomer); Vargatef Impurity 82; OFEV Impurity 82
EINECS	Contact for details

Quality Control

Every batch of Nintedanib Impurity 82 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC and LC-MS to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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 (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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