Description

Nintedanib Impurity 107 is a designated process-related impurity and reference standard used in the analytical profiling of the active pharmaceutical ingredient, Nintedanib. This compound is critical for ensuring the quality, safety, and regulatory compliance of the final drug product by enabling accurate identification and quantification of this specific impurity. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and contract research organizations (CROs) involved in the development and manufacturing of Nintedanib.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Nintedanib.
• Method Development and Validation: Critical for developing and validating robust HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control and Batch Release: Used in QC laboratories to monitor and control the level of this specific impurity in active pharmaceutical ingredient (API) and drug product batches.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing necessary impurity characterization and specification data.
• Stability Studies: Employed to track the formation or increase of this impurity over time under various stress conditions.
• Process Chemistry Research: Aids chemists in understanding and optimizing the synthetic pathway to minimize the formation of this impurity.

Basic Information

Product Name	Nintedanib Impurity 107
CAS No.	78466-25-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nintedanib Related Compound 107; Nintedanib EP Impurity G; BIBF 1120 Impurity 107; Methyl N-[4-[(2,4-dioxo-1,3-thiazolidin-5-yl)methyl]phenyl]carbamate; 5-[[4-[(Methoxycarbonyl)amino]phenyl]methyl]-1,3-thiazolidine-2,4-dione
EINECS	Contact for details

Quality Control

Our Nintedanib Impurity 107 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency, meeting the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests including HPLC purity, related substances, and identification (IR/NMR). We support compliance with ICH Q3A, Q3B, and relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%

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