Description

Nintedanib Impurity 70 is a designated impurity standard used in the analytical profiling 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 serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and production of Nintedanib-based medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Nintedanib Impurity 70 in drug substance and drug product testing.
• Method Development and Validation: Essential for developing, optimizing, and validating stability-indicating HPLC/UPLC methods for Nintedanib.
• Quality Control (QC) Testing: Employed in routine batch release testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) during drug stability studies.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., with FDA, EMA) to support drug approval.
• Research and Development: Aids in process chemistry research to understand and minimize the formation of this impurity during API synthesis.

Basic Information

Item	Detail
Product Name	Nintedanib Impurity 70
CAS No.	74327-86-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nintedanib Related Compound 70; Nintedanib EP Impurity 70; Nintedanib USP Impurity 70; Methyl 3-({[4-(N-methylcarbamoyl)phenyl]amino}methyl)benzoate; BIBF 1120 Impurity 70; (3-((4-(Methylcarbamoyl)phenylamino)methyl)phenyl)methanol derivative; Intedanib Impurity 70; OFEV Impurity 70
EINECS	Contact for details

Quality Control

Our Nintedanib Impurity 70 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, GC, MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided, detailing the results for identity, assay, purity, and related substances. Our quality commitment aligns with cGMP principles and supports compliance with major pharmacopoeial standards (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.