Description

Nintedanib Impurity 9 CAS NO 99846-70-5 is a specific organic impurity associated with the active pharmaceutical ingredient Nintedanib. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development and validation. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Nintedanib drug substances and products. The precise identification and quantification of this impurity are essential for meeting stringent global pharmacopeial and ICH regulatory guidelines.

Application

• Primary use as a Pharmaceutical Reference Standard for the identification and quantification of impurities in Nintedanib API and finished dosage forms.
• Critical component in Analytical Method Development and Validation (HPLC, UPLC, LC-MS) for stability-indicating assays.
• Essential for conducting Stability Studies and degradation pathway elucidation of Nintedanib.
• Used in Quality Control (QC) and Quality Assurance (QA) laboratories to establish impurity profiles and release specifications.
• Supports Regulatory Submissions (e.g., ANDA, NDA) by providing necessary impurity data to agencies like the FDA and EMA.
• Valuable for Research and Development in process chemistry to optimize synthesis and purification steps.
• Employed in Pharmacopeial Testing to verify compliance with monographs from USP, EP, or other international standards.

Basic Information

Product Name	Nintedanib Impurity 9
CAS No.	99846-70-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nintedanib Related Compound 9; Nintedanib EP Impurity 9; Nintedanib USP Impurity 9; BIBF 1120 Impurity 9; Methyl 3-({[4-(N-methylcarbamoyl)piperazin-1-yl]carbonyl}amino)-4-{[(2-methyl-1H-indol-5-yl)oxy]methyl}benzoate; 4-{[(2-Methyl-1H-indol-5-yl)oxy]methyl}-3-({[4-(N-methylcarbamoyl)piperazin-1-yl]carbonyl}amino)benzoic acid methyl ester; OFEV Impurity 9; Vargatef Impurity 9
EINECS	Contact for details

Quality Control

Our Nintedanib Impurity 9 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure high purity and batch-to-batch consistency. Each lot is characterized using advanced techniques including HPLC, LC-MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all specified parameters. Our quality commitment aligns with cGMP principles and supports compliance with ICH Q3A/B, USP, and EP guidelines for pharmaceutical impurities.

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 dry, inert conditions to maintain stability and purity. The original container should only be opened in a controlled, low-humidity environment.

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)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
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.