Description

Nintedanib Demethyl-o-Glucuronic Acid is a key metabolite and reference standard of the active pharmaceutical ingredient Nintedanib, a tyrosine kinase inhibitor. This compound is critical for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics (PK), and bioanalytical method validation. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and academic institutions engaged in the development and quality control of nintedanib-based therapies.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the qualitative and quantitative analysis of nintedanib and its metabolites in biological matrices.
• Metabolite Identification & Profiling: Essential for in vitro and in vivo studies to identify, characterize, and quantify the demethyl-o-glucuronide metabolite pathway of nintedanib.
• Bioanalytical Method Development: Used as a critical standard for developing and validating robust HPLC, LC-MS, and LC-MS/MS methods for pharmacokinetic studies.
• Drug Impurity Testing: Employed as an impurity standard to monitor and control the quality of nintedanib active pharmaceutical ingredient (API) and finished drug products according to ICH guidelines.
• Preclinical & Clinical Research: Supports non-clinical and clinical trial studies to understand the absorption, distribution, metabolism, and excretion (ADME) profile of nintedanib.
• Regulatory Submissions: Provides essential data and certified materials for inclusion in regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive understanding of the drug's metabolic fate.

Basic Information

Product Name	Nintedanib Demethyl-o-Glucuronic Acid
CAS No.	1352789-50-4
Molecular Formula	C33H38N4O9
Molecular Weight	634.68 g/mol
Synonyms	Nintedanib N-Desmethyl Glucuronide; Nintedanib Demethyl Glucuronide; BIBF 1120 N-Desmethyl Glucuronide; 1-[({Methyl[4-({[2-(4-{[(Ethylcarbamoyl)amino]phenyl}-1H-pyrrol-1-yl)carbonyl]phenyl}amino)phenyl]amino}carbonyl)-2-methylpropyl]carbamoyl]-β-D-glucopyranuronic Acid; Nintedanib Metabolite; BIBF 1202 Glucuronide; Vargatef Metabolite; OFEV Metabolite
EINECS	Contact for details

Quality Control

Our Nintedanib Demethyl-o-Glucuronic Acid is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, LC-MS for identity confirmation, and residual solvent analysis to ensure it meets the stringent requirements for use as a reference standard. Certificates of Analysis (COA) with detailed chromatographic data are provided and traceable to primary standards.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry, controlled environment. This product is hygroscopic (moisture-sensitive); allow the sealed vial to equilibrate to room temperature before opening to minimize moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
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.