Description

D 13223-D4 (Flupirtine Metabolite) is a key reference standard and analytical intermediate, specifically the D4-labeled (deuterated) metabolite of the centrally acting analgesic Flupirtine. This compound is essential for conducting precise pharmacokinetic and metabolic studies, enabling accurate quantification and tracing of the parent drug's fate in biological systems. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical service providers involved in drug development, bioanalytical method validation, and regulatory compliance testing.

Application

• Pharmacokinetic and Metabolism Studies: Used as an internal standard in LC-MS/MS and GC-MS assays to quantify Flupirtine and its metabolites in plasma, serum, and other biological matrices.
• Bioanalytical Method Development and Validation (BMV): Critical for developing, optimizing, and validating robust analytical methods in accordance with FDA, EMA, and ICH guidelines.
• Drug Discovery and Development: Supports ADME (Absorption, Distribution, Metabolism, Excretion) profiling to understand the metabolic pathways and clearance mechanisms of Flupirtine.
• Clinical Research: Facilitates therapeutic drug monitoring (TDM) and clinical trial sample analysis to ensure patient safety and study accuracy.
• Reference Material for Quality Control: Serves as a certified reference standard for calibrating equipment and ensuring the accuracy and reproducibility of analytical data within quality control laboratories.

Basic Information

Product Name	D 13223-D4 (Flupirtine Metabolite)
CAS No.	1216989-17-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Flupirtine D4 Metabolite; Deuterated Flupirtine Metabolite; [D4]-Flupirtine Metabolite; D-13223-D4; 2-Amino-3-carbethoxyamino-6-(4-fluorobenzylamino)-pyridine D4 Metabolite; FLP Metabolite D4; FLP-d4 Metabolite
EINECS	Contact for details

Quality Control

Every batch of D 13223-D4 (Flupirtine Metabolite) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards for reference materials. Certificates of Analysis (COA) detailing purity, isotopic enrichment, and analytical data are provided to guarantee traceability and reliability for your critical research applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as specified on the label or COA. For long-term storage, consider storing desiccated at -20°C. Handle with appropriate laboratory safety practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC/MS)	Conforms
Purity (HPLC)	≥ 95%
Isotopic Purity (Deuterium Enrichment)	≥ 98 atom % D
Water Content (KF)	< 1.0%
Residual Solvents (GC)	Complies with ICH limits

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