Description

Roxadustat-D5 is a deuterium-labeled isotopologue of the hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor Roxadustat, specifically designed for use as an internal standard in quantitative analytical methods. This compound is essential for ensuring the accuracy and reliability of mass spectrometry-based assays, particularly in pharmacokinetic and metabolic studies. It is a critical tool for pharmaceutical research and development laboratories, contract research organizations (CROs), and analytical service providers focused on drug metabolism and bioanalytical method validation.

Application

• Internal Standard for LC-MS/MS analysis in bioanalytical method development and validation.
• Quantitative analysis of Roxadustat in biological matrices (e.g., plasma, serum, urine) for pharmacokinetic (PK) and toxicokinetic (TK) studies.
• Metabolite identification and profiling studies to track the parent drug and its derivatives.
• Quality control and assurance in pharmaceutical manufacturing for batch consistency testing.
• Use in clinical research to monitor drug concentration levels in patient samples.
• Supporting regulatory submissions to agencies like the FDA and EMA by providing validated analytical data.

Basic Information

Product Name	Roxadustat-D5
CAS No.	2043026-13-5
Molecular Formula	C19H11D5N2O5
Molecular Weight	355.37 g/mol
Synonyms	Roxadustat-d5; FG-4592-d5; (4-Hydroxy-1-methyl-7-phenoxyisoquinoline-3-carboxamide)-d5; 1-Methyl-4-hydroxy-7-phenoxy-3-isoquinolinecarboxamide-d5; HIF-PH Inhibitor-d5; AZD-9941-d5 (if applicable); GSK1278863-d5 (if applicable); Deuterated Roxadustat
EINECS	Contact for details

Quality Control

Our Roxadustat-D5 is manufactured under strict quality control protocols to ensure the highest standards of isotopic purity and chemical integrity, which are critical for its function as an analytical standard. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing results for isotopic enrichment (D5), chemical purity by HPLC, and confirmation of structure. We adhere to relevant quality management systems to support research and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a freezer. 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 (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Purity (D5)	≥98.0 atom % D
Water Content (KF)	≤1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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