Description

Riociguat-13C-D3 is a stable isotope-labeled analog of the pulmonary arterial hypertension (PAH) drug Riociguat, specifically incorporating carbon-13 and deuterium atoms. This compound is an essential internal standard for the precise and accurate quantification of Riociguat in complex biological matrices using advanced analytical techniques like LC-MS/MS. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and regulatory testing facilities engaged in pharmacokinetic studies, bioequivalence testing, and drug metabolism research.

Application

• Quantitative Bioanalysis: Serves as a critical internal standard for the LC-MS/MS quantification of Riociguat in plasma, serum, and other biological samples.
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables accurate measurement of drug concentration-time profiles to understand absorption, distribution, metabolism, and excretion.
• Drug Metabolism and Excretion Studies: Used in mass spectrometry to trace and quantify metabolites, aiding in the understanding of metabolic pathways.
• Clinical Trial Support: Essential for ensuring data integrity and regulatory compliance in bioanalytical assays during clinical development phases.
• Bioequivalence Testing: Provides the reference point needed for comparing the bioavailability of generic formulations to the innovator drug.
• Forensic and Anti-Doping Analysis: Supports highly specific and confirmatory testing in specialized toxicology and sports doping control laboratories.

Basic Information

Product Name	Riociguat-13C-D3
CAS No.	2749393-44-8
Molecular Formula	C20H22D3N5O4 (with 13C labeling)
Molecular Weight	Contact for details
Synonyms	Riociguat (13C,D3 labeled); BAY 63-2521-13C-D3; 4,6-Diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinecarbonitrile-13C-D3; Methyl 4,6-diamino-2-[5-fluoro-1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinecarboxylate-13C-D3; Adempas-13C-D3 (labeled analog); Stable Isotope-Labeled Riociguat
EINECS	Contact for details

Quality Control

Every batch of Riociguat-13C-D3 is manufactured and analyzed under strict quality protocols to ensure the highest standards of isotopic purity, chemical purity, and stability. Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request, providing detailed data on isotopic enrichment, chemical purity by HPLC, and identity confirmation by spectroscopic methods.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dry, moisture-free environment. For long-term storage, keep desiccated under an inert atmosphere. 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/MS)	Conforms
Purity (HPLC)	≥98.0%
Isotopic Purity	≥99.0 atom % 13C; ≥98.0 atom % D
Chemical Purity	≥95.0%
Water Content (KF)	≤1.0%
Residual Solvents (GC)	Meets ICH guidelines

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