Description

Riociguat Impurity CAS NO 2920299-23-4 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Riociguat. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in drug development and quality control. The impurity standard is essential for method validation, stability studies, and meeting stringent pharmacopeial requirements.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Riociguat API batches.
• Analytical Method Development and Validation (HPLC/LC-MS): Serves as a critical component in developing and validating chromatographic methods for purity analysis.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency of the final drug product.
• Regulatory Compliance and Submission: Supports regulatory filings (e.g., for FDA, EMA) by providing data on impurity characterization and control strategies.
• Stability Studies: Used to track the formation of degradation products under various stress conditions to determine drug shelf life.
• Research and Development: Facilitates chemical and pharmacological research to understand the impact of impurities on drug efficacy and safety.

Basic Information

Product Name	Riociguat Impurity
CAS No.	2920299-23-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Riociguat Related Compound; Riociguat Process Impurity; Riociguat Degradant; 4,6-Diamino-2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl)-5-nitropyrimidine (proposed); BAY 63-2521 Impurity; Adempas Impurity; Soluble Guanylate Cyclase (sGC) Stimulator Impurity
EINECS	Contact for details

Quality Control

Our Riociguat Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS). We provide comprehensive Certificates of Analysis (COA) with detailed chromatograms and spectral data. The material is suitable for use as a reference standard in compliance with ICH Q3A/B guidelines and current Good Manufacturing Practice (cGMP) principles.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 0.5% Total impurities ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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