Description

Riociguat Impurity 6 is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Riociguat. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by enabling precise identification and quantification of process-related impurities. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs teams involved in the development and manufacturing of Riociguat-based therapies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Riociguat Impurity 6 in API and finished drug products.
• Method Development and Validation: Crucial for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS).
• Quality Control & Batch Release: Used in routine QA/QC testing to monitor impurity levels and ensure compliance with strict pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation of this specific impurity over time under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control of the impurity profile.
• Process Chemistry Research: Aids chemists in understanding and optimizing the synthesis pathway of Riociguat to minimize the formation of this impurity.

Basic Information

Product Name	Riociguat Impurity 6
CAS No.	1702271-98-4
Molecular Formula	C20H25FN6O3
Molecular Weight	416.45 g/mol
Synonyms	BAY 63-2521 Impurity 6; 4,6-Diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinecarboxylic acid methyl ester; Methyl 4,6-diamino-2-(1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl)pyrimidine-5-carboxylate; Riociguat Related Compound 6; Adempas Impurity 6
EINECS	Contact for details

Quality Control

Every batch of Riociguat Impurity 6 is manufactured and controlled under a strict quality management system. The material undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for use as a reference standard. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results. Our quality protocols are designed to support compliance with current Good Manufacturing Practice (cGMP) principles and ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). Keep the container in a dry environment to prevent moisture uptake. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Any individual impurity ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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