Description

Finerenone Impurity 34 is a designated process-related impurity used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Finerenone. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and regulatory compliance of the final drug product. It serves as a key reference standard for method development, validation, and routine batch analysis in the production of this non-steroidal mineralocorticoid receptor antagonist.

Application

• Primary use as a certified reference standard for the identification and quantification of Finerenone Impurity 34 in Finerenone API.
• Essential for analytical method development and validation (HPLC, UPLC, LC-MS) in quality control laboratories.
• Used in stability studies and forced degradation studies to monitor impurity profiles over time.
• Critical for regulatory submissions (e.g., FDA, EMA) to establish impurity limits and control strategies.
• Supports process chemistry research and development to understand and minimize impurity formation.
• Employed in pharmacopoeial testing to verify compliance with established monographs and specifications.

Basic Information

Product Name	Finerenone Impurity 34
CAS No.	2924224-42-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Finerenone Related Compound 34; BAY 94-8862 Impurity 34; (4S)-4-(4-Cyano-2-methoxyphenyl)-5-ethoxy-2,8-dimethyl-1,4-dihydro-1,6-naphthyridine-3-carboxamide; Kerendia Impurity 34
EINECS	Contact for details

Quality Control

Every batch of Finerenone Impurity 34 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmaceutical reference standard requirements. Comprehensive Certificates of Analysis (COA) detailing batch-specific results are provided and traceable to primary standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry 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 (HPLC)	Retention time matches reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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