Finerenone Impurity 127 NEW

Finerenone Impurity 127

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• Product Information

• Product Number: F044127

• English Name: Finerenone Impurity 127

• English Alias: ethyl 4-(4-cyano-2-methoxyphenyl)-5-ethoxy-2,8-dimethyl-1,4-dihydro-1,6-naphthyridine-3-carboxylate

• CAS Number: 2764833-07-8

• Molecular Formula: C₂₃H₂₅N₃O₄

• Molecular Weight: 407.46

• Advantages

• As an impurity of Finerenone, this compound has the following advantages:
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• Well-defined with distinct functional groups: Contains 1,6-naphthyridine core, 4-(4-cyano-2-methoxyphenyl) substituent, 5-ethoxy, 2,8-dimethyl, and 3-ethyl carboxylate. Unlike finerenone (mineralocorticoid receptor antagonist), its cyano polarity, ether hydrophobicity, and conjugated naphthyridine create significant physicochemical differences, enabling precise differentiation via HPLC/SFC as a specific marker;

• High stability and traceability: Rigid naphthyridine structure and stability of cyano/ether/ester groups ensure neutral-to-weakly-acidic stability. As a byproduct from incomplete cyclization or substituent deviation in finerenone synthesis, it directly reflects key step efficiency, improving process tracing accuracy;

• High detection sensitivity: Conjugated naphthyridine-benzene shows strong UV absorption (250-300nm), combined with m/z 408 [M+H]⁺ enabling ppb-level analysis via LC-MS, compatible with naphthyridine drug impurity systems.

• Applications

• Pharmaceutical quality control: Used as an impurity reference standard to quantify Finerenone Impurity 127 in APIs, ensuring compliance with specific impurity limits in quality standards;

• Synthesis optimization: Optimizing cyclization conditions (catalyst dosage) by monitoring impurity levels to reduce byproducts and enhance target specificity;

• Method validation: Verifying accuracy and specificity of finerenone impurity assays to ensure effective separation and quantification.

• Background Description

• Finerenone’s structure is based on a 1,6-naphthyridine core, synthesized via multi-step substitution and cyclization. Deviations in substituent position/type (e.g., ethoxy misplacement) may generate analogs like Finerenone Impurity 127. Due to structural similarity affecting receptor binding, its residues impact finerenone quality and safety, making control critical for assurance.

• Research Status

• Current research focuses on:
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• Analytical method validation: Developing UPLC assays with C18 columns for baseline separation, achieving 0.05 ppb detection limits;

• Synthesis kinetics: Studying impurity formation under varying cyclization reagents to clarify substituent-cyclization efficiency correlation;

• Control strategies: Optimizing intermediate purity to keep impurity levels below 0.1% and enhance API quality;

• Structural confirmation: Using ¹H/¹³C-NMR and MS/MS to verify substituent positions, distinguishing from finerenone for authoritative identification.

We can also customize related analogues and modified peptides including HPLC, MS, 1H-NMR, MS, HPLC, IR, UV, COA, MSDS.
This product is intended for laboratory use only!

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