Basic Information of Finerenone
- Product Name: Finerenone
- Synonyms: Kerendia, BAY94-8862
- CAS No.: 1050477-31-0
- Molecular Formula: C21H22N4O3
- Molecular Weight: 378.42
- Drug Class: Novel Non-steroidal Selective Mineralocorticoid Receptor Antagonist
What is Finerenone?
Finerenone (CAS No.: 1050477-31-0) appears as a white or off-white powder.It is the active ingredient of a medication used to treat chronic kidney disease associated with type 2 diabetes.As a small-molecule chemical drug, it has an absolute bioavailability of approximately 44%. Therefore, it can be directly formulated into tablets for oral administration.
Our Finerenone API is supplied exclusively for overseas pharmaceutical formulation R&D and large-scale production. If you have any purchasing requirements, please contact us promptly for a quotation.
Why Choose Highassay?
- Dual Regulatory Endorsement: NMPA Filing + EU WC Export Qualification
- Quality Benchmarked Against Bayer’s Innovator Drug: Impurity Profile, Crystalline Form, and Dissolution Rate
- Flexible Supply: From 1 mg to 25 kg—Fully Covering Needs from R&D to Commercial Production
- Free Samples:Small-Scale Testing Samples Available Upon Request
- Technical Support: Impurity Reference Standards and Method Validation Reports Provided
Click to Request a Quote; We Respond Within 24 Hours. Tiered Pricing Available for Bulk Purchases.
Mechanism of Action of Finerenone
As a novel, non-steroidal mineralocorticoid receptor antagonist, Finerenone works by precisely blocking the overly active mineralocorticoid receptors in patients with diabetes and hypertension. This action inhibits renal inflammation and fibrosis, slows the progression of diabetic kidney disease, and significantly reduces the risk of end-stage renal disease and heart failure—thereby achieving the objective of protecting both the heart and the kidneys.
Highassay’s Finerenone
Highassay is a China-based supplier of Finerenone API. We provide Finerenone APIs that meet GMP standards and possess a purity of ≥99%. Each product is accompanied by a Certificate of Analysis (COA), supporting your R&D and manufacturing efforts for tablet-based formulations.
Our Finerenone powder is soluble in methanol; slightly soluble in acetonitrile and ethanol; and practically insoluble in water.
Our Finerenone is used to produce Finerenone tablets (film-coated tablets), which are typically available in two dosage strengths: 10 mg and 20 mg.
Finerenone is a novel, selective mineralocorticoid receptor (MR) antagonist; it specifically blocks the detrimental pathways in the kidneys and heart, presenting a lower risk of hyperkalemia and minimal side effects.
Spironolactone is an older-generation mineralocorticoid antagonist; it is prone to causing hyperkalemia and breast tenderness, and is associated with severe side effects.
For patients with kidney disease, Finerenone is a safer option.
Ordinary patients can take Finerenone tablets directly with water.For people with difficulty swallowing,they can perform special processing on the tablets.Like crush it and mix it with water or soft food.But it must be taken immediately after mixing.
Core Indication: Chronic kidney disease associated with Type 2 Diabetes-Associated Chronic Kidney Disease (Dual Cardiorenal Protection: Delays Renal Failure, Reduces Risk of Heart Failure & Cardiovascular Death). It is a globally significant active pharmaceutical ingredient (API) for specialized nephrology treatments.
Small-batch orders (e.g., milligram-scale quantities for research purposes): In-stock items are available for immediate shipment.
Large-batch orders (e.g., kilogram-scale API quantities): Expected to ship within 3–7 days.
Urgent requests? Contact us directly. We will do our best to accommodate.
Finerenone Packaging
We offer packaging options ranging from small-scale quantities (milligram-level) for research purposes to bulk Active Pharmaceutical Ingredients (API) (kilogram-level). Unless specific instructions are provided, products will be packaged according to our standard procedures; if you have any special requirements, please inform us in advance.
| Type | Inner Packaging | Outer Packaging | Typical Specification |
| Laboratory small package | Vial / Double-layer PE bag | Aluminum foil bag + Carton | 5mg ~ 500mg |
| Bulk API (1-5kg) | Double-layer PE bag | Aluminum foil bag | 1kg, 2kg, 5kg |
| Bulk API (5-25kg) | Double-layer PE bag | Paper drum | 10kg, 20kg, 25kg |
The unit price for laboratory-scale, milligram-level packaging is substantially higher than that for kilogram-scale bulk API due to fixed costs associated with repackaging, testing, and quality control.
About the latest Finerenone price, please click below to contact us; we will respond to your inquiry within 24 hours.
For your Finerenone API procurement needs, choose Highassay.
Impurity Control of Finerenone PAI
The following are Highassay’s Finerenone impurity control standard, which comply with the requirements of the ICH Q3A and ICH M7 guidelines.
| Category | Impurity Name | Control Limit | Test Method |
| Chiral Stereoisomeric Impurities | R-Finerenone (Enantiomer) | ≤0.15% | Chiral HPLC |
| Diastereomer 1 | ≤0.10% | Chiral HPLC | |
| Diastereomer 2 | ≤0.10% | Chiral HPLC | |
| Total Stereoisomeric Impurities | ≤0.20% | Normalization Method | |
| Organic Impurities | Single Unknown Impurity | ≤0.10% | Conventional HPLC |
| Total Related Substances | ≤0.50% | Normalization Method | |
| Potential Genotoxic Impurities | Aromatic Primary Amine Impurities | ≤1.0ppm, AI≤1.5μg/day | GC-MS |
| N-Nitrosamine Impurities | Not Detected, AI≤96ng/day | LC-MS/MS | |
| Physicochemical Properties | API Assay | ≥99.0% | HPLC |
| Water Content | ≤0.50% | Karl Fischer Titration | |
| Residue on Ignition | ≤0.10% | Ignition Method | |
| Heavy Metals & Harmful Elements | ≤10ppm | Atomic Absorption Spectroscopy | |
| Residual Solvents (ICH Q3C) | Class 1: Not detected; Class 2: Compliant; Class 3: ≤0.5% | GC | |
| Impurity Thresholds | Reporting Threshold | 0.05% | — |
| Identification Threshold | 0.10% | — | |
| Qualification Threshold | 0.15% | — |
