Epalrestat Powder Cas No.82159-09-9
Product source: Synthetic products
Content specification: ≥ 98%
CAS NO：82159-09-9
The chemical formula is: C15H13NO3S2
Molecular weight: 319.4
Detection method: HPLC
Active ingredient: Epalrestat
Product Description: Yellow to orange powder or deep red needle shaped crystals
Product usage: Medical and scientific research
Product packaging: 1kg/bag; 25kg/barrel
Product storage: Keep in a ventilated, low temperature, dry environment, away from light, recommended temperature is -20 ℃
Shelf life: 24 months
Epalrestat API Powder (Aldose Reductase Inhibitor)
CAS 82159-09-9 | High-Purity Crystalline API | For Diabetic Peripheral Neuropathy (DPN)
⚠️ REGULATORY COMPLIANCE & STORAGE PROTOCOLS: This active pharmaceutical ingredient (API) is strictly supplied as a bulk raw material for B2B industrial pharmaceutical manufacturing, commercial drug compounding, and laboratory research. Epalrestat is highly photosensitive. Storage at -20°C in airtight, light-protected containers is mandatory. To prevent degradation into inactive isomers, maintain a low-temperature, dry environment and avoid exposure to direct sunlight during handling.
Advanced Polyol Pathway Blockade
Epalrestat (CAS No. 82159-09-9) is a carboxylic acid derivative and a potent, non-competitive aldose reductase inhibitor (ARI). Specifically engineered to manage the chronic microvascular complications of diabetes, it functions by impeding the polyol pathway, which is highly active under hyperglycemic conditions.
Manufactured under rigorous cGMP protocols at Xi'an Tihealth Biotechnology Co., Ltd., our synthetic Epalrestat powder achieves a validated HPLC purity of ≥98.0%. This pharmaceutical-grade API is optimized for oral solid dosage formulations, ensuring exceptional crystalline stability and minimal residual impurities for global drug manufacturers.
Technical Specification (TDS Profile)
| Testing Parameter | Tihealth Specification Limits |
|---|---|
| Chemical Name | 2-[(5Z)-5-[(E)-2-methyl-3-phenylprop-2-enylidene]-4-oxo-2-thioxo-1,3-thiazolidin-3-yl]acetic acid |
| CAS Registry Number | 82159-09-9 |
| Molecular Formula / Weight | C₁₅H₁₃NO₃S₂ / 319.4 g/mol |
| Assay (HPLC, Purity) | ≥ 98.0% |
| Loss on Drying | ≤ 0.5% |
| Appearance | Deep red needle crystalline powder |
* Complete technical package-including HPLC chromatograms, NMR charts, ESI-MS mass spectrometry, and photo-stability profile curves-are bundled with each shipment.
Pharmacological Mechanism of Action
Epalrestat facilitates neuroprotection and microvascular improvement by selectively inhibiting the rate-limiting enzyme of the polyol pathway:
- Aldose Reductase (AR) Inhibition: Epalrestat competitively binds to the active site of aldose reductase, halting the conversion of excessive intracellular glucose into sorbitol and subsequently fructose.
- Osmotic Pressure Normalization: By reducing sorbitol accumulation in nerve fibers and microvascular tissues, it restores intracellular osmotic balance, alleviating edema and structural damage to the myelin sheath.
- Oxidative Stress & Inflammation Reduction: It inhibits the expression of pro-inflammatory cytokines such as IL-1β and TNF-α, while decreasing the formation of advanced glycation end products (AGEs), thereby repairing nerve conduction velocity and restoring peripheral microvascular blood flow.
Primary Pharmaceutical & R&D Applications
- Diabetic Peripheral Neuropathy (DPN) Formulations: The essential active pharmaceutical ingredient for manufacturing clinical treatments indicated to improve subjective symptoms such as numbness, pain, and paresthesia in limbs.
- Diabetic Retinopathy & Nephropathy Research: Broadly utilized in preclinical pharmacological research to investigate microvascular damage delay and the regulation of metabolic homeostasis in renal tissues.
- Oral Solid Dosage Compression: High-purity crystalline needle form optimized for tableting and capsule compounding, ensuring stable bioavailability for geriatric populations.
Technical Support & Procurement FAQ
Why is the light sensitivity of Epalrestat critical during the manufacturing process?
Epalrestat is a rhodanine-3-acetic acid derivative which is highly sensitive to light. Exposure to UV or strong visible light can trigger photodegradation or cis-trans isomerization, resulting in a loss of assay potency and increased impurity profiles. We recommend amber-glass handling and light-shielded tablet coating processes.
Does Epalrestat directly lower blood glucose levels (HbA1c)?
No. Epalrestat is not an antihyperglycemic agent. It does not affect blood glucose or HbA1c levels directly. Instead, it addresses the pathological outcomes of chronic hyperglycemia by preventing the accumulation of sorbitol, thereby treating the neuropathy complications rather than the underlying diabetic state.
How do you ensure batch consistency for the deep red needle crystal form?
The deep red needle crystalline structure is an indicator of high isomeric purity and specific polymorphic stability. At Xi'an Tihealth, we control crystallization kinetics and solvent systems meticulously to ensure that every batch meets the standardized morphological and HPLC requirements (≥ 98.0%).
What are the primary metabolic routes for Epalrestat in vivo?
Epalrestat is primarily metabolized via biliary excretion. It undergoes conjugation and reduction of the rhodanine ring. Due to its systemic distribution, it can effectively reach the peripheral nerves where aldose reductase activity is highest, providing targeted therapeutic benefits.
What documentation can Xi'an Tihealth provide for regulatory drug filings?
We provide a comprehensive technical data package, including the Certificate of Analysis (COA), Method of Analysis (MOA), Stability Data (including photo-stability), and MSDS. Our quality team is ready to assist with GMP audits and regulatory registrations globally.
Empower Your Microvascular Complications R&D
Contact our technical sales director for bulk pricing, customized physical specifications, and complete regulatory dossiers (COA/MSDS/DMF).
👤 Technical Director: Wang Xueyan
📧 peter@xatihealth.com 📞 WhatsApp: +86 13991246876
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