Edaravone FDA

Edaravone FDA
Details:
Edaravone API (CAS 89-25-8) is a Edaravone fda-approved core neuroprotective API recognized by regulatory authorities worldwide. It is widely used in the clinical treatment of acute cerebral infarction and amyotrophic lateral sclerosis.
  • CAS Number 89-25-8
  • Formula C10H10N2O
  • Storage Below 25°C
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Description
Technical Parameters

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Edaravone API (CAS 89-25-8) is a Edaravone fda-approved core neuroprotective API recognized by regulatory authorities worldwide. It is widely used in the clinical treatment of acute cerebral infarction and amyotrophic lateral sclerosis. By effectively scavenging free radicals and inhibiting oxidative damage, it precisely protects nerve cells and delays disease progression. We supply high-purity Edaravone Raw Material in line with ICH Q7 standards, supported by complete registration documents to meet stable supply and customized development needs of global pharmaceutical companies.

 

Technical Specifications

 

 

Product Name

Edaravone API

Synonyms

Edaravone Powder, Edaravone Raw Material

Characteristics

A off-white to yellow crystalline powder

CAS Number

89-25-8

Assay

≥99.0% (HPLC, Subject to the COA)

Formula

C10H10N2O

Package

Technical Package

Storage

Store in airtight container, protect from light, moisture and oxidation.Recommended temperature: below 25°C; long-term storage preferably at 2–8°C refrigerated.

Structure

product-255-189

 

As a key API for neurological disorders, Edaravone (CAS 89-25-8) has gained clinical recognition and wide application globally. With reliable product quality and standardized production management, we continue to provide compliant raw materials to pharmaceutical enterprises, helping formulations achieve safe and effective clinical performance. As trusted China Edaravone API manufacturers, we ensure consistent and stable supply.

 

 
 
Product Features

Edaravone API

As a core neuroprotective API, Edaravone 99% Purity Powder features efficient free radical scavenging and oxidative stress inhibition. With a clear mechanism and proven clinical efficacy, it plays an important role in neurological disease treatment with outstanding pharmaceutical value.

Edaravone API

Subject to strict quality control, the product meets major pharmacopoeia standards for purity and assay, with low impurities and excellent batch-to-batch consistency. It ensures the safety and uniformity of downstream formulations and fully satisfies R&D and production requirements.

Produced under standardized manufacturing processes in full compliance with international GMP guidelines, Edaravone Powder features controllable raw materials and traceable production. Complete quality research data is available to support registration of various formulations.

 

It is compatible with multiple dosage forms and well adaptable to industrial mass production and innovative R&D demands of pharmaceutical companies. It provides stable and reliable support for drug development in the neurological field, ideal for bulk Edaravone orders.

 

Full-Cycle Quality Control & Consistent Quality

 

 

 

Edaravone (CAS 89-25-8) is a core API in neuroprotection, and its quality directly determines the safety and efficacy of downstream formulations. We implement a full-cycle quality control system to ensure consistent, compliant quality for every batch and support global pharmaceutical partners.

 

 

We strictly control raw material procurement and supply chain management, using only pharmaceutically qualified starting materials. A dual mechanism of supplier audit and incoming inspection eliminates impurity risks at the source, laying a solid foundation for stable and compliant production.

 

 

All production follows ICH Q7 and international standards with real-time monitoring of critical process parameters and in-line testing. Fine control is applied to synthesis, purification and drying to ensure stable purity and assay in every batch.

Finished products undergo comprehensive testing covering purity, impurities and stability. Accelerated and long-term stability studies verify shelf-life consistency. Complete COA and registration dossiers are provided for full-chain support in production and registration.

 

Application Scenarios

 

 

As a clinically recognized core neuroprotective API, Edaravone API exerts strong antioxidant and free radical-scavenging effects. It is widely used in global neurological diagnosis and treatment, supporting various formulations for safe and effective clinical use.

 

It serves as a key raw material for acute cerebral infarction emergency medications, quickly scavenging cerebral oxygen free radicals and alleviating ischemia-reperfusion injury. It is suitable for industrial production of emergency injections such as Edaravone MDF.

 

As a globally approved API for ALS treatment, it slows disease progression and improves motor function, offering long-term therapeutic solutions. It supports R&D and large-scale production of long-acting injections.

Edaravone Application Scenarios

 

Edaravone API can be used in nerve injury scenarios such as traumatic brain injury and spinal cord injury. It reduces nerve cell apoptosis by inhibiting oxidative stress and promotes neurological recovery for various repair formulations.

 

With well-established pharmacological properties, it supports extended-release and compound preparations. It is suitable for combination therapies for stroke and neurodegenerative diseases, strengthening product portfolios for global pharmaceutical clients.

 

Packaging and Transportation
 

To maintain the quality of Edaravone Raw Material throughout storage and transportation, we adopt professional, compliant packaging and standardized logistics systems with excellent sealing, safety and traceability to meet strict global shipping requirements.

Professional Protective Packaging

The product uses pharmaceutical-grade sealed packaging with moisture-proof and light-resistant inner layers and sturdy outer protection. It effectively isolates light, moisture and physical impact, preserving product quality during storage and delivery.

Standardized Logistics & Transportation

We cooperate with qualified professional pharmaceutical logistics providers with full temperature control and real-time tracking. Transportation conditions are strictly controlled to avoid shock and temperature/humidity deviations, ensuring safe and on-time global delivery.

Export Compliance Support

Clear and standardized labeling meets international shipping and customs declaration requirements. Complete qualification documents are provided to facilitate cross-border logistics, customs clearance and inspection for smooth global cooperation.

 
 
Our Advantages

Quality and compliance are guaranteed under ICH Q7 and global pharmacopoeia standards. Full-cycle quality control ensures high purity and batch consistency. Complete COA and registration dossiers are available to meet global regulatory demands.

Strong large-scale production capacity enables stable mass output of Edaravone API made in China. Flexible production supports orders from lab R&D to industrial manufacturing, ensuring on-time delivery.

A complete supply chain, strict raw material control and professional pharmaceutical logistics ensure efficient temperature-controlled transportation and customs clearance, enabling stable and secure worldwide delivery.

We provide thoughtful customized Edaravone services, including tailored specifications and packaging, technical support and registration guidance throughout R&D, registration and production.

With rich experience in neuroprotective APIs, we understand global regulatory policies and serve customers worldwide. Reliable quality and efficient service have earned wide market recognition and trust.

 

FAQ

 

Q: Do you provide complete registration documents?

A: Yes, we offer full registration packages including process description, impurity study, stability data and GMP documents to support domestic and international formulation registration.

Q: Do you offer lab samples? Is sample purity consistent with bulk products?

A: Yes, we provide qualified Edaravone Powder free sample produced with the same process and tested under the same standards as bulk goods, with identical purity and key indicators.

Q: Is production capacity sufficient for long-term stable supply?

A: Yes, we have large-scale production capacity with stable output to support long-term supply, annual agreements and continuous order fulfillment. We also maintain Edaravone Raw Material in stock for urgent needs.

Q: How do you handle quality complaints?

A: We have a comprehensive after-sales system. Any quality objection will be promptly investigated and properly resolved to prioritize customer compliance and interests.

Q: Is the cooperation process complicated?

A: The process is simple and clear. We provide full assistance from sample request, quotation and order to delivery, ensuring easy cooperation even for new partners.

 

We focus on technological innovation in neuroprotective APIs, with an independently developed efficient production process for Edaravone (CAS 89-25-8) and superior quality control. Our professional R&D team provides one-stop services including customized production, process optimization and registration support to accelerate product commercialization. As leading China Edaravone suppliers, we provide one-stop services and support Edaravone fda-compliant development, partnering with global pharmaceutical clients to advance neurological treatment and human health.

 

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