HK Neopharm Limited is one of the most reliable manufacturers and suppliers of gadobutrol fda in China, featured by quality products and good price. Please rest assured to buy gadobutrol fda in stock here and get quotation from our factory. Customized orders are welcome.
Gadobutrol API (Gadobutrol CAS 138071-82-6) is a mature gadolinium contrast agent raw material with over 20 years of global clinical validation. Approved in 1998, it is widely used in CNS, whole-body and vascular MRI in over 100 countries, with its excellent imaging performance and safety verified by over 100 million clinical uses. As a professional China Gadobutrol manufacturer, we produce Gadobutrol Raw Material complying with ICH Q7, with well-controlled impurities and complete preclinical data to support fast product launches.
Technical Specifications
|
Product Name |
Gadobutrol API |
|
Synonyms |
Gadobutrol Powder, Gadobutrol Raw Material |
|
Characteristics |
A white or off-white crystalline powder |
|
CAS Number |
138071-82-6 |
|
Assay |
≥99.0% (HPLC, Subject to the COA) |
|
Formula |
C18H31GdN4O9 |
|
Package |
Technical Package |
|
Storage |
Store in a tightly closed container, protected from light, in a cool and dry place at 2°C to 8°C. |
|
Structure |
|
Gadobutrol (CAS 138071-82-6) is a critical raw material for modern high-end MRI. With superior imaging efficiency and reliable safety, it enables accurate diagnosis of complex lesions. Backed by intelligent continuous production and full-scale impurity control, we deliver consistent and compliant Gadobutrol Powder to global clients, accelerating formulation R&D, registration and large-scale supply.
Product Features
With a stable macrocyclic chelate structure, Gadobutrol API tightly binds gadolinium ions and significantly reduces residual free gadolinium risk. Its non-ionic nature further lowers osmotic adverse reactions, ensuring excellent clinical safety.
As a 1.0 mol/L high-concentration gadolinium contrast agent, Gadobutrol Raw Material delivers industry-leading relaxivity, allowing higher-resolution imaging in shorter scan time and improving detection of small and early lesions.
Manufactured under strict ICH Q7 standards with proprietary purification technology, our Gadobutrol Powder achieves ≥99.0% purity and controllable impurities. It meets USP, EP, JP requirements and delivers excellent batch-to-batch consistency.
Gadobutrol has wide applications in CNS, whole-body and vascular MRI. It is safe for all age groups, including patients with renal insufficiency and the elderly.
Full-Cycle Quality Control & Consistent Quality
Quality is the lifeline of Gadobutrol API. We have built a closed-loop quality system covering raw material intake to finished product delivery, ensuring stable quality for every batch and supplying safe, reliable key materials to global customers.
We implement strict supplier qualification and audit systems; all raw materials undergo comprehensive testing. Complete traceable records are kept for each batch to eliminate quality risks at the source.
Production of Gadobutrol Raw Material strictly follows ICH Q7 and GMP with 24/7 online monitoring of critical parameters. Automated closed production minimizes human interference and cross-contamination.
Complete testing standards are set for intermediates and final Gadobutrol Powder using advanced analytical instruments. Key indexes such as purity, impurity profile and crystal form are fully tested to meet global pharmacopoeia requirements.
Pharmaceutical-grade packaging and aseptic processing are adopted for Gadobutrol API. A full-range temperature and humidity monitoring logistics system with unique trace codes ensures stable quality during shipment and storage.
We conduct long-term stability studies and establish a sound post-marketing quality monitoring mechanism for Gadobutrol Raw Material. Customer feedback is addressed promptly to optimize production and quality standards continuously.
Application Scenarios
Gadobutrol is a globally used high-concentration macrocyclic gadolinium contrast agent API. With outstanding imaging performance and safety, it covers full clinical MRI scenarios and supports accurate diagnosis and treatment evaluation for various diseases.
Gadobutrol Powder is widely used in enhanced CNS MRI to clearly display brain tumors, cerebrovascular diseases, multiple sclerosis and neurodegenerative disorders, greatly improving detection sensitivity of small and early lesions.
Gadobutrol API is suitable for abdominal, pelvic, breast and musculoskeletal imaging, assisting in tumor differentiation, staging and follow-up to provide precise imaging support for personalized treatment.
Gadobutrol (Gadobutrol CAS 138071-82-6) is the preferred raw material for MRA, clearly showing fine structures of coronary, cerebral, peripheral and aortic vessels for non-invasive screening and diagnosis of stenosis and aneurysms.
Safe for children, the elderly and patients with mild to moderate renal insufficiency, Gadobutrol Raw Material also supports functional MRI and dynamic enhanced scanning to meet diverse diagnostic needs.
Packaging and Transportation
Compliance is the foundation of global pharmaceutical distribution. Our packaging and transportation systems for Gadobutrol API comply with ICH Q7 and global regulations, validated under Gadobutrol FDA and EU GMP to meet top international quality standards.
We use pharmacopoeia-compliant pharmaceutical-grade packaging materials for Gadobutrol Powder, with verified sealability and compatibility for each batch to prevent contamination and ensure shelf-life stability.
Transportation of Gadobutrol fully complies with EU GDP and US cGMP standards, equipped with calibrated temperature recorders and fully traceable shipping data for regulatory audits in major markets.
All exported Gadobutrol API products come with complete customs documents and compliance certificates. Multi-language label customization is supported to ensure smooth customs clearance and regulatory inspection worldwide.
Our Advantages
With years of expertise in pharmaceutical APIs, we are a reliable China Gadobutrol supplier with industry-leading large-scale production bases and fully automated lines, enabling stable year-round production of Gadobutrol API to support Bulk Gadobutrol demands globally.
Our professional team consists of senior R&D and compliance experts, mastering core synthesis and purification technologies for Gadobutrol with independent intellectual property rights, continuously upgrading processes and strengthening technical barriers.
Our quality system for Gadobutrol Raw Material meets global top standards with Gadobutrol FDA, EMA and GMP certifications. Closed-loop control and international testing equipment ensure industry-leading product quality.
With a global layout, we have long-term partnerships with dozens of renowned pharmaceutical companies. Our mature international supply chain and registration system enable efficient response, fast delivery and smooth customs clearance for Gadobutrol Powder.
Adhering to "Quality First, Innovation Driven", we keep investing in R&D and capacity expansion. With strong technology, production and compliance strengths, we are a trusted global supplier of Gadobutrol made in China and provide Customized Gadobutrol solutions.
FAQ
To meet the demand for precise clinical imaging, we focus on high-end contrast agent APIs and have mastered large-scale production of Gadobutrol CAS 138071-82-6, providing stable, high-quality raw materials for MRI enhancement. We support global clients to buy Gadobutrol and offer Gadobutrol Free Sample for evaluation. Guided by clinical value, our technical team assists partners in formulation optimization and registration. We will keep innovating and upgrading systems to improve global early disease diagnosis and protect public health.
Hot Tags: gadobutrol FDA, China gadobutrol FDA manufacturers, suppliers, factory
