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Gadolinium API (CAS 933983-75-6) is a high-performance gadolinium-based contrast agent raw material with excellent structural stability and formulation compatibility. It meets professional diagnostic requirements for MRI examinations of the central nervous system, blood vessels and multiple organs.
Produced in strict accordance with ICH quality standards, Gadolinium Raw Material features precise impurity control and consistent batch quality. Supported by complete research data and technical documentation, it enables efficient R&D registration and clinical application of finished formulations.
Technical Specifications
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Product Name |
Gadolinium API |
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Synonyms |
Gadolinium Powder, Gadolinium Raw Material |
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Characteristics |
A white or off-white crystalline powder |
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CAS Number |
933983-75-6 |
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Assay |
≥99.0% (HPLC, Subject to the COA) |
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Formula |
C35H54GdN7O15 |
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Package |
Technical Package |
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Storage |
Store in a tightly closed container, protected from light, at 2°C to 8°C in a dry place. It is recommended to protect with nitrogen and freeze at -20°C, which can extend the shelf life. |
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Structure |
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Gadobutrol (Gadolinium CAS 138071-82-6) serves as a core component for the development of MRI contrast agents. Its stable chelate structure and clinical adaptability fulfill high standards for advanced diagnostic preparations. With standardized production management and strict impurity traceability, Gadolinium Powder maintains reliable quality performance. Full regulatory support is provided to support clinical translation and commercial operation of contrast agent products.
Product Features
As a high-performance gadolinium-based MRI contrast agent raw material, Gadolinium API (CAS 933983-75-6) delivers outstanding relaxation efficiency and structural stability, supporting high-resolution and high-contrast imaging performance.
This Gadolinium Raw Material is manufactured under ICH Q7 and GMP quality systems with full-process precise impurity control. The impurity profile is clear and controllable, with assay purity ≥99.0% and excellent batch consistency, fully complying with major international pharmacopoeia standards.
Supported by large-scale intelligent continuous production, Gadolinium Powder enables stable mass production and supply. Complete preclinical research data and registration dossiers are available to support global R&D and filing projects.
The product appears as a white or off-white crystalline powder with stable properties, to be stored at 2–8°C. It is suitable for R&D and production of various MRI contrast agents and can satisfy customized demands for different dosage forms and clinical scenarios. As one of the trusted China Gadolinium API manufacturers, we also support Customized Gadolinium API requests.
Full-Cycle Quality Control & Consistent Quality
The full-cycle quality control system of Gadolinium API (CAS 933983-75-6) is the cornerstone of sustained stability and regulatory compliance. From raw material sourcing to final product release, stringent standards are implemented throughout the process to deliver consistent, high-quality Gadolinium Raw Material to global formulation clients.
Full-Process Traceability Control
From starting material procurement to intermediate synthesis, a strict quality traceability system is established at each step. Key process parameters are monitored online in real time, ensuring traceable sources and controllable production, minimizing quality risks from the source and maintaining stable core properties of Gadolinium Powder.
Comprehensive Impurity Control
Based on high-precision testing and ICH Q7 compliance, process impurities and degradation products are fully analyzed and precisely controlled. The impurity profile is transparent and purity remains stable, meeting global pharmacopoeia requirements and safeguarding clinical safety. Data supporting Gadolinium FDA compliance is also available upon request.
Full-Link Stability Assurance
Through large-scale standardized production and regular process validation, long-term batch-to-batch consistency is achieved. A complete stability program ensures product quality remains compliant throughout shelf life, supporting reliable large-volume supply and full-cycle technical support. We are proud to be among professional China Gadolinium API suppliers with steady Gadolinium API in stock.
Application Scenarios
As a core high-performance gadolinium-based MRI contrast agent raw material, Gadolinium API (CAS 933983-75-6) features excellent imaging performance and regulatory compliance, widely used in diverse clinical diagnostic and industrial applications.
Central Nervous System MRI: Gadolinium Raw Material is suitable for high-field MRI examinations of the central nervous system, clearly outlining brain lesions and supporting accurate identification of tumors, inflammations and vascular diseases.
Body Organ MRI Diagnosis
This API is applicable for imaging of liver, kidney, pancreas and other abdominal organs, enhancing contrast between lesions and normal tissues to assist clinical differential diagnosis.
Vascular MR Angiography
With excellent vascular targeting properties, Gadolinium Powder clearly displays vascular morphology and hemodynamics, detecting stenosis, embolism and malformations accurately.
Advanced Clinical Research
It supports multi-center clinical studies and innovative MRI technology development, meeting strict requirements of research institutions for contrast agent raw materials.
Global Commercial Formulation Production
Compliant with major international pharmacopoeias and ICH guidelines, it supports large-scale production for global pharmaceutical enterprises and facilitates worldwide registration and commercial supply.
Packaging and Transportation
As a critical API for MRI imaging, the packaging and transportation of Gadolinium API (CAS 933983-75-6) directly affect product quality and supply reliability. Supported by a professional pharmaceutical logistics system, standardized packaging and full-process temperature control ensure safe and efficient supply chain services worldwide.
Standardized Sealed Packaging
The product uses pharmaceutical-grade sealed packaging with high-strength moisture-proof outer materials to isolate air, moisture and contamination. Packaging can be customized to prevent moisture deterioration and ensure strength during long-distance delivery.
Professional Temperature-Controlled Transportation
In line with the 2–8°C storage requirement, dedicated cold-chain equipment is applied with real-time temperature monitoring. Transport vehicles meet pharmaceutical cold-chain standards to maintain stable quality during cross-border delivery.
Full-Link Regulatory Logistics Services
A complete logistics compliance system is established with strict packaging inspection and complete shipping documentation. A professional logistics team responds to global delivery demands, ensuring on-time and safe arrival to support production schedules.
Our Advantages
We have established a full-process quality system covering raw material traceability, production and final release, strictly following ICH Q7 and GMP standards. The impurity profile is precisely controlled with excellent batch consistency, ensuring clinical safety and regulatory compliance of Gadolinium API.
Intelligent and large-scale continuous production enables stable mass output. A complete inventory and supply system ensures quick response to global orders and uninterrupted production for formulation clients. We maintain sufficient Bulk Gadolinium API capacity as a reliable China Gadolinium API factory.
A professional R&D team provides complete preclinical data, registration dossiers and customized technical services, supporting customers through global registration and shortening time-to-market.
Customized packaging, specifications and logistics solutions are available in compliance with global regulatory requirements. Flexible and efficient services satisfy personalized production and market layout needs for clients worldwide. We also offer Gadolinium API Free Sample for evaluation purposes.
FAQ
As a key ingredient for MRI contrast agents, Gadolinium API (CAS 933983-75-6) features excellent physicochemical properties and formulation compatibility, meeting strict requirements for high-end contrast product development. This Gadolinium Raw Material complies with international quality standards, with verified purity and impurity control to ensure clinical safety and reliability. Supported by a complete quality system, Gadolinium API made in China provides stable performance and solid support for clinical diagnosis and treatment.
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