In the complex world of pharmaceutical manufacturing, the choice of excipients is paramount to the success, stability, and performance of the final dosage form. Among the array of functional excipients, Sodium Stearyl Fumarate, identified by its CAS number 4070-80-8, stands out as a highly valued pharmaceutical excipient, particularly for its efficacy as a lubricant in solid dosage formulations.
As a lubricant, Sodium Stearyl Fumarate plays a crucial role in tablet and capsule production. It effectively reduces friction between the solid material being compressed and the surfaces of the tableting machine, such as the dies and punches. This reduction in friction is essential for smooth operation of high-speed tableting equipment, preventing issues like sticking and binding, which can lead to reduced production efficiency and defects in the final product, such as capping or lamination.
One of the significant advantages of Sodium Stearyl Fumarate compared to some conventional lubricants, such as magnesium stearate, is its lower hydrophobicity. This characteristic often results in minimal to no negative impact on the dissolution and disintegration profiles of tablets and capsules. For formulations containing active pharmaceutical ingredients (APIs) that are sensitive to hydrophobic environments or where rapid dissolution is critical for bioavailability, Sodium Stearyl Fumarate is often the preferred choice. Its chemical inertness further contributes to its compatibility with a wide range of APIs, reducing the risk of unwanted interactions that could compromise the drug's stability or efficacy over time.
This high-performance excipient is typically supplied in a fine powder form, ensuring ease of handling and incorporation into various pharmaceutical processes, including direct compression, dry granulation, and wet granulation. Its medicine grade quality guarantees suitability for human consumption products, adhering to the strict purity and safety standards required by the pharmaceutical industry.
Quality is non-negotiable in pharmaceutical production. Sodium Stearyl Fumarate is manufactured to meet stringent international pharmacopeial standards, including those set by USP, European Pharmacopoeia (EP), and British Pharmacopoeia (BP). Compliance with these monographs is critical and ensures the product's identity, purity, and quality are consistently maintained. Rigorous testing confirms parameters such as water content, impurity levels (including specific related substances like sodium stearyl maleate and stearyl alcohol), saponification value, and assay percentage fall within accepted ranges, guaranteeing a high-purity product suitable for demanding pharmaceutical applications. This commitment to quality ensures reliability and performance in the final drug product.
As a dedicated provider of high-quality pharmaceutical raw materials, NINGBO INNO PHARMCHEM CO.,LTD. specializes in the production and supply of Sodium Stearyl Fumarate CAS 4070-80-8. Our manufacturing processes adhere to strict Good Manufacturing Practices (GMP) principles, ensuring traceability and consistent quality from raw material sourcing to final product packaging. Each batch undergoes rigorous quality control testing in accordance with pharmacopeial monographs, providing our customers with confidence in the material they receive.
With a significant production capacity, NINGBO INNO PHARMCHEM CO.,LTD. is a reliable source for pharmaceutical manufacturers worldwide. The product is typically packaged in robust 25 kilogram fiber drums, designed to protect the material during transit and storage and ensure its integrity upon arrival. Proper storage is essential to maintain product integrity. Sodium Stearyl Fumarate should be stored in a cool, dry environment, ideally below 30 degrees Celsius, protected from humidity and physical pressure. Under these recommended storage conditions, it maintains a validity period of two years, providing flexibility for inventory management.
Choosing the right excipient is vital for successful pharmaceutical formulation and manufacturing efficiency. Sodium Stearyl Fumarate from NINGBO INNO PHARMCHEM CO.,LTD. offers excellent performance, reliability, and compliance with global standards. For those seeking a trusted supplier of pharmaceutical lubricants, considering Sodium Stearyl Fumarate manufacturer options is key. NINGBO INNO PHARMCHEM CO.,LTD. stands as a leading supplier, offering competitive price structures for bulk purchase. To inquire about Sodium Stearyl Fumarate price or to buy this essential pharmaceutical excipient, contacting a reputable supplier is recommended. Whether you need to purchase a specific quantity for your next batch or want to discuss supply chain options, partnering with an experienced manufacturer like NINGBO INNO PHARMCHEM CO.,LTD. ensures access to high-quality material. We are ready to provide details on how to buy Sodium Stearyl Fumarate and provide transparent pricing information tailored to your needs. Our team is available to assist with technical inquiries and support your formulation efforts, making us a valuable partner in your pharmaceutical development and production processes.
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