Sodium Stearyl Fumarate (SSF), identified by its CAS number 4070-80-8, stands as a premium pharmaceutical excipient, widely recognized for its superior performance as a lubricant and anti-adherent in the manufacturing of solid dosage forms such as tablets and capsules. Unlike some traditional lubricants, SSF offers distinct advantages concerning drug compressibility, dissolution profiles, and overall formulation stability. This fine, white, crystalline powder is essential for ensuring smooth and efficient production processes while preserving the critical therapeutic properties of the final pharmaceutical product.

The role of a lubricant in pharmaceutical manufacturing is crucial. It reduces friction between particles during compression, preventing sticking to the punches and dies of tablet presses, and facilitates the ejection of the finished tablet. SSF performs this function exceptionally well, even at relatively low concentrations. Its unique chemical structure, being a sodium salt of a long-chain fatty acid ester of fumaric acid, contributes to its effectiveness. Furthermore, one of the most significant benefits of SSF is its minimal impact on tablet disintegration time and drug dissolution rate. This is a common challenge with other hydrophobic lubricants like magnesium stearate, which can form a water-repellent layer around drug particles, hindering their release. SSF's hydrophilic nature, owing to the sodium salt group, allows water to penetrate the tablet matrix more readily, thus promoting efficient disintegration and dissolution. This makes SSF the preferred choice for formulations containing moisture-sensitive drugs or those requiring rapid onset of action.

Primary applications for Sodium Stearyl Fumarate are diverse within the pharmaceutical industry. It is predominantly used as a high-performance lubricant and anti-adherent in both wet granulation and direct compression methods for tablet manufacturing. Its excellent flow properties also benefit capsule filling processes. Beyond its crucial role in formulation mechanics, SSF finds utility in specific coating applications. It is an important component in certain enteric coating systems, designed to protect acidic-sensitive drugs from the stomach's harsh environment and ensure their targeted release in the alkaline environment of the intestine. SSF contributes to the flexibility, adhesion, and crack resistance of these functional film coatings, ensuring the integrity and performance of the enteric layer.

Adherence to stringent quality standards is paramount for pharmaceutical excipients. High-quality Sodium Stearyl Fumarate, such as the material meeting pharmacopoeial specifications, rigorously complies with major international standards, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Chinese Pharmacopoeia (CP). Compliance with these monographs ensures the material's identity, purity, potency, and overall quality are suitable for human medicinal use. Key parameters tested according to these standards typically include the material's assay (percentage of SSF), limits for related substances and impurities (such as sodium stearyl maleate and stearyl alcohol), moisture content (Water %), heavy metals (like Lead), and specific values like the Saponification Value. These comprehensive quality control measures are fundamental to guaranteeing the safety, stability, and efficacy of the final drug product containing SSF.

The manufacturing process for Sodium Stearyl Fumarate involves complex chemical synthesis, typically starting with stearyl alcohol and fumaric acid, followed by esterification and subsequent neutralization to form the sodium salt. A reliable manufacturer of pharmaceutical excipients must implement sophisticated synthesis methods and robust quality management systems, such as ISO 9001 or even GMP guidelines relevant to excipients, to ensure consistent batch-to-batch quality, purity, and traceability. Sourcing high-quality SSF necessitates partnering with a reputable supplier experienced in the pharmaceutical sector. A well-established supplier not only provides material meeting pharmacopoeial specifications but also offers crucial technical documentation, regulatory support, and reliable logistics. Choosing the right manufacturer or supplier is a strategic decision for pharmaceutical companies, directly impacting the quality, compliance, and success of their drug development and production.

For pharmaceutical companies looking to purchase Sodium Stearyl Fumarate, understanding market dynamics and procurement options is key. The price of SSF can fluctuate based on factors such as order quantity, required grade, specific packaging, and global supply chain conditions. Engaging in bulk buying is often a cost-effective strategy for high-volume users. It is standard practice to request detailed product specifications, certificates of analysis (CoAs), samples for evaluation, and clear price quotations from potential **suppliers**. Discussions around lead times, minimum order quantities (MOQs), and payment terms are integral parts of the **purchase** process. Reputable **manufacturers** and **suppliers** are transparent regarding their **price** structures and available volumes for **buy**ing. When deciding where to **buy** high-quality Sodium Stearyl Fumarate, emphasis should be placed on the supplier's consistent quality, regulatory compliance track record, and customer service capabilities. NINGBO INNO PHARMCHEM CO.,LTD. is a source for high-quality pharmaceutical raw materials and excipients.

Packaging and storage conditions are also vital for maintaining the quality of Sodium Stearyl Fumarate. It is typically supplied in packaging designed to protect it from environmental factors, commonly in 25kg fiber drums with inner liners. Proper storage is essential to preserve its physical and chemical integrity. The material should be stored in a cool, dry place, ideally at temperatures below 30°C, and protected against excessive humidity and physical pressure which could cause caking. Adhering to the manufacturer's recommended storage conditions, which typically indicates a validity period of around two years when stored correctly, ensures the excipient remains suitable for its intended pharmaceutical use throughout its shelf life.

In conclusion, Sodium Stearyl Fumarate (CAS 4070-80-8) is a highly valued pharmaceutical lubricant and excipient, offering significant functional advantages over many alternatives, particularly regarding its minimal impact on drug dissolution and excellent performance across various formulation types. Its compliance with major pharmacopoeial standards underscores its suitability and reliability for demanding pharmaceutical applications. For pharmaceutical **manufacturers** seeking to **purchase** this essential ingredient, selecting a reliable **supplier** offering competitive **price**s, consistent quality, and strong technical support is crucial for ensuring the success and compliance of their final products. NINGBO INNO PHARMCHEM CO.,LTD. serves as a source for high-quality Sodium Stearyl Fumarate to meet pharmaceutical **buy**ing requirements. Companies looking to **buy** or inquire about the **price** of pharmaceutical grade Sodium Stearyl Fumarate, or discuss **buy**ing options from a trusted **manufacturer** or **supplier**, are encouraged to seek information.