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The pharmaceutical industry places paramount importance on the safety and efficacy of its products. Every excipient used in drug formulations, including Sodium Stearyl Fumarate (SSF), must be handled with the utmost care and understanding of its safety profile. At NINGBO INNO PHARMCHEM CO., LTD., we provide high-purity SSF and believe in empowering our clients with comprehensive information regarding its safe usage. This article outlines the key safety considerations for Sodium Stearyl Fumarate (CAS 4070-80-8).
Sodium Stearyl Fumarate is generally regarded as safe for its intended pharmaceutical applications, primarily as a lubricant in solid dosage forms. However, like many chemical substances, it requires careful handling to prevent potential adverse effects. The most commonly cited safety concerns relate to direct contact. SSF can cause mild skin and eye irritation. Redness, itching, and discomfort may occur upon contact. Therefore, it is essential for personnel handling SSF to wear appropriate personal protective equipment (PPE), including gloves and eye protection, such as safety goggles or glasses. This adherence to safety protocols is fundamental in pharmaceutical lubricant handling.
Beyond direct contact, it is important to follow good manufacturing practices (GMP) when working with SSF. This includes ensuring adequate ventilation in the workplace to minimize inhalation of airborne particles. While SSF is not typically associated with significant systemic toxicity or long-term health effects, adhering to proper handling guidelines is crucial for maintaining a safe working environment. For instance, avoiding the generation of dust during transfer and weighing operations can significantly reduce exposure risks.
One area of particular attention in formulation design involves potential incompatibilities. Recent studies have highlighted that SSF might react with secondary amines under humid and basic conditions, potentially forming degradation products. This is a critical consideration for drug formulation stability analysis. NINGBO INNO PHARMCHEM CO., LTD. advises formulators to conduct thorough compatibility studies and implement moisture control measures to prevent such reactions, ensuring the integrity and stability of the final drug product. Understanding these nuances is part of the broader application of pharmaceutical excipient safety.
In the event of accidental ingestion or prolonged exposure beyond recommended guidelines, seeking immediate medical attention is advised. Always refer to the Material Safety Data Sheet (MSDS) provided with the product for detailed information on handling, storage, and emergency procedures. By prioritizing safety and adhering to best practices, the benefits of Sodium Stearyl Fumarate as a superior pharmaceutical excipient can be fully realized, contributing to the production of safe and effective medications.
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1. 20 years of R&D, manufacturing and sales experience, serving customers in 60 countries and regions around the world;
2. Own R&D laboratory, pilot platform and large-scale production workshop, which can meet the audit requirements of global customers;
3. We can satisfy customers' perfect transition from small scale lab requirements (gram level) to commercialization requirements (hundred tons level).
A: We don't have Minimum Order Quantity, exact quantity should be provided before quotation for us to calculate the exact cost.
A: We don't provide free samples due to lots of request and expensive international courier's cost, we can deduct the sample charge after commercial order placed.
A: Our payment terms: Small or sample order: T/T IN ADVANCE. Commercial order: First order should be by T/T IN ADVANCE or L/C at sight, and following orders T/T 30~90days is acceptable subject to approval of credit application.
