| Powder: | Yes |
|---|---|
| Customized: | Non-Customized |
| Certification: | USP |
| Suitable for: | Adult |
| State: | Solid |
| Purity: | >99% |
| Samples: |
|---|
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Sodium stearate fumarate is a hydrophilic lubricant, which is used as the lubricant in tablets to reduce friction between tablets and mold walls and prevent materials from adhering to the punch or mold walls of the pharmaceutical industry. It is also used as a lubricant in the manufacture of capsules and other oral dosage forms, as well as in food production, as a dough conditioner, conditioner and stabilizer.
| Test Items | Standard | Result |
| Description | white or almost white powder | Conforms |
| Identification | IR | Conforms |
| Water(K.F.) | ≤5.0% | 2.9% |
| Lead | ≤10ppm | <10ppm |
| Heavy metals | ≤20ppm | <20ppm |
| Saponification value (anhydrous dasis) | 142.2-146.0 | 143.7 |
| Limit of sodium stearyl maleate and stearyl alcohol | ||
| sodium stearyl maleate | ≤0.25% | Conforms |
| Stearyl alcohol | ≤0.5% | Conforms |
| Related substances (GC) | ||
| Single impurity | ≤0.5% | 0.3% |
| Total impurities | ≤5.0% | 2.3% |
| Assay | 99.0%-101.5% | 99.7% |
| Conclusion | The results conform with USP39/NF34 standard | |
Sodium stearate fumarate is a widely used and important pharmaceutical and food excipient. In the metabolic process of sodium stearate fumarate in animals, most of it can be absorbed, and the hydrolysis produces stearic alcohol and stearic acid. A small part can be directly and rapidly metabolized, which is non-toxic and non irritating.
In the pharmaceutical field, sodium stearate fumarate is added to pharmaceutical preparations, which can be used as the lubricant for tablets and capsules, and can also form a protective film in effervescent tablets, which can solve the problems of stearate lubricants, improve drug disintegration, and promote drug dissolution.
In the field of food, FDA allows sodium stearate fumarate to be directly added into foods for human consumption as a regulator and stabilizer, such as various baked foods, flour thickened foods, baked potatoes and processed cereals.
Packaging:
Standard export packing (25KGS/bag).
Storage:
Store in a closed, cool and dry place
SCM Pioneering Co., Ltd is an emerging supplier of high quality ingredients which based in Shandong province, China.
SCM was established by group of experts who have more than ten years experiences in pharmaceutical and food ingredients industries. with our deep knowledge and diligence, together with our associated plants, we would like to provide one-stop sourcing solutions for customers, to save your time and secure your purchasing.
1. What is the Sodium Stearyl Fumarate?
Sodium Stearyl Fumarate (SSF) is used as a lubricant in tableting to reduce the friction between the tablet and the die wall and to prevent adhesion of the material to punches or the die wall in the pharmaceutical industries. It is used also as a lubricant in the manufacturing of capsules and other oral dosage forms. Sodium stearyl fumarate is also used in food production as a dough conditioner, a conditioning agent, and a stabilizing agent.
2.Which filed can be used of Sodium Stearyl Fumarate?
Well, it is widely used as lubricant in pharmaceutical excipients,Food sector as regulator and stabilizer etc.
3.Can I get some sample for test?
Sure, we can supply samples free for your test. Normally 20g is enough.
4.How can you guarantee the quality?
We cooperate with factory with following standard: Natural product fermented from Saccharomyces cerevisiae. GMP, KFDA, DCGI, Kosher, halal and HACCP certificates.
Dear friends, now contact us to get more benefit!
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