Sodium Stearyl Fumarate

Name:Sodium Stearyl Fumarate

CAS No.:4070-80-8

Package:1kg/bag, 5kg/drum, 20kg/drum.

Appearance:

White to off-white powder or granule.

Almost insoluble in water, slightly soluble in methanol, insoluble in acetone and anhydrous ethanol.

QualityStandard: CHP2020; USP40-NF35; EP9.0.

Application:

*As lubricants for tablets and capsules with a concentration of 0.5 ~ 2.0% (w/w).

*It can form a protective coat film in effervescent tablets.

As this product has one fatty chain less and one hydrophilic group more compared with magnesium stearate, so it can solve the slow dissolution of magnesium stearate as lubricant.

*Suitable for lubricants of razole drugs, which are easy to react with magnesium stearate and cannot use magnesium stearate as lubricant.

*As a regulator and stabilizer, such as baked foods, floured thickened foods, baked potatoes and processed grains, with dosage for 0.2 %~ 1.0% of the food weight.

Benefits:

·Improved drug stability

· Shorter disintegration times

. Faster dissolution rates

. Enhanced lubrication efficiency

. Harder tablets in comparison to tablets produced with magnesium stearate

· Faster formulation development and scale-up

Incompatibility: Incompatible with chlorhexidine acetate.

Safety:Generally considered non-toxic and non-irritating.

Storage: Preserve in well-closed containers.

Properties

Sodium stearate fumarate is a widely used and important pharmaceutical food excipient. During the metabolism of sodium stearate fumarate in animals, most of it can be absorbed and hydrolyzed to produce stearyl alcohol and stearic acid, and a small part can be directly and quickly metabolized out, which is non-toxic and non irritating. In the pharmaceutical field, sodium stearate fumarate is added to pharmaceutical preparations, which can be used as a 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 as a regulator and stabilizer to be directly added to foods for human consumption, such as various baked foods, flour thickened foods, dried potatoes and processed grains.

CAS No.

4070-80-8

Formula

C22H39NaO4

Molecular Mass

390.53200

Exact Mass

390.27500

PSA

77.43000

Logp

5.39890