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Magnesium Stearate

Excipients for Oral and Topical Applications

Magnesium Stearate USP/NF, EP, JP is a hydrophobic fine white powder of vegetable origin offered by SVDH Pharma Chem. It is made by reacting saturated fatty acid (mainly stearic acid) with a base such as Magnesium hydroxide to form Magnesium Stearate. It is available in three different grades with distinct specific surface area that provides an option in critical formulations. Support for customized grades with desired specific surface area can also be provided

Product Description

Magnesium Stearate is the most commonly used lubricant for tablets.

Magnesium Stearate is also useful because it has lubricating properties, preventing ingredients from sticking to manufacturing equipment during the compression of chemical powders into solid tablets.

Magnesium Stearate is often used as an anti-adherent in the manufacture of medical tablets, capsules and powder.

Magnesium Stearate can also be used efficiently in dry coating processes. e Magnesium Stearate is also used to bind sugar in hard candies like mints, and is acommon ingredient in baby formulas.

Product Description:

No.	Index	Specifications
1	Appearance	White or almost white, very fine, light powder, eypealg ice greasy to the touch
2	Identification	Passes
3	Assay (Magnesium)	B/W 4.0 and 5.0%
4	Chlorides	NMT 0.1%
5	Sulphates	NMT 1.0%
6	Cadmium	NMT 3 ppm
7	Nickel	NMT 5 ppm
8	Lead	NMT 10 ppm
9	The sum of the stearate and palmitate peaks	NLT 40% for the stearate peak and the sum of the stearate and palmitate peaks is NLT 90% of the total peak areas of all the fatty acids.
10	Acidity or Alkalinity	NMT 0.05 ml. of 0.1 N Hydrochloric acid or NMT 0.1 N sodium hydroxide is required to change the color of the indicator
11	Loss on Drying (dry at 105째C)	NMT 6.0% w/w
12	Solubility	Practically insoluble in water and in anhydrous ethanol
13	Microbial Limit :
	Total Aerobic Count	NMT 1000 cfu/g
	Total Yeast and Molds	NMT 100 cfu/g
	Escherichia coli	Not detected
	Salmonella	Not detected