Magnesium Stearate IP, BP, USP-NF
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.
|1||Appearance||White or almost white, very fine, light powder, eypealg ice greasy to the touch|
|3||Assay (Magnesium)||B/W 4.0 and 5.0%|
|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 105°C)||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|
25 kg HDPE Bags & Drums
Stability & Storage:
The product is stable when sealed container stored in shady, dry and ventilated warehouse in normal condition.