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Magnesium Stearate

Magnesium stearate, also called octadecanoic acid, magnesium salt, is a white substance, powder which becomes solid at room temperature.
  • Specification
  • Benefit
  • Application
  • Storage & Packing
  • Pharmacopoeia

Parameters

Specification

Description

Very fine, Light powder, Greasy to the touch

Color

White

Solubility

Practically insoluble in water & in Anhydrous ethanol

Identification A(Freezing point)

Have to correspond as USP/NF,,Ph.Eur.,BP

Identification B(Acid Value)

195 to 210 as USP/NF,,Ph.Eur.,BP

Identification C,D

Have to correspond as USP,BP,Ph.Eur

Acidity or Alkalinity

Have to correspond as USP,BP,Ph.Eur

Chloride

NMT0.1%  as USP/NF,,Ph.Eur.,BP

Sulphates

NMT 0.5% as USP/NF,,Ph.Eur.,BP

Cadmium

NMT 3 PPM as USP/NF,,Ph.Eur.,BP

Lead

NMT 10 PPM as USP/NF,,Ph.Eur.,BP

Nickel

LOD

Assay of Magnesium

Fatty Acid composition

 

NMT 5 PPM as  USP/NF,,Ph.Eur.,BP

NMT 6% as USP/NF,,Ph.Eur.,BP

4.0%  to 5.0% as USP/NF,,Ph.Eur.,BP

NLT 40% of Stearic Acid & NLT 90% of  sum of stearic acids & palmitic acid as USP/NF,,Ph.Eur.,BP

Bulk Density

0.22 to 0.35 gm/ml

Sieve Analysis

200 mesh( passing through)

 

NLT 90.00%

 

 

MICROBIAL LIMITS

Total Viable Aerobic Count 

N.M.T. 1000cfu/g  as USP/NF,Ph.Eur.,BP

Total  yeast & Mould Count

N.M.T  100cfu/g as USP/NF,Ph.Eur.,BP

Escherichia Coli.

Absent  as USP/NF

Salmonella species

Absent  as USP/NF

 

The raw materials, manufacturing process, and product do not contain any of solvents listed in Organic Volatile Impurities (USP<467>) & residual solvents (Ph – Eur<5.4>).

  • It is an inactive ingredient that binds the active ingredient in a pill or capsule
  • The FDA classifies magnesium Stearate as a glidant, or granulating agent.
  • Magnesium Stearate functions in medicine by preventing the different molecules used to make up the medicine from clumping together, thus ensuring that the correct dose is achieved in every pill made.
  • It is added to supplements to increase production speed as the machines fill the supplement capsules.
  • As an excipient, magnesium Stearate helps to prolong the shelf life of pharmaceuticals and masks the taste and odour of active ingredients.
  • Used as a lubricant in Tableting & Pharmaceuticals
  • Used in Paints and varnishes, as a flattening agent
  • Stabilizer & Lubricant in Engineering Plastics
  • As a stabilizer and lubricant for plastics
  • Soothing agent in Talcum Powder & Cosmetics
  • Emulsifying agent in cosmetics,
  • An anti-caking agent in foods

PackSize: 20/25 KGS 
   A. Exportworthy paper bags. 
   B. Fiber pack drum 
   C. Corrugated box 
   C. HDPE Drums 

Packing is done as required by the end user, and all above said options contains inside LDPE liner.

Container

       Paper Bag                                  

       Corrugated box                                  

       Fiber Drums                                  

       HDPE Drums                                  

 

   Palletized

   Non-pal

   Palletized

   Non-pal

   Palletized

   Non-pal

   Palletized

   Non-pal

 

    20 KG

   20 KG

    20 KG

   20 KG

   25 KG

   25 KG

   25 KG

   25 KG

 20" Feet

  10000 appx.

  12,000 appx.

   9000 appx

  10,000 appx.

   6000 kgs

  8400 kgs

   6000 kgs

   8400 kgs

 40" Feet

  20,000 appx.

  24,000 appx.

  18,000 appx.

  17,500 appx.

  16,000 kgs

  16800 kgs

  16,000 kgs

  16800 kgs

 

HDPE Paper Bag with LDPE Inner Liner

 

Carton Box Packing


 

HDPE Drum packing

 

Fiber Drum Packing

  • USP/NF
  • JP
  • PH.EUR
  • BP
  • EP

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