Magnesium Stearate

Specification

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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

NMT 5 PPM as
USP/NF,,Ph.Eur.,BP

LOD

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

Assay of Magnesium

4.0% to 5.0% as
USP/NF,,Ph.Eur.,BP

Fatty Acid composition

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

Benefit

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.

Application

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

Storage & Packing

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

Pharmacopoeia

USP/NF
JP
PH.EUR
BP
EP

Specification

Very fine, Light powder, Greasy to the touch

white

Practically insoluble in water & in Anhydrous ethanol

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

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

Have to correspond as USP,BP,Ph.Eur

Have to correspond as USP,BP,Ph.Eur

NMT0.1% as USP/NF,,Ph.Eur.,BP

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

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

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

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

0.22 to 0.35 gm/ml

NLT 90.00%

MICROBIAL LIMITS

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

N.M.T 100cfu/g as USP/NF,Ph.Eur.,BP

Absent as USP/NF

Absent as USP/NF

Benefit

Application

Storage & Packing

Pharmacopoeia

Products

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

Have to correspond as
USP,BP,Ph.Eur

Have to correspond as
USP,BP,Ph.Eur

NMT0.1% as
USP/NF,,Ph.Eur.,BP

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

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

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

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

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

N.M.T 100cfu/g as
USP/NF,Ph.Eur.,BP

Absent as
USP/NF

Absent as
USP/NF