Sodium Stearate Pure & BP USP NF Manufacturers |
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MSDS of Sodium Stearate BP USP NF Manufacturers
Sodium Stearate
Technical & Pure
Also IP BP Ph. Eur. USP-NF ACS AR LR FCC Food Grades
Specifications of Sodium Stearate BP Ph Eur
Action
and use
Excipient
DEFINITION
Mixture of
sodium salts of different fatty acids consisting mainly of stearic (octadecanoic)
acid [C17H35COONa] and palmitic (hexadecanoic) acid [C15H31COONa].
Content:
sodium: 7.4 per cent to 8.5 per cent (dried substance);
stearic acid in the fatty acid fraction: minimum 40 per cent;
sum
of stearic acid and palmitic acid in the fatty acid fraction: minimum 90 per
cent.
CHARACTERS
Appearance
White or
yellowish, fine powder, greasy to the touch.
Solubility
Slightly
soluble in water and in ethanol (96 per cent).
IDENTIFICATION
First identification C, D.
Second identification A, B, D.
A. Freezing
point Minimum 53
°C for the residue obtained in the preparation of solution S (see Tests).
B. Acid
value 195 to 210, determined on 0.200 g of the residue obtained in the
preparation of solution S dissolved in 25 ml of the prescribed mixture of
solvents.
C. Examine the chromatograms
obtained in the assay of stearic acid and palmitic acid.
Results
The 2 principal peaks in the chromatogram obtained with the test solution are
similar in retention time and size to the 2 principal peaks in the chromatogram
obtained with the reference solution.
D. Solution
S gives reaction of sodium.
TESTS
Solution S
To 10.0 g
Sodium
Stearate add 100 ml of peroxide-free ether and 80 ml of acetic acid. Boil
under a reflux condenser until dissolution is complete. Allow to cool. In a
separating funnel, separate the aqueous layer and shake the ether layer with 2
quantities, each of 8 ml, of acetic acid. Combine the aqueous layers,
wash with 30 ml of peroxide-free ether and dilute to 100 ml with distilled water
(solution S). Evaporate the ether layers to dryness on a
water-bath and dry the residue at 100-105C.
Acidity
or alkalinity
Suspend 2.0 g in 50 ml of previously neutralized ethanol (96 per cent).
Heat under
reflux to dissolve and add 3 drops of phenolphthalein solution; the
solution is colourless. Not less than 0.60 ml and not more than 0.85 ml of 0.1 M sodium hydroxide
is required to change the colour of the indicator.
Chlorides
Maximum 0.2
per cent.
Sulphate
Maximum 0.3
per cent.
Nickel
Maximum 5.0
ppm.
Atomic
absorption spectrometry.
To pass
the test.
Loss on
drying
Maximum 5.0 per cent.
Microbial contamination
Total viable aerobic count not more than 103
micro-organisms per gram, determined by plate count. It complies with the test
for Escherichia coli.
Sodium Stearate USP NF
Octadecanoic acid, sodium salt.
[822-16-2]
Sodium Stearate is a mixture of sodium stearate (C18H35NaO2) and sodium palmitate (C16H31NaO2), which together constitute not less than 90.0 percent of the total content. The content of C18H35NaO2 is not less than 40.0 percent of the total. Sodium stearate contains small amounts of the sodium salts of other fatty acids.
USP
Reference standards—
USP
Palmitic Acid RS
USP
Stearic Acid RS
Identification—
A: When heated, it fuses. At a high temperature it decomposes, emitting flammable
vapors and the odor of burning fat, finally leaving a residue that, when
moistened with water, is alkaline to litmus paper, effervesces with acids, and
colors a non-luminous flame intensely yellow.
B: Dissolve 25 g in 300 mL of hot water, add 60 mL of 2 N sulfuric acid, and heat
the solution, with frequent stirring, until the separated fatty acid layer is
clear. Wash the fatty acids with boiling water until they are free from sulfate,
collect in a small beaker, and warm on a steam bath until the water has settled
and the fatty acids are clear. Allow the acids to cool, pour off the water
layer, then melt the acids, filter into a dry beaker while hot, and dry at 105
for 20 minutes: the solidification temperature of the fatty acids is not less
than 54.
Acid
value of fatty acids: between 196 and 211, determined on 1 g of the fatty
acids obtained in
Identification test B.
Iodine
value of fatty acids: not more than 4.0, determined on the fatty acids
obtained in Identification test B.
Acidity—
Heat 50 mL of alcohol to the same temperature, ±5 , as that attained when
the pink endpoint is reached in the titration of the test specimen. Add 3 drops
of phenolphthalein TS and sufficient 0.020 N sodium hydroxide to produce a faint
pink color. Add 2.00 g of Sodium Stearate, and dissolve with the aid of a small
amount of heat: no pink color is produced. Titrate the solution with 0.020 N
sodium hydroxide until a pink color is produced: between 1.00 mL and 4.25 mL of
0.020 N sodium hydroxide is required (between 0.28% and 1.2% as stearic acid).
Loss on
drying— Tare a beaker containing about 1 g of washed sand, previously dried
at 105 , add about 500 mg of Sodium Stearate, and again weigh. Add 10 mL of
alcohol, evaporate the mixture at about 80 to dryness, and dry at 105 for 4
hours: it loses not more than 5.0% of its weight.
Alcohol-insoluble substances— Reflux 1.0 g with 25 mL of alcohol: it
dissolves completely, and the resulting solution is clear or not more than
slightly opalescent.
Sodium Stearate BP USP NF Manufacturers at:
Muby Chem Ltd.
Toll manufacturing & Warehouse at Houston & Midland, Texas, USA and India
USA, Canada, Mexico Customers may e-mail: usa@mubygroup.com
Call 1-844-682-9243
Europe Africa Asia India Mumbai e-mail: info@mubygroup.com
Call +91-22-23774610
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