Mubychem Group, established in 1976, is the pioneer manufacturer of Calcium Stearate, Pharmaceutical, Fragrance & Flavor chemicals in India. Mubychem Group has several manufacturing facilities spread across Gujarat and Mumbai India and world wide contacts and toll manufacturers. We are exporting globally to countries like USA, Europe, UAE, South Africa, Tanzania, Kenya, Egypt, Nigeria, Uganda, Turkey, Mexico, Brazil, Chile, Argentina, Dubai, Indonesia, Spain etc. |
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The participating units have one or more accreditations like FDA - GMP approval; ISO-9001 Certified; "REACH" Pre-registered; ISO-22000; Kosher Certified; Halal Certified; HACCP. We offer Pure & IP BP USP FCC Food Grade ACS AR Analytical Reagent Grades of Chemicals |
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Calcium Stearate BP Ph Eur USP NF IP FCC Food Grade Manufacturers
MSDS of Calcium Stearate BP USP NF FCC Manufacturers
Calcium Stearate
Octadecanoic Calcium Salt
CAS Number 1592-23-0, IP BP Ph. Eur. USP ACS AR LR FCC Food Grades
Calcium Stearate BP
Calcium Stearate BP Ph Eur Grade Specifications
Action
and use
Excipient.
DEFINITION
Mixture of
calcium salts of different fatty acids consisting mainly of stearic octadecanoic
acid [(C17H35COO)2Ca; M r 607] and palmitic (hexadecanoic) acid
[(C15H31COO)2Ca; M r 550.9] with minor proportions of other fatty acids.
Content:
calcium: 6.4 per cent to 7.4 per cent (dried substance),
stearic acid in the fatty acid fraction: minimum 40.0 per cent,
sum
of stearic acid and palmitic acid in the fatty acid fraction: minimum 90.0
per cent.
CHARACTERS
Appearance
Fine, white
or almost white, crystalline powder.
Solubility
Practically
insoluble 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: 95 to 210.
C. Examine
the chromatograms obtained in the test for fatty acid composition.
Results
The retention times of the principal peaks in the chromatogram obtained with the
test solution are approximately the same as those of the principal peaks in the
chromatogram obtained with the reference solution.
D.
Neutralize 5 ml of solution S to red litmus paper R using strong
sodium hydroxide solution: The solution gives reaction of calcium.
TESTS
Solution S
To 5.0 g
of Calcium
Stearate add 50 ml of peroxide-free ether, 20 ml of dilute nitric acid
and
20 ml of distilled water. 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 5 ml, of distilled
water. Combine the aqueous layers, wash with 15 ml of peroxide-free ether
and dilute the aqueous layer to 50 ml with distilled water (solution
S). Evaporate the ether layer to dryness and dry the residue at 100-105 °C. Keep
the residue for identification tests A and B.
Acidity
or alkalinity
To 1.0 g
Calcium
Stearate add 20 ml of carbon dioxide-free water and boil for 1 min with continuous
shaking. Cool and filter. To 10 ml of the filtrate add 0.05 ml of bromothymol
blue solution.
Not more
than 0.5 ml of 0.01 M hydrochloric acid or 0.01 M sodium hydroxide is required to change the colour of the indicator.
Chlorides
Maximum 0.1
per cent.
Sulphates
Maximum 0.3
per cent.
Cadmium
Maximum 3.0
ppm.
Atomic
absorption spectrometry.
To pass the
test
Lead
Maximum
10.0 ppm.
Nickel
Maximum 5.0
ppm.
Loss on
drying
Maximum 6.0
per cent, determined on 1.000 g by drying in an oven at 105 °C.
Microbial contamination
Total
viable aerobic count (2.6.12) not more than 103
micro-organisms per gram determined by plate count. It complies with the test
for Escherichia coli.
ASSAY of
Calcium and Composition of fatty acids
To be done and to pass the
limits as stated above.
Calcium Stearate USP NF Grade Specifications
Calcium
Stearate USP-NF
Octadecanoic acid, calcium salt.
Calcium
stearate [CAS Number 1592-23-0].
Calcium
Stearate NF
Calcium Stearate is a compound of calcium with a mixture of solid organic acids obtained from fats and consists chiefly of variable proportions of calcium stearate and calcium palmitate. It contains the equivalent of not less than 9.0 percent and not more than 10.5 percent of calcium oxide (CaO).
Identification—
A: Heat 1 g Calcium
Stearate with a mixture of 25 mL of water and 5 mL of hydrochloric acid: fatty
acids are liberated and appear as an oily layer floating on the surface of the
liquid. The water layer responds to the tests for Calcium.
B: Mix 25 g Calcium
Stearate with 200 mL of hot water, add 60 mL of 2 N sulfuric acid, and heat the
mixture, with frequent stirring, until the separated fatty acid layer is clear.
Wash the fatty acids with boiling water until free from sulfate, collect them in
a small beaker, and warm on a steam bath until the water has separated and the
fatty acids are clear. Allow the acids to cool, pour off the water layer, melt
the acids, filter into a dry beaker, and dry at 105 for 20 minutes: the fatty
acids so obtained congeal at a temperature not below 54.
Loss on
drying— Dry it at 105 to constant weight, using 2-hour increments of
heating: it loses not more than 4.0% of its weight.
Heavy
metals— The limit is 10 µg per g.
Assay—
Boil about 1.2 g of Calcium Stearate, accurately weighed, with 50 mL of 1 N
sulfuric acid for about 3 hours using a watch glass cover to avoid splattering,
or until the separated fatty acid layer is clear, adding water, if necessary, to
maintain the original volume. [NOTE—Stirring may be helpful in obtaining a clear
layer and decreasing extraction time.] Cool, filter, and wash the filter and the
flask thoroughly with water until the last washing is not acid to litmus.
Neutralize the filtrate with 1 N sodium hydroxide to litmus. While stirring,
preferably with a magnetic stirrer, titrate with 0.05 M edetate disodium
VS as follows. Add about 30 mL from a 50-mL burette, then add 15 mL of 1 N sodium
hydroxide and 300 mg of hydroxy naphthol blue, and continue the titration to a
blue endpoint. Each mL of 0.05 M edetate disodium is equivalent to 2.804
mg of CaO.
Calcium Stearate FCC Food Grade Specifications
Calcium
Stearate FCC
CAS 1592-23-0
DESCRIPTION
Calcium
Stearate occurs as a fine, white to yellow-white, bulky powder. It is a compound
of calcium with a mixture of solid organic acids obtained from edible sources
and consists chiefly of variable proportions of calcium stearate and calcium
palmitate. It is unctuous and free from grittiness. It is insoluble in water, in
alcohol, and in ether.
Function: Ant caking agent; binder; emulsifier.
REQUIREMENTS
Identification
A. Heat 1 g
of Calcium
Stearate with a mixture of 25 mL of water and 5 mL of hydrochloric acid. Fatty
acids are liberated, floating as an oily layer on the surface of the liquid. The
water layer gives positive tests for Calcium.
B. Mix 25 g
of Calcium
Stearate with 200 mL of hot water, then add 60 mL of 2 N sulfuric acid,
and heat the mixture, while stirring frequently, until the fatty acids separate
cleanly as a transparent layer. Wash the fatty acids with boiling water until
free from sulfate, collect them in a small beaker, and warm them on a steam bath
until the water has separated 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,
and dry at 105° for 20 min. The solidification point of the fatty acids so
obtained is not below 54
Assay: Not less than 9.0% and not more than 10.5% of CaO, calculated on the dried
basis.
Free
Fatty Acids (as stearic acid): Not more than 3.0%.
Lead: Not more than 2 mg/kg.
Loss on
Drying: Not more than 4.0%.
Calcium Stearate IP BP USP FCC Manufacturers at:
MUBYCHEM GROUP
CHINCHBUNDER, MUMBAI 400009, INDIA
TEL: (OFFICE)
91-22-23774610, 91-22- 23723564. 91-22-23728264
e-mail: info@mubychem.com
USA & Canadian Customers may e-mail: us@mubychem.com
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29-Apr-2022