Zinc Stearate BP
Zinc Stearate BP
(C17H35CO2)2Zn -- 632 -- CAS Number 557-05-1
DEFINITION
Zinc stearate [(C17H35COO)2Zn; Mr 632] may contain varying proportions of zinc palmitate
[(C15H31COO)2Zn; Mr 576.2] and zinc oleate [(C17H33COO)2Zn; Mr 628].
Content
10.0 per cent to 12.0 per cent of Zn.
CHARACTERS
Appearance
Light, white or almost white, amorphous powder, free from gritty particles.
Solubility
Practically insoluble in water and in anhydrous ethanol.
IDENTIFICATION
A. Freezing point (2.2.18): minimum 53 °C, determined on the residue obtained in the preparation of
solution S (see Tests).
B. Neutralize 5 ml of solution S to red litmus paper R with strong sodium hydroxide solution. The
solution gives the reaction of zinc.
TESTS
Solution S
To 5.0 g Zinc Stearate add 50 ml of ether R and 40 ml of a 7.5 per cent V/V solution of cadmium- and
lead-free nitric acid in distilled water. Heat 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 4 ml,
of distilled water R. Combine the aqueous layers, wash with 15 ml of ether R and heat on a
water-bath until ether is completely eliminated. Allow to cool and dilute
to 50.0 ml with distilled water (solution S). Evaporate the ether layer to dryness and dry the
residue at 105C.
Appearance of solution
Solution S is not more intensely coloured than reference solution.
Appearance of solution of fatty acids
Dissolve 0.5 g of the residue obtained in the preparation of solution S in 10 ml of chloroform R.
The solution is clear and not more intensely coloured than reference
solution.
Acidity or alkalinity
Shake 1.0 g with 5 ml of ethanol (96 per cent) R and add 20 ml of carbon dioxide-free water and 0.1
ml of phenol red solution R. Not more than 0.3 ml of 0.1 M
hydrochloric acid or 0.1 ml of 0.1 M sodium hydroxide is required to change the colour of the
indicator.
Acid value of the fatty acids
195 to 210.
Chlorides
Maximum 250 ppm.
Sulphates
Maximum 0.6 per cent.
Cadmium
Maximum 5.0 ppm.
Atomic absorption spectrometry
To pass the test
Lead
Maximum 25.0 ppm.
Atomic absorption
To pass the test
Zinc Stearate USP NF
Zinc Stearate USP NF
Octadecanoic acid, zinc salt.
Zinc stearate [CAS Number 557-05-1]
Zinc Stearate is a compound of zinc with a mixture of solid organic acids obtained from fats, and consists chiefly of variable proportions of zinc stearate and zinc palmitate. It contains the equivalent of not less than 12.5 percent and not more than 14.0 percent of ZnO.
Identification—
A: Mix 25 g Zinc Stearate with 200 mL of hot water, add 60 mL of 2 N sulfuric acid, and boil until
the fatty acids separate as a transparent layer. Cool the mixture,
and remove the solidified layer of fatty acids: a portion of the water layer responds to the tests
for Zinc.
B: Place the separated fatty acids obtained in Identification test A in a filter wetted with water,
and wash with boiling water until free from sulfate. Collect the
fatty acids in a small beaker, allow to cool, pour off the separated water, then melt the acids,
filter into a dry beaker while hot, and dry at 105 for 20 minutes: the
fatty acids congeal at a temperature not below 54.
Arsenic— The limit is 1.5 ppm.
Lead— The limit is 0.001%.
Alkalies and alkaline earths— Mix 2.0 g with 50 mL of water, add 10 mL of hydrochloric acid,
boil until the solution is clear, filter while hot, and wash the
separated fatty acids with about 50 mL of hot water. Render the combined filtrate and washings
alkaline with 6 N ammonium hydroxide, add ammonium sulfide TS to
precipitate the zinc completely, dilute with water to 200 mL, mix, and filter. To 100 mL of the
clear filtrate add 0.5 mL of sulfuric acid, evaporate to dryness, and
ignite to constant weight: the weight of the residue does not exceed 10 mg (1.0%).
Certifications :
We manufacture Bulk Drugs / API, Excipients,
Pharmaceuticals (IP/BP/USP/NF/Ph. Eur, JP/ CP), Speciality Chemicals(Pure/AR/ACS), Mineral
Fortifiers, Food Chemical Codex (FCC) and Flavour chemicals. Our manufacturing facility is
cGMP,
GLP, ISO 9001, ISO 14001, ISO 22000, ISO/IEC 17025, FSSC 22000, FSSAI, Kosher, HALAL,
EXCiPACT, WC,
COPP, WHO-GMP and WC certified. We are also REACH registered for export to European
countries.