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Sodium Stearate & Zinc Stearate USP NF BP Ph Eur Grade Supplier, Manufacturer's Representative, CAS Number 822-16-2 for C17H35CO2Na and 557-05-1 for (C17H35CO2)2Zn
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For MSDS Sheet Click MSDS SDS of Sodium Stearate Suppliers
For MSDS Sheet Click MSDS SDS of Zinc Stearate Suppliers
Sodium Stearate & Zinc Stearate
CAS Number 822-16-2 for C17H35CO2Na and 557-05-1 for (C17H35CO2)2Zn USP NF BP Ph Eur Grade Suppliers
Sodium Stearate USP NF
Octadecanoic acid, sodium salt.
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
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 Ph Eur
Action and use: Excipient
Mixture of sodium salts of different fatty acids consisting mainly of stearic (octadecanoic) acid [C17H35COONa] and palmitic (hexadecanoic) acid [C15H31COONa].
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.
Appearance: White or yellowish, fine powder, greasy to the touch.
Solubility: Slightly soluble in water and in ethanol (96 per cent).
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.
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.
Zinc Stearate USP NF
Octadecanoic acid, zinc salt.
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.
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%).
Zinc Stearate BP
(C17H35CO2)2Zn -- 632 -- CAS 557-05-1
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.
Appearance: Light, white or almost white, amorphous powder, free from gritty particles.
Solubility: Practically insoluble in water and in anhydrous ethanol.
A. Freezing point: minimum 53C, determined on the residue obtained in the preparation of solution S (see Tests).
B. Neutralize 5 ml of solution S to red litmus paper with strong sodium hydroxide solution. The solution gives the reaction of zinc.
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
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1 June, 2021