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Zinc Stearate Manufacturer Exporter BP Ph Eur USP Grade Manufacturer Exporter

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Hazard Statements:
Not a hazardous substance or mixture according to Regulation (EC) No. 1272/2008.
This substance is not classified as dangerous according to Directive 67/548/EEC.
Not considered hazardous by the OSHA Hazard Communication Standard (29 CFR 1910.1200)
Signal Word: None

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Zinc Stearate SDS of Manufacturers

Zinc Stearate IP BP Ph Eur USP NF FCC Food AR ACS Reagenr Grade Manufacturers

CAS Number 557-05-1 Zinc Stearate, EINECS: 209-151-9, Molecular Weight: 632.2, Chemical Formula: Zn(C18H35O2)2

Specifications of Zinc Stearate USP grade:
Octadecanoic acid, zinc salt;
Zinc stearate CAS 557-05-1.

DEFINITION
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 NLT 12.5% and NMT 14.0% of ZnO.

IDENTIFICATION
A. Identification Tests General, Zinc:
Sample solution: Mix 25 g 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.
Acceptance criteria: A portion of the water layer meets the requirements.
B. Congealing Temperature:
Analysis: 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 105C for 20 minutes.
Acceptance criteria: The fatty acids congeal at a temperature not below 54C.

ASSAY
Procedure:
Sample solution: Boil 1 g of Zinc Stearate with 50 mL of 0.1 N sulfuric acid for at least 10 min, or until the fatty acids layer is clear, adding more water as necessary to maintain the original volume. Cool, and filter. Wash the filter and the flask thoroughly with water until the last washing is not acid to litmus paper.
Analysis: Add to the combined filtrate and washings 15 mL of ammonia–ammonium chloride buffer and 0.2 mL of eriochrome black. Heat the solution to about 40C and titrate with 0.05 M EDTA disodium until the solution is deep blue in color. Each mL of 0.05 M EDTA disodium is equivalent to 4.069 mg of ZnO.
Acceptance criteria: 12.5% to 14.0% of ZnO

Arsenic: NMT 1.5 ppm
Lead: NMT 10 ppm.
Alkalies and Alkaline Earths:
Sample solution: Mix 2.0 g with 50 mL of water and 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 to precipitate the zinc completely, dilute with water to 200 mL, mix, and filter.
Analysis: To 100 mL of the clear filtrate add 0.5 mL of sulfuric acid, evaporate to dryness, and ignite to constant weight.
Acceptance criteria: The weight of the residue does not exceed 10 mg (1.0%).

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Specifications of Zinc Stearate BP Ph Eur Grade:
CAS 557-05-1
Action and use: Excipient.

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: minimum 53C, determined on the residue obtained in the preparation of solution S (see Tests).
B. Neutralise 5 mL of solution S to red litmus paper with strong sodium hydroxide solution. The solution gives the reaction of zinc.

TESTS
Solution S: To 5.0 g add 50 mL of ether and 40 ;mL of a 7.5 per cent V/V solution of cadmium- and lead-free nitric acid in distilled water R. 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. Combine the aqueous layers, wash with 15 mL of ether and heat on a water-bath until ether is completely eliminated. Allow to cool and dilute to 50 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. The solution is clear and not more intensely coloured than reference solution5
Acidity or alkalinity: Shake 1.0 g with 5 mL of ethanol (96 per cent) and add 20 mL of carbon dioxide-free water and 0.1 mL of phenol red solution. 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.
Sulfates: Maximum 0.6 per cent.
Cadmium: Maximum 5 ppm.
Lead: Maximum 25 ppm.

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Last updated 11/19/2022

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