Hydrogenated Soybean Oil

Specifications of Hydrogenated Soybean Oil:

Hydrogenated Soyabean Oil BP Ph Eur Grade Specifications
Ph Eur
Action and use: Excipient.

DEFINITION
Product obtained by refining, bleaching, hydrogenation and deodorisation of oil obtained from seeds of Glycine max (L) Merr. (G. hispida (Moench) Maxim.). The product consists mainly of triglycerides of palmitic and stearic acids.

CHARACTERS
Appearance: White or almost white mass or powder which melts to a clear, pale yellow liquid when heated.
Solubility: Practically insoluble in water, freely soluble in methylene chloride, in light petroleum (bp: 65-70 °C) after heating and in toluene, very slightly soluble in ethanol (96 per cent)

IDENTIFICATION
A. Melting point (see Tests).
B. Composition of fatty acids (see Tests).

TESTS
Melting point: 66C to 72C.
Acid value: Maximum 0.5.
Peroxide value: Maximum 5.0.
Unsaponifiable matter: Maximum 1.0 per cent, determined on 5.0 g.
Alkaline impurities: Dissolve 2.0 g with gentle heating in a mixture of 1.5 mL of ethanol (96 per cent) R and 3 mL of toluene R. Add 0.05 mL of a 0.4 g/L solution of bromophenol blue R in ethanol (96 per cent) R. Not more than 0.4 mL of 0.01 M hydrochloric acid is required to change the colour to yellow.
Composition of fatty acids:
Composition of the fatty-acid fraction of the oil:
saturated fatty acids of chain length less than C14: maximum 0.1 per cent
myristic acid : maximum 0.5 per cent
palmitic acid : 9.0 per cent to 16.0 per cent
stearic acid : 79.0 per cent to 89.0 per cent
oleic acid and isomers: maximum 4.0 per cent
linoleic acid and isomers: maximum 1.0 per cent
linolenic acid and isomers: maximum 0.2 per cent
arachidic acid: maximum 1.0 per cent
behenic acid: maximum 1.0 per cent.
Nickel: Maximum 1 ppm.

Hydrogenated Soybean Oil USP NF Grade
[CAS 8016-70-4].
Hydrogenated Soybean Oil is the product obtained by refining, bleaching, hydrogenation, and deodorization of oil obtained from seeds of the soya plant Glycine max Merr. (Fabaceae). The product consists mainly of triglycerides of palmitic and stearic acids.

Packaging and storage: Preserve in tight, light-resistant containers. No storage requirements specified.

Identification:
A: It meets the requirements of the test for Fatty acid composition.
B: It meets the requirements of the test for Melting range.
Melting range: between 66 and 72 .
Acid value: Dissolve about 10 g of Hydrogenated Soybean Oil, accurately weighed, in 50 mL of a hot mixture of neutralized alcohol and toluene (1:1), add 0.5 mL of phenolphthalein, and immediately titrate, while still hot, with 0.1 N potassium hydroxide to produce a permanent, faint pink color: the acid value so obtained is not more than 0.5.
Peroxide value: not more than 5.0.
Unsaponifiable matter: not more than 1.0%, determined on 5.0 g.
Fatty acid composition: Hydrogenated Soybean Oil exhibits the following composition profile of fatty acids, as determined in the section Fatty Acid Composition.

Alkaline impurities: Dissolve by gently heating 2.0 g of Hydrogenated Soybean Oil in a mixture of 1.5 mL of alcohol and 3.0 mL of toluene. Add 0.05 mL of bromophenol blue, and titrate with 0.01 N hydrochloric acid to a yellow end-point: not more than 0.4 mL of 0.01 N hydrochloric acid is required.
Water: not more than 0.3%.
Limit of nickel: To pass the test 1 micro-gm per gm.

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.