Refined Soya Oil BP Grade

Ph Eur
Refined Soyabean Oil
Refined Soya-bean Oil, Ph Eur monograph 1473

Action and use: Excipient.
When Soya Oil, Soyabean Oil or Soya-bean Oil is demanded, Refined Soya Oil shall be supplied.
When intended for use in the manufacture of a parenteral dosage form, Refined Soya Oil complying with the requirement for Water below should be used.

DEFINITION
Fatty oil obtained from seeds of Glycine max (L.) Merr. (Glycine hispida (Moench) Maxim.) by extraction and subsequent refining. It may contain a suitable antioxidant.

CHARACTERS
Appearance: Clear, pale yellow liquid.
Solubility: Practically insoluble in ethanol (96 per cent), miscible with light petroleum (bp: 50-70C).
Relative density: About 0.922.
Refractive index: About 1.475.

IDENTIFICATION
Identification of fatty oils by thin-layer chromatography.
Results The chromatogram obtained is similar to the corresponding chromatogram shown in Figure 2.3.2.-1.

TESTS
Acid value: Maximum 0.5.
Peroxide value: Maximum 10.0, and maximum 5.0 if intended for use in the manufacture of parenteral preparations.
Unsaponifiable matter: Maximum 1.5 per cent, determined on 5.0 g.
Alkaline impurities: To pass the test.
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 0.2 per cent;
palmitic acid: 9.0 per cent to 13.0 per cent;
palmitoleic acid : maximum 0.3 per cent;
stearic acid : 2.5 per cent to 5.0 per cent;
oleic acid : 17.0 per cent to 30.0 per cent;
linoleic acid : 48.0 per cent to 58.0 per cent;
linolenic acid : 5.0 per cent to 11.0 per cent;
arachidic acid: maximum 1.0 per cent;
eicosenoic acid: maximum 1.0 per cent;
behenic acid: maximum 1.0 per cent.
Brassicasterol: Maximum 0.3 per cent in the sterol fraction of the oil.
Water: Maximum 0.1 per cent, determined on 1.00 g.

STORAGE
In a well-filled container, protected from light, at a temperature not exceeding 25C.

LABELLING
The label states, where applicable, that the substance is suitable for use in the manufacture of parenteral preparations.

Soybean Oil USP NF Grade

Soybean Oil is the refined fixed oil obtained from the seeds of the soya plant Glycine max Merr. (Fabaceae). It may contain suitable antioxidants.

Specific gravity: between 0.916 and 0.922.
Refractive index: between 1.465 and 1.475.
Heavy metals: 0.001%.
Free fatty acids: The free fatty acids in 10 g require for neutralization not more than 2.5 mL of 0.020 N sodium hydroxide.
Fatty acid composition:
Palmitate 7 to 14%
Stearate1 to 6%
Oleate 19 to 30%
Linoleate 44 to 62%
Linolenate 4 to 11%
Iodine value: between 120 and 141.
Saponification: between 180 and 200.
Unsaponifiable matter: not more than 1.0%.
Cottonseed oil: Passes the test.
Peroxide: NMT 10.0 mEq per kg.

Specifications of Hydrogenated Soybean Oil USP NF Grade

CAS 8016-70-4.

DEFINITION
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.

IDENTIFICATION
A. It meets the requirements in Specific Tests for Fats and Fixed Oils, Fatty Acid Composition.
B. It meets the requirements in Specific Tests for Melting Range or Temperature, Class II.

Limit of Nickel: To pass the test.
Acceptance criteria: NMT 1 µg/g
Alkaline Impurities:
Sample: 2.0 g
Analysis: Dissolve the Sample by gently heating in a mixture of 1.5 mL of alcohol and 3.0 mL of methylbenzene. Add 0.05 mL of bromophenol blue and titrate with 0.01 N hydrochloric acid  to a yellow endpoint.
Acceptance criteria: NMT 0.4 mL of 0.01 N hydrochloric acid  is required.
Melting Range or Temperature: 66C to 72C.
Fats and Fixed Oils:
Sample: 10 g of Hydrogenated Soybean Oil.
Analysis: Dissolve the Sample in 50 mL of a hot mixture of neutralized alcohol and methylbenzene (1:1). Add 0.5 mL of PhPh TS, and immediately titrate, while still hot, with 0.1 N potassium hydroxide VS to produce a permanent, faint pink color.
Acceptance criteria: NMT 0.5
Fats and Fixed Oils: To meet the composition requirement.
Fats and Fixed Oils, Peroxide Value: NMT 5.0
Fats and Fixed Oils, Unsaponifiable Matter:
Sample: 5.0 g
Acceptance criteria: NMT 1.0%
Water Determination: NMT 0.3%
Packaging and Storage: Preserve in tight, light-resistant containers. No storage requirements are specified.

Specifications of Soybean Oil Unhydrogenated FCC Food Grade

CAS: 8001-22-7

DESCRIPTION
Soybean Oil (Unhydrogenated) occurs as a light amber colored oil. It is obtained from the seed of the legume Glycine max (Fam. Fabaceae), usually by solvent extraction. It is refined, bleached, and deodorized to substantially remove free fatty acids, phospholipids, color, odor and flavor components, and miscellaneous other non-oil materials. It is a liquid at 21C to 27C and remains so even at refrigerator temperatures (2C to 4C). It is free from visible foreign matter at 21C to 27C.
Function: Coating agent; texturizer.

REQUIREMENTS
Identification: Unhydrogenated Soybean Oil should pass the test for composition profile of fatty acids.
Cold Test: Passes test.
Color (AOCS-Wesson): Not more than 20 yellow/2.0 red.
Free Fatty Acids (as oleic acid): Not more than 0.1%.
Iodine Value: Between 120 and 143.
Lead: Not more than 0.1 mg/kg.
Peroxide Value: Not more than 10 meq/kg.
Stability (Active Oxygen Method): Not less than 7 h.
Unsaponifiable Matter: Not more than 1.5%.
Water: Not more than 0.1%.