Hydrogenated Vegetable Oil

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Hydrogenated Vegetable Oil

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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 DEFINITION

Change to read:

Hydrogenated Vegetable Oil is a mixture of triglycerides of fatty acids. ▲The melting range, iodine value, and saponification value differ,▲ (ERR 1-May-2018) depending on Type, as described in the table below.

 Type IType II
Melting Range or Temperature 〈741〉, Procedures, Procedure for Class II57°–85°20°–50°
▲ (Official 1-Jan-2018)▲ (Official 1-Jan-2018)▲ (Official 1-Jan-2018)
Fats and Fixed Oils 〈401〉, Procedures, Iodine Value, Method II0–555–80
Fats and Fixed Oils 〈401〉, Procedures, Saponification Value175–200175–200

▲If the botanical source is identified as palm or soybean and the type as Type I, compliance with Hydrogenated Palm Oil NF or Hydrogenated Soybean Oil NF is required.▲ (2S (NF36))

2 IDENTIFICATION

Add the following:

▲• A. It meets the requirements for Fats and Fixed Oils 〈401〉, Procedures, Iodine Value.▲ (2S (NF36))

Add the following:

▲• B. It meets the requirements for Melting Range or Temperature 〈741〉.▲ (2S (NF36))

3 SPECIFIC TESTS

Loss on Drying 〈731〉

Analysis: Dry a sample at 105° for 4 h.

Acceptance criteria: NMT 0.1%

Fats and Fixed Oils 〈401〉, Procedures, Acid Value

Sample: 20 g in a conical flask

Analysis: Melt the Sample on a steam bath, add 100 mL of hot alcohol previously neutralized with 0.1 N sodium hydroxide to phenolphthalein TS, swirl, and add 1 mL of phenolphthalein TS. Titrate with 0.10 N sodium hydroxide until the solution remains faintly pink after being shaken for 15 s.

Acceptance criteria: NMT 4.0

Fats and Fixed Oils 〈401〉, Procedures, Unsaponifiable Matter: NMT 0.8%

4 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight containers, in a cool place.

Change to read:

Labeling: ▲Label it to indicate the botanical source of vegetable oil.▲ (2S (NF36)) Label it to state whether it is Type I or Type II.

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