Sterotex® HM is a fully-hydrogenated, vegetable-oil powder that is widely used as a lubricant in tablet manufacturing in pharmaceutical and food supplement industries. It may be used in compacting and compounding processes in the catalyst, ceramic and powder metallurgy fields. Sterotex® HM is derived from renewable vegetable oils that are fully refined, bleached, and deodorized and is a neutral organic ester (triglyceride) that is low in ash content and is produced according to Kosher requirements. It is manufactured in USA.

INCI Name: Hydrogenated Soybean Oil

Ingredient Name: Hydrogenated Soybean Oil

Chemical Name: Vegetable Oil, Hydrogenated

CAS Number: 68334-28-1

Functions: Binder, Bioavailability Enhancer, Bulking Agent, Carrier, Controlled Release Agent, Encapsulant, Lubricant

Dosage Form: Capsules, Suppositories, Tablets

Synonyms: Hardened vegetable oils, Hydrogenated mixed vegetable oils, Hydrogenated plant oils, Hydrogenated shortening, Hydrogenated vegetable fats, Hydrogenated vegetable oil, Hydrogenated vegetable shortening, Vegetable shortening

Technical Data Sheet

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Identification & Functionality

Cosmetic Ingredients Functions
Food Ingredients Functions
CAS No.
68334-28-1
Ingredients
Hydrogenated Soybean Oil
EC No.
269-820-6

Features & Benefits

Benefit Claims
Food Ingredients Features

Applications & Uses

Manufacturing Technology
Applications
  • Lubricant
  • Sustained Release
  • Binder

Properties

Physical Form
Appearance
Pale yellow oily liquid, Almost fine white powder
Typical Properties
ValueUnitsTest Method / Conditions
Color (Red)max. 4.0Lovibond
Melting Pointapprox. 69°C
Nutritional Information (per 100 gm)
ValueUnitsTest Method / Conditions
Added Sugars†0g
Calcium0mg
Calories / Energy900Calories
Calories from Fat900Calories
Carbohydrate0g
Cholesterol0mg
Dietary Fiber**0g
Insoluble Fiber0g
Iron0mg
Monounsaturated Fat0.5g
Other Carbohydrate‡0g
Polyunsaturated Fat0.5g
Potassium0mg
Protein0g
Saturated Fat98g
Sodium0mg
Soluble Fiber0g
Sugar Alcohols0g
Total Fat100g
Total Sugars (sum of all mono- and disaccharides)0g
Trans Fat1g
Vitamin A0μg RAE
Vitamin C0mg
Vitamin D0μg
Vitamin E (as alpha-tocopherols)0mg
Specifications
ValueUnitsTest Method / Conditions
Acid Valuemax. 4.0mg KOH/g¹AOCS 3d-63/2BP
Identification Tests⁴PassBP
Iodine Valuemax. 5.0cg I2/gAOCS Cd 1d-92/BP
Loss on Dryingmax. 0.1%AOCS Ca 2e-84/BP
Melting Point57 - 70°CAOCS Cc 1-25/BP
Saponification Value175 - 200AOCS Cd 3-25/BP
Unsaponifiable Matter³max. 0.8%AOCS Ca 6b-53/BP
Sieve Test
ValueUnitsTest Method / Conditions
Particle Size (through 100 mesh)min. 95%
Particle Size (through 40 mesh)min. 99%
Note

1AOCS: American Oil Chemists’ Society

2BP: British Pharmacopeia

3Compliance based on periodic testing.

4Compliance to Identification test is certified based on controls in place that assures the identity of the excipient.

5Iodine Value will meet fully-hydrogenated definition requirements as outlined in the FDA’s Part-Hydrogenated Oils (PHO) regulation.

* The nutritional information is calculated based on typical composition of the product and the data for individual products may vary from the information. Calculations based on 4, 4, and 9 calories per gram for protein, carbohydrate, and fat, respectively. This material is provided for informational purposes only and is not a specification.

** Dietary Fiber defined as non-digestible carbohydrates (≥ 3 monomeric units) and lignin that are intrinsic and intact in plants, or added (isolated or synthetic) non-digestible carbohydrates (≥ 3 monomeric units) that have been determined by FDA to have a physiological benefit.

† Added Sugars defined as any “sugar” added during the processing of foods including sugars, sugar syrups, naturally occurring sugars isolated from a whole food and concentrated so that sugar is the primary component (e.g. fruit juice concentrates), or other caloric sweeteners.

‡ Other Carbohydrate: *Note: Certain food additive constituents are not reasonably classified as standard nutritional components. In order to distinguish these constituents from the substances commonly understand to be dietary carbohydrates, they are listed in the “Other Carbohydrate” category.

Regulatory & Compliance

Regulatory
  • Meets specified tests outlined by the British Pharmacopeia (BP) monograph for Hydrogenated Vegetable Oil.
  • 21 CFR §101.4 Food; designation of ingredients

Safety & Health

Product Stewardship

ABITEC’s product stewardship rests with all individuals involved with the products, from the initial concept and research, to manufacture, testing, use, sale, storage, distribution and disposition of each product. Each individual takes the appropriate steps to protect employee health, public health and the environment.

Packaging & Availability

Packaging Type
Standard Packaging

50 lb (22.7 kg) carton

Storage & Handling

Shelf Life
24 months
Recommended Storage and Handling
  • Retest/requalify 24 months after date of manufacture.
  • Typical storage for vegetable oils (E.g. tightly closed, in a dry location, below ≈70°F).