Sterotex® K, NF

1 of 5 products in this brand
Sterotex® K, NF is a powder that is widely used as a lubricant in tablet manufacturing in pharmaceutical industries. It may be used in compacting and compounding processes in the catalyst, ceramic and powder metallurgy fields. Sterotex® K, NF 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. It is manufactured in USA.

INCI Name: Hydrogenated Soybean Oil

Ingredient Name: Triglyceride

Chemical Name: Hydrogenated Soybean Oil

Functions: Binder, Bulking Agent, Controlled Release Agent, Lubricant

Dosage Form: Capsules, Suppositories, Tablets

Synonyms: Hardened soy oils, Hardened soybean oils, Hydrocote

Technical Data Sheet

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Identification & Functionality

Ingredient Name
Cosmetic Ingredients Functions
Food Ingredients Functions
Pharma & Nutraceuticals Functions
CAS No.
8016-70-4
Ingredients
Hydrogenated Soybean Oil, Castor Oil
EC No.
232-410-2

Features & Benefits

Benefit Claims
Food Ingredients Features

Applications & Uses

Application Format
Manufacturing Technology
Pharmaceutical Applications
  • Lubricant
  • Sustained Release
  • Binder
  • Encapsulation
  • Processing Aid

Properties

Physical Form
Appearance
Pale yellow oily liquid, Almost fine white powder
Typical Properties
ValueUnitsTest Method / Conditions
Color (Red)max. 4.0Lovibond
Melting Pointapprox. 83°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 Fat0.3g
Other Carbohydrate‡0g
Polyunsaturated Fat0.2g
Potassium0mg
Protein0g
Saturated Fat99g
Sodium0mg
Soluble Fiber0g
Sugar Alcohols0g
Total Fat100g
Total Sugars (sum of all mono- and disaccharides)0g
Trans Fat0.5g
Vitamin A0μg RAE
Vitamin C0mg
Vitamin D0μg
Vitamin E (as alpha-tocopherols)0mg
Elemental Impurities
ValueUnitsTest Method / Conditions
Arsenic Contentmax. 0.1μg/g
Cadmium Contentmax. 0.1μg/g
Cobalt Contentmax. 1μg/g
Lead Contentmax. 0.1μg/g
Mercury Contentmax. 0.1μg/g
Nickel Contentmax. 4μg/g
Vanadium Contentmax. 1μg/g
Specifications
ValueUnitsTest Method / Conditions
Acid Valuemax. 4.0mg KOH/g1NF
Iodine Valuemax. 5.0cg I2/gNF
Loss on Dryingmax. 0.1%NF
Melting Point57 - 85°CNF
Saponification Value175 - 200mg KOH/gNF
Unsaponifiable Matte²max. 0.8%NF
Sieve Test
ValueUnitsTest Method / Conditions
Particle Size (through 100 mesh)min. 95%
Particle Size (through 40 mesh)min. 99%
Note

1USP/NF: United States Pharmacopeia/National Formulary

2Compliance based on periodic testing

* 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.

For Elemental Impurities : Data obtained for all samples were below the listed initial-results ranges levels. Initial-results ranges data are for informational purposes only and do not constitute specifications. Testing is expected to continue on a periodic basis for the material, however, the frequency is to be determined.

Regulatory & Compliance

Regulatory

United States Pharmacopeia/National Formulary (USP/NF) monograph for Hydrogenated Vegetable Oil, Type 1.

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

Country Availability
Packaging Type
Regional Availability
  • Europe
  • North America
Standard Packaging

50 lb (22.7 kg) carton

Storage & Handling

Shelf Life
24 months
Recommended Storage and Handling
  • Retest/requalify 24 months from date of manufacture.
  • Typical storage for vegetable oils, (E.g. tightly closed, in a dry location, below ≈25°C).