Mubychem logo
  • Contact No.: +91-22-23770100
  • Corporate: Sarifa Mansion, Chinchbunder, Mumbai


Check out our products

Macrogol Stearate

  • Home
  • IP, BP, EP, Ph Eur, USP NF, JP, FCC Food
  • Macrogol Stearate
IP, BP, EP, Ph Eur, USP NF, JP, FCC Food

Macrogol Stearate

CAS Number 9004-99-3
Molecular Weight --- g/mol
Chemical Formula ---
EINECS EC Number ---
FEMA ---

Macrogol stearate is a chemical compound, hydroxypolyether and an octadecanoate ester. It is used in cosmetics as a surfactant and emulsifier.


Polyoxyl Stearate USP NF Grade Specifications:
Polyethylene glycol stearate;
Polyethylene glycol monostearate;
Poly(oxy-1,2-ethanediyl), α-hydro-ω-hydroxyoctadecanoate CAS 9004-99-3


DEFINITION
Polyoxyl Stearate is a mixture of monoesters and diesters of mainly stearic (octadecanoic) acid and/or palmitic (hexadecanoic) acid and polyethylene glycols. The fatty acids may be of vegetable, animal, or synthetic origin. Polyoxyl Stearate Type I or Type II differs in its content of stearic acid. It may contain free polyethylene glycols. The average polymer length is equivalent to 6–100 ethylene oxide units per molecule (nominal value).


IDENTIFICATION
A. Infrared Absorption
Sample: Use an undried specimen.
B. It meets the requirements of the test for Content of Stearic Acid and Palmitic Acid.


ASSAY
Content of Stearic Acid and Palmitic Acid
Polyoxyl Stearate exhibits the composition profiles of fatty acids shown in Table 1 below, as determined in Fats and Fixed Oils 〈401〉 , Fatty Acid Composition.


Table 1
Polyoxyl Stearate Type I

Stearic Acid: 40.0%–60.0%; Sum of Palmitic and Stearic acids: NLT 90.0%

Polyoxyl Stearate Type II

Stearic Acid: 90.0%–99.0%; Sum of Palmitic and Stearic acids: NLT 96.0%

Content of Free Polyethylene Glycols: To pass the test.
Note— This test is for Polyoxyl 40 Stearate only.
Acceptance criteria: 17%–27% of free polyethylene glycols for Polyoxyl 40 Stearate only.
Articles of Botanical Origin, Total Ash: NMT 0.3%, determined on 1.0 g
Limit of Ethylene Oxide and Dioxane: To pass the test.
Acceptance criteria
Ethylene oxide: 1 ppm
Dioxane: 380 ppm.
Alkalinity: To pass the test.
Fats and Fixed Oils, Acid Value: NMT 6.0
Fats and Fixed Oils, Hydroxyl Value: Within the ranges specified in Table 2
Fats and Fixed Oils, Iodine Value: NMT 3.0
Fats and Fixed Oils, Peroxide Value: NMT 10.0
Fats and Fixed Oils, Saponification Value: Within the ranges specified in Table 2
Melting Range or Temperature: To pass the test.
Acceptance criteria: Within the ranges specified in Table 2.


Table 2
Ethylene Oxide Units/ Molecule (Nominal Value) Melting Range °C Hydroxyl Value Saponification Value
6 26–37 80–110 90–115
8 26–35 80–105 88–100
32 46–50 20–40 30–45
40 Measure Congealing Temperature 25–40 25–35
75 53–59 15–35 8–25
100 48–60 15–30 5–20

Congealing Temperature: 37C –47C for Polyoxyl 40 Stearate only.
Water Determination: NMT 3.0%
Packaging and Storage: Preserve in tight containers, and store at room temperature. Protect from light and moisture.
Labeling: Label it to indicate the number of ethylene oxide units/molecule (nominal value), and the type of Polyoxyl Stearate. Label it to indicate whether the fatty acids are derived from vegetable, animal, or synthetic sources.


Macrogol Stearate BP Ph Eur Grade Specifications:
Action and use: Non-ionic surfactant.


DEFINITION
Mixture of monoesters and diesters of mainly stearic (octadecanoic) acid and/or palmitic (hexadecanoic) acid and macrogols. It may be obtained by ethoxylation or by esterification of macrogols with stearic acid 50 (type I) or stearic acid 95 (type II). It may contain free macrogols. The average polymer length is equivalent to 6 to 100 ethylene oxide units per molecule (nominal value).


CHARACTERS
Appearance: White or slightly yellowish waxy mass.
Solubility: Soluble in ethanol (96 per cent) and in 2-propanol. Macrogol stearate corresponding to a product with 6 to 9 units of ethylene oxide per molecule is practically insoluble, but freely dispersible in water and miscible with fatty oils and with waxes. Macrogol stearate corresponding to a product with 20 to 100 units of ethylene oxide per molecule is soluble in water and practically insoluble in fatty oils and in waxes.


IDENTIFICATION
A. Saponification value (see Tests).
B. Composition of fatty acids (see Tests).


TESTS
Alkalinity: Dissolve 2.0 g in alcohol and dilute to 20 mL with the same solvent. To 2 mL of this solution add 0.05 mL of phenol red solution. The solution is not red.
Melting point: See Table 1234.-1.
Melt about 10 g at 80-90C. Introduce enough of the substance into the tube by capillary action to form a column of the prescribed height. Allow to stand at 0°C for 2 h.
Acid value: Maximum 2.0, determined on 2.0 g.
Hydroxyl value: To pass the test.
Iodine value: Maximum 2.0.
Saponification value: To pass the test.
Composition of fatty acids: To pass the test.
Ethylene oxide and dioxan: Maximum 1 ppm of ethylene oxide and 10 ppm of dioxan.
Water: Maximum 3.0 per cent, determined on 0.50 g. Use as the solvent a mixture of equal volumes of anhydrous methanol and methylene chloride.
Total ash: Maximum 0.3 per cent, determined on 1.0 g.


STORAGE
In an airtight container.


LABELLING
The label states:
— the number of ethylene oxide units per molecule (nominal value),
— the type of macrogol stearate.

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.