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Macrogol Stearate or Polyethylene Glycol Stearate USP NF Grade Supplier Exporter Manufacturers' Representative |
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Macrogol Stearate or Polyethylene Glycol Stearate
CAS Number: 9004-99-3 or 9005-08-7
Molecular Formula: Varies
Molecular Weight: Varies
Macrogol Stearate or Polyethylene Glycol Stearate
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.
| 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.
| 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.
We also supply Macrogol Stearate or Polyethylene Glycol Stearate of BP Ph Eur Grade.
Please visit SDS Safety Data Sheet of Macrogol Stearate or Polyethylene Glycol Stearate USP NF Suppliers.
American Molecules, also known as ammol.org is a distributor, supplier and manufacturers' representative of all types of Pharmaceuticals, Functional Ingredients, Excipients and Specialty Chemicals in Texas USA. Our principals manufacture supply and export USP NF BP, Ph Eur, etc grades of chemicals pure and reagent grade, mineral fortifiers, FCC food grade. Tailor made particle size and customized specifications are offered. The principal's facility is having one or more of the certifications like FDA approval and GLP, cGMP, ISO9001, ISO14001, ISO/IEC 17025, ISO22000, FSSC 22000, ISO45001, FSSAI, Kosher, HALAL, COPP, WHO-GMP certified and Written Confirmation (WC) for export to Europe is available. The manufacturers suppliers and exporters observe WHO Good Manufacturing Practices and Good Laboratory Practices.
Suppliers and Manufacturers' Representative:
9910 Bent Oak Dr
Houston, TX 77040, USA
Call Toll Free: 1-855-55-AMMOL 1-855-552-6665
Email: info@ammol.org