Macrogol Stearate or Polyethylene Glycol Stearate USP NF BP Ph Eur Manufacturers, with SDS GHS MSDS Sheet

Supplier, Manufacturer, Exporter of Macrogol Stearate or Polyethylene Glycol Stearate, Muby Chemicals of Mubychem Group, established in 1976, is the original manufacturers of Specialty Chemicals, Pharmaceutical Excipient, Fragrance Food & Flavor chemicals, Reagent Grade Chemicals, Shale Gas Fracturing Chemicals in India. Mubychem Group has several manufacturing facilities spread across Western India and world wide contacts and toll manufacturers. We are exporting globally to countries like USA, Canada, Europe, UAE, South Africa, Tanzania, Kenya, Egypt, Nigeria, Cameroon, Uganda, Turkey, Mexico, Brazil, Chile, Argentina, Dubai, Korea, Vietnam, Thailand, Malaysia, Indonesia, Australia, China, Germany, France, Italy, Portugal, Bangladesh, etc.

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Macrogol Stearate or Polyethylene Glycol Stearate CAS Number 9004-99-3 or 9005-08-7, EINECS EC Number: 203-886-9 or 618-405-1, Molecular Formula: 203-886-9 or 618-405-1, Molecular Weight: yy, HS Code ---**

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SDS MSDS Sheet of Macrogol Stearate or Polyethylene Glycol Stearate Manufacturers

Macrogol Stearate
Polyethylene Glycol Stearate USP NF BP Ph Eur Suppliers
Macrogol Stearate or Polyethylene Glycol Stearate

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

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).

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

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.

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).

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.

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

In an airtight container.

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

For Original Monographs of IP Indian Pharmacopoeia BP British Pharmacopoeia USP US Pharmacopoeia FCC Food Grade product, please check with the respective web-pages or books.

We also manufacture and supply as under:

Cetomacrogol 1000 or CM 1000

Ethylene Glycol Monostearate

Ethylene Glycol Distearate

Ethylene Glycol Monoethyl Ether


Macrogol 20 Glycerol Monostearate

Macrogol Cetostearyl Ether

Macrogol Stearate

PEG-150 Distearate

Polyoxyl 40 Stearate

Propylene Carbonate.


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Last 30 May, 2024

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Macrogol Stearate or Polyethylene Glycol Stearate SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet

Section 1: Chemical Product and Company Identification

Product Name & Other Names: Polyoxyl 40 stearate or Polyethylene glycol monostearate.
CAS Number: 9004-99-3 or 9005-08-7
EINECS EC Number: 203-886-9 or 618-405-1
Relevant uses and uses advised against (if any): Industrial Manufacturing
Supplier: As per letterhead.

Section 2: Hazards Identification
GHS, Globally Harmonized System Classification in accordance with 29 CFR 1910
Classification according to Regulation (EC) No 1272/2008

Not a hazardous substance or mixture according to Regulation (EC) No. 1272/2008.
This substance is not classified as dangerous according to Directive 67/548/EEC.

Labeling according to GHS & Regulation (EC) No 1272/2008

GHS Label Elements

Signal Word: None

Hazards not otherwise classified (HNOC):
May causes mild skin irritation.
May causes mild eye irritation.

Precautionary statements:
P261: Avoid breathing dust/fume/gas/mist/vapors/spray.
P262: Do not get in eyes, on skin, or on clothing.
P281: Use personal protective equipment as required.
P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P303+P361+P353: IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin with water/shower.
P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+313: If eye irritation persists get medical advice/attention.

Section 3: Composition and Information on Ingredients

Product Name & Other Names: Polyoxyl 40 stearate or Polyethylene glycol monostearate.
CAS Number: 9004-99-3 or 9005-08-7
EINECS EC Number: 203-886-9 or 618-405-1

Section 4: First Aid Measures

Always seek medical advice after the first aid treatment.

Skin: Rinse with water. Soap may be used. Seek Medical Aid.
Eyes: Wash eyes with plenty of water for at least 15 minutes, lifting lids occasionally. Seek Medical Aid.
Inhalation: Remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen.
Ingestion: If swallowed, induce vomiting immediately after giving two glasses of water. Never give anything by mouth to an unconscious person.
Notes to Physician: Treat symptomatically.

Section 5: Fire and Explosion Data

Flammability of the Product: Combustible.
Products of Combustion: Fumes and Oxides of carbon.
Fire Fighting Media and Instructions: Use water spray, alcohol-resistant foam, dry chemical, or carbon dioxide. Water and sand may also be used.
Extinguishing Media Not recommended: Avoid using solid water jet as it may scatter the fire.
Special Information: In the event of a fire, wear full protective clothing and NIOSH-approved self-contained breathing apparatus with full face piece operated in the pressure demand or other positive pressure mode. At high temperatures under fire conditions, it may produce toxic or irritating fumes. Fire-extinguishing work is done from the windward and the suitable fire-extinguishing method according to the surrounding situation is used. Uninvolved persons should evacuate to a safe place.

Section 6: Accidental Release Measures

Personal precautions, protective equipment, and emergency procedures: Avoid breathing dust/fumes/gas/mist/vapors/spray. Ensure adequate ventilation. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.). Restrict unprotected personnel from the area. Prevent any contact with hot surfaces. Do not approach facing the wind. Do not touch the spilled material.
Environmental precautions: Do not let the product enter drains, soil, or water sources.
Methods and materials used for containment cleanup procedures and Storage:
Small Spill: Use appropriate tools to put the spilled solid in a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and dispose of according to legal requirements.
Large Spill: Contain spilled material. Do not inhale vapors, mist, or gas. Avoid dust formation. Cover with an inert, non-combustible absorbent material, (e.g., sand, earth, diatomaceous earth, vermiculite). Vacuum or sweep-up and remove to an approved disposal container. Use a shovel to put the material into a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and allow to evacuate as per law.

Section 7: Handling and Storage

Precautions for safe handling: This material may burn but will not ignite readily. Keep all sources of ignition away Apply according to good manufacturing and industrial hygiene practices. Ensure proper ventilation. Wash thoroughly after handling. Do not drink, eat, or smoke while handling. Avoid contact with skin, eyes, and clothing. Minimize dust generation. Avoid breathing dust/fumes/gas/mist/vapors/spray. Avoid contact with eyes, skin, and clothing. Keep container tightly closed. Avoid ingestion and inhalation. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.). Prevent any contact with hot surfaces.
Conditions for safe storage, including any incompatibilities: Store in cool, dry, and ventilated area away from heat sources and protected from sunlight in tightly closed original container. Keep air contact to a minimum. Do not leave the material container open. Store protected from heat, sparks and ignition sources and incompatible materials. Avoid contact with skin and eyes. Avoid inhalation of dust/mist/vapor. Do not store with incompatible materials like oxidizing agents.

Section 8: Exposure Controls/Personal Protection

Occupational Exposure Limit: Not applicable
Engineering Controls: Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels below recommended exposure limits. If user operations generate dust, fume, or mist, use ventilation to keep exposure to airborne contaminants below the exposure limit.
Ventilation System: A system of local and/or general exhaust is recommended to keep employee exposures as low as possible. Local exhaust ventilation is preferred because it can control the emissions of the contaminant at its source, preventing dispersion of it into the general work area.
Personal Respirators (NIOSH Approved): For conditions of use where exposure to dust or mist is apparent and engineering controls are not feasible, a particulate respirator may be worn. For emergencies or instances where the exposure levels are not known, use a full-face positive-pressure, air-supplied respirator.
Skin Protection: Wear protective gloves and clean body-covering clothing.
Eye Protection: Use chemical safety goggles and/or full-face shield where dusting or splashing of solutions is possible. Maintain eye wash fountain and quick-drench facilities in work area.
Other Control Measures: Maintain good housekeeping in work area. Dust deposits on floors and other surfaces may pick up moisture and cause the surfaces to become slippery and present safety hazards. Handle in accordance with good industrial hygiene and safety practice. Wash hands after handling.

Section 9: Physical and Chemical Properties

Physical state and appearance:White or slightly yellowish waxy mass.
Odor: Almost Odorless.
Odor threshold: Not available.
pH: Not available.
Relative density: Not available.
Boiling Point: Not available.
Melting Point: Not available.
Flash point: Not available.
Auto-ignition temperature: Not available.
Decomposition temperature: Not available.
Upper/lower flammability or explosive limits: Not available.
Vapor pressure: Not available.
Vapor density: Not available.
Evaporation rate: Not available.
Flammability (solid, gas): Not available.
Partition coefficient: n-octanol/water: Not available.
Solubility: Not available.
Viscosity: Not available.

Section 10: Stability and Reactivity Data

Stability: It is stable.
Conditions of instability: Incompatible materials
Incompatibility with various substances: Heat, light, strong oxidizing agents.
Polymerization: Will not occur.

Section 11: Toxicological Information

Toxicity to Animals: Not available.
Carcinogenic Effects: Not a reported carcinogen by IARC, NTP, ACGIH, OSHA.
Mutagenic Effects: Not available.
Developmental Toxicity: Not available.
Reproductive Effects: No information available.

Section 12: Ecological Information

LC50 Fish: Not available.
Ecotoxicity: The product is not considered harmful to aquatic organisms or to cause long-term adverse effects in the environment. Not dangerous for the ozone layer.
Persistence and Degradability: Biodegradable.
Mobility: No information available.
Bioaccumulation/ Accumulation: Unlikely to accumulate.
Results of PBT and vPvB assessment: No data available for assessment.

Section 13: Disposal Considerations

Waste Disposal: Waste must be disposed of in accordance with federal, state, and local environmental control regulations.

Section 14: Transport Information

DOT USA, TDG Canada & ADR/RID Europe: Not dangerous goods.
IMDG/IMO: Not dangerous goods.
IATA: Not dangerous goods.

Section 15: Other Regulatory Information

USA Federal and State Regulations:
SARA 311/312 Hazards: No SARA Hazards. See section 2.
California Prop. 65 Components: This product does not contain any chemicals known to State of California to cause cancer, birth defects, or any other reproductive harm.

Section 16 - Additional Information

Our company provides this MSDS sheet in good faith but makes no representation as to its comprehensiveness or accuracy. This SDS sheet is intended only as a guide to the appropriate precautionary handling of the material by a properly trained person using this product. The above information has been compiled from various sources and has the possibility of discrepancy and being out-dated information. Individuals receiving the information must exercise their independent judgment and do further search in determining its appropriateness for a particular purpose. In no case shall our company be liable to loss or damages by the product user.