Polyoxyl 40 Hydrogenated Castor Oil or Macrogolglycerol Hydroxystearate Manufacturers, with SDS GHS MSDS Sheet |
Supplier, Manufacturer, Exporter of Polyoxyl 40 Hydrogenated Castor Oil, 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 etc. The products are offered as per required specifications and in correct shape and size in mm or meshs or microns as specified by the buyer. The participating units have one or more accreditations like FDA - cGMP and GLP approval, ISO-9001 Certified, "REACH" Registered, ISO-14001, ISO/IEC 17025, ISO-22000, FSSC 22000, ISO 45001, Kosher Certified, Halal Certified, HACCP, FSSAI. We offer Commercial Pure & IP BP EP Ph Eur USP NF JP FCC Food Grade Analytical Reagent Grades of Chemicals |
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Polyoxyl 40 Hydrogenated Castor Oil or Macrogolglycerol Hydroxystearate also referred to as Cresol RH 40: CAS Number: 61788-85-0, EINECS EC Number: 500-147-5, Molecular Formula: yy, Molecular Weight: yy, HS Code ---**
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SDS MSDS Sheet of Polyoxyl 40 Hydrogenated Castor Oil or Macrogolglycerol Hydroxystearate Manufacturers
Polyoxyl 40 Hydrogenated Castor Oil
Macrogolglycerol Hydroxystearate Pure Suppliers
Polyoxyl 40 Hydrogenated Castor Oil or Macrogolglycerol Hydroxystearate also referred to as Cresol RH 40 is a non-ionic solubilizers and emulsifying agents that is obtained by reacting hydrogenated castor oil with ethylene oxide. It is widely used in self-emulsifying drug delivery systems or micro-emulsifying systems in combination with a co-solubilizer or co-solvent. It is almost tasteless and hence ideal for oral applications.
General Properties and Specifications of Polyoxyl 40 Hydrogenated Castor Oil or Macrogolglycerol Hydroxystearate:
Appearance: White to pale yellow paste at 20C and oily at 30C+.
Odor: Almost Odorless.
Flash point: 242C.
Solubility: > 490 g/L in water at 23C. Soluble in ethanol.
Acid value: < 0.8 mg KOH/g.
Polyoxyl 40 Hydrogenated Castor Oil USP NF Grade:
DEFINITION
Polyoxyl 40 Hydrogenated Castor Oil contains mainly the tri-hydroxystearate ester of ethoxylated glycerol, with smaller amounts of polyethylene glycol tri-hydroxystearate and of the corresponding free glycols. It results from the reaction of glycerol tri-hydroxystearate with 40 –45 moles of ethylene oxide.
IDENTIFICATION
A.
Sample: 0.1 g
Analysis: Dissolve the Sample in 1 mL of water, add 9 mL of sodium chloride solution (50 mg/mL), and heat in a water bath.
Acceptance criteria: The solution becomes turbid at 70C –85C.
B.
Sample: 0.1 g
Analysis: Dissolve the Sample in 10 mL of alcoholic potassium hydroxide TS, boil for 3 min, and evaporate to dryness. Mix the residue with 5 mL of water.
Acceptance criteria: The residue dissolves, yielding a clear solution. Add a few drops of glacial acetic acid. A white precipitate is formed.
Residue on Ignition: NMT 0.3%
Congealing Temperature: 16C –26C
Fats and Fixed Oils: NMT 2.0
Fats and Fixed Oils, Hydroxyl Value: 60–80
Fats and Fixed Oils, Iodine Value: NMT 2.0
Fats and Fixed Oils, Saponification Value: 45–69
Water Determination: NMT 3.0%
Packaging and Storage: Preserve in tight containers.
Specifications of Hydrogenated Polyoxyl Castor Oil BP Ph Eur Grade:
Macrogolglycerol Hydroxystearate, Ph. Eur.
DEFINITION
Contains mainly tris(12-hydroxystearyl) glycerol ethoxylated with 7 to 60 molecules of ethylene oxide (nominal value), with small amounts of macrogol hydroxystearate and of the corresponding free glycols. It results from the reaction of hydrogenated castor oil with ethylene oxide.
CHARACTERS
Appearance:
— if less than 10 units of ethylene oxide per molecule: yellowish, turbid, viscous liquid;
— if more than 20 units of ethylene oxide per molecule: white or yellowish semi-liquid or pasty mass.
Solubility:
— if less than 10 units of ethylene oxide per molecule: practically insoluble in water, soluble in acetone, dispersible in ethanol (96 per cent);
— if more than 20 units of ethylene oxide per molecule: freely soluble in water, in acetone and in ethanol (96 per cent), practically insoluble in light petroleum.
IDENTIFICATION
A. Iodine value.
B. Saponification value.
C. Thin-layer chromatography. To pass the test.
Results: The principal spot in the chromatogram obtained with the test solution is similar in position and colour to the principal spot in the chromatogram obtained with the reference solution.
D. Place about 2 g in a test-tube and add 0.2 mL of sulfuric acid. Close the tube using a stopper fitted with a glass tube bent twice at right angles. Heat the tube until white fumes appear. Collect the fumes in 1 mL of mercuric chloride solution. A white precipitate is formed and the fumes turn a filter paper impregnated with alkaline potassium tetraiodomercurate solution black.
TESTS
Solution S: Dissolve 5.0 g of macrogolglycerol hydroxystearate with less than 40 units of ethylene oxide per molecule in a mixture of 50 volumes of acetone and 50 volumes of anhydrous ethanol and dilute to 50 mL with the same mixture of solvents.
Dissolve 5.0 g of macrogolglycerol hydroxystearate with 40 units or more of ethylene oxide per molecule in carbon dioxide-free water and dilute to 50 mL with the same solvent.
Appearance of solution: Solution S is not more opalescent than reference suspension III and not more intensely coloured than reference solution.
Alkalinity: To 2 mL of solution S add 0.5 mL of bromothymol blue solution. The solution is not blue.
Acid value: Maximum 2.0, determined on 5.0 g.
Hydroxyl value: To pass the test.
Iodine value: Maximum 5.0.
Saponification value: To pass the test.
Residual ethylene oxide and dioxan: Maximum 1 ppm of residual ethylene oxide and 10 ppm of residual dioxan.
Water: Maximum 3.0 per cent, determined on 2.000 g.
Total ash: Maximum 0.3 per cent, determined on 2.0 g.
LABELLING
The label states the number of ethylene oxide units per molecule (nominal value).
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:
Polyoxyl 40 Hydrogenated Castor Oil
Manufacturers:
MUBY CHEMICALS
Ambernath Mumbai, Ankleshwar Gujarat, India
TEL: (OFFICE) +912223770100, +912223726950
Current Date Time in India GMT+5:30
e-mail: info@mubychem.com
USA, Canada, Mexico and other American
neighbouring buyers may
e-mail: us@mubychem.com
Call toll-free 1-877-682-9243 (1-877-MUBYCHEM)
Copyright and Usual Disclaimer is Applicable.
Last
4 October, 2023
Exporters to USA Canada UAE Europe South Africa Tanzania Kenya Uganda Egypt Nigeria Turkey Mexico Brazil Argentina Chile Dubai etc.
Global or International Suppliers, Exporters, Importers, Manufacturers
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Polyoxyl 40 Hydrogenated Castor Oil or Macrogolglycerol Hydroxystearate SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 13-Nov-20
Section 1: Chemical Product and Company Identification
Product Name & Other Names: Polyoxyl 40 Hydrogenated Castor Oil or Macrogolglycerol Hydroxystearate or Hydrogenated, ethoxylated castor oil; also referred to as Cresol RH 40.
CAS Number: 61788-85-0
EINECS EC Number: 500-147-5
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 NONE |
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 Hydrogenated Castor Oil or Macrogolglycerol Hydroxystearate also referred to as Cresol RH 40.
CAS Number: 61788-85-0
EINECS EC Number: 500-147-5
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.
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 generally 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 to pale yellow paste at 20C and oily at 30C+.
Odor: Almost Odorless.
Odor threshold: Not available.
pH: Not available.
Relative density: 0.97
Boiling Point: Not available.
Melting Point: 16C to 26C.
Flash point: 242C.
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: > 490 g/L in water at 23C. Soluble in ethanol.
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:
LD50 Oral Rat > 20 g/kg.
LC50 Inhalation Rat - 4 h - > 2.06 mg/l
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: static test LC50 - Oryzias latipes (Orange-red killifish) - > 10.000 mg/l - 48 h.
Toxicity to daphnia and other aquatic invertebrates: static test EC50 - Daphnia magna (Water flea) - > 100 mg/l - 48 h.
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 313: This material does not contain any chemical components with known CAS numbers that exceed the threshold (De Minimis) reporting levels established by SARA Title III, Section 313.
SARA 311/312 Hazards: No SARA Hazards.
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.
Disclaimer:
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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.
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