Sorbitan monostearate or Sorbitan stearate BP Ph Eur USP NF Grade Manufacturers, with SDS GHS MSDS Sheet

Supplier, Manufacturer, Exporter of Sorbitan monostearate or Sorbitan 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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Sorbitan monostearate or Sorbitan stearate: CAS Number: 1338-41-6, EINECS EC Number: 215-664-9, Molecular Formula: C24H46O6, Molecular Weight: 430.62, HS Code ---**

Specifications, Safety Data Sheet, Manufacturing process details, Wholesale retail buy sell prices, Uses etc available on line in these pages for Sorbitan monostearate or Sorbitan stearate.

Sorbitan monostearate or Sorbitan stearate is an ester of sorbitan and stearic acid and is sometimes referred to as a synthetic wax. Sorbitan monostearate is primarily used as an emulsifier to keep water and oils mixed. Sorbitan monostearate is used in the manufacture of food and healthcare products and is a non-ionic surfactant with emulsifying, dispersing, and wetting properties. It is also employed to create synthetic fibers, metal machining fluid, and brighteners in the leather industry, and as an emulsifier in coatings, pesticides, and various applications in the plastics, food and cosmetics industries. It has an E number of E491.

General Properties and Specifications of Sorbitan monostearate or Sorbitan stearate:
Appearance: White to pale yellow waxy solids.
Odor: Slight.
Melting point: 49C to 65C literature.
Relative density: around 1.
Solubility: Soluble in ethanol, isopropanol, mineral oil, and vegetable oil. Insoluble in water and propylene glycol.

Specifications of Sorbitan Monostearate USP NF Grade:
Sorbitan, esters, monooctadecanoate;
Sorbitan Monostearate --- CAS 1338-41-6

DEFINITION
Sorbitan Monostearate is a partial ester of Stearic Acid with Sorbitol and its mono- and dianhydrides. It yields, upon saponification, NLT 68.0% and NMT 76.0% of fatty acids, and NLT 27.0% and NMT 34.0% of polyols (w/w).

IDENTIFICATION
A.
Sample: Residue obtained in the Assay for Fatty Acids
Acceptance criteria
Fats and Fixed Oils, Acid Value: 200–215 on 1-g sample
Fats and Fixed Oils, Iodine Value: NMT 4
B.
To pass the Chromatographic Test.

ASSAY
Fatty Acids:
To pass the test.
Acceptance criteria: 68.0%–76.0%
Polyols:
Acceptance criteria: 27.0%–34.0% (w/w)

Residue on Ignition: NMT 0.5%
Water Determination, Method I: NMT 1.5%
Fats and Fixed Oils, Acid Value: NMT 10
Fats and Fixed Oils, Hydroxyl Value: 235–260
Fats and Fixed Oils, Saponification: 147–157
Packaging and Storage: Preserve in well-closed containers.

Specifications of Sorbitan Stearate BP Ph Eur Grade:
Action and use: Non-ionic surfactant.
When sorbitan monostearate is demanded, Sorbitan Stearate shall be supplied.

DEFINITION
Mixture usually obtained by partial esterification of sorbitol and its mono- and di-anhydrides with Stearic acid 50 (1474) or Stearic acid 70 (1474).

CHARACTERS
Appearance: Pale yellow, waxy solid.
Solubility: Practically insoluble but dispersible in water, slightly soluble in ethanol (96 per cent).

IDENTIFICATION
A. Melting point: 50C to 60C.
Introduce the melted substance into the capillary tubes and allow to stand at a temperature below 10C for 24 h.
B. Hydroxyl value (see Tests).
C. Composition of fatty acids (see Tests).

TESTS
Acid value: Maximum 10.0, determined on 5.0 g.
Hydroxyl value: 235 to 260.
Peroxide value: Maximum 5.0.
Saponification value: 147 to 157.
Carry out the saponification for 1 h.
Composition of fatty acids: To pass the Gas chromatography test.
Water: Maximum 1.5 per cent, determined on 1.00 g.
Total ash: Maximum 0.5 per cent.

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.

MUBY CHEMICALS
Ambernath Mumbai, Ankleshwar Gujarat, India
TEL: (OFFICE) +912223770100, +912223726950
Current Date Time in India GMT+5:30

USA, Canada, Mexico and other American
neighbouring buyers may
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Call toll-free 1-877-682-9243 (1-877-MUBYCHEM)

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Sorbitan monostearate or Sorbitan stearate SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 19-Nov-20

Product Name & Other Names: Sorbitan monostearate or Sorbitan stearate.
CAS Number: 1338-41-6
EINECS EC Number: 215-664-9
Molecular Weight: 430.62
Molecular Formula: C24H46O6
Relevant uses and uses advised against (if any): Industrial Manufacturing.
Supplier: As per letterhead.

GHS, Globally Harmonized System Classification in accordance with 29 CFR 1910
Hazard Class and Category Code(s), Regulation (EC) No 1272/2008 (CLP)

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.

Hazards not otherwise classified (HNOC):
May causes mild skin irritation.
May causes mild eye irritation, if exposed in large quantity.

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.

Product Name & Other Names: Sorbitan monostearate or Sorbitan stearate.
CAS Number: 1338-41-6
EINECS EC Number: 215-664-9

Emergency and First Aid Procedures:
Eyes - Flush with water for at least 15 minutes, raising and lowering eyelids occasionally. Get medical attention if irritation persists.
Skin - Thoroughly wash exposed area for at least 15 minutes. Remove contaminated clothing. Launder contaminated clothing before reuse. Get medical attention if irritation persists.
Ingestion - If it is swallowed, if conscious, give plenty of water. Immediately call a physician. Never give anything by mouth to an unconscious person.
Inhalation - Remove to fresh air. Give oxygen if breathing is difficult; give artificial respiration if breathing has stopped. Get medical attention.

Extinguisher Media: Use media suitable to extinguish surrounding fire. Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.
Flammable Limits in Air % by Volume: N/A
Special hazards arising from the substance or mixture: Carbon oxides and fumes.
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.

Personal precautions, protective equipment and emergency procedures: Avoid breathing dust/fumes/gas/mist/vapors/spray. 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: Contain spilled material. 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.

Precautions for safe handling: 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, acids and bases.

Exposure Limits: This product does not contain any hazardous materials with occupational exposure limits established by the region-specific regulatory bodies.
Respiratory Protection (Specify Type): None needed under normal conditions of use with adequate ventilation. NIOSH approved equipment should be worn if exposure is high.
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.

Appearance: White to pale yellow waxy solids.
Odor: Slight.
Odor threshold: Not available.
pH: Not available.
Relative density: around 1.
Melting Point: 49C to 65C literature.
Boiling 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(ies): Soluble in ethanol, isopropanol, mineral oil, and vegetable oil. Insoluble in water and propylene glycol.
Viscosity: Not available.
Molecular Weight: 430.62
Molecular Formula: C24H46O6

Stability: It is stable under normal conditions of use and storage.
Conditions to Avoid: Heat, Dust generation.
Incompatibility (Materials to Avoid): Strong oxidizing agents, acids and bases.
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, fumes.
Hazardous Polymerization: Will not occur

Acute toxicity: LD50 Oral – Rat: >30000 mg/kg
Carcinogenicity: This product present at levels greater than or equal to 0.1% is identified as probable, possible or confirmed human carcinogen by IARC, NTP, ACGIH & OSHA.
Mutagenic Effects: Not available.
Developmental Toxicity: Not available.
Reproductive Effects: No information available.

Toxicity to fish: No information available.
Bioaccumulative potential: Does not bioaccumulate.
Persistence and degradability: Degradable.
Mobility: No information available.
Results of PBT and vPvB assessment: No data available for assessment.

Waste Disposal Methods: Dispose in accordance with all applicable Federal, State and Local regulations.

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

USA:
SARA 302: No chemicals in this material are subject to the reporting requirements of SARA Title III, Section 302.
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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