Poloxamer 188, 237, 331, 338, 407 USP NF BP Ph Eur FCC Food Grade Manufacturers, with SDS GHS MSDS Sheet

Supplier, Manufacturer, Exporter of Poloxamer 188, 237, 331, 338, 407, 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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Poloxamer 188, 237, 331, 338, 407: CAS Number: 9003-11-6, EINECS EC Number: yy, Molecular Formula: yy, Molecular Weight: yy, HS Code ---**

Specifications, Safety Data Sheet, Manufacturing process details, Wholesale retail buy sell prices, Uses etc available on line in these pages for Poloxamer 188, 237, 331, 338, 407.

Poloxamers are nonionic triblock copolymers composed of a central hydrophobic chain of polyoxypropylene flanked by two hydrophilic chains of polyoxyethylene. Because the lengths of the polymer blocks can be customized, many different poloxamers exist that have slightly different properties. Because of their amphiphilic structures, the polymers have surfactant properties that make them useful in industrial applications. Among other things, they can be used to increase the water solubility of hydrophobic, oily substances or otherwise increase the miscibility of two substances with different hydrophobicities. For this reason, these polymers are commonly used in industrial applications, cosmetics, and pharmaceuticals.

Poloxamer 407 is used to increase the viscosity of topical aqueous formulations, as a thickening agent and gel former, as well as co-emulsifier and consistency enhancer in creams and liquid emulsions. Poloxamer 407 functions as an emulsifier in mouthwash formulations, providing cleaning and solubilization functions without creating too much foam or as a thickener in toothpaste.

Specifications of Poloxamer USP NF Grade:
HO(C2H4O)a(C3H6O)b(C2H4O)aH
Polyethylene-polypropylene glycol --- [CAS 9003-11-6].

DEFINITION
Poloxamer is a synthetic block copolymer of ethylene oxide and propylene oxide. It is available in several types, conforming to the requirements shown in the following table.

IDENTIFICATION
A. Infrared Absorption: Use a thin film of melted specimen if it is a solid. Use USP Poloxamer Liquid for Poloxamer 124, and use USP Poloxamer Solid for Poloxamer 188, 237, 338, and 407. Because of the differences in the ratios of copolymer composition, the intensity of some absorption bands may vary.

ASSAY
Average Molecular Weight:
To pass the test.
Acceptance criteria: See the table in the Definition.
Weight Percent Oxyethylene:
To pass the test.
Acceptance criteria: See the table in the Definition.
Unsaturation:
To pass the test.
Acceptance criteria: See the table in the Definition.
Limit of Free Ethylene Oxide, Propylene Oxide, and 1,4-Dioxane:
To pass the test by Chromatography.
Acceptance criteria:
Ethylene oxide: NMT 1 micro-g/g
Propylene oxide: NMT 5 micro-g/g
1,4-Dioxane: NMT 5 micro-g/g

pH: 5.0–7.5, in a solution (1 in 40)
Packaging and Storage: Preserve in tight containers. No storage requirements specified.
Labeling: Label it to state, as part of the official title, the Poloxamer number. Label it to indicate the name and quantity of any antioxidant.

Specifications of Poloxamers BP Ph Eur Grade:
Action and use: Non-ionic surfactant.

DEFINITION
Synthetic block copolymer of ethylene oxide and propylene oxide.
A suitable antioxidant may be added.

CHARACTERS
Appearance:
-poloxamer 124: colourless or almost colourless liquid;
-poloxamers 188, 237, 338, 407: white or almost white, waxy powder, microbeads or flakes.
Solubility:
-poloxamers 124, 237, 338, 407: very soluble in water and in ethanol (96 per cent), practically insoluble in light petroleum (bp: 50-70 °C);
-poloxamer 188: soluble in water and in ethanol (96 per cent).
mp: About 50C for poloxamers 188, 237, 338 and 407.

IDENTIFICATION
First identification: A, B.
Second identification: B, C.
A. Infrared absorption spectrophotometry.
Comparison Chemical reference substance of the Ph. Eur. corresponding to the type of poloxamer to be examined.
B. Average relative molecular mass (see Tests).
C. Oxypropylene:oxyethylene ratio (see Tests).

TESTS
Solution S: Dissolve 10.0 g in carbon dioxide-free water and dilute to 100 mL with the same solvent.
Appearance of solution: Solution S is not more intensely coloured than reference solution.
pH: 5.0 to 7.5 for solution S.
Ethylene oxide, propylene oxide and dioxan:
To pass the test by Chromatography.
Limits:
-ethylene oxide: not more than 0.5 times the area of the corresponding peak in the chromatogram obtained with the reference solution (1 ppm);
-propylene oxide: not more than 0.5 times the area of the corresponding peak in the chromatogram obtained with the reference solution (5 ppm);
-dioxan: not more than 0.5 times the area of the corresponding peak in the chromatogram obtained with the reference solution (10 ppm).
Average relative molecular mass:
To pass the test.
Oxypropylene:oxyethylene ratio:
To pass the test.
Water: Maximum 1.0 per cent, determined on 1.000 g.
Total ash: Maximum 0.4 per cent, determined on 1.0 g.

Specifications of Poloxamer 407 FCC Food Grade:
αHydro-omega-hydroxy-poly(oxyethylene)-poly(oxypropylene)(63-71 moles)poly(oxyethylene) Block Copolymer
Formula weight: (average) 12,500

DESCRIPTION
Poloxamer 407 occurs as a white solid. It is a copolymer condensate of ethylene oxide and propylene oxide with a melting range of about 52C to 56C. It is freely soluble in alcohol and in water but is insoluble in propylene glycol and in ethylene glycol.
Function: Solubilizing and stabilizing agent in flavor concentrates.

REQUIREMENTS
Cloud Point of a 1:10 Solution: Above 100C.
Ethylene Oxide, Propylene Oxide, and 1,4-Dioxane: Not more than 5 mg/kg of each.
Hydroxyl Value: Between 8.5 and 11.5.
Lead: Not more than 2 mg/kg.
Molecular Weight: Between 9760 and 13,200.
pH of a 2.5% Solution: Between 6.0 and 7.4.

Specifications of Poloxamer 331 FCC Food Grade:
αHydro-omega-hydroxy-poly(oxyethylene)-poly(oxypropylene)(51-57 moles)poly(oxyethylene) Block Copolymer
Formula weight: (average) 3800

DESCRIPTION
Poloxamer 331 occurs as a practically colorless liquid. It is a block copolymer condensate of ethylene oxide and propylene oxide with an average formula weight of 3800, a specific gravity of about 1.02, and a refractive index of about 1.452. It is very slightly soluble in water at 25C but is freely soluble at 0C; it is freely soluble in alcohol but is insoluble in propylene glycol and in ethylene glycol.
Function: Solubilizing and stabilizing agent in flavor concentrates.

REQUIREMENTS
Cloud Point of a 1:10 Solution: Between 9C and 12C.
Ethylene Oxide, Propylene Oxide, and 1,4-Dioxane: Not more than 5 mg/kg of each.
Hydroxyl Value: Between 27.2 and 32.1.
Lead: Not more than 2 mg/kg.
Molecular Weight: Between 3500 and 4125.
pH of a 2.5% Solution: Between 6.0 and 7.4.

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.

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Poloxamer 124, 188, 237, 331, 338, 407 SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 13-Nov-20

Product Name & Other Names: Poloxamer 124, 188, 237, 331, 338, 407
CAS Number: 9003-11-6
EINECS EC Number: NA
Molecular Weight: -
Molecular Formula: -
Relevant uses and uses advised against (if any): Industrial Manufacturing.
Suppliers: As per letterhead.

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.

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.

Product Name & Other Names: Poloxamer 124, 188, 237, 331, 338, 407
CAS Number: 9003-11-6
EINECS EC Number: NA

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 Polyvinyl Acetate 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.

Fire: Not a fire hazard but it can burn at high temperature producing oxides of carbon and toxic fumes.
Extinguisher Media: Water spray. Carbon dioxide (CO 2). Dry chemical. alcohol-resistant foam.
Flammable Limits in Air % by Volume: N/A
Special Fire fighting Procedures: Firefighters should wear full protective equipment and NIOSH approved self-contained breathing apparatus.
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: Ventilate area of leak or spill. 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. Small amounts of residue may be flushed to sewer with plenty of water or as per law.

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: Keep Polyvinyl Acetate in a well closed container stored under cold to warm conditions, 2C to 40C, (36F to 104F) in a ventilated area and protected from sunlight. 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 strong oxidizing. Protect against physical damage. Containers of this material may be hazardous when empty since they retain product residues.

Exposure Guidelines: 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 PELs are exceeded.
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 and Odor: Solid white material for Poloxamer 188, 237, 338, 407 and liquid for Poloxamer 124, 331.
Odor: Almost odorless.
Odor threshold: Not available.
pH: 5.0–7.5, in a solution (1 in 40).
Relative density: Not available.
Melting point/freezing point: Not available.
Initial boiling point and boiling range: 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): Very soluble in water and in ethanol (96 per cent).
Viscosity: Not available.

Stability: It is stable
Conditions to Avoid: Heat.
Incompatibility (Materials to Avoid): Strong oxidizing.
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, fumes.
Hazardous Polymerization: Will not occur

Oral LD50: LD50 Oral - rat - > 5000 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: Avoid release into the environment.
Persistence and Degradability: No information available.
Mobility: No information available.
Bioaccumulation/ Accumulation: No information available.
Results of PBT and vPvB assessment: No data available for assessment.

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

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

USA:
SARA 302 Components: SARA 302: No chemicals in this material are subject to the reporting requirements of SARA Title III, Section 302.
SARA 313 Components: 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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Poloxamer --- Physical Form --- Avg M. Wt.	Weight (% Oxyethylene)	Unsaturation (mEq/g)
124 ----------- Liquid ----------- 2090–2360	46.7 ± 1.9	0.020 ± 0.008
188 ----------- Solid ----------- 7680–9510	81.8 ± 1.9	0.026 ± 0.008
237 ----------- Solid ----------- 6840–8830	72.4 ± 1.9	0.034 ± 0.008
338 ----------- Solid ------------12700– 17400	83.1 ± 1.7	0.031 ± 0.008
407 ----------- Solid ----------- 9840–14600	73.2 ± 1.7	0.048 ± 0.017

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