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Poloxamer 188, 237, 331, 338, 407 Manufacturer Exporter IP BP Ph Eur USP NF FCC Food AR ACS Grade Manufacturer Exporter
Crystal Clear Products is a manufacturer exporter company manufacturing several chemicals including Poloxamer 188, 237, 331, 338, 407 and IP BP Ph Eur USP NF JP ACS AR Analytical Reagent FCC Food Grade, Pharmaceutical Chemicals at best prices. The group has offices and factories in India USA and UAE and toll manufacturers in China and sells to almost every country in the world.
The manufacturing facilities of our partner manufacturers have one or more of FDA-cGMP-GLP certification, ISO-9001 certification, Halal and/or Kosher certification, REACH pre-registration ISO-22000 HACCP. We also allow third party inspection of products offered. We can offer small quantities from laboratory and trial packs to large shipments of container loads of material.
Hazard Statements:
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.
Not considered hazardous by the OSHA Hazard Communication Standard (29 CFR 1910.1200)
Signal Word: None
Transport Information
DOT USA, TDG Canada & ADR/RID Europe: Not dangerous goods.
IMO/IMDG: Not dangerous goods.
IATA/ICAO: Not dangerous goods.
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Poloxamer 188, 237, 331, 338, 407 SDS of Manufacturers
Poloxamer 188, 237, 331, 338, 407 IP BP Ph Eur USP NF FCC Food AR ACS Reagent Grade Manufacturers
CAS Number 9003-11-6 Poloxamer 188, 237, 331, 338, 407
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.
| Poloxamer --- Physical Form --- Avg M. Wt. | Wt. (% 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 |
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)
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.
Contact for Monograph, Uses, Matnfacturing Process, etc of Poloxamer 188, 237, 331, 338, 407 and JP IP BP Ph Eur USP NF FCC Food AR ACS Reagent Grade Manufacturer Supplier Exporter
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Last updated
11/19/2022
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