Poloxamer 188, 237, 331, 338, 407 USP NF BP Ph Eur FCC Food Grade Liquid Powder Manufacturers Exporters

Aadhunik Industries is a manufacturing group company. Aadhunik Industries is pioneer manufacturers of Poloxamer, Specialty Chemicals, Pharmaceutical Excipients, Food Fragrance & Flavor chemicals in India. It has toll manufacturers and representatives in UAE, Europe, Canada & USA and agents & customers in all countries like USA, Canada, Europe, UAE, South Africa, Tanzania, Kenya, Egypt, Nigeria, Uganda, Turkey, Mexico, Brazil, Chile, Argentina, Dubai, Netherlands, Italy, Spain, Germany, Portugal, France, Malaysia, Indonesia, Thailand, Korea, Japan, Russia etc.

Aadhunik Industries and/or associated units are FDA-GMP certified, Halal and/or Kosher certified, REACH registered, ISO-9001, ISO-22000 HACCP certified. We offer crystals granules in precise micron or mesh size as per buyers needs. We offer very high purity standards as per specifications required.

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 USP NG 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 Molecular Weight	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

It may contain a suitable antioxidant.

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 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

CAS Number 9003-11-6, Poloxamer manufacturers suppliers exporters at:

manufacturer supplier exporter
Aadhunik Industries
Ankleshwar Gujarat & Mumbai, India
TEL: (OFFICE) 91-22-23774610, 23723564.