Product Introduce

Product Name	Poloxamer 188
Pharmacopoeia specification compliance	USP/EP/ChP
CAS NO.	9003-11-6
Molecular Formula	H(C2H4O)a(C3H6O)b(C2H4O) aOH
Density	1.2±0.1 g/cm3
Flash Point	160.5±26.5 °C
Boiling Point	370.7±37.0 °C
Appearance	White to slightly yellow, translucent powder

Poloxamer 188 is a polyoxyethylene-polyoxypropylene block copolymer-also known as a polyether polyol-and serves as a common polymeric pharmaceutical excipient. As a non-ionic surfactant, it offers excellent emulsifying properties and a favorable safety profile; it has garnered significant attention for its ability to stabilize cell membrane structural defects caused by various factors. It belongs to a novel class of polymeric non-ionic surfactants. Poloxamer is readily soluble in water or ethanol; it dissolves in anhydrous ethanol, ethyl acetate, and chloroform, but is practically insoluble in diethyl ether or petroleum ether, and exhibits some foaming capability. The pH of a 2.5% aqueous solution ranges from 5.0 to 7.5, while the pH for injectable grades is between 6.0 and 7.0. Its aqueous solution is relatively stable in air, though exposure to light causes the pH to decrease. The substance remains stable in the presence of acidic or alkaline aqueous solutions and metal ions.

Products Specifications

Test Item	Executive Standard	Test Result
Appearance	This product is colorless or pale yellow clear liquid. It is highly soluble in ethanol, absolute ethanol, or ethyl acetate, but practically insoluble in ether or petroleum ether	This product is colorless or pale yellow clear liquid. It is highly soluble in ethanol, absolute ethanol, or ethyl acetate, but practically insoluble in ether or petroleum ether
Identification	The characteristic absorption perks should appear at wavenumbers of 1100±10cm,2860±10cm,and 2970±10cm	Conformed
pH	5.0-7.5	6.4
Clarity and Color of Solution	Clear and colorless	Clear and colorless
Oxyethylene Weight,%	20%-28%(Third-party testing)	26%
Unsaturation	NMT0.034mmol/g	0.026mmol/g
Average Molecular Weight	2000-2600	2535
Ethylene Oxide,%	Ethylene Oxide NMT 0.0001%	Ethylene Oxide:None Detected
Propylene Oxide,%	Propylene Oxide NMT 0.0005%	Propylene Oxide:None Detected
1,4-Dioxane,%	1,4-Dioxane NMT 0.0005%	1,4-Dioxane:None Detected
Ethylene Glycol,%	Ethylene Glycol,NMT 0.01%	Ethylene Glycol,% None Detected
Diethylene Glycol,%	Diethylene Glycol,NMT 0.01%	Diethylene Glycol,% None Detected
Triethylene Glycol,%	Triethylene Glycol,NMT 0.01%	Triethylene Glycol,% 0.002%
Butylated Hydroxytoluene(BHT)	NMT Labeled Amount(0.01%)	0.004%
Moisture	NMT 1.0%	0.1%
Residue on lgnition	NMT 0.4%	0.1%
Heavy Metal,ppm	NMT 20	Conformed
Arsenic	Should be Conformed(0.0002%)	Conformed
Microbial Limit	Total Aerobic Microbial Count:NMT 100 cfu/g	Total Aerobic Microbial Count:＜10 cfu/g
	Total Combined Yeasts and Molds Count:NMT 10cfu/g	Total Combined Yeasts and Molds Count＜10 cfu/g
	The sample shall comply with the test for absence of Staphylococcus Aureus and Pseudomonas Aeruginosa(limit:not detected in 1g)	No Staphylococcus Aureus or Pseudomonas Aeruginosa were detected in 1g of the sample.

Conclusion:Passed.Complied with standards.

1. Used as an emulsifier, solubilizer, wetting agent, and suspension stabilizer for oral liquid and topical preparations;

2. Can be used as a coating plasticizer for oral solid preparations;

3. Used as a gel base for liquid or semi-solid preparations.

Safety and Storage

Safety

1. Toxicity:Poloxamer 182 has undergone extensive safety assessments in pharmaceutical and cosmetic applications and has no significant acute toxicity.

2. Irritancy:Non-irritating to skin and eyes.

3. Allergenicity:No significant allergenicity observed.

4. Usage limitations:In pharmaceutical formulations, the dosage should be adjusted according to the specific application and formulation to avoid excessive use.

Storage:It is recommended to store at room temperature (15-25°C) in a sealed container to avoid moisture and contamination.

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