Specifications
| Grade | EP grade; injection grade |
| Appearance | White or almost white, waxy powder, microbeads or flakes |
| Solubility | Soluble in water and in ethanol (96%) |
| Melting point | About 50 °C |
| Identification A | Infrared absorption spectrophotometry |
| Identification B | Average relative molecular mass |
| Appearance of solution | Solution S is not more intensely coloured than reference solution BY7 |
| pH | 5.0 – 7.5 |
| Ethylene oxide | 1 ppm max |
| Propylene oxide | 5 ppm max |
| Dioxane | 10 ppm max |
| Average relative molecular mass | 7680 – 9510 |
| Oxyethylene ratio | 79.9 – 83.7% |
| Water | 1.0% max |
| Total ash | 0.4% max |
| Heavy metals | 20 ppm max |
| Bacterial endotoxin test | 10 EU/g max |
| Microbial contamination | Total aerobic microbial count ≤ 50 cfu/g; total combined molds and yeasts ≤ 10 cfu/g; absence of Salmonella, E. coli, P. aeruginosa, S. aureus, and Enterobacteriaceae resistant to bile |
Applications
Poloxamer 188 is a nonionic triblock copolymer composed of polyethylene oxide and polypropylene oxide segments, widely used in pharmaceutical, biomedical, cosmetic, and industrial formulations. In pharmaceutical applications, it serves as a surfactant, solubilizer, and stabilizer in injectable formulations, oral liquids, and topical products to enhance the solubility and bioavailability of poorly water-soluble drugs. Poloxamer 188 is also applied in cell culture, gene delivery, and protein formulation to protect cells and biomolecules from shear stress and aggregation. In biomedical research, it is studied for its membrane-sealing properties and is used in investigations related to ischemia-reperfusion injury and muscle or nerve cell protection. Additionally, the compound is used in cosmetics and personal care products as an emulsifier and mild cleansing agent, as well as in industrial applications requiring controlled wetting and dispersion.
Benefits
Poloxamer 188 offers several advantages due to its excellent biocompatibility, low toxicity, and multifunctional performance. Its nonionic nature provides stability over a wide pH range and compatibility with various active ingredients and excipients. The compound effectively reduces surface and interfacial tension, improving solubilization and formulation stability. Poloxamer 188 is water-soluble, chemically stable, and resistant to enzymatic degradation, making it suitable for sensitive biological and pharmaceutical applications. Its ability to protect cell membranes and proteins under stress conditions further enhances its value in biomedical and research settings.
Conclusion
Poloxamer 188 is a versatile and widely used polymer with important applications in pharmaceuticals, biomedical research, cosmetics, and industrial formulations. Its benefits, including biocompatibility, solubilization capability, formulation stability, and protective effects on cells and biomolecules, make it an essential excipient and research material. The compound continues to support advances in drug delivery, therapeutic development, and high-performance formulation design.
