English 
Español 
français 
العربية Search
Search
Polyoxyl 15 hydroxystearate (Kolliphor HS 15) is a non-ionic surfactant and emulsifier. Its primary selling point is enhancing the solubility and dissolution of poorly water-soluble drugs. It is highly valued for its low toxicity, minimal hemolysis, and excellent safety profile. Additionally, it forms stable micelles to improve drug delivery and bioavailability. Thermally stable and versatile, it is widely used in oral, injectable, ophthalmic, and topical pharmaceutical formulations.
Items | Specifications | Results |
Appearance(25℃) | Off-white to yellowish paste | Conforms |
Identification(TLC) | Must conform | Conforms |
Identification(viscosity) | Must conform | Conforms |
Identification(free macrogols) | Must conform | Conforms |
Identification(IR) | Must conform | Conforms |
Appearance of solution | Not more opalescent than reference sol.III,max.B6 or BY6 | Conforms |
Acid value | Max:1.0 mg KOH/g | 0.2 |
Hydroxyl value | 90-110 mg KOH/g | 104 |
Iodine value | Max:2.0 g Iodine/100g | 0.4 |
Peroxide value | Max:3.0 meq/kg | ＜1.0 |
Saponification value | 53-63 mg KOH/g | 60 |
Free macrogols | 27.0-39.0 g/100g | 32.4 |
Nickel | Max:1 mg/kg | ＜1 |
Water(Karl-Fischer-titration) | Max:0.5 g/100g | 0.1 |
Ph-value(10g/100ml water) | 5.0-7.0 | 6.2 |
Heavy metals*(test solution:12ml of a 5.0g in 50ml water solution CO2 free) | Must conform(max. 10mg/kg) | Conforms |
Freezing point | 22-30 | Degree C 23 |
Ethylene oxide | Max:1 mg/kg | ＜1 |
1,4-Dioxane | Max.:10 mg/kg | ＜10 |
Diethylene glycol | Max:620 mg/kg | ＜50 |
Residual solvents acetic acid | Max:0.5 g/100g | 0.1 |
Residual solvents ethylene glycol | Max:620 mg/kg | ＜50 |
Total aerobic microbial count(TAMC) Test method Ph.Eur.,2.6.12 | Max:200 CFU/g | ＜10 |
Total combined yeasts/moulds count(TYMC) Test method Ph.Eur.,2.6.12 | Max:20 CFU/g | ＜10 |
Escherichia coli Test method Ph.Eur.,2.6.13 | Max.:0 CFU/g | 0 |
Staphylococcus aureus Test method Ph.Eur.,2.6.13 | Max.:0 CFU/g | 0 |
Pseudomonas aeruginosa Test method Ph.Eur.,2.6.13 | Max:0 CFU/g | 0 |
Salmonella Test method Ph.Eur.,2.6.13 | Max.:0 CFU/10g | 0 |
Bacterial endotoxins Ph.Eur.,2.6.14 Meth.A | Max.:10 I.U./g | ＜3 |
Elemental impurities | Must conform-ICH Q3D class 1,2A und 3(parenteral conc.limits) | Conforms |
Conclusion | The product conforms to the above specifications. | |
Fortunachem Provides Not Only Professional Chemical Products But Also Professional Help
Keeping you up-to-date with all the latest information, news, and events about Fortunachem!
Quick Links
Add:
E-mail:
中文
