医薬品開発用原料
ポリソルベート80(HX2)™
日油株式会社の高純度オレイン酸誘導体ポリソルベート80（HX2）™は、アルデヒド価や過酸化物価が極めて低い世界最高品質のポリソルベート80です。
この特徴は安全性にもつながっており、ラット肥満細胞を用いた試験において、一般のポリソルベート80に比較してヒスタミン遊離が少ないという結果が得られています。また、犬を用いたIn vivo の試験においてもヒスタミン遊離が少ないことが確認されており、アレルギーを起こしにくいポリソルベートとして世界中から注目を集めています。
JP: Japanese Pharmacopoeia
EP: European Pharmacopoeia
USP/NF: National Formulary
ChP: Chinese Pharmacopoeia
Appearance comparison of Ultra-purity Polysorbate 80
Degranulation Test (An allergic study model)
Effect of Polysorbate 80 on degranulation of RBL-2H3 mast cells. Cells were treated with different concentrations of Polysorbate 80 for 60 mins. The degree of degranulation was determined by measurement of the released ß-hexosaminidase into the supernatant.
Cell Toxicity Test
Effect of Polysorbate 80 concentration on the cytotoxicity using SIRC Cells. Cells were treated with each Polysorbate 80 for 24 hrs. The number of viable cells was determined by the Neutral Red Uptake method.
Influence on Basophillic leukocyte
Basophilic leukocytes were immersed in 1% Polysorbate 80 solution for 30 min.
The cells were immobilized in glutaraldehyde and observed by SEM.
| Hemolysis Test | Survival Rate | Stability Test |
|---|---|---|
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| Effect of Polysorbate 80 concentration on the Hemolytic Ratio. Red blood cells from the guinea pig were treated with Polysorbate 80 for 60 mins. The hemolytic ratio was determined by the absorbance of the solution at 576 nm. | Effect of Polysorbate 80 concentration on the Survival Rate of BALB/c mice. Polysorbate 80 was diluted with PBS and administered to mice by intravenous injection. | This formaldehyde test was performed under air sealed conditions at 40˚C. |
Status of Chinese Pharmacopoeia (ChP)
Polysorbate 80(HX2)™ is in compliance with “Polysorbate 80 (Ⅱ)” monograph of Chinese Pharmacopoeia. NOF has submitted DMFs regarding our Polysorbate 80(HX2)™ to the NMPA China. (Registration number: F20190000324)
Specification
| Item | Specification | ||
|---|---|---|---|
| USP/NF Requirement | Identification | Meet the Requirement | |
| Viscosity(25°C, cSt) | 300-500 | ||
| Specific Gravity | 1.06-1.09 | ||
| Acid Value | NMT2.0 | ||
| Hydroxyl Value | 65-80 | ||
| Saponification Value | 45-55 | ||
| Water(%) | NMT3.0 | ||
| Residue on Ignition(%) | NMT0.25 | ||
| Elemental Impurities(μg/g) | Meet the Requirement | ||
| Residual Solvents | Meet the Requirement | ||
| Compoition of Fatty Acid(%) | Meet the Requirement | ||
| Ethylene Oxide and Dioxan(ppm) | NMT 1(Ethylene Oxide), NMT 10(Dioxan) | ||
| Peroxide Value | NMT10 | ||
| EP Requirement | Identification | Meet the Requirement | |
| Acid Value | NMT2.0 | ||
| Hydroxyl Value | 65-80 | ||
| Peroxide Value | NMT 10.0(Actual value 0-2) | ||
| Saponification Value | 45-55 | ||
| Composition of Fatty Acids(%) | Meet the Requirement | ||
| Ethylene Oxide and Dioxan(ppm) | NMT 1(Ethylene Oxide), NMT 10(Dioxan) | ||
| Elemental Impurities(μg/g) | Meet the Requirement | ||
| Water(%) | NMT3.0 | ||
| Total Ash(%) | NMT0.25 | ||
| JP Requirement | Appearence | Colorless or Brownish Yellow, Clear or Slightly Opalescent, Oily Liquid |
|
| Identification | Meet the Requirement | ||
| Composition of Fatty Acids(%) | Meet the Requirement | ||
| Acid Value | NMT2.0 | ||
| Saponification Value | 45-55 | ||
| Hydroxy Value | 65-80 | ||
| Purity(1) Heavy Metals(ppm) | NMT20 | ||
| Purity(2) | Ethylene Oxide(ppm) | NMT1 | |
| 1,4-dioxane(ppm) | NMT10 | ||
| Purity(3) Peroxide Value | NMT10.0 | ||
| Water(%) | NMT3.0 | ||
| Residue on Ignition(%) | NMT0.25 | ||
| ChP "Polysorbate 80 (For Injection)" Requirement |
Description | Colorless or light yellow viscous liquid | |
| Relative Density | 1.06-1.09 | ||
| Viscosity (25°C,mm²/s) | 350-450 | ||
| Acid Value | NMT 1.0 | ||
| Saponification Value | 45-55 | ||
| Hydroxyl Value | 65-80 | ||
| Iodine Value | 18-24 | ||
| Peroxide Value | NMT 3 | ||
| Identification | Meet the Requirement | ||
| Acidity and Alkalinity | 5.0-7.5 | ||
| Absorbance | NMT 1.0 (A225) NMT 0.10 and no maximum absorption peak at 267 nm (A267) |
||
| Color | Not more intensely colored than reference solution Y2 | ||
| Freezing Test | It must not be frozen at ice bath for 24h | ||
| Water (%) | NMT 0.5 | ||
| Residue on Ignition (%) | NMT 0.1 | ||
| Heavy Metals (ppm) | NMT 10 | ||
| Arsenic (%) | NMT 0.0002 | ||
| Ethylene Oxide and Dioxane (%) | NMT 0.0001 (Ethylene Oxide), NMT 0.001 (Dioxane) |
||
| Ethylene Glycol, Diethylene Glycol and Triethylene Glycol (%) |
NMT 0.01 (Ethylene Glycol), NMT 0.01 (Diethylene Glycol), NMT 0.01 (Triethylene glycol) |
||
| Composition of Fatty Acids (%) | Meet the Requirement (NLT98%) | ||
| Bacterial Endotoxins (EU/mg) | LT 0.012 | ||
| Others | Color(APHA) | NMT160 | |
| Microbial Limit Test(cfu/ml) | NMT100 | ||
| Bacterial Endotoxins Test(EU/g) | NMT50 | ||
| Composition of Fatty Acid Oleic Acid Contents(%) | NLT99 | ||
Package Size : 1kg amber glass bottle, 10kg stainless steel can
The product is the grade of Polysorbate 80 in Chinese pharmacopoeia 2020.
