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端に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、最新のデータでは、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。

Polysorbate 80(HX2) Polysorbate 80(HX2)の表

JP: Japanese Pharmacopoeia
EP: European Pharmacopoeia
USP/NF: National Formulary
ChP: Chinese Pharmacopoeia

Polysorbate 80(HX2)

Appearance comparison of Ultra-purity Polysorbate 80

Degranulation Test (An allergic study model)

Degranulation Test

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

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

Influence on Basophillic leukocyte1 Influence on Basophillic leukocyte2 Influence on Basophillic leukocyte3

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
Hemolysis Test Survival Rate
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 (For injection)" monograph of Chinese Pharmacopoeia 2015 edition.
NOF has submitted DMFs regarding our Polysorbate 80(HX2) ™ to the NMPA China. (Registration number: F20190000324 and F20190000325)

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)
Paroxide 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
JR Requirement Appearence Colorless or Brownish Yellow,
Clear or Slightly Opalescent, Oily Liquid
Identification Meets the Requirements of the Composition of Fatty acids
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
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 (ppm) NMT 2
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 steal can

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