Polysorbate and Solubilizer
Polysorbate 80 (HX) (NOFABLE® ESO-9920)
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Quality
Structure of Polysorbate 80
Low impurity
| NOFABLE® ESO-9920 (Polysorbate 80) is used high-purity oleic acid (EXTRA OLEIN 99TM), which is a purity of < 99% and is produced by our proprietary technology as a compornent of Polysorbate 80. Extra Olein 99TM is fully eliminated poly unsatulated fatty acids which are ready oxidized by oxygen and other fatty acid. NOF is the only manufacturer who can produce and commercialize such high-purity oleic acid in the world. |
 Gas chromatogram for NOF oleic acid comparared to conventional product |
Low peroxide
NOFABLE® ESO-9920 (Polysorbate 80) contains low peroxide products. The peroxides products in Polysorbate 80 cause some problem of stability of drug in their formulation.
The following data shows the stability of protein drug (IL-2) comparison with Polysorbate 80s. Low peroxide value (POV) of Polysorbate 80 maintains good stability of the drug.
Formuation of oxidized IL-2 mutein in solution during incubation at 40ºC. EMILY HA et.al. (Bayer) J. Pharma. Sci. 91,(10) 2252-, 2002
Colorless
| NOFABLE® ESO-9920 (Polysorbate 80) is colorless and odorless product.Conventianal Polysorbate 80 which has a yellowish colormay interfere a UV analysis for certain drug due to its color. These outstanding features give an advantage for drug formulation |
 Left: NOF Polysorbate 80, Right: Competitors Polysorbate 80 |
Specification
| Item | Specification |
| USP requirement | |
| Identification | Meet the requirement |
| Viscosity (25ºC, cSt) | 300-500 |
| Specific gravity | 1.06-1.09 |
| Acid value | NMT 2.2 |
| Hydroxyl value | 65-80 |
| Saponification value | 45-55 |
| Water (%) | NMT 3.0 |
| Residue on ignition (%) | NMT 0.25 |
| Heavy metals (%) | NMT 0.001 |
| Organic Volatile impurities | Meet the requirement |
| EP requirement | |
| Identification | Meet the requirement |
| Acid value | NMT 2.0 |
| Hydroxyl value | 65-80 |
| Peroxide value | NMT 10.0 |
| Saponification value | 45-55 |
| Composition of fatty acid | Meet the requirement |
| Ethylene oxide and dioxan (ppm) | NMT 1 (Ethylene oxide) NMT 10 (Dioxan) |
| Heavy metals (ppm) | NMT 10 |
| Water (%) | NMT 3.0 |
| Total ash (%) | NMT 0.25 |
| JP requirement | |
| Appearance | Colorless to light yellowish viscous liquid |
| pH (5%aq. 25ºC) | 5.5-7.5 |
| Identification | Meet the requirement |
| Viscosity (25ºC, mm2/s) | 345-445 |
| Specific gravity (20/20ºC) | 1.065-1.095 |
| Acid value | NMT 2.0 |
| Saponification value | 45-55 |
| Iodine value | 19-24 |
| Purity (1) Heavy metal (ppm) | NMT 20 |
| Purity (2) Arsenic (ppm) | NMT 2 |
| Moisture (%) | NMT 3.0 |
| Residue on ignition (%) | NMT 0.15 |
| Others | |
| Composition of fatty acid oleic acid content (%) |
NLT 99 |
| Color (APHA) | Conform |
| Microbial Limit Test (cfu/ml) | Conform |
| Bacterial Endotoxins Test (EU/g) | Conform |
   
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