Polysorbate and Solubilizer
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Specification
| Item | Specification |
USP Requirement |
|
| Identification | Meet the Requirement |
| Composition of Fatty Acid (%) | Myristic acid, NMT 5.0 Palmitic adid, NMT 16.0 Palmitoleic acid, NMT 8.0 Stearic acid, NMT 6.0 Oleic acid, NLT 58.0 Linoleic acid, NMT 18.0 Linolenic acid, NMT 4.0 |
| Viscosity (25ºC, mPa･s) | about 400 |
| Specific Gravity | about 1.10 |
| Acid Value | NMT 2.0 |
| Hydroxyl Value | 65-80 |
| Peroxide Value | NMT 10 |
| Saponification Value | 45-55 |
| Water (%) | NMT 3.0 |
| Residue on Ignition (%) | NMT 0.25 |
| Heavy Metals (ppm) | NMT 10 |
| Ethylene Oxide and Dioxan (ppm) | NMT 1 (Ethylene Oxide) NMT 10 (Dioxan) |
| Residual Solvents | 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 | Myristic acid, NMT 5.0 Palmitic adid, Max. 16.0 Palmitoleic acid, Max. 8.0 Stearic acid, Max. 6.0 Oleic acid, Min. 58.0 Linoleic acid, Max. 18.0 Linolenic acid, Max. 4.0 |
| 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.) | 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 0.1 |
Others |
|
| Composition of Fatty Acid Oleic Acid Content (%) |
NLT 99 |
| Color (APHA) | NMT 160 |
| Microbial Limit Test (cfu/ml) | NMT 100 |
| Bacterial Endotoxins Test (EU/g) | NMT 50 |
   
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