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Polysorbate 80 NF,Multi-Compendial,J.T.Baker^®（Polysorbate 80 NF,J.T.Baker^®,4117-04）の特徴

試験結果

Meets E.P. Chemical Specifications
Meets B.P. Chemical Specifications
Meets N.F. Requirements
Meets J.P. Chemical Specifications
GMP Manufactured Product
CAUTION: For Manufacturing, processing or repackaging
Bulk Pharmaceutical Chemical
NF - Acid Value ≤ 2.0
NF - Hydroxyl Value 65 - 80
NF - Identification A Passes Test
NF - Identification B Passes Test
NF - Residue on Ignition ≤ 0.25 %
NF - Saponification Value 45 - 55
NF - Specific Gravity at 25°C 1.06 - 1.09
NF - Viscosity at 25°C, cSt 300 - 500
NF - Water (H₂O) ≤ 3.0 %
NF - Peroxide Value ≤ 10.0
NF - Ethylene Oxide ≤ 1 ppm
NF - Dioxane ≤ 10 ppm
NF - Composition of Fatty Acids - Myristic Acid ≤ 5.0 %
NF - Composition of Fatty Acids - Palmitic Acid ≤ 16.0 %
NF - Composition of Fatty Acids - Palmitoleic Acid ≤ 8.0 %
NF - Composition of Fatty Acids - Stearic Acid ≤ 6.0 %
NF - Composition of Fatty Acids - Oleic Acid ≥ 58.0 %
NF - Composition of Fatty Acids - Linoleic Acid ≤ 18.0 %
NF - Composition of Fatty Acids - Linolenic Acid ≤ 4.0 %
EP - Acid Value ≤ 2.0
EP - Total Ash ≤ 0.25 %
EP - Hydroxyl Value 65 - 80
EP - Identification A Passes Test
EP - Identification D Passes Test
EP - Peroxide Value ≤ 10.0
EP - Ethylene Oxide ≤ 1 ppm
EP - Dioxan ≤ 10 ppm
EP - Saponification Value 45 - 55
EP - Water (H₂O) ≤ 3.0 %
EP/BP - Composition of Fatty Acids - Myristic Acid ≤ 5.0 %
EP/BP - Composition of Fatty Acids - Palmitic Acid ≤ 16.0 %
EP/BP - Composition of Fatty Acids - Palmitoleic Acid ≤ 8.0 %
EP/BP - Composition of Fatty Acids - Stearic Acid ≤ 6.0 %
EP/BP - Composition of Fatty Acids - Oleic Acid ≥ 58.0 %
EP/BP - Composition of Fatty Acids - Linoleic Acid ≤ 18.0 %
EP/BP - Composition of Fatty Acids - Linolenic Acid ≤ 4.0 %
Appearance Passes Test
JP - Acid Value ≤ 2.0
JP - Composition of Fatty Acids - Myristic Acid ≤ 5.0 %
JP - Composition of Fatty Acids - Palmitic Acid ≤ 16.0 %
JP - Composition of Fatty Acids - Palmitoleic Acid ≤ 8.0 %
JP - Composition of Fatty Acids - Stearic Acid ≤ 6.0 %
JP - Composition of Fatty Acids - Oleic Acid ≥ 58.0 %
JP - Composition of Fatty Acids - Linoleic Acid ≤ 18.0 %
JP - Composition of Fatty Acids - Linolenic Acid ≤ 4.0 %
JP - Dioxane ≤ 10 ppm
JP - Ethylene Oxide ≤ 1 ppm
JP - Heavy Metals (as Pb) ≤ 20 ppm
JP - Hydroxyl Value, meq KOH/g 65 - 80
JP - Identification Passes Test
JP - Peroxide Value ≤ 10.0
JP - Residue on Ignition ≤ 0.25 %
JP - Water (H₂O) ≤ 3.0 %
JP - Saponification Value 45 - 55
Additional Tests - Color (Gardner) ≤ 7
Additional Tests - Odor (Faint) Passes Test
Additional Tests - Water (H₂O) ≤ 0.2 %
Additional Tests - Peroxide Value, meqO₂/kg ≤ 2.0
Additional Tests - Endotoxin Concentration (EU/mL) ≤ 10
Free Ethylene Oxide ≤ 1 ppm
1,4-Dioxane ≤ 5 ppm
Microbiological - Total Aerobic Microbial Count (cfu/g) ≤ 100
Microbiological - Escherichia Coli Passes Test
Microbiological - Pseudomonas aeruginosa Passes Test
Microbiological - Salmonella Passes Test
Microbiological - Staphylococcus aureus Passes Test
Microbiological - Total Yeast and Mold Count (cfu/g) ≤ 50
Residual Solvents - Ethylene Glycol, For Information Only
Residual Solvents - Acetic Acid, For Information Only
Residual Solvents - 2-Propanol, For Information Only
Vegetable Based
This product utilizes ingredients of non-animal origin and non-peanut
origin.
Suitable for use in the manufacture of parenteral dosage forms.
Only Class 2 (1,4 Dioxane, Ethylene Glycol) and Class 3 (acetic acid,
2-propanol) solvents are likely to be present. Class 2 solvents are below the Option 1 limits and any Class 3 solvent is
<0.5%.
Typical Oleic Acid Content, 77%
Elemental Impurities (USP 232, EP 5.20) - Information on elemental
impurities for this product is available on the associated Product
Regulatory Data Sheet and elemental impurity profile report.
Due to the anhydrous nature of this product, sodium oleate, a
carboxylate salt/soap formed naturally in the process and which can be
white to brown in color, can precipitate with time and may affect
product viscosity.

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