JT Baker® 4117-03 Polysorbate 80, NF Grade, Multi-Compendial, 4L Glass Bottle TWEEN 80 HP-LQ-(MH)
- TWEEN 80 HP-LQ-(MH). NF Grade, Multi-Compendial Grade. Meets NF Grade Requirements as well as BP, EP & JPE Requirements.
- Suitable for use in the manufacture of parenteral dosage forms.
- Vegetable Based. This product utilizes ingredients of non-animal origin and non-peanut origin.
- Metallic Residues: No metal catalysts or metal reagents, as defined by EMA Guideline EMEA/CHMP/SWP/4446/2000 , are used in the production of this material.
- Typical Oleic Acid Content: 77%
- 4L Glass Bottle
- Manufacturer Part No: JT-4117-03
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Details
Product Information
CAS Number | 9005-65-6 |
Density | 1L = 1.08 Kg |
Flash Point | 148.00° C |
Management of Change | R |
Product Specifications
TEST | SPECIFICATION |
GMP Manufactured Product | |
Meets B.P. Chemical Specifications | |
Meets E.P. Chemical Specifications | |
Meets J.P. Chemical Specifications | |
Meets N.F. Requirements | |
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% | |
TWEEN 80-LQ-(MH)™ is a trademark of Croda International Plc. | |
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. |
Documents & Videos
Product Information
CAS Number | 9005-65-6 |
Density | 1L = 1.08 Kg |
Flash Point | 148.00° C |
Management of Change | R |
Product Specifications
TEST | SPECIFICATION |
GMP Manufactured Product | |
Meets B.P. Chemical Specifications | |
Meets E.P. Chemical Specifications | |
Meets J.P. Chemical Specifications | |
Meets N.F. Requirements | |
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% | |
TWEEN 80-LQ-(MH)™ is a trademark of Croda International Plc. | |
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. |