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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Item Number: JTB-4117-03
$3,719.96

Sold in: Eaches

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Details

Product Information

CAS Number9005-65-6
Density1L = 1.08 Kg
Flash Point148.00° C
Management of ChangeR



Product Specifications

TESTSPECIFICATION
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 Value65 - 80
NF - Identification APasses Test
NF - Identification BPasses Test
NF - Residue on Ignition<= 0.25 %
NF - Saponification Value45 - 55
NF - Specific Gravity at 25°C1.06 - 1.09
NF - Viscosity at 25°C, cSt300 - 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 Value65 - 80
EP - Identification APasses Test
EP - Identification DPasses Test
EP - Peroxide Value<= 10.0
EP - Ethylene Oxide<= 1 ppm
EP - Dioxan<= 10 ppm
EP - Saponification Value45 - 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 %
AppearancePasses 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/g65 - 80
JP - IdentificationPasses Test
JP - Peroxide Value<= 10.0
JP - Residue on Ignition<= 0.25 %
JP - Water (H₂O)<= 3.0 %
JP - Saponification Value45 - 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 ColiPasses Test
Microbiological - Pseudomonas aeruginosaPasses Test
Microbiological - SalmonellaPasses Test
Microbiological - Staphylococcus aureusPasses 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 Number9005-65-6
Density1L = 1.08 Kg
Flash Point148.00° C
Management of ChangeR



Product Specifications

TESTSPECIFICATION
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 Value65 - 80
NF - Identification APasses Test
NF - Identification BPasses Test
NF - Residue on Ignition<= 0.25 %
NF - Saponification Value45 - 55
NF - Specific Gravity at 25°C1.06 - 1.09
NF - Viscosity at 25°C, cSt300 - 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 Value65 - 80
EP - Identification APasses Test
EP - Identification DPasses Test
EP - Peroxide Value<= 10.0
EP - Ethylene Oxide<= 1 ppm
EP - Dioxan<= 10 ppm
EP - Saponification Value45 - 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 %
AppearancePasses 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/g65 - 80
JP - IdentificationPasses Test
JP - Peroxide Value<= 10.0
JP - Residue on Ignition<= 0.25 %
JP - Water (H₂O)<= 3.0 %
JP - Saponification Value45 - 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 ColiPasses Test
Microbiological - Pseudomonas aeruginosaPasses Test
Microbiological - SalmonellaPasses Test
Microbiological - Staphylococcus aureusPasses 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.

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