Polysorbate 80 NF, Multi-Compendial, J.T.Baker®

Catalog #: CAJT4117-4

Supplier: AVANTOR PERFORMANCE MATERIAL LLC

CAS Number: 9005-65-6

MOC: Regulated

SDS

Certificates

Polysorbate 80 NF, Multi-Compendial, J.T.Baker®

Catalog #: CAJT4117-4

Supplier: AVANTOR PERFORMANCE MATERIAL LLC

CAS Number: 9005-65-6

MOC: Regulated

SDS

Certificates

Restricted Products: To process your orders without delay, please provide the required business documentation to purchase this product.

To order chemicals, medical devices, or other restricted products please provide ID that includes your business name & shipping address via email [email protected] or fax 484.881.5997 referencing your VWR account number. Acceptable forms of ID are:

• State issued document with your organization's Federal Tax ID Number
• State issued document with your organization's Resale Tax ID Number
• City or County issued Business License
• State Department of Health Services License
• Any other ID issued by the State that includes the business name & address

* ATTN: California Customers may require additional documentation as part of the CA Health & Safety Code. Products that fall under this regulation will be placed on a mandatory 21-day hold after documentation is received. VWR will not lift restrictions for residential shipping addresses.

Specifications

Packaging:
Glass bottle, amber, narrow mouth
Size:
200 ml
Supplier No.:
4117-04

Specifications

Specification Test Results

Microbiological - Pseudomonas aeruginosa:
Passes Test
Microbiological - Salmonella:
Passes Test
Microbiological - Staphylococcus aureus:
Passes Test
Microbiological - Total Yeast and Mold Count (cfu/g):
≤ 50
Ethylene glycol:
≤ 0.10 %
Diethylene glycol :
≤ 0.10 %
Residual Solvents - Acetic Acid, For Information Only:
Residual Solvents - Ethylene Glycol, 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.:
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 - 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
J.T.Baker®, Polysorbate 80 NF, Multi-Compendial: