Polysorbate 80



  • Product Code
  • Grade
  • Description
  • CAS
  • Formula
  • Formula Weight
  • UN
  • FlashPoint (°C)
  • Density (kg/L)
  • 4117
  • NF/EP/BP
  • Multi-compendial grade
  • 9005-65-6
  •  
  •  
  •  
  •  
  • 1.11


Code
Size
Price
03
4.00 L
CAD $ 785.00 Each
07
19.00 L
CAD $    
12
1.00 L
CAD $ 335.00 Each
Payment can be made by Visa, Mastercard, AMEX, Interac, money order, certified cheque, or bank transfer.

Please make cheques and money orders payable to ANK Pharmaceuticals Inc. (Sister company for web orders)

When using a credit card or Interac bank card, your statement will show ANK Pharmaceuticals Inc for your order.

* We only ship within Canada. We do not ship to the United States or anywhere else worldwide.

All sales are final. Please confirm desired grade before ordering.

Product Specifications


Test Specification
GMP Manufactured Product  
Vegetable Based  
This product utilizes ingredients of non-animal origin and non-peanut origin.  
Meets N.F. Requirements  
Acid Value max. 2.2
Heavy Metals (as Pb) max. 0.001 %
Hydroxyl Value 65 - 80
Identification A Passes Test
Identification B Passes Test
Identification C Passes Test
Residue on Ignition max. 0.25 %
Saponification Value 45 - 55
Specific Gravity at 25°/25°C 1.06 - 1.09
Viscosity at 25.0°C, cSt 300 - 500
Water (H2O) max. 3.0 %
   
Meets Ph.Eur. Chemical Specifications  
Acid Value max. 2.0
Total Ash max. 0.25 %
Heavy Metals (as Pb) max. 10 ppm
Hydroxyl Value 65 - 80
Identification A Passes Test
Identification D Passes Test
Peroxides, meq/1000g max. 10.0
Ethylene Oxide max. 1 ppm
Dioxan max. 10 ppm
Saponification Value 45 - 55
Water (H2O) max. 3.0 %
Composition of Fatty Acids  
Myristic Acid max. 5.0 %
Palmitic Acid 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 %
   
Meets JP Chemical Specifications  
Appearance Passes Test
pH of 5% Aqueous Solution 5.5 - 7.5
Identification A Passes Test
Identification B Passes Test
Identification C Passes Test
*The manufacturer has assurance, based on knowledge of the manufacturing process and controlled handling, shipping, and storage of the material that it meets the Ph.Eur. Test Specifications for Pyrogens.  
Identification D Passes Test
Viscosity at 25.0°C, (mm/S)2 345 - 445
Specific Gravity at 20°/20°C 1.065 - 1.095
Acid Value max. 2.0
Saponification Value 45 - 55
Iodine Value 19 - 24
Heavy Metals (as Pb) max. 20 ppm
Arsenic (As) max. 2 ppm
Water (H2O) max. 3.0 %
Residue on Ignition max. 0.1 %
   
Additional Tests:  
Color (Gardner) max. 7
Odor (Faint) Passes Test
Water (H2O) max. 0.2 %
Peroxides, meq/1000g max. 2.0
Endotoxin Concentration (EU/mL) max. 10
Organic Volatile Impurities:  
Free Ethylene Oxide max. 1 ppm
1,4-Dioxane max. 5 ppm
Microbiological:  
Total Plate Count (opg) max. 100
Escherichia Coli Passes Test
Pseudomonas aeruginosa Passes Test
Salmonella Passes Test
Staphylococcus aureus Passes Test
Yeast and Mold (opg) max. 50
   
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%.
 
Bulk Pharmaceutical Chemical  
Typical Oleic Acid Content, 77%  
CAUTION: For manufacturing, processing or repacking.  
CRILLET 4 HP˜ is a trademark of Croda International Plc.