Polysorbate 80
- 4117
- NF/EP/BP
- Multi-compendial grade
- 9005-65-6
-
-
-
-
- 1.11
|
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
| 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. |
|