| 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. |