| TEST | SPECIFICATION |
| GMP Manufactured Product |
| 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 - Heavy Metals (as Pb) | <= 10 ppm |
| NF - Hydroxyl Value | 65 - 80 |
| NF - Identification | Passes Test |
| NF - Residue on Ignition | <= 0.25 % |
| NF - Saponification Value | 45 - 55 |
| NF - Specific Gravity at 25°/25°C | 1.06 - 1.09 |
| NF - Viscosity at 25.0°C, cSt | 300 - 500 |
| NF - Water (H₂O) | <= 3.0 % |
| NF - Peroxide Value | <= 10 |
| 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 - Heavy Metals (as Pb) | <= 10 ppm |
| 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 % |
| JP - Appearance | Passes Test |
| JP - pH of 5% Aqueous Solution | 5.5 - 7.5 |
| JP - Identification A | Passes Test |
| JP - Identification B | Passes Test |
| JP - Identification C | Passes Test |
| JP - Identification D | Passes Test |
| JP - Viscosity at 25.0°C, (mm²/s) | 345 - 445 |
| JP - Specific Gravity at 20°/20°C | 1.065 - 1.095 |
| JP - Acid Value | <= 2.0 |
| JP - Saponification Value | 45 - 55 |
| JP - Iodine Value | 19 - 24 |
| JP - Heavy Metals (as Pb) | <= 20 ppm |
| JP - Arsenic (As) | <= 2 ppm |
| JP - Water (H₂O) | <= 3.0 % |
| JP - Residue on Ignition | <= 0.1 % |
| Additional Tests - Color (APHA) | <= 150 |
| Additional Tests - Odor | Passes Test |
| Additional Tests - Water (H₂O) | <= 0.2 % |
| Additional Tests - Peroxide Value (meq/kg) | <= 2.0 |
| Additional Tests - Endotoxin Concentration (EU/mL) | <= 2 |
| Microbiological - Total Plate Count (opg) | <= 100 |
| Microbiological - Escherichia coli | Passes Test |
| Microbiological - Pseudomonas aeruginosa | Passes Test |
| Microbiological - Salmonella | Passes Test |
| Microbiological - Staphylococcus aureus | Passes Test |
| Microbiological - Yeast and Mold (opg) | <= 50 |
| 1,4-Dioxane | <= 5 ppm |
| Formaldehyde | <= 10 ppm |
| Sodium (Na) | <= 5 ppm |
| Potassium (K) | <= 5 ppm |
| 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% |