| TEST |
SPECIFICATION |
| GMP Manufactured Product |
| Meets B.P. Chemical Specifications |
| Meets E.P. Chemical Specifications |
| Meets JPE Specifications |
| Meets N.F. Requirements |
| Store in airtight container, protected from light |
| CAUTION: For Manufacturing, processing or repackaging |
| Bulk Pharmaceutical Chemical |
| NF- Acid Value |
<= 2.0 |
| NF- Residue on Ignition |
<= 0.25% |
| NF- Dioxane |
<= 10 ppm |
| NF- Ethylene Oxide |
<= 1 ppm |
| NF- Hydroxyl Value, mg KOH/g |
96 - 108 |
| NF- Identification A |
Passes Test |
| NF- Identification B |
Passes Test |
| NF- Saponification Value, mg KOH/g |
40 - 50 |
| NF- Caproic Acid (Composition of Fatty Acids) |
<= 1.0% |
| NF- Caprylic Acid (Composition of Fatty Acids) |
<= 10.0% |
| NF- Capric Acid (Composition of Fatty Acids) |
<= 10.0% |
| NF- Lauric Acid (Composition of Fatty Acids) |
40.0 - 60.0% |
| NF- Myristic Acid (Composition of Fatty Acids) |
14.0 - 25.0% |
| NF- Palmitic Acid (Composition of Fatty Acids) |
7.0 - 15.0% |
| NF- Stearic Acid (Composition of Fatty Acids) |
<= 11.0% |
| NF- Oleic Acid (Composition of Fatty Acids) |
<= 11.0% |
| NF- Linoleic Acid (Composition of Fatty Acids) |
<= 3.0% |
| NF- Peroxide Value |
<= 5.0 |
| NF- Water (H2O) |
<= 3.0% |
| Endotoxin Concentration (EU/mL) |
<= 10 |
| EP/BP- Acid Value |
<= 2.0 |
| EP/BP- Total Ash |
<= 0.25% |
| EP/BP- Composition of Fatty Acids- Caproic Acid |
<= 1.0% |
| EP/BP- Composition of Fatty Acids- Caprylic Acid |
<= 10.0% |
| EP/BP- Composition of Fatty Acids- Capric Acid |
<= 10.0% |
| EP/BP- Composition of Fatty Acids- Lauric Acid |
40.0 - 60.0% |
| EP/BP- Composition of Fatty Acids- Myristic Acid |
14.0 - 25.0% |
| EP/BP- Composition of Fatty Acids- Palmitic Acid |
7.0 - 15.0% |
| EP/BP- Composition of Fatty Acids- Stearic Acid |
<= 7.0% |
| EP/BP- Composition of Fatty Acids- Oleic Acid |
<= 11.0% |
| EP/BP- Composition of Fatty Acids- Linoleic Acid |
<= 3.0% |
| EP- Identification A |
Passes Test |
| EP- Identification D |
Passes Test |
| EP/BP- Hydroxyl Value |
96 - 108 |
| EP- Peroxide Value |
<= 10.0 |
| EP- Saponification Value |
40 - 50 |
| EP- Water (H2O) |
<= 3.0% |
| EP- Ethylene Oxide |
<= 1 ppm |
| EP- Dioxan |
<= 10 ppm |
| Water (H2O) |
<= 0.2% |
| Appearance |
Passes Test |
| pH of 5% Solution at 25°C |
5.0 - 7.0 |
| Arsenic (As) |
<= 1.000 ppm |
| Peroxide Value, meqO2/kg |
<= 2.0 |
| 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 |
| JPE- Identification 1 |
Passes Test |
| JPE- Identification 2 |
Passes Test |
| JPE- Identification 3 |
Passes Test |
| JPE- Moisture Content |
<= 3.0% |
| JPE- Acid Value |
<= 4.0 |
| JPE- Saponification Value (mg KOH/g) |
43 - 55 |
| JPE- pH |
4.0 - 7.0 |
| JPE- Residue on Ignition |
<= 0.25% |
| JPE- Specific Gravity at 20°C |
1.090 - 1.130 |
| JPE- Viscosity (mm²/S) |
350 - 550 |
| JPE- Heavy Metals (as Pb) |
<= 20 ppm |
| JPE- Arsenic (As) |
<= 2 ppm |
| Vegetable Based- this product utilizes ingredients of non-animal origin and non-peanut origin. |
| |
| 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%. |
| |
| Suitable for use in injectable dosage forms. |
| 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. |