Résultats des tests de spécification
Meets B.P. Chemical Specifications |
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Meets ChP Chemical Specifications |
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Meets E.P. Chemical Specifications |
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Meets J.P. Chemical Specifications |
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Meets N.F. Requirements |
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GMP Manufactured Product |
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CAUTION: For Manufacturing, processing or repackaging |
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Bulk Pharmaceutical Chemical |
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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 % |
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 |
ChP - Relative Density @ 20 °C |
1.06 - 1.09 |
ChP - Viscosity @ 25 °C |
350 - 550 mm2/s |
ChP - Acid Value |
≤ 2.0 |
ChP - Saponification Value |
45 - 55 |
ChP - Hydroxyl Value |
65 - 80 |
ChP - Iodine Value |
18 - 24 |
ChP - Peroxide Value |
≤ 10 |
ChP - Identification 1 |
Passes Test |
ChP - Identification 2 |
Passes Test |
ChP - Identification 3 |
Passes Test |
ChP - Identification 4 |
Passes Test |
ChP - Acidity or Alkalinity |
5.0 - 7.5 |
ChP - Color |
Passes Test |
ChP - Ethylene glycol |
≤ 0.01 % |
ChP - Diethylene glycol |
≤ 0.01 % |
ChP - Ethylene oxide |
≤ 0.0001 % |
ChP - Dioxane |
≤ 0.001 % |
ChP - Freezing Test |
Passes Test |
ChP - Water |
≤ 3.0 % |
ChP - Residue on ignition |
≤ 0.2 % |
ChP - Heavy Metals |
≤ 0.001 % |
ChP - Arsenic (As) |
≤ 0.0002 % |
ChP - Fatty acid composition: oleic acid |
≥ 58.0 % |
ChP - Fatty Acid Composition: myristic acid |
≤ 5.0 % |
ChP - Fatty Acid Composition: palmitic acid |
≤ 16.0 % |
ChP - Fatty Acid Composition: palmitoleic acid |
≤ 8.0 % |
ChP - Fatty Acid Composition: stearic acid |
≤ 6.0 % |
ChP - Fatty Acid Composition: linoleic acid |
≤ 18.0 % |
ChP - Fatty Acid Composition: linolenic acid |
≤ 4.0 % |
Additional Tests - Endotoxin Concentration (EU/mL) |
≤ 10 |
Microbiological - Total Aerobic Microbial Count (cfu/g) |
≤ 100 |
Microbiological - Escherichia Coli Microbiological - Pseudomonas aeruginosa Microbiological - Salmonella Microbiological - Staphylococcus aureus |
Passes Test |
Microbiological - Total Yeast and Mold Count (cfu/g) |
≤ 50 |
Ethylene glycol |
≤ 0.10 % |
Diethylene glycol |
≤ 0.10 % |
Vegetable Based |
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This product utilizes ingredients of non-animal origin and non-peanut origin. Suitable for use in the manufacture of parenteral dosage forms |
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Elemental Impurities (USP 232, EP 5.20) Information on elemental impurities for this product is available on the associated Product |
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% |