Specification Test Results
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Meets B.P. Chemical Specifications |
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Meets N.F. Requirements |
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Meets E.P. Chemical Specifications |
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Meets J.P. Chemical Specifications |
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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 |
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NF - Hydroxyl Value |
65 - 80 |
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NF - Identification A |
Passes Test |
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NF - Identification B |
Passes Test |
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NF - Residue on Ignition |
≤ 0.25 % |
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NF - Saponification Value |
45 - 55 |
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NF - Specific Gravity at 25°C |
1.06 - 1.09 |
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NF - Viscosity at 25°C, cSt |
300 - 500 |
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NF - Water (H₂O) |
≤ 3.0 % |
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NF - Peroxide value, meq/kg |
≤ 10 |
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NF - Ethylene Oxide |
≤ 1 ppm |
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NF - Dioxane |
≤ 10 ppm |
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NF - Composition of Fatty Acids - Myristic Acid |
≤ 5.0 % |
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NF - Composition of Fatty Acids - Palmitic Acid |
≤ 16.0 % |
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NF - Composition of Fatty Acids - Palmitoleic Acid |
≤ 8.0 % |
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NF - Composition of Fatty Acids - Stearic Acid |
≤ 6.0 % |
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NF - Composition of Fatty Acids - Oleic Acid |
≥ 58.0 % |
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NF - Composition of Fatty Acids - Linoleic Acid |
≤ 18.0 % |
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NF - Composition of Fatty Acids - Linolenic Acid |
≤ 4.0 % |
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EP - Acid Value |
≤ 2.0 |
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EP - Total Ash |
≤ 0.25 % |
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EP - Hydroxyl Value |
65 - 80 |
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EP - Identification A |
Passes Test |
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EP - Identification D |
Passes Test |
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EP - Peroxide Value |
≤ 10.0 |
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EP - Ethylene Oxide |
≤ 1 ppm |
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EP - Dioxan |
≤ 10 ppm |
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EP - Saponification Value |
45 - 55 |
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EP - Water (H₂O) |
≤ 3.0 % |
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EP/BP - Composition of Fatty Acids - Myristic Acid |
≤ 5.0 % |
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EP/BP - Composition of Fatty Acids - Palmitic Acid |
≤ 16.0 % |
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EP/BP - Composition of Fatty Acids - Palmitoleic Acid |
≤ 8.0 % |
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EP/BP - Composition of Fatty Acids - Stearic Acid |
≤ 6.0 % |
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EP/BP - Composition of Fatty Acids - Oleic Acid |
≥ 58.0 % |
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EP/BP - Composition of Fatty Acids - Linoleic Acid |
≤ 18.0 % |
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EP/BP - Composition of Fatty Acids - Linolenic Acid |
≤ 4.0 % |
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Appearance |
Passes Test |
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JP - Acid Value |
≤ 2.0 |
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JP - Composition of Fatty Acids - Myristic Acid |
≤ 5.0 % |
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JP - Composition of Fatty Acids - Palmitic Acid |
≤ 16.0 % |
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JP - Composition of Fatty Acids - Palmitoleic Acid |
≤ 8.0 % |
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JP - Composition of Fatty Acids - Stearic Acid |
≤ 6.0 % |
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JP - Composition of Fatty Acids - Oleic Acid |
≥ 58.0 % |
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JP - Composition of Fatty Acids - Linoleic Acid |
≤ 18.0 % |
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JP - Composition of Fatty Acids - Linolenic Acid |
≤ 4.0 % |
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JP - Dioxane |
≤ 10 ppm |
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JP - Ethylene Oxide |
≤ 1 ppm |
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JP - Heavy Metals (as Pb) |
≤ 20 ppm |
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JP - Hydroxyl Value, meq KOH/g |
65 - 80 |
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JP - Identification |
Passes Test |
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JP - Peroxide Value |
≤ 10.0 |
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JP - Residue on Ignition |
≤ 0.25 % |
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JP - Water (H₂O) |
≤ 3.0 % |
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JP - Saponification Value |
45 - 55 |
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Microbiological - Total Aerobic Microbial Count (cfu/g) |
≤ 100 |
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Microbiological - Total Yeast and Mold Count (cfu/g) |
≤ 50 |
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Residual Solvents - Ethylene Glycol, For Information Only |
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Residual Solvents - Acetic Acid, For Information Only |
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Residual Solvents - 2-Propanol, For Information Only |
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Bacterial endotoxins, EU/mL |
≤ 50 |
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Ethylene glycol |
≤ 0.10 % |
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Diethylene glycol |
≤ 0.10 % |
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Vegetable Based |
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This product utilizes ingredients of non-animal origin and non-peanut origin. |
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Suitable for use in the manufacture of parenteral dosage forms. |
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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%. |
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Typical Oleic Acid Content, 77% |
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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. |
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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. |
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