Résultats des tests de spécification
GMP Manufactured Product |
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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 JPE Specifications |
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Meets N.F. Requirements |
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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 - 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 % |
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 |
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 |
ChP - Relative Density @ 20 C |
1.09 - 1.12 |
ChP - Viscosity, mm2/s @ 25 C |
250 - 400 |
ChP - Acid Value,meq/g |
≤ 2.0 |
ChP - Saponification Value |
40 - 50 |
ChP - Hydroxyl Value |
96 - 108 |
ChP - Peroxide Value |
≤ 10 |
ChP - Identification 1 |
Passes Test |
ChP - Identification 2 |
Passes Test |
ChP - Identification 3 |
Passes Test |
ChP - Acidity or Alkalinity (pH) |
4.0 - 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 - Water |
≤ 3.0 % |
ChP - Heavy Metals |
≤ 10 ppm |
ChP - Arsenic |
≤ 0.0002 % |
ChP - Fatty Acid Composition: Lauric acid |
40.0 - 60.0 % |
ChP - Fatty Acid Composition: Myristic acid |
14.0 - 25.0 % |
ChP - Fatty Acid Composition: Palmitic acid |
7.0 - 15.0 % |
ChP - Fatty Acid Composition: Caproic acid |
≤ 1.0 % |
ChP - Fatty Acid Composition: Caprylic acid |
≤ 10.0 % |
ChP - Fatty Acid Composition: Capric acid |
≤ 10.0 % |
ChP - Fatty Acid Composition: Stearic acid |
≤ 7.0 % |
ChP - Fatty Acid Composition: Oleic acid |
≤ 11.0 % |
ChP - Fatty Acid Composition: Linoleic acid |
≤ 3.0 % |
Endotoxin Concentration (EU/mL) |
≤ 10 |
Peroxide Value, meqO2/kg |
≤ 2.0 |
Appearance |
Passes Test |
pH of 5% solution at 25°C |
5.0 - 7.0 |
Arsenic |
≤ 1 ppm |
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. |
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Only Class 2 (1,4 Dioxane, Ethylene Glycol) and Class 3 (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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Suitable for use in injectable 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 Regulatory Data Sheet and elemental impurity profile report. |
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