Résultats des tests de spécification
GMP Manufactured Product |
≤2.0 |
Meets J.P. Chemical Specifications |
≤10 ppm |
Meets N.F. Requirements |
65 - 80 |
Meets E.P. Chemical Specifications |
Passes test |
CAUTION: For Manufacturing, processing or repackaging |
Passes test |
Bulk Pharmaceutical Chemical |
≤0.25% |
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 - Appearance |
Passes Test |
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 |
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 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 |
1,4-Dioxane |
≤5 ppm |
Ethylene glycol |
≤ 0.10 % |
Diethylene glycol |
≤ 0.10 % |
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% |
|
Metallic Residues: No metal catalysts or metal reagents, as defined by EMA Guideline EMEA/CHMP/SWP/4446/2000 , are used in the production of this material. |
|
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. |
|