Résultats des tests de spécification
GMP Manufactured Product |
≤2.0 |
Meets E.P. Chemical Specifications |
≤0.25% |
Meets B.P. Chemical Specifications |
≤10 ppm |
Meets JPE Specifications |
≤1 ppm |
Meets N.F. Requirements |
≤10 ppm |
CAUTION: For Manufacturing, processing or repackaging |
96 - 108 |
Bulk Pharmaceutical Chemical |
Passes Test |
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 - Hydroxyl Value |
96 - 108 |
EP/BP - Identification A |
Passes Test |
EP/BP - Identification D |
Passes Test |
EP/BP - Saponification Value |
40 - 50 |
EP/BP - Ethylene Oxide |
≤1 ppm |
EP/BP - Dioxan |
≤10 ppm |
EP/BP - Water (H₂O) |
≤3.0 % |
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 - Peroxide Value |
≤10.0 |
JPE - Identification 1 |
Passes Test |
JPE - Identification 2 |
Passes Test |
JPE - Identification 3 |
Passes Test |
JPE - pH at 25°C (5% Aqueous) |
4.0 - 7.0 |
JPE - Water (H₂O) |
≤3.0 % |
JPE - Acid Value |
≤4.0 |
JPE - Saponification Value |
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 |
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 |
Endotoxin Concentration (EU/g) |
≤10 |
Color (APHA) |
≤150 |
Formaldehyde |
≤10 ppm |
Potassium (K) |
≤5 ppm |
Sodium (Na) |
≤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 the Class 2 solvents 1,4-dioxane (<5ppm) and ethylene glycol (<620 ppm) and the Class 3 solvent 2-propanol (<0.1%) are likely to be present. |
|