The International Pharmacopoeia

Monographs: Pharmaceutical substances: Arachis oil (Oleum arachidis)

Chemical name. Peanut oil; CAS Reg. No. 8002-03-7.

Other name. Peanut oil.

Description. A yellowish, clear, and viscous liquid; odourless, or with a very faint nut-like odour.

Miscibility. Very slightly miscible with ethanol (~750 g/l) TS; miscible with ether R and light petroleum R.

Category. Oleaginous vehicle; solvent.

Storage. Arachis oil should be kept in a well-filled and well-closed container and protected from light.

Additional information. The quality of the material described is not suitable for parenteral
administration.

Requirements

Definition. Arachis oil is the refined fixed oil obtained from the seed kernels of Arachis hypogaea L.

Identity test

To 0.5 mL add 10 mL of potassium hydroxide/ethanol TS1 and, while shaking intermittently, heat in a
water-bath at 80 °C for 15 minutes. Allow to stand for 1 hour; a cloudy, gelatinous mixture is formed
which adheres to the walls of the tube.

Refractive index.   = 1.468 - 1.472

Relative density.   = 0.912 - 0.920.

Acid value. Not more than 0.6.

Saponification value. 185-195.

Iodine value. 83-103.

Unsaponifiable matter. Not more than 15 mg/g.

Peroxide value. Not more than 5.0.

USP
Comparison:

Identification: The identification test for this particular substance in the USP is more extensive
than the one provided for in the IP. Also, more reagents were also used compared to the IP which only
used KOH or ethanol.
 Also, it is only the USP that provides further identification tests of the substance, like
determining the Rancidity or identification of cottonseed oil.

Description: “A yellowish, clear, and viscous liquid; odourless, or with a very faint nut-like
odour.” This description is only present in the IP. No physical description was given for the substance in
the USP.

It can also be said that the IP contains more descriptions of the drug since it also assigns it a
category: “Oleaginous vehicle; solvent.” It is also noted that only the IP counterpart has information
about the miscibility.

Storage: Both of the pharmacopoeias have similar storage indications.

Additional Information: The IP contains additional information, whereas the USP does not. It
states that this substance is not suitable for parenteral use.

Here is a table that presents what information about the substance is present from both
pharmacopoeias:

IP USP
Refractive Index: 1.468-1.472 Refractive Index: 1.462-1.464 at 40 degrees
Relative Density: 0.912-0.920 Specific Gravity: 0.912-0.920
Acid Value: NMT 0.6 Free Fatty Acids: in 10g NMT 2ml of 0.020 N
NaOH
Saponification Value: 185-195 Saponification Value: 185-195
Iodine Value: 83-103 Iodine Value: 84-100
Unsaponifiable Matter: NMT 15mg/g Unsaponifiable Matter: NMT 1.5%
Peroxide Value: NMT 5 Solidification Range of fatty acids: 26-33 degrees
Heavy Metals: 0.001%
Organic Volatile impurities: Meets requirements
Residual solvents: Meets requirements

Of the data, that which is highlighted red is what is unique in each monographs.

Comparing existing similar categories of data, the content is nearly the same, for example: both
dictate that the specific gravity is around 0.912-0.920. The data between the two being exactly the same
is the specific gravity of the substance, saponification value, and unsaponifiable matter.

It can be noted that the USP standards are much more specific like indicating a set temperature
to test for the refractive index and the specific assay formula for the calculation of the acid value.

Overall, it can be said that in terms of information, the IP has more qualitative information
about the substance when compared to the USP, as stated above. However, USP has more quantitative
information to provide about the substance.

Depending on the purpose, one can opt to use one over the other when it comes to research.
 Upon further research, I discovered that there are more than 1 types of peanut oil (ex:
hydrogenated, hardened) with differing chemical structures. If I were to add a section to both
monographs, it would be to provide the different types of peanut oil and its chemical structures. This
would contribute to the monograph since it would give more specificity.

Ex:

Left: Peanut Oil, hydrogenated

Right: Peanut Oil, hardened