EUROPEAN PHARMACOPOEIA 8.

Place 2.0 mL of each solution in a separate 25 mL volumetric

ask. Heat on a water-bath to eliminate acetone. Cool to room
temperature and add 5.0 mL of 2,7-dihydroxynaphthalene
solution R to each ask. Shake and add 15.0 mL of
2,7-dihydroxynaphthalene solution R. Close the asks with
aluminium foil and heat on a water-bath for 20 min. Cool
under running water and dilute to 25.0 mL with sulfuric
acid R. Within 10 min, transfer 10.0 mL of each solution to a
at-bottomed tube. Examine the solutions viewing vertically.
The test solution is not more intensely coloured than the
reference solution (0.4 per cent).
Chlorides (2.4.4). Dilute 2 mL of solution S to 15 mL with
water R. The solution complies with the limit test for chlorides
(0.25 per cent).
Heavy metals (2.4.8). To the residue obtained in the
determination of the sulfated ash, add 1 mL of hydrochloric
acid R and evaporate on a water-bath. Take up the residue in
20 mL of water R. 12 mL of the solution complies with test A
for heavy metals (20 ppm). Prepare the reference solution
using lead standard solution (1 ppm Pb) R.
Loss on drying (2.2.32). Not more than 10.0 per cent,
determined on 1.000 g by drying in an oven at 105 C.
Sulfated ash (2.4.14) : 20.0 per cent to 33.3 per cent,
determined on 1.0 g using a mixture of equal volumes of
sulfuric acid R and water R and calculated with reference to
the dried substance. These limits correspond to a content of
6.5 per cent to 10.8 per cent of sodium (Na).

Castor oil, rened

C. Composition of fatty acids (see Tests).

TESTS
Appearance. The substance to be examined is clear (2.2.1)
and not more intensely coloured (2.2.2, Method II) than 20 mL
of a mixture of 0.25 mL of blue primary solution, 0.25 mL
of red primary solution, 0.8 mL of yellow primary solution,
and 18.7 mL of a solution prepared by diluting 4.0 mL of
hydrochloric acid R1 to 100.0 mL with water R.
Optical rotation (2.2.7) : + 3.5 to + 6.0.
Specic absorbance (2.2.25) : greater than 0.7 and maximum
1.5, determined at the absorption maximum at 270 nm.
To 1.00 g add ethanol (96 per cent) R and dilute to 100.0 mL
with the same solvent.
Acid value (2.5.1) : maximum 0.8.
Dissolve 5.00 g in 25 mL of the prescribed mixture of solvents.
Hydroxyl value (2.5.3, Method A) : minimum 160.
Peroxide value (2.5.5, Method A) : maximum 5.0.
Unsaponiable matter (2.5.7) : maximum 0.8 per cent,
determined on 5.0 g.
Oil obtained by extraction and adulteration. In a
ground-glass-stoppered tube about 125 mm long and 18 mm
in internal diameter, thoroughly mix 3 mL of the substance to
be examined with 3 mL of carbon disulfide R. Shake for 3 min
with 1 mL of sulfuric acid R. The mixture is less intensely
coloured than a freshly prepared mixture of 3.2 mL of ferric
LABELLING
chloride solution R1, 2.3 mL of water R and 0.5 mL of dilute
The label states the apparent viscosity in millipascal seconds
ammonia R1.
for a 20 g/L solution ; for a product of low viscosity, the label
Composition of fatty acids. Gas chromatography (2.4.22)
states the concentration of the solution to be used and the
with the following modications.
apparent viscosity in millipascal seconds.
Use the mixture of calibrating substances in Table 2.4.22.-3.
Test solution. Introduce 75 mg of the substance to be examined
into a 10 mL centrifuge tube with a screw cap. Dissolve in
01/2015:2367 2 mL of 1,1-dimethylethyl methyl ether R1 with shaking and
heat gently (50-60 C). To the still-warm solution, add 1 mL
of a 12 g/L solution of sodium R in anhydrous methanol R,
CASTOR OIL, REFINED
prepared with the necessary precautions, and shake vigorously
for at least 5 min. Add 5 mL of distilled water R and shake
vigorously for about 30 s. Centrifuge for 15 min at 1500 g.
Ricini oleum rafnatum
Use the upper layer.
DEFINITION
Reference solution. Dissolve 50 mg of methyl ricinoleate CRS
and 50 mg of methyl stearate CRS in 10.0 mL of
Fatty oil obtained from the seeds of Ricinus communis L. by
cold expression. It is then rened. A suitable antioxidant may 1,1-dimethylethyl methyl ether R1.
be added.
Column :
material : fused silica ;
PRODUCTION
size : l = 30 m, = 0.25 mm ;
During the expression step, the temperature of the oil must
not exceed 50 C.
stationary phase : macrogol 20 000 R (lm thickness
0.25 m).
CHARACTERS
Carrier gas : helium for chromatography R.
Appearance : clear, almost colourless or slightly yellow, viscous,
Flow rate : 0.9 mL/min.
hygroscopic liquid.
Split ratio : 1:100.
Solubility : slightly soluble in light petroleum, miscible with
Temperature :
ethanol (96 per cent) and with glacial acetic acid.
Relative density : about 0.958.
Time
Temperature
(min)
(C)
Refractive index : about 1.479.
0 - 55
215
Column
Viscosity : about 1000 mPas.
IDENTIFICATION
First identification : B, C.
Second identification : A, B.
A. A mixture of 2 mL of the substance to be examined and
8 mL of ethanol (96 per cent) R is clear (2.2.1).
B. Specic absorbance (see Tests).
General Notices (1) apply to all monographs and other texts

Injection port

250

Detector

250

Detection : ame ionisation.

Injection : 1 L.
Calculate the percentage content of each fatty acid by the
normalisation procedure.

4281

EUROPEAN PHARMACOPOEIA 8.3

Castor oil, virgin

Correct the area of the peak due to methyl ricinoleate, by

multiplying by a factor R calculated using the following
expression :

Specic absorbance (2.2.25) : maximum 0.7, determined at

the absorption maximum at 270 nm.
To 1.00 g add ethanol (96 per cent) R and dilute to 100.0 mL
with the same solvent.
Acid value (2.5.1) : maximum 1.5.
Dissolve 5.00 g in 25 mL of the prescribed mixture of solvents.
m1 = mass of methyl ricinoleate in the reference solution ;
Hydroxyl value (2.5.3, Method A) : minimum 160.
m2 = mass of methyl stearate in the reference solution ;
Peroxide value (2.5.5, Method A) : maximum 10.0.
A1
= area of the peak due to methyl ricinoleate in
Unsaponiable matter (2.5.7) : maximum 0.8 per cent,
the chromatogram obtained with the reference
determined on 5.0 g.
solution ;
Composition of fatty acids. Gas chromatography (2.4.22)
A2
= area of the peak due to methyl stearate in the
with the following modications.
chromatogram obtained with the reference
Use the mixture of calibrating substances in Table 2.4.22.-3.
solution.
Test solution. Introduce 75 mg of the substance to be examined
Composition of the fatty-acid fraction of the oil :
into a 10 mL centrifuge tube with a screw cap. Dissolve in
palmitic acid : maximum 2.0 per cent ;
2 mL of 1,1-dimethylethyl methyl ether R1 with shaking and
heat gently (50-60 C). Add, while still warm, 1 mL of a 12 g/L
stearic acid : maximum 2.5 per cent ;
solution of sodium R in anhydrous methanol R, prepared with
oleic acid : 2.5 per cent to 6.0 per cent ;
the necessary precautions, and mix vigorously for at least
linoleic acid : 2.5 per cent to 7.0 per cent ;
5 min. Add 5 mL of distilled water R and mix vigorously for
linolenic acid : maximum 1.0 per cent ;
about 30 s. Centrifuge for 15 min at 1500 g. Use the upper
eicosenoic acid : maximum 1.0 per cent ;
layer.
ricinoleic acid : 85.0 per cent to 92.0 per cent ;
Reference solution. Dissolve 50 mg of methyl ricinoleate CRS
and 50 mg of methyl stearate CRS in 10.0 mL of
any other fatty acid : maximum 1.0 per cent.
1,1-dimethylethyl methyl ether R1.
Water (2.5.32) : maximum 0.3 per cent, or maximum 0.2 per
Column :
cent if intended for use in the manufacture of parenteral
material : fused silica ;
preparations, determined on 1.00 g.
size : l = 30 m, = 0.25 mm ;
STORAGE
stationary phase : macrogol 20 000 R (lm thickness
In an airtight, well-lled container, protected from light.
0.25 m).
Carrier gas : helium for chromatography R.
LABELLING
The label states, where applicable, that the substance is suitable Flow rate : 0.9 mL/min.
for use in the manufacture of parenteral preparations.
Split ratio : 1:100.
Temperature :
01/2015:0051
Time
Temperature

CASTOR OIL, VIRGIN

Ricini oleum virginale

Column

(min)
0 - 55

(C)
215

Injection port

250

Detector

250

DEFINITION
Fatty oil obtained by cold expression from the seeds of Ricinus Detection : ame ionisation.
Injection : 1 L.
communis L. A suitable antioxidant may be added.
Calculate the percentage content of each fatty acid by the
PRODUCTION
normalisation procedure.
During the expression step, the temperature of the oil must
Correct the area of the peak due to methyl ricinoleate, by
not exceed 50 C.
multiplying by a factor R calculated using the following
expression :
CHARACTERS
Appearance : clear at 40 C, slightly yellow, viscous, hygroscopic
liquid.
Solubility : slightly soluble in light petroleum, miscible with
m1
ethanol (96 per cent) and with glacial acetic acid.
Relative density : about 0.958.
m2
Refractive index : about 1.479.
IDENTIFICATION
First identification : B, C.
Second identification : A, B.
A. A mixture of 2 mL of the substance to be examined and
8 mL of ethanol (96 per cent) R is clear (2.2.1).
B. Specic absorbance (see Tests).
C. Composition of fatty acids (see Tests).
TESTS
Optical rotation (2.2.7) : + 3.5 to + 6.0.

4282

= mass of methyl ricinoleate in the reference solution ;

= mass of methyl stearate in the reference solution ;

A1

= area of the peak due to methyl ricinoleate in

the chromatogram obtained with the reference
solution ;

A2

= area of the peak due to methyl stearate in the

chromatogram obtained with the reference
solution.

Composition of the fatty-acid fraction of the oil :

palmitic acid : maximum 2.0 per cent ;
stearic acid : maximum 2.5 per cent ;
See the information section on general monographs (cover pages)