EUROPEAN PHARMACOPOEIA 5.

0 Cotton, absorbent

10 min and cortisone acetate about 12 min. The test is TESTS

not valid unless the resolution between the peaks due to Solution S. Place 15.0 g in a suitable vessel, add 150 ml
hydrocortisone acetate and cortisone acetate is at least 4.2 ;of water R, close the vessel and allow to macerate for 2 h.
if necessary, adjust the concentration of acetonitrile in the Decant the solution, squeeze the residual liquid carefully
mobile phase. from the sample with a glass rod and mix. Reserve 10 ml of
Inject 20 µl of the test solution, 20 µl of reference the solution for the test for surface-active substances and
solution (b) and 20 µl of acetonitrile as a blank. Continue filter the remainder.
the chromatography for twice the retention time of the
principal peak. In the chromatogram obtained with the test Acidity or alkalinity. To 25 ml of solution S add 0.1 ml
solution : the area of any peak apart from the principal peak,of phenolphthalein solution R and to another 25 ml add
is not greater than half the area of the principal peak in the0.05 ml of methyl orange solution R. Neither solution is
chromatogram obtained with reference solution (b) (0.5 per pink.
cent) ; the sum of the areas of all the peaks apart from the Foreign fibres. Examined under a microscope, it is seen
principal peak, is not greater than 1.5 times the area of the to consist exclusively of typical cotton fibres, except that
principal peak in the chromatogram obtained with reference occasionally a few isolated foreign fibres may be present.
solution (b) (1.5 per cent). Disregard any peak with an area Fluorescence. Examine a layer about 5 mm in thickness
less than 0.05 times the area of the principal peak in the under ultraviolet light at 365 nm. It displays only a slight
chromatogram obtained with reference solution (b). brownish-violet fluorescence and a few yellow particles. It
Loss on drying (2.2.32). Not more than 0.5 per cent, shows no intense blue fluorescence, apart from that which
determined on 0.500 g by drying in an oven at 100-105 °C. may be shown by a few isolated fibres.
ASSAY Neps. Spread about 1 g evenly between 2 colourless
transparent plates each 10 cm square. Examine for neps by
Dissolve 0.100 g in alcohol R and dilute to 100.0 ml with the transmitted light and compare with Absorbent cotton RM.
same solvent. Dilute 2.0 ml of the solution to 100.0 ml with The product to be examined is not more neppy than the
alcohol R. Measure the absorbance (2.2.25) at the maximum standard.
of 237 nm.
Absorbency
Calculate the content of C23H30O6 taking the specific
absorbance to be 395. Apparatus. A dry cylindrical copper wire basket 8.0 cm high
and 5.0 cm in diameter. The wire of which the basket is
STORAGE constructed is about 0.4 mm in diameter, the mesh is 1.5 cm
Store protected from light. to 2.0 cm wide and the mass of the basket is 2.7 ± 0.3 g.
IMPURITIES Sinking time. Not more than 10 s. Weigh the basket
to the nearest centigram (m1). Take a total of 5.00 g in
A. hydrocortisone acetate. approximately equal quantities from 5 different places in
the product to be examined, place loosely in the basket and
weigh the filled basket to the nearest centigram (m2). Fill
01/2005:0036 a beaker 11 cm to 12 cm in diameter to a depth of 10 cm
with water at about 20 °C. Hold the basket horizontally
COTTON, ABSORBENT and drop it from a height of about 10 mm into the water.
Measure with a stopwatch the time taken for the basket to
sink below the surface of the water. Calculate the result as
Lanugo gossypii absorbens the average of 3 tests.
DEFINITION Water-holding capacity. Not less than 23.0 g of water per
Absorbent cotton consists of new fibres or good quality gram. After the sinking time has been measured, remove
combers obtained from the seed-coat of various species of the basket from the water, allow it to drain for exactly 30 s
the genus Gossypium L., cleaned, purified, bleached and suspended in a horizontal position over the beaker, transfer
carefully carded. It may not contain any compensatory it to a tared beaker (m3) and weigh to the nearest centigram
colouring matter. (m4). Calculate the water-holding capacity per gram of
absorbent cotton using the following expression :
CHARACTERS
It is white and is composed of fibres of average length not
less than 10 mm, determined by a suitable method, and
contains not more than traces of leaf residue, pericarp,
seed-coat or other impurities. It offers appreciable resistance Calculate the result as the average of 3 tests.
when pulled. It does not shed any appreciable quantity of Ether-soluble substances. Not more than 0.50 per cent. In
dust when gently shaken. an extraction apparatus, extract 5.00 g with ether R for 4 h
at a rate of at least 4 extractions per hour. Evaporate the
IDENTIFICATION ether extract and dry the residue to constant mass at 100 °C
A. Examined under a microscope, each fibre is seen to to 105 °C.
consist of a single cell, up to about 4 cm long and up to
Extractable colouring matter. In a narrow percolator,
40 µm wide, in the form of a flattened tube with thick and
slowly extract 10.0 g with alcohol R until 50 ml of extract is
rounded walls and often twisted.
obtained. The liquid obtained is not more intensely coloured
B. When treated with iodinated zinc chloride solution R, (2.2.2, Method II) than reference solution Y5, GY6 or a
the fibres become violet. reference solution prepared as follows : to 3.0 ml of blue
C. To 0.1 g add 10 ml of zinc chloride-formic acid solution R. primary solution add 7.0 ml of hydrochloric acid (10 g/l HCl).
Heat to 40 °C and allow to stand for 2 h 30 min, shaking Dilute 0.5 ml of this solution to 10.0 ml with hydrochloric
occasionally. It does not dissolve. acid (10 g/l HCl).

General Notices (1) apply to all monographs and other texts 1369
Cottonseed oil, hydrogenated
Surface-active substances. Introduce the 10 ml portion of
solution S reserved before filtration into a 25 ml graduated
ground-glass-stoppered cylinder with an external diameter
of 20 mm and a wall thickness of not greater than 1.5 mm,
previously rinsed 3 times with sulphuric acid R and then
with water R. Shake vigorously 30 times in 10 s, allow to
stand for 1 min and repeat the shaking. After 5 min, any
foam present must not cover the entire surface of the liquid.
Water-soluble substances. Not more than 0.50 per cent. Boil
5.000 g in 500 ml of water R for 30 min, stirring frequently.
Replace the water lost by evaporation. Decant the liquid,
squeeze the residual liquid carefully from the sample with
a glass rod and mix. Filter the liquid whilst hot. Evaporate
400 ml of the filtrate (corresponding to 4/5 of the mass of
the sample taken) and dry the residue to constant mass at
100 °C to 105 °C.
Loss on drying (2.2.32). Not more than 8.0 per cent,
determined on 5.000 g by drying in an oven at 100 °C to
105 °C.
Sulphated ash (2.4.14). Not more than 0.40 per cent.
Introduce 5.00 g into a previously heated and cooled, tared
crucible. Heat cautiously over a naked flame and then
carefully to dull redness at 600 °C. Allow to cool, add a few
drops of dilute sulphuric acid R, then heat and incinerate
until all the black particles have disappeared. Allow to
cool. Add a few drops of ammonium carbonate solution R.
Evaporate and incinerate carefully, allow to cool and weigh
again. Repeat the incineration for periods of 5 min to
constant mass.
STORAGE
Store in a dust-proof package in a dry place.
01/2005:1305 — linoleic acid and isomers (C equivalent chain length
COTTONSEED OIL, HYDROGENATED
Gossypii oleum hydrogenatum
DEFINITION
Hydrogenated cottonseed oil is the product obtained by
refining and hydrogenation of oil obtained from seeds
of cultivated plants of various varieties of Gossypium
hirsutum L. or of other species of Gossypium. The product examined into a platinum or silica crucible tared after
consists mainly of triglycerides of palmitic and stearic acids. ignition. Cautiously heat and introduce into the substance
CHARACTERS
A white mass or powder which melts to a clear, pale yellow
liquid when heated, practically insoluble in water, freely
soluble in methylene chloride and in toluene, very slightly
soluble in alcohol.
IDENTIFICATION
A. It complies with the test for melting point (see Tests).
B. It complies with the test for foreign fatty oils (see Tests). adding 1.0 ml, 2.0 ml and 4.0 ml of nickel standard solution
TESTS
Melting point (2.2.14) : 57 °C to 70 °C.
Acid value (2.5.1). Not more than 0.5, determined on 10.0 g. hollow-cathode lamp as a source of radiation, a graphite
Dissolve the substance to be examined in 50 ml of a hot
mixture of equal volumes of alcohol R and toluene R,
previously neutralised with 0.1 M potassium hydroxide
using 0.5 ml of phenolphthalein solution R1 as indicator.
Titrate the solution immediately while still hot.
1370 See the information section on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 5.0
Peroxide value (2.5.5). Not more than 5.0.
Unsaponifiable matter (2.5.7). Not more than 1.0 per cent,
determined on 5.0 g.
Alkaline impurities. Dissolve by gentle heating 2.0 g of the
substance to be examined in a mixture of 1.5 ml of alcohol R
and 3 ml of toluene R. Add 0.05 ml of a 0.4 g/l solution of
bromophenol blue R in alcohol R. Not more than 0.4 ml of
0.01 M hydrochloric acid is required to change the colour
to yellow.
Composition of fatty acids (2.4.22, Method A).
The chromatographic procedure may be carried out using :
— a fused-silica capillary column 25 m long and 0.25 mm
in internal diameter coated on the inner wall with
poly(cyanopropyl)siloxane R (film thickness 0.2 µm),
— helium for chromatography R as the carrier gas at a flow
rate of 0.65 ml/min,
— a flame-ionisation detector,
— a split injector (1:100),
maintaining the temperature of the column at 180 °C for
35 min and that of the injection port and the detector at
250 °C.
The fatty acid fraction of the oil has the following
composition :
— saturated fatty acids of chain length less than C14 : not
more than 0.2 per cent,
— myristic acid : not more than 1.0 per cent,
— palmitic acid : 19.0 per cent to 26.0 per cent,
— stearic acid : 68.0 per cent to 80.0 per cent,
— oleic acid and isomers (C18:1 equivalent chain length on
poly(cyanopropyl)siloxane 18.5 to 18.8): not more than
4.0 per cent,
18:2
on poly(cyanopropyl)siloxane 19.4 to 19.8) : not more
than 1.0 per cent,
— arachidic acid : not more than 1.0 per cent,
— behenic acid : not more than 1.0 per cent,
— lignoceric acid : not more than 0.5 per cent.
Nickel. Not more than 1 ppm of Ni, determined by atomic
absorption spectrometry (2.2.23, Method II).
Test solution. Introduce 5.0 g of the substance to be
a wick formed from twisted ashless filter paper. Ignite the
wick. When the substance ignites, stop heating. After
combustion, ignite in a muffle furnace at about 600 °C.
Continue the incineration until white ash is obtained. After
cooling, take up the residue with two quantities, each of
2 ml, of dilute hydrochloric acid R and transfer into a 25 ml
graduated flask. Add 0.3 ml of nitric acid R and dilute to
25.0 ml with distilled water R.
Reference solutions. Prepare three reference solutions by
(0.2 ppm Ni) R to 2.0 ml portions of the test solution,
diluting to 10.0 ml with distilled water R.
Measure the absorbance at 232 nm using a nickel
furnace as an atomic generator and argon R as the carrier
gas.
STORAGE
Store protected from light.