Cotton, absorbent EUROPEAN PHARMACOPOEIA 11.

IMPURITIES Neps. Spread about 1 g evenly between 2 colourless

Specified impurities : A. transparent plates each 10 cm square. Examine for neps by
transmitted light and compare with Cotton wool standard for
neps CRS. The product to be examined is not more neppy
than the standard.
Absorbency
Apparatus. A dry cylindrical copper wire basket 8.0 cm high
and 5.0 cm in diameter. The wire of which the basket is
constructed is about 0.4 mm in diameter, the mesh is 1.5 cm
to 2.0 cm wide and the mass of the basket is 2.7 ± 0.3 g.
A. 11β,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate
(hydrocortisone acetate). Sinking time. Not more than 10 s. Weigh the basket to the
nearest centigram (m1). Take a total of 5.00 g in approximately
equal quantities from 5 different places in the product to be
examined, place loosely in the basket and weigh the filled
01/2008:0036 basket to the nearest centigram (m2). Fill a beaker 11 cm to
corrected 7.0 12 cm in diameter to a depth of 10 cm with water at about
20 °C. Hold the basket horizontally 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 the average of 3 tests.
Water-holding capacity. Not less than 23.0 g of water per
COTTON, ABSORBENT gram. After the sinking time has been measured, remove
the basket from the water, allow it to drain for exactly 30 s
Lanugo gossypii absorbens suspended in a horizontal position over the beaker, transfer it
to a tared beaker (m3) and weigh to the nearest centigram (m4).
DEFINITION Calculate the water-holding capacity per gram of absorbent
Absorbent cotton consists of new fibres or good quality cotton using the following expression :
combers obtained from the seed-coat of various species of the
genus Gossypium L., cleaned, purified, bleached and carefully m4 - ( m 2 + m3)
carded. It may not contain any compensatory colouring m 2 - m1
matter.
Calculate the result as the average of 3 tests.
CHARACTERS Ether-soluble substances. Not more than 0.50 per cent. In
It is white or almost white and is composed of fibres of average an extraction apparatus, extract 5.00 g with ether R for 4 h at
length not less than 10 mm, determined by a suitable method, a rate of at least 4 extractions per hour. Evaporate the ether
and contains not more than traces of leaf residue, pericarp, extract and dry the residue to constant mass at 100 °C to
seed-coat or other impurities. It offers appreciable resistance 105 °C.
when pulled. It does not shed any appreciable quantity of dust Extractable colouring matter. In a narrow percolator, slowly
when gently shaken. extract 10.0 g with alcohol R until 50 mL of extract is obtained.
IDENTIFICATION The liquid obtained is not more intensely coloured (2.2.2,
Method II) than reference solution Y5, GY6 or a reference
A. Examined under a microscope, each fibre is seen to consist solution prepared as follows : to 3.0 mL of blue primary
of a single cell, up to about 4 cm long and up to 40 μm wide, solution add 7.0 mL of hydrochloric acid (10 g/L HCl). Dilute
in the form of a flattened tube with thick and rounded walls 0.5 mL of this solution to 10.0 mL with hydrochloric acid
and often twisted. (10 g/L HCl).
B. When treated with iodinated zinc chloride solution R, the Surface-active substances. Introduce the 10 mL portion of
fibres become violet. solution S reserved before filtration into a 25 mL graduated
C. To 0.1 g add 10 mL of zinc chloride-formic acid solution R. ground-glass-stoppered cylinder with an external diameter
Heat to 40 °C and allow to stand for 2 h 30 min, shaking of 20 mm and a wall thickness of not greater than 1.5 mm,
occasionally. It does not dissolve. previously rinsed 3 times with sulfuric acid R and then with
water R. Shake vigorously 30 times in 10 s, allow to stand for
TESTS 1 min and repeat the shaking. After 5 min, any foam present
Solution S. Place 15.0 g in a suitable vessel, add 150 mL must not cover the entire surface of the liquid.
of water R, close the vessel and allow to macerate for 2 h. Water-soluble substances. Not more than 0.50 per cent. Boil
Decant the solution, squeeze the residual liquid carefully from 5.000 g in 500 mL of water R for 30 min, stirring frequently.
the sample with a glass rod and mix. Reserve 10 mL of the Replace the water lost by evaporation. Decant the liquid,
solution for the test for surface-active substances and filter squeeze the residual liquid carefully from the sample with
the remainder. a glass rod and mix. Filter the liquid whilst hot. Evaporate
Acidity or alkalinity. To 25 mL of solution S add 0.1 mL of 400 mL of the filtrate (corresponding to 4/5 of the mass of the
phenolphthalein solution R and to another 25 mL add 0.05 mL sample taken) and dry the residue to constant mass at 100 °C
of methyl orange solution R. Neither solution is pink. to 105 °C.
Foreign fibres. Examined under a microscope, it is seen Loss on drying (2.2.32). Not more than 8.0 per cent,
to consist exclusively of typical cotton fibres, except that determined on 5.000 g by drying in an oven at 105 °C.
occasionally a few isolated foreign fibres may be present. Sulfated ash (2.4.14). Not more than 0.40 per cent. Introduce
Fluorescence. Examine a layer about 5 mm in thickness 5.00 g into a previously heated and cooled, tared crucible.
under ultraviolet light at 365 nm. It displays only a slight Heat cautiously over a naked flame and then carefully to
brownish-violet fluorescence and a few yellow particles. It dull redness at 600 °C. Allow to cool, add a few drops of
shows no intense blue fluorescence, apart from that which dilute sulfuric acid R, then heat and incinerate until all the
may be shown by a few isolated fibres. black particles have disappeared. Allow to cool. Add a few

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EUROPEAN PHARMACOPOEIA 11.0 Cresol, crude

drops of ammonium carbonate solution R. Evaporate and Composition of the fatty-acid fraction of the substance :
incinerate carefully, allow to cool and weigh again. Repeat the – saturated fatty acids of chain length less than C14 : maximum
incineration for periods of 5 min to constant mass. 0.2 per cent ;
STORAGE – myristic acid : maximum 1.0 per cent ;
Store in a dust-proof package in a dry place. – 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: maximum 4.0 per cent ;
01/2020:1305
– linoleic acid and isomers : maximum 1.0 per cent ;
– arachidic acid : maximum 1.0 per cent ;
– behenic acid : maximum 1.0 per cent ;
– lignoceric acid : maximum 0.5 per cent.
COTTONSEED OIL, HYDROGENATED STORAGE
Protected from light.
Gossypii oleum hydrogenatum
DEFINITION 01/2008:1628
Product obtained by refining and hydrogenation of oil corrected 11.0
obtained from seeds of cultivated plants of various varieties
of Gossypium hirsutum L. or of other species of Gossypium.
The product consists mainly of triglycerides of palmitic and
stearic acids.
CHARACTERS CRESOL, CRUDE
Appearance : white or almost white mass or powder which
melts to a clear, pale yellow liquid when heated. Cresolum crudum
Solubility : practically insoluble in water, freely soluble in
methylene chloride and in toluene, very slightly soluble in
ethanol (96 per cent).
IDENTIFICATION C 7H 8O Mr 108.1
A. Melting point (see Tests).
B. Composition of fatty acids (see Tests). DEFINITION
Mixture of 2-, 3- and 4-methylphenol.
TESTS
Melting point (2.2.14) : 57 °C to 70 °C. CHARACTERS
Acid value (2.5.1) : maximum 0.5. Appearance : colourless or pale brown liquid.
Dissolve 10.0 g in 50 mL of a hot mixture of equal volumes Solubility : sparingly soluble in water, miscible with ethanol
of ethanol (96 per cent) R and toluene R, previously (96 per cent) and with methylene chloride.
neutralised with 0.1 M potassium hydroxide using 0.5 mL of IDENTIFICATION
phenolphthalein solution R1 as indicator. Titrate the solution
A. To 0.5 mL add 300 mL of water R, mix and filter. To 10 mL
immediately while still hot.
of the filtrate add 1 mL of ferric chloride solution R1. A
Peroxide value (2.5.5, Method A) : maximum 5.0. blue colour is produced.
Unsaponifiable matter (2.5.7): maximum 1.0 per cent, B. To 10 mL of the filtrate obtained in identification test A,
determined on 5.0 g. add 1 mL of bromine water R. A pale yellow flocculent
Alkaline impurities. Dissolve with gentle heating 2.0 g in precipitate is produced.
a mixture of 1.5 mL of ethanol (96 per cent) R and 3 mL of C. Relative density (see Tests).
toluene R. Add 0.05 mL of a 0.4 g/L solution of bromophenol
blue R in ethanol (96 per cent) R. Not more than 0.4 mL of TESTS
0.01 M hydrochloric acid is required to change the colour to Solution S. To 2.5 g of the substance to be examined add
yellow. 50 mL of water R, shake for 1 min and filter through a
Composition of fatty acids. Gas chromatography moistened filter.
(2.4.22, Method A) with the following modifications. Use the Acidity or alkalinity. To 10 mL of solution S add 0.1 mL of
mixture of calibrating substances in Table 2.4.22.-3. methyl red solution R and 0.2 mL of 0.01 M sodium hydroxide.
Column : The solution is yellow. Add 0.3 mL of 0.01 M hydrochloric
acid. The solution is red.
– material : fused silica ;
– size : l = 25 m, Ø = 0.25 mm ; Relative density (2.2.5): 1.029 to 1.044.
– stationary phase : cyanopropylpolysiloxane R (film thickness Distillation range (2.2.11) : a maximum of 2.0 per cent V/V
0.2 μm). distils below 188 °C and a minimum of 80 per cent V/V distils
between 195 °C and 205 °C.
Carrier gas : helium for chromatography R.
Flow rate : 0.65 mL/min. Sulfur compounds. Place 20 mL in a small conical flask. Over
the mouth of the flask fix a piece of filter paper moistened with
Split ratio : 1:100. lead acetate solution R. Heat on a water-bath for 5 min. Not
Temperature : more than a light yellow colour is produced on the filter paper.
– column : 180 °C for 35 min ; Residue on evaporation : maximum 0.1 per cent.
– injection port and detector : 250 °C. Evaporate 2.0 g to dryness on a water-bath and dry at
Detection : flame ionisation. 100-105 °C for 1 h. The residue weighs not more than 2 mg.

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