Nomegestrol Acetate

EUROPEAN PHARMACOPOEIA 5.

Nomegestrol acetate

DEFINITION
Nomegestrol acetate contains not less than 97.0 per cent
and not more than the equivalent of 103.0 per cent of
6-methyl-3,20-dioxo-19-norpregna-4,6-dien-17-yl acetate,
calculated with reference to the dried substance.
D. R = S-CH2-CH2-NH2 : 2-[[[2-[(dimethylamino)methyl]thiazol-4-yl]methyl]sulphanyl]ethanamine,
E. R = S-CH2-CH2-NH-CO-CH2-NO2 :N-[2-[[[2-[(dimethylamino)methyl]thiazol-4-yl]methyl]sulphanyl]ethyl]-2-nitroacetamide,
I. R = S-CH2-CH2-NH-CO-NH-CH3 :N-[2-[[[2-[(dimethylamino)methyl]thiazol-4-yl]methyl]sulphanyl]ethyl]-N-methylurea,

CHARACTERS
A white or almost white, crystalline powder, practically
insoluble in water, freely soluble in acetone, soluble in
alcohol.
IDENTIFICATION
Examine by infrared absorption spectrophotometry (2.2.24),
comparing with the spectrum obtained with nomegestrol
acetate CRS.
J. R = OH : [2-[(dimethylamino)methyl]thiazol-4-yl]methanol, TESTS
Appearance of solution. Dissolve 1.0 g in methylene
chloride R and dilute to 10 ml with the same solvent. The
solution is clear (2.2.1) and not more intensely coloured
than reference solution Y5 (2.2.2, Method II).
Specific optical rotation (2.2.7). Dissolve 0.500 g in
ethanol R and dilute to 25.0 ml with the same solvent. The
1 1
F. (EZ)-N ,N -[thiazole-2,4-diylbis(methylenesulphanediylspecific optical rotation is 60.0 to 64.0, calculated with
ethylene)]bis(N-methyl-2-nitroethene-1,1-diamine),
reference to the dried substance.
Related substances. Examine by liquid chromatography
(2.2.29).
Test solution. Dissolve 25.0 mg of the substance to be
examined in methanol R and dilute to 50.0 ml with the same
solvent.
Reference solution (a). Dilute 1.0 ml of the test solution to
200.0 ml with the mobile phase.
Reference solution (b). Dissolve 25.0 mg of nomegestrol
G. N,N-bis[2-[[[2-[(dimethylamino)methyl]thiazol-4acetate impurity A CRS in methanol R and dilute to 50.0 ml
yl]methyl]sulphanyl]ethyl]-2-nitroethene-1,1-diamine,
with the same solvent.
Reference solution (c). Dissolve 25.0 mg of nomegestrol
acetate CRS in 20 ml of methanol R, add 0.25 ml of reference
solution (b) and dilute to 50.0 ml with the mobile phase.
The chromatographic procedure may be carried out using :
H. 2-(dimethylamino)thioacetamide,
a stainless steel column 0.25 m long and 4.6 mm in
internal diameter packed with octadecylsilyl silica gel for
chromatography R (5 m),
as mobile phase at a flow rate of 1.3 ml/min a mixture of
24 volumes of acetonitrile R, 38 volumes of methanol R
and 38 volumes of water R,
K. 3-(methylamino)-5,6-dihydro-2H-1,4-thiazin-2-one oxime.
as detector, a variable wavelength spectrophotometer
capable of operating at 245 nm and at 290 nm.
01/2005:1551 Inject 10 l of reference solution (c) and record the
chromatogram with the detector set at 245 nm.
When the chromatogram is recorded in the prescribed
NOMEGESTROL ACETATE
conditions, the retention times are : nomegestrol acetate
about 17 min and impurity A about 18.5 min. Adjust the
Nomegestroli acetas
sensitivity of the system at 245 nm so that the height of the
peak due to impurity A in the chromatogram obtained with
reference solution (c) is at least 50 per cent of the full scale
of the recorder.
Measure the height Hp above the baseline of the peak due
to impurity A and the height Hv above the baseline of the
lowest point of the curve separating this peak from the peak
due to nomegestrol acetate. The test is not valid unless Hp is
greater than 5 times Hv.
Inject 10 l of reference solution (a) and record the
chromatogram with the detector set at 290 nm. Adjust the
C23H30O4
Mr 370.5 sensitivity of the system at 290 nm so that the height of the
General Notices (1) apply to all monographs and other texts
2113
Nonoxinol 9
EUROPEAN PHARMACOPOEIA 5.0
principal peak in the chromatogram obtained with reference

solution (a) is at least 50 per cent of the full scale of the
recorder.
Inject 10 l of the test solution and record the chromatograms
at 245 nm and 290 nm for 1.5 times the retention time of
the principal peak.
In the chromatogram obtained with the test solution at
290 nm : the area of any peak, apart from the principal peak,
is not greater than 0.2 times the area of the principal peak
in the chromatogram obtained with reference solution (a)
(0.1 per cent). Disregard any peak with an area less than
0.04 times that of the principal peak in the chromatogram
obtained with reference solution (a) (0.02 per cent). In the
chromatogram obtained with the test solution at 245 nm : the
area of any peak corresponding to impurity A is not greater
than 0.4 times the area of the peak due to impurity A in the
chromatogram obtained with reference solution (c) (0.2 per
cent) ; the area of any peak, apart from the principal peak
and any peak corresponding to impurity A, is not greater
than 0.2 times the area of the peak due to impurity A in the
chromatogram obtained with reference solution (c) (0.1 per
cent). Disregard any peak with an area less than 0.1 times
that of the peak due to impurity A in the chromatogram
obtained with reference solution (c) (0.05 per cent).
In the chromatograms obtained at 290 nm and 245 nm, the
sum of the related substances apart from impurity A is not
greater than 0.3 per cent.
Loss on drying (2.2.32). Not more than 0.5 per cent,
determined on 1.000 g by drying in an oven at 100-105 C.
ASSAY
Dissolve 50.0 mg in ethanol R and dilute to 100.0 ml with
the same solvent. Dilute 2.0 ml of the solution to 100.0 ml
with ethanol R. Measure the absorbance (2.2.25) at the
maximum at 287 nm.
Calculate the content of C23H30O4 taking the specific
absorbance to be 685.
STORAGE
Store protected from light.
IMPURITIES
CHARACTERS
Appearance : clear, colourless or light yellow, viscous liquid.
Solubility : miscible with water, with alcohol and with
vegetable oils.
IDENTIFICATION
A. Infrared absorption spectrophotometry (2.2.24).
Comparison : Ph. Eur. reference spectrum of
nonoxinol 9.
Preparation : film between sodium chloride R plates.
B. It complies with the test for cloud point (see Tests).
TESTS
Acidity or alkalinity. Boil 1.0 g with 20 ml of carbon
dioxide-free water R for 1 min, with constant stirring.
Cool and filter. To 10 ml of the filtrate, add 0.05 ml of
bromothymol blue solution R1. Not more than 0.5 ml of
0.01 M hydrochloric acid or 0.01 M sodium hydroxide is
required to change the colour of the indicator.
Hydroxyl value (2.5.3, Method A) : 84 to 94.
Cloud point : 52 C to 58 C.
Dissolve 1.0 g in 99 g of water R. Transfer about 30 ml of
this solution into a test-tube, heat on a water-bath and stir
continuously until the solution becomes cloudy. Remove the
test-tube from the water-bath (ensuring that the temperature
does not increase more than 2 C) and continue to stir.
The cloud point is the temperature at which the solution
becomes sufficiently clear that the entire thermometer bulb
is plainly seen.
Ethylene oxide and dioxan (2.4.25) : maximum 1 ppm of
ethylene oxide and maximum 10 ppm of dioxan.
Heavy metals (2.4.8) : maximum 10 ppm.
Dissolve 2.0 g in distilled water R and dilute to 20.0 ml with
the same solvent. 12 ml of this solution complies with limit
test A. Prepare the standard using lead standard solution
(1 ppm Pb) R.
Water (2.5.12) : maximum 0.5 per cent, determined on 2.00 g.
Total ash (2.4.16) : maximum 0.4 per cent, determined on
1.0 g.
STORAGE
In an airtight container.
01/2005:0732
NORADRENALINE HYDROCHLORIDE
Noradrenalini hydrochloridum
A. 6-methyl-3,20-dioxo-19-norpregn-4-en-17-yl acetate.
01/2005:1454
C8H12ClNO3
NONOXINOL 9
Nonoxinolum 9
DEFINITION
-(4-Nonylphenyl)--hydroxynona(oxyethylene).
Mixture consisting mainly of monononylphenyl
ethers of macrogols corresponding to the formula :
C9H19C6H4-[OCH2-CH2]n-OH where the average value of n is 9.
It may contain free macrogols.
2114
Mr 205.6
DEFINITION
(R)-2-Amino-1-(3,4-dihydroxyphenyl)ethanol hydrochloride.
Content : 98.5 per cent to 101.0 per cent (anhydrous
substance).
CHARACTERS
Appearance : white or brownish-white, crystalline powder.
Solubility : very soluble in water, slightly soluble in alcohol.
It becomes coloured on exposure to air and light.
See the information section on general monographs (cover pages)

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EUROPEAN PHARMACOPOEIA 5.

EUROPEAN PHARMACOPOEIA 5.0

principal peak in the chromatogram obtained with reference

See the information section on general monographs (cover pages)

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