Beruflich Dokumente
Kultur Dokumente
STORAGE
Under pressure in suitable containers complying with the
legal regulations.
IMPURITIES
Specified impurities : A, B, C, D, E, F.
A. CO2 : carbon dioxide,
B. CH4 : methane,
C. H2 : hydrogen,
D. Ni(CO)4 : nickel tetracarbonyl,
E. Fe(CO)5 : iron pentacarbonyl,
F. H2O : water.
07/2009:1081
corrected 7.5
CARBOPLATIN
Carboplatinum
C6H12N2O4Pt
[41575-94-4]
Mr 371.3
DEFINITION
(SP-4-2)-Diammine[cyclobutan-1,1-dicarboxylato(2-)-O,O]platin.
Content : 98.0 per cent to 102.0 per cent (dried substance).
CHARACTERS
Appearance : colourless, crystalline powder.
Solubility : sparingly soluble in water, very slightly soluble in
acetone and in ethanol (96 per cent).
mp : about 200 C, with decomposition.
IDENTIFICATION
Infrared absorption spectrophotometry (2.2.24).
Comparison : Ph. Eur. reference spectrum of carboplatin.
TESTS
Solution S. Dissolve 0.25 g in carbon dioxide-free water R and
dilute to 25 mL with the same solvent.
Appearance of solution. Solution S is clear (2.2.1) and
colourless (2.2.2, Method II).
Impurity B and acidity : maximum 0.5 per cent, calculated
as impurity B.
To 10 mL of solution S add 0.1 mL of phenolphthalein
solution R1. The solution is colourless. Not more than 0.7 mL
of 0.01 M sodium hydroxide is required to change the colour
of the indicator to pink.
Related substances. Liquid chromatography (2.2.29).
Test solution. Dissolve 20.0 mg of the substance to be
examined in a mixture of equal volumes of acetonitrile R
ASSAY
and water R and dilute to 20.0 mL with the same mixture of
solvents.
Infrared analyser (2.5.25).
Gas to be examined. The substance to be examined, previously Reference solution. Dilute 0.5 mL of the test solution to
200.0 mL with the mobile phase.
ltered to avoid stray light phenomena.
Column :
Reference gas (a). Carbon monoxide R.
size : l = 0.25 m, = 4.6 mm ;
Reference gas (b). A mixture containing 95.0 per cent V/V of
stationary phase : aminopropylsilyl silica gel for
carbon monoxide R and 5.0 per cent V/V of nitrogen R1.
chromatography R (5 m).
Calibrate the apparatus and set the sensitivity using reference
Mobile
phase : water R, acetonitrile R (13:87 V/V).
gases (a) and (b). Measure the content of carbon monoxide in
Flow rate : 2 mL/min.
the gas to be examined.
1770
Carboprost trometamol
A. cis-diamminedichloroplatinum(II) (cisplatin),
General Notices (1) apply to all monographs and other texts
B. cyclobutane-1,1-dicarboxylic acid.
01/2008:1712
CARBOPROST TROMETAMOL
Carboprostum trometamolum
C25H47NO8
[58551-69-2]
Mr 489.7
DEFINITION
2-Amino-2-(hydroxymethyl)propane-1,3-diol
(5Z)-7-[(1R,2R,3R,5S)-3,5-dihydroxy-2-[(1E,3S)-3hydroxy-3-methyloct-1-enyl]cyclopentyl]hept-5-enoate
((15S)-15-methyl-PGF2).
Content : 94.0 per cent to 102.0 per cent (anhydrous substance).
CHARACTERS
Appearance : white or almost white powder.
Solubility : soluble in water.
IDENTIFICATION
A. Specic optical rotation (see Tests).
B. Infrared absorption spectrophotometry (2.2.24).
Comparison : Ph. Eur. reference spectrum of carboprost
trometamol.
TESTS
Specic optical rotation (2.2.7) : + 18 to + 24 (anhydrous
substance).
Dissolve 0.100 g in ethanol (96 per cent) R and dilute to
10.0 mL with the same solvent.
Related substances. Liquid chromatography (2.2.29).
Test solution. Dissolve 15.0 mg of the substance to be
examined in a mixture of 23 volumes of acetonitrile R and
77 volumes of water for chromatography R and dilute to
10.0 mL with the same mixture of solvents.
Reference solution (a). Dissolve 15.0 mg of carboprost
trometamol CRS (containing impurity A) in a mixture of
23 volumes of acetonitrile R and 77 volumes of water for
chromatography R and dilute to 10.0 mL with the same
mixture of solvents.
Reference solution (b). Dilute 1.0 mL of reference solution (a)
and 0.15 mL of (15R)-15-methylprostaglandin F2 R
(impurity B) to 100.0 mL with a mixture of 23 volumes of
acetonitrile R and 77 volumes of water for chromatography R.
Reference solution (c). Dilute 2.0 mL of the test solution to
20.0 mL with a mixture of 23 volumes of acetonitrile R and
77 volumes of water for chromatography R. Dilute 2.0 mL
of this solution to 20.0 mL with a mixture of 23 volumes of
acetonitrile R and 77 volumes of water for chromatography R.
Column :
size : l = 0.15 m, = 4.6 mm,
stationary phase : octadecylsilyl silica gel for
chromatography R1 (5 m) with a pore size of
8-10 nm and a carbon loading of 12-19 per cent.
Mobile phase : mix 23 volumes of acetonitrile R1 and
77 volumes of a 2.44 g/L solution of sodium dihydrogen
phosphate R in water for chromatography R previously adjusted
to pH 2.5 with phosphoric acid R.
1771