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10 mL each of these solutions as directed under Liquid Chromatography <2.01> according to the following conditions,
and calculate the ratios, QT and QS, of the peak area of
ceftriaxone to that of the internal standard.
Amount [mg (potency)] of ceftriaxone (C18H18N8O7S3)
WS (QT/QS) 1000
Cefuroxime Axetil
C20H22N4O10S: 510.47
(1RS)-1-Acetoxyethyl (6R,7R)-3-carbamoyloxymethyl-7[(Z)-2-furan-2-yl-2-(methoxyimino)acetylamino]-8-oxo-5-
JP XV
thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
[64544-07-6]
JP XV
test with exactly 2 mL each of the sample solution and standard solution as directed under Liquid Chromatography
<2.01> according to the following conditions, and determine
each peak area by the automatic integration method: the area
of the peak other than cefuroxime axetil obtained from the
sample solution is not more than 1.5 times the sum area of
two peaks of cefuroxime axetil obtained from the standard
solution, and the sum area of the peaks other than
cefuroxime axetil from the sample solution is not more than 4
times the sum area of two peaks of cefuroxime axetil from
the standard solution.
Operating conditions
Detector, column, column temperature, mobile phase, and
ow rate: Proceed as directed in the operating conditions in
the Assay.
Time span of measurement: About 3 times as long as the
retention time of the peak having the larger retention time of
the two peaks of cefuroxime axetil beginning after the solvent
peak.
System suitability
Test for required detectability: Measure exactly 1 mL of
the standard solution, and add 4 mL of methanol and a solution of ammonium dihydrogen phosphate (23 in 1000) to
make exactly 10 mL. Conrm that the sum area of the two
peaks of cefuroxime axetil obtained from 2 mL of this solution is equivalent to 7 to 13z of that obtained from 2 mL of
the standard solution.
System performance: Proceed as directed in the system
suitability in the Assay.
System repeatability: When the test is repeated 6 times with
2 mL of the standard solution under the above operating conditions, the relative standard deviation of the sum area of the
two peaks of cefuroxime axetil is not more than 2.0z.
(4) AcetoneWeigh accurately about 1 g of Cefuroxime
Axetil, add exactly 0.2 mL of the internal standard solution
and dimethylsulfoxide to make exactly 10 mL, and use this
solution as the sample solution. Separately, weigh accurately
about 0.5 g of acetone, and add dimethylsulfoxide to make
exactly 100 mL. Pipet 0.2 mL of this solution, add exactly 0.2
mL of the internal standard solution and dimethylsulfoxide
to make exactly 10 mL, and use this solution as the standard
solution. Perform the test with 1 mL each of the sample solution and standard solution as directed under Gas Chromatography <2.02> according to the following conditions, determine each peak area by the automatic integration method,
and calculate the ratios, QT and QS, of the peak area of acetone to that of the internal standard: the amount of acetone is
not more than 1.3z.
Amount (z) of acetone (WS/WT) (QT/QS) 0.2
475
Isomer ratio Perform the test with 10 mL of the sample solution obtained in the Assay as directed under Liquid Chromatography <2.01> according to the following conditions,
and determine the area, Aa, of the peak having the smaller
retention time and the area, Ab, of the peak having the bigger
retention time of the two peaks of cefuroxime axetil:
Ab/(Aa Ab) is between 0.48 and 0.55.
Operating conditions
Detector, column, column temperature, mobile phase, and
ow rate: Proceed as directed in the operating conditions in
the Assay.
System suitability
System performance, and system repeatability: Proceed as
directed in the system suitability in the Assay.
Assay Weigh accurately an amount of Cefuroxime Axetil
and Cefuroxime Axetil Reference Standard, equivalent to
about 50 mg (potency), and dissolve each in methanol to
make exactly 50 mL. Pipet 10 mL each of these solutions,
add exactly 5 mL of the internal standard solution, 5 mL of
methanol and a solution of ammonium dihydrogen phosphate (23 in 1000) to make 50 mL, and use these solutions as
the sample solution and the standard solution. Perform the
test with 10 mL each of the sample solution and standard solution as directed under Liquid Chromatography <2.01>
according to the following conditions, and determine the
ratios, QT and QS, of the sum area of the two peaks of
cefuroxime axetil to the peak area of the internal standard.
Amount [mg (potency)] of cefuroxime (C16H16N4O8S)
WS (QT/QS) 1000
476
Cefuroxime Sodium
C16H15N4NaO8S: 446.37
Monosodium (6 R,7 R )-3-carbamoyloxymethyl-7-[( Z )-2furan-2-yl-2-(methoxyimino)acetylamino]-8-oxo-5-thia-1azabicyclo[4.2.0]oct-2-ene-2-carboxylate [56238-63-2 ]
JP XV
wave numbers.
(3) Determine the spectrum of a solution of Cefuroxime
Sodium in heavy water for nuclear magnetic resonance spectroscopy (1 in 10) as directed under Nuclear Magnetic
Resonance Spectroscopy <2.21> (1H), using sodium 3trimethylsilylpropanesulfonate
for
nuclear
magnetic
resonance spectroscopy as an internal reference compound: it
exhibits a single signal A at around d 4.0 ppm, a quartet signal B at around d 6.6 ppm, and double signals, C and D, at
around d 6.9 ppm and around d 7.7 ppm, respectively. The
ratio of integrated intensity of each signal, A:B:C:D, is about
3:1:1:1.
(4) Cefuroxime Sodium responds to the Qualitative Tests
<1.09> (1) for sodium salt.
Optical rotation <2.49> [a]20
D : 59 669(0.5 g calculated
on the anhydrous bases, water, 100 mL, 100 mm).
pH <2.54> Dissolve 1.0 g of Cefuroxime Sodium in 10 mL
of water: the pH of the solution is between 6.0 and 8.5.
Purity (1) Clarity and color of solutionDissolve 1.0 g of
Cefuroxime Sodium in 10 mL of water: the solution is clear,
and its absorbance <2.24> at 450 nm is not more than 0.25.
(2) Heavy metals < 1.07 > Proceed with 1.0 g of
Cefuroxime Sodium according to Method 2, and perform the
test. Prepare the control solution with 3.0 mL of Standard
Lead Solution (not more than 30 ppm).
(3) Arsenic <1.11>Prepare the test solution with 1.0 g
of Cefuroxime Sodium according to Method 3, and perform
the test (not more than 2 ppm).
(4) Related substancesDissolve 25 mg of Cefuroxime
Sodium in 25 mL of water, and use this solution as the sample solution. Pipet 1 mL of the sample solution, add water to
make exactly 100 mL, and use this solution as the standard
solution. Perform the test with exactly 20 mL each of the sample solution and standard solution as directed under Liquid
Chromatography <2.01> according to the following conditions, and calculate the areas of each peak by the automatic
integration method: each peak area other than cefuroxime
from the sample solution is not more than the peak area of
cefuroxime from the standard solution, and the total of the
peak areas other than cefuroxime from the sample solution is
not more than 3 times of the peak area of cefuroxime from
the standard solution.
Operating conditions
Detector, column, column temperature, mobile phase, and
ow rate: Proceed as directed in the operating conditions in
the Assay.
Time span of measurement: About 4 times as long as the
retention time of cefuroxime beginning after the solvent
peak.
System suitability
Test for required detection: Pipet 1 mL of the standard solution, add water to make exactly 10 mL, and conrm that
the peak area of cefuroxime obtained from 20 mL of this solution is equivalent to 7 to 13z of that of cefuroxime obtained
from 20 mL of the standard solution.
System performance: Proceed as directed in the system
suitability in the Assay.
System repeatability: When the test is repeated 6 times with
20 mL of the standard solution under the above operating
conditions, the relative standard deviation of the peak areas
of cefuroxime is not more than 2.0z.