244 Monographs, Part I

Loss on Drying Not more than 4.5 % (0.5 g, reduced

pressure not exceeding 0.67 kPa, 60 °C, 3 hours). Cefditoren Pivoxil Tablets
Dissolution Test Perform the test as directed in the Cefditoren Pivoxil Tablets contain not less than 90.0 %
Dissolution Test under Cefditoren Pivoxil Tablets. and not more than 110.0 % of the labeled amount of
Weigh accurately an amount of Cefditoren Pivoxil Fine cefditoren (C19H18N6O5S3: 506.58).
Granules, equivalent to about 0.1 g (potency) accord-
ing to the labeled amount, and perform the test at 50 Method of Preparation Prepare as directed under
revolutions per minute according to Method 2 under Tablets, with Cefditoren Pivoxil.
Dissolution Test, using 900 mL of the 1st fluid for dis-
solution test as the dissolution solution. Take not less Identification (1) To an amount of powdered
than 20 mL of the dissolved solution after 20 minutes Cefditoren Pivoxil Tablets, equivalent to 35 mg (po-
from the start of the test, and filter. Discard the first 10 tency) of cefditoren pivoxil according to the labeled
mL of the filtrate, pipet 2 mL of the subsequent filtrate, amount, add 100 mL of methanol, shake, and filter. To
add water to make exactly 20 mL, and use this solution 5 mL of the filtrate add methanol to make 100 mL, and
as the test solution. Determine the absorbances at 272 determine the absorption spectrum of this solution as
nm of the test solution and standard solution as di- directed under Ultraviolet-visible Spectrophotometry:
rected under Ultraviolet-visible Spectrophotometry, it exhibits a maximum between 229 nm and 233 nm.
using the dissolution solution as the blank. The dissolu- (2) Proceed as directed in the Assay: the test solu-
tion rate of Cefditoren Pivoxil Fine Granules in 20 tion and standard solution exhibit peaks at the same
minutes is not less than 80 % of the labeled amount. retention time.

Particle Size Distribution Test It meets the require- Loss on Drying Not more than 4.0 % (0.5 g, reduced
ment. pressure not exceeding 0.67 kPa, 60 °C, 3 hours).

Uniformity of Dosage Units (divided) It meets the Dissolution Test Perform the test with 1 tablet of
requirement. Cefditoren Pivoxil Tablets at 50 revolutions per minute
according to Method 2 under Dissolution Test, using
Assay Conduct this procedure using light-resistant 900 mL of the first solution under Dissolution Test as
vessels. Weigh accurately an amount of powdered the dissolution solution. Take not less than 20 mL of
Cefditoren Pivoxil Fine Granules, equivalent to about the dissolved solution 20 minutes after the start of the
40 mg (potency) of cefditoren pivoxil according to the test, and filter through a membrane filter with a pore
labeled amount, add 70 mL of diluted acetonitrile (3 in size not exceeding 0.45 μm. Discard the first 10 mL of
4), and shake vigorously. To this solution add exactly the filtrate, pipet V mL of the subsequent filtrate, add
10 mL of the internal standard solution and acetonitrile water to make exactly V’ mL so that each mL contains
to make 100 mL, filter, and use the filtrate as the test about 11 μg (potency) of cefditoren pivoxil, and use
solution. Separately, weigh accurately about 20 mg this solution as the test solution. Separately, weigh ac-
(potency) of Cefditoren Pivoxil RS, dissolve in 20 mL curately about 22 mg (potency) of Cefditoren Pivoxil
of acetonitrile, add exactly 5 mL of the internal stand- RS, dissolve in 20 mL of diluted acetonitrile (3 in 4),
ard solution and acetonitrile to make 50 mL, and use and add the first solution under Dissolution Test to
this solution as the standard solution. Then, proceed as make exactly 200 mL. Pipet 2 mL of this solution, add
directed in the Assay under Cefditoren Pivoxil. water to make exactly 20 mL, and use this solution as
the standard solution. Determine the absorbances, AT
Amount [μg (potency)] of Cefditoren (C19H18N6O5S3) and AS, at 272 nm of the test solution and standard so-
= Amount [μg (potency)] of Cefditoren Pivoxil RS lution as directed under Ultraviolet-visible Spectropho-
tometry, using water as the blank. The dissolution rate
Q
× T ×2 of Cefditoren Pivoxil Tablets in 20 minutes is not less
QS than 85 %.

Internal standard solution⎯A solution of propyl Dissolution rate (%) with respect to the labeled amount
parahydroxybenzoate in acetonitrile (1 in 200) of cefditoren pivoxil (C19H18N6O5S3)
= Amount [mg (potency)] of Cefditoren Pivoxil RS
Containers and Storage Containers—Tight con- A V' 1
tainers. × T × × × 45
AS V C
Storage—Light-resistant.
C: Labeled amount [mg (potency)] of cefditoren
pivoxil (C25H28N6O7S3) in 1 tablet
 KP X 245

Uniformity of Dosage Units Perform the test ac- Description Cefepime Dihydrochloride for Injection
cording to the following method: it meets the require- appears as white to pale yellow powder.
ment of the Content uniformity test.
Conduct this procedure using light-resistant vessels. To Identification Perform the test with Cefepime
1 tablet of Cefditoren Pivoxil Tablets add exactly 12.5 Dihydrochloride for Injection as directed in the Identi-
mL of the 1st fluid for disintegration test, and shake fication (1) and (3) under Cefepime Dihydrochloride
vigorously. Add 25 mL of acetonitrile, shake, and add Hydrate.
acetonitrile to make exactly 50 mL. Pipet V mL, equiv-
alent to about 20 mg (potency) of cefditoren pivoxil pH The pH of a solution obtained by dissolving an
according to the labeled amount, add exactly 5 mL of amount of Cefepime Dihydrochloride for Injection,
the internal standard solution and diluted acetonitrile (3 equivalent to 0.1 g (potency) of cefepime
in 4) to make 50 mL, filter, and use the filtrate as the dihydrochloride, in 1 mL of water is between 4.0 and
test solution. Separately, weigh accurately about 20 mg 6.0.
(potency) of Cefditoren Pivoxil, dissolve in 20 mL of
acetonitrile, add exactly 5 mL of the internal standard Purity (1) Color of solution—Dissolve an amount of
solution and acetonitrile to make 50 mL, and use this Cefepime Dihydrochloride for Injection, equivalent to
solution as the standard solution. Then, proceed as di- 0.5 g (potency) of cefepime dihydrochloride hydrate
rected in the Assay under Cefditoren Pivoxil. according to the labeled amount, in 5 mL of water: the
solution is colorless to pale yellow.
Internal standard solution⎯A solution of propyl (2) N-Methylpyrrolidine—Perform the test as di-
parahydroxybenzoate in acetonitrile (1 in 200) rected in Purity (2) under Cefepime Dihydrochloride
Hydrate. Weigh accurately about 0.2 g (potency) of
Assay Conduct this procedure using light-resistant Cefepime Dihydrochloride for Injection, according to
vessels. To an amount of Cefditoren Pivoxil Tablets, the labeled potency, dissolve in diluted nitric acid (2 in
equivalent to 0.5 g (potency) of cefditoren pivoxil ac- 625) to make exactly 20 mL, and use this solution as
cording to the labeled amount, add 63 mL of the first the test solution (not more than 1.0 %).
solution under Disintegration Test, shake vigorously,
add 125 mL of acetonitrile, shake, and add acetonitrile Water Not more than 4.0 %. Perform the test as di-
to make exactly 250 mL. Pipet 10 mL of this solution, rected in Water under Cefepime Dihydrochloride hy-
add exactly 5 mL of the internal standard solution and drate (volumetric titration, direct titration).
diluted acetonitrile (3 in 4) to make 50 mL, filter, and
use the filtrate as the test solution. Separately, weigh Sterility Test It meets the requirement.
accurately about 20 mg (potency) of Cefditoren Pivoxil
RS, dissolve in 20 mL of acetonitrile, add exactly 5 mL Bacterial Endotoxins It meets the requirement. Less
of the internal standard solution and acetonitrile to than 0.06 EU/mg (potency) of cefepime. Dissolve
make 50 mL, and use this solution as the standard solu- about 1 g (potency) of Cefepime Dihydrochloride for
tion. Then, proceed as directed in the Assay under Injection, according to the labeled potency, in water for
Cefditoren Pivoxil. bacterial endotoxins test. If necessary, adjust the pH to
6.0 to 7.5 with 0.1 mol/L sodium hydroxide TS for
Internal standard solution⎯A solution of propyl bacterial endotoxins test or 0.1 mol/L hydrochloric acid
parahydroxybenzoate in acetonitrile (1 in 200) TS for bacterial endotoxins test, then add water for
bacterial endotoxins test to make a solution so that
Containers and Storage Containers—Tight con- each mL contains about 0.1 g (potency). Pipet an
tainers. amount of this solution, and add water for bacterial
endotoxins test to make a test solution of suitable con-
centration.
Cefepime Dihydrochloride Foreign Insoluble Matter Test It meets the re-
for Injection quirement.

Cefepime Dihydrochloride for Injection is a prepara- Insoluble Particulate Matter Test for Injections It
tion for injection, which is dissolved before use. meets the requirement.
Cefepime Dihydrochloride for Injection contains not
less than 95.0 % and not more than 110.0 % of the la- Uniformity of Dosage Units It meets the require-
beled amount of cefepime (C19H24N6O5S2: 480.56). ment.

Method of Preparation Prepare as directed under Assay Proceed as directed in the Assay under
Injections, with Cefepime Dihydrochloride Hydrate. Cefepime Dihydrochloride Hydrate. Weigh accurately
about 60 mg (potency) of Cefepime Dihydrochloride
for Injection, according to the labeled potency, dissolve