Supplement I to the Japanese Pharmacopoeia Fourteenth Edition

Supplement I, JP XIV
O‹cial Monographs for Part I
1525
water to make exactly 250 mL. To 100 mL of this solution
add 4 mL of ammonium molybdate-sulfuric acid TS and 0.1
mL of tin (II) chloride-hydrochloric acid TS, and allow to
stand for 10 minutes.
(5) Bromides—To 0.50 mL of the sample solution obtained
in (2) add 4.0 mL of water, 2.0 mL of dilute phenol
red TS and 1.0 mL of a solution of sodium toluenesulfonchloramide
trihydrate (1 in 10,000), and mix immediately.
After allowing to stand for 2 minutes, add 0.15 mL of 0.1
mol/L sodium thiosulfate VS, mix, add water to make exactly
10 mL, and use this solution as the sample solution.
Separately, to 5.0 mL of a solution of potassium bromide (3
in 1,000,000) add 2.0 mL of dilute phenol red TS and 1.0 mL
of a solution of sodium toluenesulfonchloramide trihydrate
(1 in 10,000), and mix immediately. Proceed in the same
manner as for the preparation of the sample solution, and
use the solution so obtained as the standard solution. Perform
the test with the sample solution and the standard solution
as directed under the Ultraviolet-visible Spectrophotometry
using water as the control: the absorbance at 590 nm
of the sample solution is not more than that of the standard
solution.
(6) Iodides—Wet 5 g of Sodium Chloride with dropwisely
added 0.15 mL of a freshly prepared mixture of starch
TS, 0.5 mol/L sulfuric acid TS and sodium nitrite TS
(1000:40:3), allow to stand for 5 minutes, and examine under
daylight: a blue color does not appear.
(7) Ferrocyanides—Dissolve 2.0 g of Sodium Chloride
in 6 mL of water, and add 0.5 mL of a mixture of a solution
of iron (II) sulfate heptahydrate (1 in 100) and a solution of
ammonium iron (III) sulfate 12-water in diluted sulfuric acid
(1 in 400) (1 in 100) (19:1): a blue color does not develop within
10 minutes.
(8) Heavy metals—Proceed with 5.0 g of Sodium Chloride
according to Method 1, and perform the test. Prepare
the control solution with 1.5 mL of Standard Lead Solution
(not more than 3 ppm).
(9) Iron—To 10 mL of the sample solution obtained in
(2) add 2 mL of a solution of citric acid monohydrate (1 in 5)
and 0.1 mL of mercapto acetic acid, alkalize with ammonia
TS,addwatertomake20mL,andallowtostandfor5
minutes: the solution has not more color than the following
control solution.
Control solution: Pipet 1 mL of Standard Iron Solution,
and add water to make exactly 25 mL. To 10 mL of this solution
add 2 mL of a solution of citric acid monohydrate (1
in 5) and 0.1 mL of mercapto acetic acid, and proceed in the
same manner as directed for the sample solution.
(10) Barium—To 5.0 mL of the sample solution obtained
in (2) add 5.0 mL of water and 2.0 mL of dilute sulfuric
acid, and allow to stand for 2 hours: the solution has
not more turbidity than the following control solution.
Control solution: To 5.0 mL of the sample solution obtained
in (2) add 7.0 mL of water, and allow to stand for 2
hours.
(11) Magnesium and alkaline-earth materials—To 200
mL of water add 0.1 g of hydroxylammonium chloride, 10
mL of ammonium chloride buŠer solution, pH 10, 1 mL of
0.1 mol/L zinc sulfate VS and 0.2 g of eriochrome black T-
sodium chloride indicator, and warm to 409C. Add 0.01
mol/L disodium dihydrogen ethylenediamine tetraacetate
VS dropwise until the red-purple color of the solution
changes to blue-purple. To this solution add a solution prepared
by dissolving 10.0 g of Sodium Chloride in 100 mL of
water, and add 2.5 mL of 0.01 mol/L disodium dihydrogen
ethylenediamine tetraacetate VS: the color of the solution is
a blue-purple.
(12) Arsenic—Prepare the test solution with 1.0 g of Sodium
Chloride according to Method 1, and perform the test
(not more than 2 ppm).
Loss on drying
Not more than 0.5z (1 g, 1059C, 2 hours).
Assay Weigh accurately about 50 mg of Sodium Chloride,
previously dried, dissolve in 50 mL of water, and titrate with
0.1 mol/L silver nitrate VS (potentiometric titration).
Each mL of 0.1 mol/L silver nitrate VS
= 5.844 mg of NaCl
Containers and storage
Containers—Tight containers.
10z Sodium Chloride Injection
10 塩 化 ナトリウム 注 射 液
Change the Containers and storage to read:
Containers and storage Containers—Hermetic containers.
Plastic containers for aqueous injections may be used.
Add the following:
Sodium Fusidate
フシジン 酸 ナトリウム
C 31 H 47 NaO 6 :538.69
Monosodium (17Z)-ent-16a-acetoxy-3b,11b-dihydroxy-
4b,8b,14a-trimethyl-18-nor-5b,10a-cholesta-17(20),24-
dien-21-oate [751-94-0 ]
Sodium Fusidate contains not less than 935 mg
(potency) per mg, calculated on the anhydrous basis.
The potency of Sodium Fusidate is expressed as mass
(potency) of fusidic acid (C 31 H 48 O 6 : 516.71).
Description
Sodium Fusidate occurs as white, crystals of