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JP XVII Official Monographs / Zinc Oxide 1783

between these peaks being not less than 1.4, and the symme- Assay Weigh accurately about 0.3 g of Zinc Chloride, add
try factor of the peak of zidovudine is not more than 1.5. 0.4 mL of dilute hydrochloric acid and water to make exactly
System repeatability: When the test is repeated 6 times 200 mL. Measure exactly 20 mL of the solution, add 80 mL
with 10 mL of the standard solution under the above condi- of water, 2 mL of ammonia-ammonium chloride buffer so-
tions, the relative standard deviation of the peak area of lution (pH 10.7) and titrate <2.50> with 0.01 mol/L disodium
zidovudine is not more than 2.0z. dihydrogen ethylenediamine tetraacetate VS (indicator:
0.04 g of eriochrome black T-sodium chloride indicator).
Containers and storage Containers—Tight containers.
Storage—Light-resistant. Each mL of 0.01 mol/L disodium dihydrogen
ethylenediamine tetraacetate VS
= 1.363 mg of ZnCl2
Zinc Chloride Containers and storage Containers—Tight containers.
塩化亜鉛

Zinc Oxide
ZnCl2: 136.29
酸化亜鉛
Zinc Chloride contains not less than 97.0z of zinc
chloride (ZnCl2).
ZnO: 81.38
Description Zinc Chloride occurs as white, crystalline pow-
der, rods, or masses. It is odorless. Zinc Oxide, when ignited, contains not less than
It is very soluble in water, and freely soluble in ethanol 99.0z of zinc oxide (ZnO).
(95), and its solution may sometimes be slightly turbid. The
Description Zinc Oxide occurs as a white, amorphous pow-
solution becomes clear on addition of a small amount of hy-
der. It is odorless and tasteless.
drochloric acid.
It is practically insoluble in water, in ethanol (95), in acetic
The pH of a solution of 1.0 g of Zinc Chloride in 2 mL of
acid (100) and in diethyl ether.
water is between 3.3 and 5.3.
It dissolves in diute hydrochloric acid and in sodium hy-
It is deliquescent.
droxide TS.
Identification A solution of Zinc Chloride (1 in 30) re- It gradually absorbs carbon dioxide from air.
sponds to the Qualitative Tests <1.09> for zinc salt and chlo-
Identification (1) Heat Zinc Oxide strongly: a yellow
ride.
color develops on strong heating, and disappears on cooling.
Purity (1) Clarity and color of solution—Dissolve 1.0 g (2) A solution of Zinc Oxide in dilute hydrochloric acid
of Zinc Chloride in 10 mL of water and 2 drops of hydro- (1 in 10) responds to the Qualitative Tests <1.09> for zinc
chloric acid: the solution has no color, and is clear. salt.
(2) Sulfate <1.14>—Perform the test with 2.0 g of Zinc
Purity (1) Carbonate, and clarity and color of solu-
Chloride. Prepare the control solution with 0.40 mL of 0.005
tion—Mix 2.0 g of Zinc Oxide with 10 mL of water, add 30
mol/L sulfuric acid VS (not more than 0.010z).
mL of dilute sulfuric acid, and heat on a water bath with
(3) Ammonium—Dissolve 0.5 g of Zinc Chloride in 5
stirring: no effervescence occurs, and the solution obtained
mL of water, and warm with 10 mL of a solution of sodium
is clear and colorless.
hydroxide (1 in 6): the evolving gas does not change
(2) Alkalinity—To 1.0 g of Zinc Oxide add 10 mL of
moistened red litmus paper to blue.
water, and boil for 2 minutes. Cool, filter through a glass
(4) Heavy metals—Dissolve 0.5 g of Zinc Chloride in 5
filter (G3), and to the filtrate add 2 drops of phenolphthalein
mL of water in a Nessler tube, shake thoroughly with 15 mL
TS and 0.20 mL of 0.1 mol/L hydrochloric acid VS: no
of potassium cyanide TS, add 1 drop of sodium sulfide TS,
color develops.
allow to stand for 5 minutes, and immediately observe from
(3) Sulfate <1.14>—Shake 0.5 g of Zinc Oxide with 40
the top downward against a white background: the solution
mL of water, and filter. Take 20 mL of the filtrate, add 1
has no more color than the following control solution.
mL of dilute hydrochloric acid and water to make 50 mL,
Control solution: To 2.5 mL of Standard Lead Solution
and perform the test using this solution as the test solution.
add 3 mL of water and 15 mL of potassium cyanide TS,
Prepare the control solution with 0.50 mL of 0.005 mol/L
shake thoroughly, and add 1 drop of sodium sulfide TS (not
sulfuric acid VS (not more than 0.096z).
more than 50 ppm).
(4) Iron—Dissolve 1.0 g of Zinc Oxide in 50 mL of di-
(5) Alkali earth metals and alkali metals—Dissolve 2.0 g
luted hydrochloric acid (1 in 2), dissolve 0.1 g of ammonium
of Zinc Chloride in 120 mL of water, add ammonium sulfide
peroxodisulfate in this solution, and extract with 20 mL of 4-
TS to complete precipitation, add water to make 200 mL,
methyl-2-pentanone. Add 30 mL of acetic acid-sodium ace-
shake thoroughly, and filter through dry filter paper. Dis-
tate buffer solution for Iron Limit Test (pH 4.5) to the 4-
card the first 20 mL of the filtrate, take the following 100
methyl-2-pentanone layer, extract again, and use the layer of
mL of the filtrate, evaporate with 3 drops of sulfuric acid to
the buffer solution as the test solution. Separately, perform
dryness, and heat the residue strongly at 6009C to constant
the test in the same manner with 1.0 mL of Standard Iron
mass: the mass is not more than 10.0 mg.
Solution, and use the layer so obtained as the control solu-
(6) Arsenic <1.11>—Prepare the test solution with 0.40 g
tion. Add 2 mL each of L-ascorbic acid solution for Iron
of Zinc Chloride according to Method 1, and perform the
Limit Test (1 in 100) to the test solution and the control solu-
test (not more than 5 ppm).
tion, respectively, mix, allow to stand for 30 minutes, add 5
(7) Oxychloride—Shake gently 0.25 g of Zinc Chloride
mL of a solution of 2,2?-bipyridyl in ethanol (95) (1 in 200)
with 5 mL of water and 5 mL of ethanol (95), and add 0.3
and water to make 50 mL. After allowing to stand for 30
mL of 1 mol/L hydrochloric acid VS: the solution is clear.
minutes, compare the color of the both liquids against a

The JP Drugs are to be tested according to the provisions given in the pertinent monographs, General Notices, General Rules for Crude Drugs,
General Rules for Preparations, and General Tests for their conformity to the Japanese Pharmacopoeia. (See the General Notices 5.)

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