Supplement I to the Japanese Pharmacopoeia Fourteenth Edition

1366 General Tests, Processes and Apparatus
Supplement I, JP XIV
Change the following:
Arecoline hydrobromide for thin-layer chromatography
C 8 H 13 NO 2 .HBr White crystals. Freely soluble in water,
soluble in methanol, and practically insoluble in diethyl
ether.
Melting point: 169–1719C
Purity Related substances—Dissolve 50 mg of arecoline
hydrobromide for thin-layer chromatography in exactly 10
mL of methanol. Perform the test with 10 mL of this solution
as directed in the Identiˆcation under Areca: any spot other
than the principal spot at the Rf value of about 0.4 does not
appear.
N-Demethylroxithromycin C 40 H 74 N 2 O 15 White powder.
Identiˆcation—Determine the infrared absorption spectrum
of a solution of the substance to be tested in chloroform
(1 in 20) as directed in the solution method under the
Infrared Spectrophotometry using a 0.1-mm cell made of
potassium bromide: it exhibits absorption at the wave numbers
of about 3600 cm -1 , 3520 cm -1 ,3450cm -1 , 3340 cm -1 ,
1730 cm -1 and 1627 cm -1 .
Geniposide for thin-layer chromatography C 17 H 24 O 10
White crystals or crystalline powder. Melting point: 159 –
1639C.
Purity Related substances—Dissolve 1.0 mg of geniposide
for thin-layer chromatography in exactly 1 mL of
methanol, and perform the test with 20 mLofthissolutionas
directed in the Identiˆcation (2) under Gardenia Fruit: any
spot other than the principal spot at the Rf value of about
0.3 does not appear.
Imidazole TS Dissolve 8.25 g of imidazole in 65 mL of
water, adjust the pH to 6.8 with 5 mol/L hydrochloric acid
TS, and add water to make 100 mL.
Add the following:
2-Acetamidoglutarimide C 7 H 10 N 2 O 3 : 170.17
Identiˆcation—Determine the infrared absorption spectrum
of 2-acetamidoglutarimide as directed in the potassium
bromide disk method under the Infrared Spectrophotometry:
it exhibits absorption at the wave numbers of about 3350
cm -1 , 1707 cm -1 , 1639 cm -1 and 1545 cm -1 .
Purity Related substances—Dissolve 10 mg of 2-
acetamidoglutarimide in 100 mL of the mobile phase, and
use this solution as the sample solution. Pipet 1 mL of the
sample solution, add the mobile phase to make exactly 100
mL, and use this solution as the standard solution. Proceed
with 20 mL each of the sample solution and the standard solution
as directed in the Purity (3) under Aceglutamide Aluminum:
the total of the peak areas other than 2-
acetamidoglutarimide from the sample solution is not more
than the peak area from the standard solution.
Content: not less than 98.0z. Assay—Weigh accurately
about 20 mg of 2-acetamidoglutarimide, and perform the
test as directed under the Nitrogen Determination.
Each mL of 0.01 mol/L sulfuric acid VS
= 0.8509 mg of C 7 H 10 N 2 O 3
Acetaminophen C 8 H 9 NO 2 [Same as the namesake
monograph]
Acetate buŠer solution, pH 5.4 To 5.78 mL of acetic
acid (100) add water to make 1000 mL (solution A). Dissolve
8.2 g of anhydrous sodium acetate in water to make 1000
mL (solution B). Mix 176 mL of the solution A and 824 mL
of the solution B, and adjust, if necessary, the pH to 5.4
with the solution A or the solution B.
0.02 mol/L Acetic acid-sodium acetate TS Dissolve 2.74
g of sodium acetate trihydrate in a suitable amount of water,
and add 2 mL of acetic acid (100) and water to make 1000
mL.
Albi‰orin C 23 H 28 O 11 .x H 2 O Colorless powder having
no odor. Freely soluble in water and in methanol, and practically
insoluble in diethyl ether.
Purity—Dissolve 1 mg in diluted methanol (1 in 2) to
make 10 mL, and use this solution as the sample solution.
Perform the test with 10 mL of the sample solution as directed
in the Assay under Peony Root; the total area of the
peaks other than albi‰orin and other than the solvent is not
larger than 1/10 of the total area of the peaks other than the
solvent peak.
0.05 mol/L Ammonium formate buŠer solution, pH 4.0
Dissolve 3.5 g of ammonium formate in about 750 mL of
water, adjust the pH to 4.0 with formic acid, and add water
to make 1000 mL.
Amoxicillin C 16 H 19 N 3 O 5 S.3H 2 O [Same as the namesake
monograph]
a-Apooxytetracycline C 22 H 22 N 2 O 8 Yellow-brown to
green powder.
Melting point: 200–2059C
b-Apooxytetracycline C 22 H 22 N 2 O 8 Yellow-brown to
brown powder.
Purity Related substances—Dissolve 8 mg of b-apooxytetracycline
in 5 mL of 0.01 mol/L sodium hydroxide TS,
add 0.01 mol/L hydrochloric acid TS to make 100 mL, and
use this solution as the sample solution. Proceed the test
with 20 mL of the sample solution as directed in the Purity
(2) under Oxytetracycline Hydrochloride, determine each
peak area by the automatic integration method, and calculate
the amounts of them by the area percentage method: the
total amount of the peaks other than β-apooxytetracycline
is not more than 10z.
L-Arabinose C 5 H 10 O 5 [K 8054: 1991, L(+)-Arabinose,
Special class]
Aristolochic acid I for crude drugs purity test
C 17 H 11 NO 7 Yellow crystalline powder. Melting point:
about 2809C (with decomposition).
Absorbance E 1z
1cm (318 nm): 384 – 424 (1 mg, methanol,
100 mL).
Purity Related substances—Dissolve 1.0 mg of aristo-