21
22
23

(C16H23N3O4·CH4O3 S) 98.5 ~ 101.0 % .
.

.
.
2) 1 g 5 mL 2
mL 5 .
2 mL 5 mL
5
.
100000)

.
4) 0.1 g 0.2 g
20 ~ 30 .
0.5 mL 3 mL

.
90 ~ 93
pH 1.0 g 10 mL pH 4.5
~ 5.5 .
1) 1.0 g 10 mL
.
2) 2.0 g 1
. 2.0 mL
(10 ppm ).
3) 2.0 g 1 mol/L 20
mL 20
. 10 mL
. (2 ppm ).
4) 50 mg
100 mL .
5 mL 5 mL
.
5.0 mg 100 mL
. 1 mL
20 mL . 5 mL
5 mL
. 3 Lμ


QT QS QT QS
.
5) 0.20 g 5 mL
. 1 mL
100 mL .

. 5 Lμ
.
· · (3 : 1 : 1)
10 cm
.
8- (1 1000)→
·

.
0.3 % (1 g, , , 4 ).
0.1 % (1 g).

50 mg
100 mL . 5 mL
5 mL
. 3 Lμ


QT QS .
S
T
(1
: ( 245 nm)
: 5 mm, 15 cm
5 mμ
(540 : 200 : 20 : 1)
24
.
,
5 .
6

1.0 % .
Theragra chalcogramma Pallas(Gadidae)
( ) .
1 g 2000 ~ 5000
A .
,
.
.
0.1 g 10 mL
1 mL 3 mL

.
.
0.5 g A
2 .

.
(C30H60I3N3O3 ) 98.0 ~ 101.0 %
.

.

.
.
pH 1 g 50 mL pH 5.3 ~
7.0 .
.
2) 1.0 g 1
. 2.0 mL
(20 ppm ).
0.1 % (1 g).
mg 25
mL .
10 Lμ

AT AS .
S
T
C : (mg/mL)
9 (KP IX) [ 1 ]
25

: ( 200 nm)
: 4.6 mm, 25 cm
3 ~ 10 mμ
.

5000
1.4 .
5
2.0 % .
0.14 mol/L 10 mol/L
0.05 mol/L pH 3.0
.
Dried Thyroid

.
(I : 126.90) 0.30 ~ 0.35 % .
~
.
10 ~ 30
1 mL (7 →
10) 99 mL 5 ~ 10
1 . (1 100)→
1 ~ 5
(7 10) 5 ~ 10 , (4→
5) 5 ~ 10 , (9 10)→ →
1 ~ 2 , 1 ~ 5 ,
1 ~ 5 .

( ) ( )
.
10 mL 5
. 5 mL 0.5 mL,
4 4
.
2) 1.0 g
2
. 105
30 mg .
6.0 % (1 g, 105 , ).
5.0 % (0.5 g,
).
1.0 g
7 g

10 g .
600 ~ 700 25
20 mL
. 20 mL

200 mL
. 7 mL
(1 2) 40 mL→


5 .
200 mL .
(1 20) 5 mL→
5
(1 2) 2 mL 5 mL→
0.01 mol/L
( : 3 mL).
.


.
1 g 0.4 g
[ (C12H17ClN4OS·HCl : 337.27)
] 100 g .μ
~
.
9 (KP IX) 2007
26
6 ~
12 m .μ
1)
.

.
9.0 % (1 g,
).
1) 50 mg
.
(mg) g 1
××=
2) 1.0 g
1 mL 80 mL 80 ~ 85
30
100 mL 10
. 4 mL ·
5 mL 1 mL
45 ~ 50 3 . 2
mL (40 ~
110 mμ
(H ) 2.5 mL 1 cm, 17 cm
) 1
0.5 mL .
10 mL
1 1 mL
. 2 .
(1 50) 2.5 mL 1 0.5 mL→
2 .
1 mL
10 mg .
( .) 15 mg
0.001 mol/L 100 mL
. 1 mL
100 mL . 1 mL
1 mL
3 mL .
200 Lμ
.
QT QS .
12.5 (g)
(μg) g 1
×××
=
100 mL . 1 mL
(1 5) 100 mL .→

: ( 254 nm)
: 4 mm, 15 ~ 30 cm
5 ~ 10 mμ
.
: 2.7 g 1000 mL
(1 10) pH 3.5→
. 800 mL 1- 1.6 g
200 mL .
: 8
.
,
8 .
.

27

.
1 mg
C1 (C21H43N5O7 : 477.60) 590 g ( )μ
.
.
.
1) 50 mg 1 mL
- (1 500) 2 .α →
1 mL
.
.
.
50 Lμ
.
· · (2 : 1 : 1)
. 2 ~ 4 g

3 ~ 5
.
: +107 ~ +121° (
0.25 g, , 25 mL, 200 mm)
pH 0.4 g 10 mL pH 3.5
~ 5.5
.
. 1 mg 0.50 EU
.
3 )
mL
0.65 mg ( )
10 mL
5 mL 4 mL
25 mL 60
15
.

( C1
: 25 ~ 50 %, C1a : 10 ~ 35 %,
C2 C2a : 25 ~ 55 %).
100 (%)
S
F
2a21a1
: ( 330 nm)
: 5 mm, 100 mm
5 ~ 10 mμ

.
: 700 mL 250 mL
50 mL 1-
5 mg .

C1
k 2 ~ 7 , C2
1200 , R
1.25 . C1 , C1a,
C2a , C2 .
: 10 Lμ
6
2.0 % .

1.5 g 13.0 ~ 20.0 g
1000 mL
pH 7.8 ~ 8.0 .
( )
(2) Staphylococcus epidermidis ATCC
(3) 25 mg ( ) 0.1
mol/L (pH 8.0) mL 1
mg ( )
. 0.1
mol/L (pH 8.0) mL 4.0 1.0
g ( )μ
.
25 mg ( ) 0.1
mol/L (pH 8.0) mL 1
mg ( ) .
9 (KP IX) 2007
28
mol/L (pH 8.0) mL 4.0 1.0
g ( )μ
.
)(8) .

~ 101.0 % .
~
.

.
2)

.
pH 4.0 g 20 mL pH 4.0
~ 6.5 .
1) 25.0 g 50 mL

.
1.0 mL, 3.0 mL
2.0 mL 10.0 mL
3.0 mL 50 mL .
2) 5.0 g 50 mL
3 0.01 mol/L
0.60 mL
.
0.005 mol/L 1.0 mL (0.024 % ).
5) 0.5 g 5 mL 0.01
mol/L 0.25 mL .
6) 5.0 g 2
. 2.0 mL
(4 ppm ).
7) 0.5 g 5 mL
2 ~ 3 1 mL 1
.
8) 1.5 g 5 mL 5
mL 1 mL 5
5 mL
(1.3 ppm ).
9) 5- 5.0 g
100 mL .
284 nm
0.32 .
0.1 % (1 g).
4 g
0.2 mL 80 mL 30
100 mL
20 ± 1 100 mm
αD .
.
105.0 % (C6H12O6 : 180.16)
.
.
.
.
1) 1 g

20 mL .
2 ~ 3 5 mL
.
2) 1) 10 mL 0.1 g 1
mL 3
.
29
g .
2 .
2.0 mL .
2) 1.5 g

5 mL 5 mL
1 mL 8) .
2.0 g

2.0 mg .
.
. , 10 w/v%
10 w/v% . .
.
.
(C6H12O6 ) 4 g
0.2 mL
100 mL 30
20 ± 1
100 mm αD .
1087.0 α = (mg) )OH(C D6126 ×
.
.
99.0 ~ 101.0 % .
.
.
.
200 mL

105 2 4 mg
.
2) 0.40 g 10 mL 1
mL
5 mL
.
(5 ppm ).
10 mL 1 mL
2.0 mL 5 mL
.
0.5 % (1 g, , 18 ).
0.6 g
200 mL .
0.05 mol/L 25 mL 500 mL
(1 20) 200→
mL 30 ~ 35
23 mL
. 55 ~ 60
30
.
.
3.5 w/v% .

.
.

.
.
: 1.01
1 mL 1
10 mL 2 mL
1

.
2 0.1 mol/L 2.5 mL
9 (KP IX) 2007
30
2) 5.0 mL 20 mL
2 mL
2 mL
50 mL . .
2.5 mL 2 mL
50 mL (5 ppm ).
3) 10 mL 2
10 .
4) 100 mL
· (3 : 2) 50 mL, 25 mL
25 mL

( ) 2 50
mg .
105 1
30 mg .
2 mL 20 mL
20 mL
0.02 mol/L .
30
.
.
(99 mTc) .
.

(C10H22N4·H2SO4 ) 98.5 ~ 101.0 % .

.

.
: 251 ~ 256 ( , )
1) (1 4000) 4 mL α→
- 2 mL, 1 mL 15
mL 30 .
2)

3) (1 10)→
.
pH 1.0 g 50 mL pH
4.7 ~ 5.7 .
1) 1.0 g 50 mL
.
2) 2.0 g
80 mL 10 .
60 mL, 2 g
200 mL 1/60 mol/L 0.70
mL 2 mL
.
3) 2.0 g 4
. 2.0 mL
(10 ppm ).
0.2 % (1 g).
0.5 g
2 mL ·
(6 : 1) 70 mL 0.1 mol/L
(
0.1 mol/L 1 mL
= 29.639 mg C10H22N4·H2SO4
9 (KP IX) [ 1 ]
31

(C7H7KO5 S) 98.5 ~ 101.0 % .


.
,
.
1) (1 100) 10 mL→
2
.
2) 0.25 g
500 mL . 10 mL
pH 7.0 100 mL
.

.
.
pH 1.0 g 20 mL pH 4.0
~ 5.5 .
1) 1.0 g 20 mL
.
2) 0.8 g .
0.005 mol/L 0.50 mL (0.030 %
).
3) 1.0 g 1
. 2.0 mL
(20 ppm ).
4) 1.0 g 1
(2 ppm ).
5) 0.20 g 200 mL
. 1 mL
100 mL .
5 Lμ
.


.
: ( 279 nm)
: 4 mm, 20 ~ 25 cm
5 ~ 10 mμ
.
(20 : 1)
.
: 50 mg
50 mg 50 mL . 5 Lμ
,
4
.
10 mm .
: 2

3.0 ~ 4.5 % (0.3 g, )
0.3 g 2.0
mL 50 mL
0.1 mol/L (
.
.

Guaifenesin
OCH2CCH2OH
OH
OCH3
H
(C10H14O4 ) 98.0 ~ 102.0 % .
.

9 (KP IX) 2007
32
.
1) 5 mg · 1 mL
.
2) (1 →
50000)

.

.
80 ~ 83
pH 1.0 g 100 mL pH 5.0
~ 7.0 .
1) 0.20 g 10 mL
.
2) 0.7 g 25 mL
6 mL
50 mL . .
0.01 mol/L 0.40 mL (0.020
% ).
3) 1.0 g 3
(2 ppm ).
4) 2.0 g 25 mL
2 mL
50 mL . .
2.0 mL (10 ppm
).
5) 1.0 g 25 mL

. 0.10 g
1000 mL . 3 mL
25 mL
. 1.0 mL
(1 200) 5.0 mL→
5 .
(1 1200) 100 mL→
. 4-
15 25 mL

500 nm
.
6) 1.0 g 100 mL
. 1 mL
200 mL .
.
10 Lμ
.
· · (40 : 10 : 1)
10 cm
.

.
0.1 % (1 g).
60 mg
100 mL .
5 mL 100
mL .
273 nm
A .
.
% (MgO : 40.30) 20.0 %
(%)
2.2 ~ 2.5 .
.
, .
1) 0.5 g 10 mL


.

( )

.
1) 10.0 g 150 mL
60
150 mL 75
mL 100 mL
. 25 mL
700 2 20
mg .
33
2) 1) 20 mL
2 0.1 mol/L 1.0 mL
.
mL 50 mL .
. 0.01 mol/L 0.75 mL
(0.053 % ).
10 30 mL

50 mL . 4 mL
1 mL 50 mL .
. 0.005 mol/L 1.0
mL (0.480 % ).
5) 1.0 g 20 mL 3 mL
2 5 mL
2
2 mL
50 mL .
.
3.0 mL 2 mL 50 mL
(30 ppm ).
6) 0.40 g 5) (5 ppm ).
34 % (0.5 g, 850 , 3 ).
0.2 g
0.1 mol/L 30 mL
20 mL 37 ± 2 1
25 mL
0.1 mol/L pH 3.5
.
1 g 0.1
mol/L 140 ~ 160 mL .
1) 0.7 g
0.5 mol/L 10 mL
25 mL
15 .
25 mL

. 25 mL
2
1)

775 ~ 825
30 a (g)
. 6 mL
3 5
b (g) .
100 (g)
−
50 mL 0.5 mol/L 10
mL 15 .
100 mL
100 mL .
50 mL 50 mL
(1 2) 5 mL→
. 2.0 mL
pH 10.7 · 10 mL
0.05 mol/L
40 mg).
3) (SiO2 ) (MgO)
(%) 1) 2) .
.

.
.
1 g (1 5) 20 mL→

.
1) 0.5 g (1 3) 3→
mL
20 mL .

.

( )

.
1) 5.0 g 100 mL
.
9 (KP IX) 2007
34
2) 5.0 g 100 mL 15

100 mL . 10 mL
6 mL 50 mL .
. 0.01
mol/L 0.30 mL (0.021 % ).
3) 6) 3 mL
10 50 mL
. 2.0 mL 1 mL
50 mL . .
0.005 mol/L 1.0 mL
(0.480 % ).
4) 1.5 g 50 mL 5 mL
20

10 mL 2
1
1
.
0.45 g
0.45 g, 6 mL 150 mL
. 50 mL
. 2.0 mL,
0.15 g, 0.15 g, 2 mL
50 mL (40 ppm ).
5) 1.0 g 5 mL

. 5 mL
. 10 mL

5 mL .
(2 ppm ).
700 2
40 mg .
.
C :
F, G :
H :
) 5.0 g 20 mL
A 1 g
(1 2) 50 mL . A→
E
. D 0.01 mol/L 10
mL 10 mL C
. A 130
F G
B .
A 135 ~ 145 A
. 1 10 mL .
170 mL C

200 mL .

. , .
VA A 200
×× S
T
20.0 % (1 g, 105 , 3 ).
0.10 g (3 2000)→
9 (KP IX) [ 1 ]
35
20 mL 15 37 ± 2
5 . 1.0
mL 200 mL 50
mL

.
(3 2000) 1.0 mL→ 400 mL 50 mL .
.
.
, .
1 g (1 5) 20 mL→
.
.
1) 1.0 g 20 mL
.
2) 2) .
3) 2) 2.0 mL
1 mL 50 mL .
. 0.005 mol/L 1.0
mL (0.480 % ).
4) 3.0 g 4) .
3.0 mL (30 ppm ).
5) 1.0 g 10 mL
5)
(2 ppm ).
20.0 % (1 g, 105 , 3 ).
1 g
0.1 mol/L 200 mL
37 ± 2 1
. 50 mL
0.1 mol/L pH 3.5
. 1 g
0.1 mol/L 50.0 mL
.
Gramicidin
.
1 mg
900 g ( ) .μ
~
.
.
1) 10 mg 6 mol/L
2 mL 30
. 6 mol/L
· 1 mL 0.5
mL 2 ~
.
25000)

.
3.0 % (0.1 g, , 60 , 3 ).
1.0 % (1 g).
5.0 g
2.0 g
20.0 g
80 0.1 g
10.0 g
pH 6.7 ~ 6.8 .
( )
(2) Streptococcus
faecium ATCC 10541 .

( ) 5 . 1
. 8 ~
10 mL 37 20 ~ 24
. 1 mL
100 mL .
(3) 95 %
mL 0.0400 g ( )μ
.
95 % mL 1 mg (
) . 5
9 (KP IX) 2007
36
0.0320, 0.0356, 0.0400, 0.0448 0.0500 gμ
( ) .
0.1 mL

)(6) .

.
1 mg
(C17H17ClO6 ) 900 g ( )μ
.


.
100000)

.
0.25 g, 25 mL, 200 mm)
217 ~ 224
1.0 g 1
. 2.5 mL
(25 ppm ).
0.2 % (1 g).
25 mg (
)
25 mL . 5 mL
50 mL
. 20 Lμ

AT AS .
S
T

: ( 250 nm)
: 4 mm, 150 ~ 300 mm
5 ~ 10 mμ
.
.
(C12H22FeO14 : 446.14) 97.0 ~ 102.0 %
.


.
1.0 g 10 mL
.
(1 20) .→
1) 10 mg 10 mL
. 60
. 10 mg 10
mL .
. 5
Lμ
. · · ·
(50 : 30 : 10 : 10)
15 cm 110 20
. 2.5 g 1
9 (KP IX) [ 1 ]
37
mol/L 50 mL 1.0 g
1 mol/L 100 mL
110 10

.
1) 1.0 g .
0.02 mol/L 1.0 mL (0.07
% ).
2) 1.0 g .
0.01 mol/L 1.0 mL (0.1 % ).
3) 1.0 g 10 mL
2 mL 50 mL 20 mL
10 mL
. 6 mol/L 1
(1 20) 1 mL→
5 .
9 mol/L 10 mL, 10 mL,
· 20 mL
(5 100) 5 mL→
30
.
.
5 mL
100 mL 2 mL
50 mL
.

.
:
10) 2 mL→
. .
25 mL (3 ppm ).
6) 5 g
100 mL 10 mL
3.0 g . 5
0.1 mol/L
( : 3 mL).
.
0.1 mol/ 1mL = 5.585 mg Fe+3
2 % .
7) 0.5 g 10 mL
1 mL
.
30
5 mL 2
2 mL
.
10 mL
. 5 mL
20 mL 100 mL
. 5 mL 2 mL 1
1
.
6.5 ~ 10.0 % (1 g, 105 , 16 )
1.5 g 300 mL
75 mL 15 mL
. 0.25 g
20
.

10 mL 10
mL .
0.1 mol/L
.
.
(C12H22FeO14·2H2O : 482.18)
.
.
1 g 100
mL .
.
1
900 mL 1 150
9 (KP IX) 2007
38
.


.

.
:
.
.
20
.
(C12H22FeO14·2H2 O) 1.5 g
300 mL 75 mL
15 mL .
0.1 mol/L 1 mL = 48.22 mg
C12H22FeO14·2H2O
2
(C12H22CaO14·H2 O) 99.0 ~ 104.0 % .
.
(99.5)
.
mg 1 mL
.
. 5 Lμ

. · · ·
(5 : 3 : 1 : 1) 10
cm 110
20 .
·
110 20
.
2) (1 40)→
.
, 25 mL, 100 mm)
pH 1.0 g 20 mL
pH 6.0 ~ 8.0 .
1) 1.0 g 50 mL
.
2) 0.40 g .
0.01 mol/L 0.80 mL (0.071 %
).
).
4) 1.0 g 30 mL
2 mL
50 mL . .
2.0 mL 2 mL
50 mL (20 ppm ).
5) 0.6 g 5 mL
5 mL 1 mL
5 mL .
(3.3 ppm ).
6) 0.5 g 10 mL
2 mL 2
5 mL 5
20 mL . 5 mL 2
mL 1 ~
.
1.0 % (1 g, 80 , 2 ).
0.4 g
100 mL 8 mol/L 2 mL
NN 0.1 g 0.05 mol/L
. ,
.
.
39
105.0 % (Ca : 40.08) .

.
. ,
.
.
1) 5 mL
0.7 mL 1 mL
30 1) .
2) (1 5)→
.
0.17 EU .
(C12H22CaO14 ) 0.4
g 100 mL
8 mol/L 2 mL NN 0.1
g 0.05 mol/L
.
.
0.05 mol/L
.

(C5H10N2O3 ) 98.5 ~ 101.5 % .

.

.

.
: +6.3 ~ +7.3° ( 2 g,
, 50 mL, 100 mm).
pH 1.0 g 50 mL pH 4.0
~ 6.0 .
0.01 mol/L 0.50 mL
(0.05 % ).
).
3) 0.333 g 45 mL
2 mL .
1.0 mL 45 mL 2 mL
.
50 mg 30 % 3 mL

(30 ppm ).
4) 1.0 g 1
. 1.5 mL
(15 ppm ).
5) 0.10 g 10 mL
. 50 mg
100 mL 5.0 mL
50 mL .
.
5 Lμ
· ·
(3 : 1 : 1) 10
cm 80 30
. 0.2 g ·2
mol/L (95 : 5)
80 10

(0.5 % ).
0.3 % (1 g).
0.15 g 3
mL 50 mL 0.1
mol/L (
H2N OH
O O
40

(C23H28ClN3O5 S) 98.5 ~ 101.0 % .
~
.

.
1)
(1 10000)→

.

.
3) 2)
.
1) 1.0 g 2
. 2.0
mL (20 ppm ).
2) 0.20 g 20 mL
. 1 mL
50 mL .
2.5 mL
10 mL .
.
10 L (μ
) .
· · (4 5)→
(11 : 7 : 2) 12 cm
. (
254 nm)
.
0.5 % (1 g, 105 , 4 ).
0.9 g
50 mL 0.1 mol/L
( :
.
(Mg) 11.0 ~ 12.5 % .
.
1 w/v%

.
2) 0.1 g 5 mL
1 . 1
mL 2 mL
.
1) 2.5 g 50
mL .
30 mL 70 mL . .
.
2) 1.0 g 100 mL 0.1
9 (KP IX) [ 1 ]
41
3) 0.20 g .
0.01 mol/L 0.84 mL (0.15 %
).
0.005 mol/L 0.42 mL (0.1 %
).
5) 2.5 g 50 mL .
4.0 mL 100 mL
1.0 mL 100 mL
. 100 mL 4 mL
0.1 mL 10
2 mL 98 mL

(0.5 % ).
6) 1.0 g 20 mL
15 mL 25 mL
1 .
. 2 mL
50 mL .
2.0 mL (20 ppm ).
7) 67 mg
10 mL 20 w/v% 2 mL
0.1 mL 10 mol/L
20
mL 5
1.0 mL 10 mL
(150
ppm ).
25 mL 2
5 mL
70 1
(1.5 % ).
12.0 % (1 g, 150 , 4 ).
0.2 g 40 mL
· (pH
10.0) 10 mL 0.1 mol/L
.
( :
T· 50 mg).


( ).
.
.
. : 1.449 ~ 1.454
: 1.221 ~ 1.230
. .
.
Concentrated Glycerin
( ).
.
.
.
: 1.470 .
: 1.258 .
.
0.40 mL 50 mL .
2) 2 mL 8 mL
.
9 (KP IX) 2007
42
).
).
10) 5 mL
.
6) 5.0 g 1
. 2.5 mL
(5 ppm ).
.
8) 1.0 g 1
(2 ppm ).
1.0 g 1 mL 60
5 .
3 5

.
.
1 mL 0.05 mg
. 0.5 Lμ
.
AT
AS .
0.1 % .
T
T
S

A ATS .

0.1 % ,
1.0 % .
100= (%) × TSA Ai

: 0.53 mm, 30 cm
·
.
.
:
: 1 : 10
1 mL 0.5 mg
. 0.5 Lμ

7.0 .
3
15.0 % .
10 mL 15
0.1 mol/L
0.1 mol/L 3.0 mL
( : 3 ).
.
5 mL 18 ~ 20
1
H .
10 g

1 ~ 2
0.01
% .
43
(C27H33N3O6 S) 98.0 ~ 101.5 % .
.


.
50
.

.
.
1) 1.0 g 2
. 1.0
mL (10 ppm ).
2) 0.1 g
· (1 : 1) 10 mL
(1) .
· (1 : 1) 0.0030
w/v% (2) .
3.0 mg · (1
: 1) 100 mL (3) .
(2) (3) (4)
.
. , (1), (2),
(3) (4) 10 Lμ
( )
. · · ·
(45 : 45 : 5 : 5)
10 cm .

(3)
(0.3 %) (2)
(0.3 %).
(4)
.
1.0 % (1 g, 105 , ).
0. 1% (1 g).
0.3 g
70 mL 0.1
mol/L
.
(C15H21N3O3 S) 99.0 ~ 101.0 % .
.

.


1) 1.5 g 2
. 1.5
mL (10 ppm ).
2) 0.4 g
2.5 mL 10
mL 10 4 30
.
[2- -
[c] ] 20.0 mg
100 mL 1.0 mL
12 mL 50 mL
(1) . (1) 1.0 mL
9 (KP IX) 2007
44
(2) . (2) 50 Lμ


(2)
(2 ppm).
3) 50 mg
23 mL 50 mL
. 1.0 mL ·
(55 : 45) 100 mL
10.0 mL · (55 :
45) 100 mL (1)
. 5 mg
[1- [C] -2(1H )- )-3
-[(2- ) ] ] 15 mg
23 mL 50 mL
1.0 mL · (55 :
45) 20 mL (2)
. 10.0 mg
45 mL 100
mL 1.0 mL ·
(55 : 45) 100 mL
(3) . , (1) (3) 20 μ
L
.
(3)
(0.1 %),
(1)
(0.1 %),
(1) 2
(0.2 %). (1)
0.2 .
: ( 235 nm)
: 4 mm, 25 cm
5 mμ


50 % .
1.8 .
0.1 % (1 g).
0.25 g
50 mL 0.1 mol/L
( ).
.

CO2 -
49.0 ~ 52.5 % .
~
.

.
1) (1 10) 2 mL→
4 (1 10) 1 mL→

.
.
2) (1 10) 2 mL 3→
mL
.
3) (1 10) 2 mL→
1 mL 1 mL
. 20
mL
.
4) 3) .
5) 3) .
pH 1.0 g 10 mL pH 5.8
~ 6.5 .
1) 1.0 g 10 mL
.
2) 1.0 g 2
. 3.0 mL
9 (KP IX) [ 1 ]
45
(30 ppm ).
3) 1.0 g 3
(2 ppm ).
4) 0.2 g
3 mL 2 mL
. 3 mL
1000 mL . 2 mL
3 mL
. 2 Lμ


QT QS . (3.0 % )
0.7936= (mg) ×× S
T

:
: 3 mm, 3 m 150 ~ 180
mμ
.
:
.

,
4 .
6
2.0 % .
( : 105 , : 30
).
25 mg
2 mL
100 mL . 2 mL
25 mL
. 5 mL, 10
mL 15 mL
25 mL .


.
:

(C15H16O2 ) 98.0 ~ 101.0 % .
.

.
1)

.
2)
.
1) 1.0 g 2
. 1.0
mL (10 ppm ).
2) 0.1 g
100 mL
. 10 L

2.7 0.3 %
0.1 % ,
0.8 % .
F :
2.7 0.10,
0.93 0.25,
1.2 0.42,
0.85 0.94,
46
A :
.


1 mg/mL 1 g/mLμ
. 10 Lμ

1.0 0.9
, 1.5 .
: 10 Lμ
5
2.0 % .
0.1 % (1 g).
0.1 g
100 mL .
0.1 g
100 mL
. 10 L

AT AS .
S
T

: ( 254 nm)
: 4.6 mm, 15 cm
4 mμ
: A B
.
A - · (999 : 1)
B - ·

2.0 % .

C14H14N2·HCl : 246.74
(C14H14N2 ·HCl) 98.5 ~ 101.1 % .

.

.
: 255 ~ 260 ( )
1) (1 100) 10 mL→
5 mL
.
2) (1 100) 30 mL→
2 mL 25 mL 2
.
. 80 1
117 ~ 120 .
3) 2) 20 mg 2 ~ 3
5 mL 2 mL
.
4) (1 10)→
.
pH 0.10 g 10 mL
pH 5.0 ~ 7.0 .
1) 1.0 g 10 mL
.
( ) A (vol%)
B (vol%)
0 ~ 12 60 40
12 ~ 28 60 20→ 40 80→
28 ~ 29 20 60→ 80 40→
29 ~ 30 60 40
9 (KP IX) [ 1 ]
47
2) 1.0 g 2
. 2.0 mL
(20 ppm ).
0.1 % (1 g).
0.4 g
· (7 : 3) 50
mL 0.1 mol/L (
).
.

(C14H14N2·HNO3 ) 98.5 ~ 101.0 % .

.
.
1) (1 100) 10 mL→
5 mL
.
2) (1 100) 200 mL→
5 mL 25 mL 2
.
. 80 1
117 120 .∼
.
167 ~ 170
pH 0.1 g 10 mL
pH 5.0 ~ 7.0
1) 0.5 g 50 mL
.
2) 1.0 g 2
. 2.0 mL
(20 ppm ).
0.1 % (1 g).
0.4 g
· (4 : 1) 50 mL
0.1 mol/L ( :
3 ).
.
C14H14N2·HNO3

98.5 ~ 101.0 % .

.

.
.
1) 10 mg 5 mL
5 mL 2 mL
(1 100) 5 mL→
~ .
5 mL
.
· 4 mL N, N'-
· 1 mL
20
. · 1 mL
.
3) (1 →
9 (KP IX) 2007
48

.
.
: +63.0 ~ +68.5°( 0.1
g, , 10 mL, 100 mm)
154 ~ 158
.
400 nm
0.070 .
2) 2.0 g 2
. 2.0 mL
(10 ppm ).
3) 2.0 g 3
(1 ppm ).
. 0.10 g ·
(1 : 1) 10 mL . 2
mL · (1 :
1) 100 mL . 5 mL
· (1 : 1)
50 mL .
.
10 Lμ
( ) .
· · ·
(50 : 30 : 17 : 3)
12 cm .
( 254 nm)

.
0.1 % (1 g).
0.5 g
(4 5) 100 mL→
0.1 mol/L
( : 3 ).
.
0.1 mol/L 1 mL

Naproxen Tablets
(C14H14O3 : 230.26) .
.
(1
: 1)
2 .
1 0.1 mol/L
(pH 7.4) 900 mL 2
50 . 45


332 nm
.

.
.
0.1 mol/L (pH 7.4) 2.62 g 11.50 g
1000 mL .
.
20
. (C14H14O3 ) 0.25
g .

· (90 : 10) 1 mL
2.5 mg .
S
T
C : ( g/mL)μ
.
49

(C14H13NaO3 ) 98.0 ~ 102.0 % .
~ .


.
: 255 ( )
(1 40000)→

.

.
: -15.3 ~ -17.0°( 0.5
g, 0.1 mol/L , 10 mL, 100 mm)
1) 1.0 g 20 mL
1 mol/L 5 mL
20 mL, 20 mL 10 mL 3 .
1
. 2.0 mL
(20 ppm ).
5.0 mL .

1 mL 20 mg
. 1 mL, 3 mL 5 mL
100 mL
1 mL
10 mL (1), (2)
(3) .
. , (1), (2)
(3) 10 Lμ
. ·
· (30 : 3 : 1)
15 cm
. ( 254 nm)


(3)
.
(1), (2) (3) (
0.1 %, 0.3 % 0.5 % )
2.0 % .
25 mL 15
mL 3 .

0.1 mol/L
· (3 : 1) 10 mL
0.1 mol/L
2.2 mL (1.0 % ).
1.0 % (1 g, , 105 , 3 ).
0.2 g
p - 2 0.1
mol/L 50 mL
0.1 mol/L .
0.1 mol/L 1 mL = 25.224 mg C14H13NaO3
.
(C14H13NaO3 : 252.25)
.
.
1)
0.25 g
12 mL 1 mL
.
.

2 .
1 0.1 mol/L
(pH 7.4) 900 mL 2
50 . 45

(C14H13NaO3 ) 1
mL 50 gμ

9 (KP IX) 2007
50
1 mL 50 gμ
.
45 80 %
.
0.1 mol/L (pH 7.4) 2.62 g 11.5 g
1000 mL .
.
20
. (C14H13NaO3)
0.275 g 100 mL
10 mL

. 1 mL
2.0 mL
100 mL .

· (90 : 10) 1 mL
2.75 mg . 1 mL
2.0 mL
100 mL .
20 Lμ

QT QS
.
S
T
C : ( g/mL)μ
: ( 254 nm)
: 4.6 mm, 15 cm
5 mμ
: 49 : 1)

,
11.5 .
6
1.5 % .
(C19H21NO4 ·HCl) 98.5 ~ 101.0 % .
~
.

.
1) (1
10000)→
.

.
3) (1 50) 2)→
.
0.25 g, , 10 mL, 100 mm)
pH 0.10 g 10 mL
pH 4.5 ~ 5.5 .

. 80 mg 10 mL
. 1 mL
200 mL .

9 (KP IX) [ 1 ]
51
.
· (20 : 1)
12 cm
. ·
1
.
(1 100) 60 mL→
.
( ) ]
0.2 % (0.1 g)
0.3 g
80 mL .
80 mL 0.1 mol/L
( ).
.
0.1 mol/L 1 mL
= 36.384 mg C19H21NO4·HCl
Nalidixic Acid
N NH3C
99.0 ~ 101.0 % .
~
.
.
.
(1 200000)→

.
2)

.
225 ~ 231
1) 2.0 g 50 mL
70 5 .
25 mL 6 mL 50 mL
. .
0.01 mol/L 0.35 mL (0.012 %
).
2) 1.0 g 2
. 2.0 mL
(20 ppm ).
3) 20 mg 0.01 mol/L
20 mL . 5 mL
10 mL .
2 mL
1000 mL .
10 Lμ
.


.
2.5
.
: 4.6 mm, 15 cm
5 mμ
: 6.24 g 950
mL pH 2.8
1000 mL . 300 mL 200
mL .
.

: 5 mL
10 mL . 10 Lμ

40 ~ 60 % .
(1 : 1) 1 mL
10 mL . 5 mL 5 mL
. 10 Lμ
,
13 .
52
6
2.0 % .
0.2 % (1 g).
0.3 g
50 mL 0.1 mol/L
(
· (89 : 11) 13 mL
.
0.1 mol/L 1 mL
C23H46N6O13·3H2SO4 : 908.88
.
1 mg
(C23H46N6O13 : 614.65) 600 g ( )μ
.
.
.
1) 5 mg 2 mL
. 6 ~ 8 mL
.
2) (1 1000) 5 mL→
1 mL 0.5 mL 10
.
3) 0.1 g 2 mL
. 1
.
pH 0.33 g 10 mL pH 5.0
~ 7.5 .
.
(1) ( )

1.5 g 15.0 ~ 20.0 g
1000 mL 1
mol/L pH 7.8 ~
8.0 .
650 nm
80 %
.
(3) 20 mg ( ) 0.1
mol/L (pH 8.0) mL 1
mg ( )
. 0.1
mol/L (pH 8.0) mL 80.0
20.0 g ( )μ
.
20 mg ( )
0.1 mol/L (pH 8.0)
mL 1 mg ( )
. 5 30
.
0.1 mol/L (pH 8.0) mL
80.0 20.0 g ( )μ
.
)(8)
.
9 (KP IX) [ 1 ]
53

(C13H22N2O6S ) 98.0 ~ 102.0 % .
.
.
1)
(1 2000)→

.

.
145 ~ 149
pH 1.0 g 10 mL
pH 3.0 ~ 5.0 .
1) 1.0 g 10 mL
.
2) 0.20 g 10 mL
1 mL 1 mL
.
3) 0.1 g 5 mL
1 mL
1 mL
.
0.1 % (1 g).
50 mL
. 10 Lμ

AT AS .
S
T

: ( 259 nm)
: 4.6 mm, 15 cm
5 mμ
: 3.12 g 1000 mL
pH 3.0 .
0.871 g .
890 mL 110 mL .
: 9
.
25 mg 50 mL .
10 Lμ
,
6
1.0 % .
.
107.0 % (1322
26 : 334.39) .
.
.
.
pH : 5.0 ~ 6.5
5 mg
10 mL .
257 ~
261 mn .
.
EU .
9 (KP IX) 2007
54
105 3 25
mg 50 mL
. .
S
T

(C12H19BrN2O2 ) 98.0 ~ 102.0 %
.
.
.

.
.
171 ~ 176 ( ).
0.25 g 10 mL
3 mol/L 1 mL 1 mL
.
2.0 % (1 g, 105 , 3 ).
0.15 % (1 g).
0.75 g
70 mL 20 mL
0.1 mol/L
( :
4 ). .
0.1 mol/L 1 mL
1 mg
(C21H41N5O7 : 475.58) 595 g ( )μ
.
1)

.
2)
mL 1 mg
.
. 10 Lμ

. · ·
(60 : 30 : 25)
. 1 %

.
30 mg, , 10 mL, 100 mm)
pH 0.4 g 10 mL pH 3.5
~ 5.5
.
9 (KP IX) [ 1 ]
55
EU .
1.0 % (1 g)
)(2) ( ) .
, pH 7.8 ~ 8.0 .
(2) Staphylococcus epidermidis ATCC
(3) 0.1 mol/L
(pH 8.0) mL 1 mg ( )

0.1 mol/L (pH 8.0) mL
0.100 g ( )μ
.
0.1 mol/L (pH 8.0) mL
1 mg ( ) .
5 7 .
0.1
mol/L (pH 8.0) mL 0.064,
0.080, 0.100, 0.125 0.156 g ( )μ
mL 0.100 gμ
( ) .
,
)(4) .
(5 )

Norgestrel
O
H
H
H
H2C
H
H3C
OH
(C21H28O2 ) 98.0 ~ 101.0 % .
.


.
1) 1 mg 2 mL
1 mL .
( 365 nm) .
2)

.
206 ~ 212
.
(1 10) 10 mL .→
1 mL 4
. 2.0 mL
(20 ppm ).
2) 30 mg 5 mL
. 1 mL
100 mL
.
. 10 Lμ
( )
. ·
(2 : 1) 10 cm
. (
254 nm)
.
0.5 % (1 g, 105 , 3 ).
0.2 % (0.5 g).
0.2 g
40 mL (1 →
20) 10 mL 0.1 mol/L
( ).
.
0.1 mol/L 1 mL
56
(C20H26O2 ) 97.0 ~ 103.0 % .
~
.

.
.
1) 2 mg 2 mL
.
10 mL
.
2) 25 mg 50 mg
50 mg 25 mL
3.5 mL 5
. 15 mL
. 1 ~ 2 mL
( , )
5 112 ~ 118 .
: - 23 ~ - 27°( 0.25
g, , 25 mL, 200 mm)
203 ~ 209
).
0.1 % (0.5 g).
0.2 g
40 mL (1
20) 10 mL 0.1 mol/L→
( ).
.
0.1 mol/L 1 mL

Norethisterone Tablets


(C20H26O2 : 298.42) .
.
50
mg 15 mL 15
.
. 10 mL 2
.
25 mL 1 ~ 2
. 3 mL
.


.
. 15
.
.
20
. (C20H26O2)
0.7 mg 50 mL

10 .
10.0 mL
2.0 mL
30
. 10.0 mL
2.0 mL .
10.0 mL
2.0 mL
30 .

1 mL 14 gμ
10.0 mL
2.0 mL 30
.
380 nm
,
,
AT, AB AS .
S
BT
57

(C22H28O3 ) 97.0 ~ 103.0 %
.
.
.

.
0.50 g, , 25 mL, 100 mm)
1) 0.5 g 25 mL
.
0.1 g
10 mL
1 mL 150, 50, 30 10
(1), (2),
(3), (4) .
. ·
(1 : 1) 15
cm .
· 100 5

(2)
(1)
.
mL . 1.0 mL
100 mL .
20 Lμ
.

1/2 (0.5 %)

(1.0 %).
0.025 .
: ( 254 nm)
: 4.6 mm, 25 cm
3 ~ 10 mμ
.
:

100 mL . 20
Lμ
,
40 mL (1 10)→
10 mL 0.1 mol/L
( ).
.
7.13 ~ 7.17 % .
0.1 mol/L 1 mL
= 2.503 mg -C CH≡
0.1 g
200 mL . 5.0 mL
250 mL .

240 nm AT AS
.
= (mg) ×
9 (KP IX) 2007
58

Norepinephrine
HO
HO
CCH2NH2
OHH
(C8H11NO3 ) 98.0 ~ 101.0 % .
~
.
.
.
.
1) 0.1
mol/L ( 3 100000 )→

.
2)

.
1) 0.10 g 0.1 mol/L
10 mL 100 mL
.
310 nm
0.1 .
3) 10.0 mg
(1 2) 2.0 mL 1 mL→
10 mL .
(1 100) 0.3 mL 1→
.
2.0 mg 90 mg
10 mL 1 mL
(1 2) 1.0 mL→
10 mL .
1.0 % (1 g, , , 18 ).
0.1 % (1 g).
0.3 g
50 mL
0.1 mol/L ( :
2 ).
.
.
0.1 mol/L 1 mL = 16.918mg C8H11NO3

.
110.0 % (C8H11NO3 :
169.18) .
0.01 mol/L .
.

.
A B
1 mL A pH 3.5
10 mL , B pH 6.5 10 mL
. 1.0 mL 5
2.0 m A
~ B
.
10 mg
20 mL .
310 nm
0.10 .
5 mg
(1 2) 1 mL 10 mL→ 3) . .
.
(C8H11NO3 )
9 (KP IX) [ 1 ]
59
25 mL .
( ,
) 24 10 mg
25 mL
. 5 mL
0.2 mL
1
2 mL
. 0.05 mol/L
pH 6.5 pH 6.5
10 mL 3 .

1 50 mL
. 5
.
515 nm AT
AS .
×× S
T
.
.

(C19H21 N·HCl) 98.5 ~ 101.0 % .
~
.


.
1.0 g 100 mL pH 5.5
.
1) (1 100) 5 mL→
1 mL .
2) (1 100) 5 mL→
(1 40) 1 ~ 2→
.
100000)

.

5) (1 100)→
.
1) 0.10 g 10 mL
~ .
2) 1.0 g 2
. 2.0 mL
(20 ppm ).
3) 1.0 g 3
(2 ppm ).
mL . 2 mL
100 mL .
5 mL
50 mL .
.
4 L (μ
) .
· · (8 : 1 : 1)
15 cm
. ( 254 nm)

.
0.1 % (1 g).
0.5 g
5 mL
50 mL 0.1 mol/L (
).
.
9 (KP IX) 2007
60

Norfloxacin
N
C2H5
COOH
O
F
N
HN
(C16H18FN3O3 ) 99.0 ~ 101.0 % .
~ .


.
.
1) 10 mg
(1 250) 10 mL→
. 5 mL (1 250)→
100 mL

.

.

.
30 .
10 mL
1 mL
50 mL . .
0.005 mol/L 0.5 mL 0.5 mol/L
7 mL, 1
(1 3)→
1.5 mL, 1 ~ 2
50 mL (0.024 % ).
2) 2.0 g 2
. 3.0 mL
(15 ppm ).
3) 1.0 g 3
(2 ppm ).
0.10 g · (1 : 1) 50 mL
. 1 mL
· (1 : 1) 100
mL . 2 mL ·
(1 : 1) 10 mL
.
. 20 Lμ
( 5 ~ 7 m,μ
) . ·
· · · (20 : 20 :
10 : 7 : 4) 9 cm
. ( 254
nm 366 nm)
2
.
0.1 % (1 g).
0.5 g
50 mL 0.1 mol/L
( ).
.
0.1 mol/L 1 mL

98.5 ~ 101.0 % .

.
.
9 (KP IX) [ 1 ]
61
20000)→
.
.
: +42 ~ +48°( 0.5 g,
0.1 mol/L , 25 mL, 100 mm)
174 ~ 177
1) 0.7 g 20 mL
6 mL 50 mL .
. 0.01 mol/L
0.4 mL 20 mL, 6 mL
50 mL (0.02 % ).
2) 2.0 g 2
. 2.0 mL
(10 ppm ).
3) 10 mg 1 mL -α
- - 5 mLβ
(1 10) 2 mL 40 2→
. (1 5000)→
1 mL 40 5
10 mL

.
4) 0.7 g 50 mL
. 5 mL
50 mL . 5 mL
100 mL
.
. 10 Lμ

(60 : 60 : 9 : 2)
10 cm .
·
.
0.5 % (2 g, 105 , 4 ).
0.1 % (1 g).
0.8 g
30 mL 0.1 mol/L
( : 3 ).
.
0.1 mol/L 1 mL = 41.34 mg C22H23NO7
.

.
~
.
,
.
1) 1 mg · 1

.
200) 1 .
3) 20 mg 1 mL
3
.
4) 1 mg (1 35) 1 mL→
(1 50) 5→
2 mL 1
.
5) 0.1 g 10 mL
10 mL
. 5 mL
.
1 mL .
105 4 174 ~ 177
.
.

2) .
10 mg 1 mL α
- - - 5 mL (1β
10) 2 mL 40 2 .→
9 (KP IX) 2007
62
5 10
mL
.
9.0 % (0.5 g, 120 , 4 ).
0.5 % (1 g).
0.5 g
· (7 : 3) 50 mL
0.1 mol/L (
).
.

(C21H26N2O7 ) 98.5 ~ 101.5 % .

.
.
.
.

.
2)
.
mL, 100 mm)
2.5 mL
25 mL .
40 mg
2.5 mL 25
mL 1.0 mL
100 mL 2.0 mL
10 mL (1) .
[2- -1- -2,6-
-4-(3- ) -3,5-
] 20 mg
2.5 mL
25 mL 5.0 mL
100 mL (2) . (1)
2.5 mL 100 mL
(3) . (2) 1.0 mL
(3) 1.0 mL 25 mL
25 mL (4)
. , (1) (4) 20 Lμ

Ai
(4) AS
0.1 %
0.2 % 0.5 % .
S
T
C : (4) A
(mg/mL)

: ( 235 nm)
: 4.6 mm, 12.5 cm
3 ~ 10 mμ
.
: · · (3 : 1 : 1)
: 2 mL/

1.5 .
5
2.0 % .
0.5 % (1.0 g, 105 , 4 ).
0.1 % (1 g).
63
0.180 g t -
25 mL 25 mL
.
0.1 mL 0.1 mol/L .
.
0.1 mol/L 1 mL = 20.92 mg C21H26N2O7
15 ~ 30
.

.
1 mg
A1 (C47H75NO17 ) 4400 ( )
.

.
1) 10 mg
1 mol/L 0.25 mL
(4 5)→ 50 mL 50
(4 5)→
500 mL

.
2) 10 mg 5 mL
· 2 1
.
pH 0.3 g 10 mL pH
6.5 ~ 8.0 .
)(2)( )
.

1 % (pH 6.0) mL
300 150 ( )
.
10 mg
mL 3000 ( )
. 5 3
.
1 % (pH 6.0) mL
300 150 ( )
.
)(8)
.

(C12H21N6O2S2 ) 98.0 ~ 101.0 % .

.
,
.
1)

.
2)
9 (KP IX) 2007
64
1) 0.1 g 2
. 1.0 mL
(10 ppm ).
· (76 : 24)
10 mL .
50 mg
· (76 : 24) 100
mL 5.0 mL ·
(76 : 24) 50 mL
(1) . (1)
· (76 : 24)
1 mL 25 15 g/mLμ
(2) (3) . , (1),
(2) (3) 50 Lμ

(2) 3
(1.5 %), (3)
(0.3 %).

: ( 254 nm)
: 4.6 mm, 15 cm
5 mμ
: A B
.
A -
B -
12 .

2.0
.
5.9 g
760 mL 0.1 mol/L
1 mL pH
7.5 .
0.1 % (1 g).
15 mg
50 mL .
15 mg
50 mL .
10 Lμ
AT
AS .

: ( 254 nm)
: 4.6 mm, 15 cm
5 mμ

1500
2.0 .
5
1.5 % .

( ) A (vol%)
B (vol%)
3 ~ 20 76 50→ 24 50→
20 ~ 45 50 50
45 ~ 50 50 76→ 50 24→
50 ~ 70 76 24
9 (KP IX) [ 1 ]
65

.
,
.
.
(1 100000)→

.
2)

.
3) 20 mg 10 mL 3 mL
.
167 ~ 171
1) 1.0 g 4
. 2.0
mL (20 ppm ).
2) .
0.10 g 50 mL
. 1 mL
50 mL . 1 mL
10 mL
. 10 Lμ
.


.
2
.
: ( 254 nm)
: 4.6 mm, 15 cm
5 mμ
(3 : 2),
.

: 2 mg
50 mL . 10 Lμ
,
3 .
6
3.0 % .
: 2 mL
20 mL . 20 Lμ

8 ~ 12 % .
:
4 .
0.1 % (1 g).
.
0.9 g ·
(7 : 3) 100 mL 0.1
mol/L (
0.1 mol/L 1 mL
= 51.60 mg C26H29N3O6·HCl

98.0 ~ 101.0 % .

.
.
1) 10 mg 2,4-
20 mg 2 mL 5
· 4
mL .
2) 0.1 g 5 mL
5 .
3) 1 mol/L (1
100000)→
66
.

.
181 ~ 185
10 mL .
2) 1.0 g 50 mL
5 . 25 mL
0.01 mol/L 0.60 mL
2 .
3) 0.6 g 15 mL
50 mL .
. 0.01 mol/L 0.40 mL
15 mL 50 mL (0.024 %
).
4) 1.0 g 2
. 2.0 mL
(20 ppm ).
5) 1.0 g 3
(2 ppm ).
. 1 mL
20 mL . 2
mL
20 mL .
.
10 L (μ
) .
· · · (5
: 3 : 1 : 1) 10 cm
. (
254 nm)
.
1.0 % (1 g, 105 , 4 ).
0.1 % (1 g).
1.5 g
0.5 mol/L 40 mL
( )
10 .
0.25 mol/L ( :
3 ).
.
.
(C34H32N4O9 : 640.64) .
.

0.5 g 20 mL
.
. 1) 2) .
1
1 900 mL 2 75
. 60
20 mL 0.8 mμ
. 10 mL
2 mL 1
25 mL .
105 4 0.1 g
1 100 mL .
2 mL 1
100 mL .

262 nm AT AS .
60 75 %
.
225 =
S
943234
××× CA
.
20
. (C34H32N4O9 ) 1 g
1 mol/L 100
mL 500
mL . 50 mL
2 mL 1 mol/L
50 mL 250 mL
. 105 4
80 mg 1 mol/L
50 mL 100 mL
. 2 mL 1 mol/L
20 mL 100 mL
9 (KP IX) [ 1 ]
67
262 nm
AT AS .
2
×× S
T
99.5 ~ 101.0 % .

.

.
.
10 mg 5 ~ 6
· 4 mL
.
1000 mL

.
234 ~ 238
pH 0.20 g 20 mL pH 3.0
~ 4.0 .
1) 0.20 g 20 mL
.
).
3) 1.0 g 3 mL
50 mL .
. 0.005 mol/L 0.40 mL
3 mL 50 mL (0.019 %
).
4) 1.0 g 8
mL 20 mL
A .
5) 1.0 g 2
. 2.0 mL
(20 ppm ).
0.1 % (1 g).
0.3 g
50 mL 0.1 mol/L
( : 5 ).
0.1 mol/L 1 mL
110.0 % (C6H5NO2 : 123.11)
.
.

.
.
pH : 5.0 ~ 7.0
0.3 mL
2 mL .

105 1
234 ~ 238 .
1) . 2) 1) 20 mg 1000 mL
.
261 ~ 263 nm
, 235 ~ 239 nm
.
A1 , A2
A2/A1 0.35 ~ 0.39 .
9 (KP IX) 2007
68

(C6H5NO2 ) 0.1 g

100 mL . 10 mL
10 mL
100 mL .
105 1 0.1 g
100 mL .
10 mL 10 mL
100 mL
. 10 Lμ


QT , QS .
: ( 260 nm)
: 4 mm, 15 cm
5 mμ
: 1.1 g pH 3.0 0.05
mol/L · (4
: 9
.

,
10 .
6
1.0
.
(C6H6N2 O) 98.5 ~ 102.0 % .

.
.
10 mg 5 ~ 6
· 4 mL
.
2) 20 mg 5 mL

.

.
pH 1.0 g 20 mL pH 6.0
~ 7.5 .
128 ~ 131
1) 1.0 g 20 mL
.
).
).
4) 1.0 g 1
. 3.0 mL
(30 ppm ).
0.5 % (1 g, , , 4 ).
0.1 % (1 g).
25 mg 3mL
100 mL .
9 (KP IX) [ 1 ]
69
8 mL
50 mL . 5 mL
5 mL
. 20 Lμ


QT QS .
S
T
: 4.6 mm, 25 cm
5 mμ
: 1- 1.0 g
1000 mL . 700 mL 300 mL
.
.
,
5 .
6

1.0 .
110.0 % (C6H6N2O :
122.13) .
.
.
200 mg
10 mL .
2.5 mol/L 1 mL
5 mL 1 mL
.
. 3 mol/L
3 mol/L 1 mL
2 .


105 1 .



.
.
(C6H6N2 O) 50
mg
500 mL . 10 mL
100 mL
. (
) 4 50 mg

. 2 mL
pH 9.2 · ·
10 mL 3 mL 40
60 pH 9.2
· ·
25 mL . 2 mL

398 nm
AT AS .
S
T
70
Nitrazepam
N
(C15H11N3O3 ) 99.0 ~ 101.0 % .
~
.
,

.
0.1 mL
.
2) 20 mg 15 mL 5
.
.
2 mL
.
100000)

.
.
2) 1.0 g 2
. 2.0 mL
(20 ppm ).
3) 1.0 g 3
(2 ppm ).
4) 0.25 g ·
(1 : 1) 10 mL . 1
mL · (1 :
1) 20 mL .
2 mL ·
(1 : 1) 50 mL
.
. 10 Lμ
( )
. ·
(17 : 3) 10 cm
. (
254 nm)
.
0.5 % (1 g, 105 , 4 ).
0.1 % (1 g).
0.4 g
40 mL 0.1 mol/L
( ).
.
.

Nitrendipine
(C18H20N2O6 ) 98.5 ~ 101.0 % .
.

.
.
(1 50)→
.
(1 80000)→

.
.
157 ~ 161
71
1) 2.0 g 4
. 2.0
mL (10 ppm ).
2)
. 40.0 mg 5 mL
25 mL
. 1.0 mL 100
mL . 10 Lμ


A AS

0.8 1.0 % ,
1.3
0.25 %
0.2 % .
2.0 % .
(%) =
: ( 254 nm)
: 6 mm, 15 cm
5 mμ
: · ·
.

: 2 mL
10 mL . 10 Lμ

14 ~ 26 %
3 mg 5 mL
100 mL . 5 Lμ
,
6
.
6
2.0 % .
2.5
0.1 % (1 g).
0.3 g
(3 100) 60 mL→
50 mL 0.1 mol/L
( : 3
). ,
. .
0.1 mol/L 1 mL
18.02 mg C 18H20N2O6

Nitroglycerin Tablets
(C3H5N3O9 : 227.09) .
.
1)
(C3H5N3O9 ) 6 mg
12 mL
. 5 mL
1 ~ 2
1 .
2) 1) 5 mL
5
0.1 mL .
20 mg
.

40 mL 40 mL 10
. 40
mL 10
. 10 mL
30 mL
40 mL 10

. 20
mL 30 mL
· 60 mg
30
.
. , 2
9 (KP IX) 2007
72
.

. 1
1 mL (C3H5N3O9 )
30 gμ V
mL 1
.
,
1
0.05 mL
1 mL (C3H5N3O9)
30 gμ
V mL 1
. 105
4 90 mg
5 mL
100 mL . 5 mL
100 mL
. 2 mL
2 mL
15 10 mL
(2 5) 12 mL→
50 mL
. 2 mL

.
410 nm
AT AS .
(mg) )ONH(C 9353
××× S
T
20
. (C3H5N3O9)
3.5 mg
50 mL 1
.
105 4 90 mg
5 mL
100 mL . 10 mL
100 mL
. 2 mL
2 mL
15 10 mL
(2 5) 12 mL→
50 mL
. 2 mL

.
410 nm
AT AS .
(mg) )ONH(C 9353
.
(C17H18N2O6 ) 98.0 ~ 102.0 % .

.
,
.
.
1) 50 mg 5 mL
5 mL 2 g 5
.
.
2) (1 →
100000)

.
.
172 ~ 175
1) 0.5 g 5 mL
.
2) 2.5 g 12 mL
13 mL .
9 (KP IX) [ 1 ]
73
10 mL 5
mL 6 mL 50 mL
. .
0.01 mol/L 0.30 mL (0.021 %
).
mL 50 mL .
. 0.005 mol/L 0.45 mL
(0.054 % ).
4) 2.0 g 2
. 2.0 mL
(10 ppm ).
5) 1.0 g 3
(2 ppm ).
. 5.0 g ·
(5 : 3) 80 mL 0.02 mol/L
( ).
1.9 mL .
7)
. 25 mg 25 mL
250
mL .
1 mL 1 mg
.
1 mL 0.3 mg
.

1 mL 1 gμ
.
1 mL 0.6 mg
(1) .
1 mL 0.6 gμ
(2) . (1)
(2) 5 mL
5 mL .
25 Lμ

AT AS
.
0.2
% .

. 0.5 % (0.5 g, 105 , 2 ).
0.1 % (1 g).

. 0.12 g
200 mL . 5 mL
100 mL
.
350 nm A
.
40000 142.3
.

Nifedipine Capsules
(C17H18N2O6 : 346.34) .
.
1) 3
0.1 mol/L 20 mL
25 mL

. 1
2000 ~ 2500 10
.
1 mL 1.2 mg
.

.
. , 500 Lμ
(
0.5 mm) . ·
(1 : 1) 15 cm
.
( 254 nm) 0.3
.

.
2)
.
3 g 30 g 3 mol/L 10 mL
100 mL . 10 mL
3 mol/L 10 mL
9 (KP IX) 2007
74
1
1 900 mL 2
50 . 20

.

.

340 nm
.
.
1 mL 1 mg
. 1
mL 0.3 mg
.
1 mg .
1 mL 6 gμ
(1) .

1 mL 1 mg
.
1 mL 1.5 gμ
(2) . (1) (2) 5 mL
5 mL
. 25 Lμ


AT AS
.
2.0 %
-3,5- 0.5 % .
: , (1)
(2) 25 Lμ
,
,
1.5
.
6
10 % .
1 mL
0.1 mg
V mL .

1 mL 1 mg .
1 mL
0.1 mg .
25 Lμ

AT AS .
S
T
C : (mg/mL)
: ( 265 nm )
: 4.6 mm, 25 cm
5 mμ
.
25)

1.5 .
: 25 Lμ
6
1.0 % .
.
75

Nifuroxazide
ONO2
N
(C12H9N3O5 ) 98.5 ~ 101.5 % .
.

.

.
10.0 mg
10 mL
100 mL . 5.0 mL
100 mL .
1) 1.0 g 2
.
2.0 mL (20 ppm ).
2) 1 g
10 mL (1) . (1) 5.5
mL 50.0 mL 15
(1) . (1) 0.5 mL
(4-
) 50 mg 1000 mL
5.0 mL 50.0 mL
15 .
(2) 10 mL
0.5 mL 2 mol/L 10.0 mL
1 .
750 nm
(2)
(0.05% ).
100
mL .
( ) 10 mg
2 mL 20
mL . 1 mL
100 mL (1) .
5 mg 10 mg
2 mL 20
mL . 1 mL
100 mL (2) .
, (1) (2)
20 Lμ
.
(1)
0.6 1 (0.3 %)
(1) 0.2
(0.1 %).
(1)
(0.5 %). (1)
0.1 (0.05 %).

: 4.6 mm, 25 cm
5 mμ
.
:


4 .
6.5 , ,
0.4, 1.2, 2.8 5.2 .
0.5 % (1 g, 105 , 3 ).
0.1 % (1 g).
0.2 g
30 mL
20 mL 0.1 mol/L
( ).
.
0.1 mol/L 1 mL
76

.
1 mg
(C27H29NO10 ·HCl) 900 g ( )μ
.

.
1) 1 ~ 2 mg 1 mol/L
5 mL
.
1000 mL

.
: +250 ~ +275° (
15 mg, , 10 mL, 100 mm)
(495 nm) : 210 ~ 250 (
10 mg, , 500 mL)
pH 50 mg 10 mL pH 4.5
~ 6.0 .
.
. , mL 2.0
mg .

. , mL 5.0 mg
.
8.0 % (0.1 g, , 60 , 3 )
20
mg ( ) 4 mL
20 mL
. 5 Lμ


QT QS .
S
µ
µ
100 mL .
: ( 254 nm)
: 4 mm, 30 cm
10 mμ
pH 2.2 ± 0.2
: 9
.
2- ,
2.0 .
: 5 Lμ
6

2.0 % .
NNa
O
O

(C14H9N4NaO5 : 336.24) 98.0 ~ 101.0 %
.
.
9 (KP IX) [ 1 ]
77
.

.
2)

.
3) 0.1 g 20 mL 2
.
1) .
1) 0.7 g 10 mL

. 5 mL
45 mL, 3 0.1
mol/L 0.10 mL
.
2) 1.0 g 2
. 2.0 mL
(20 ppm ).
3) 50 mg 20
mL 2 mL
100 mL . 1 mL
50 mL
. 10 Lμ

.

.

: ( 300 nm)
: 4 mm, 15 cm
5 mμ
: 10 : 9)
.

: 5 mg 0.1 g
20 mL 2 mL
, 100 mL . 10
mL 100 mL .
10 Lμ
, 6 .
: 10 Lμ
10 ~ 40 % .
:
2
14.5 ~ 17.0 % (0.2 g, )
0.7 g
· (1 : 1) 180 mL 0.1
mol/L (
0.1 mol/L 1 mL
(C12H12N2O2 S) 98.0 ~ 102.0 % .

.
.
.
200000)

.

.
175 ~ 181
1) 0.10 g ·
(1 : 1) 0.5 mL 2 mL
.
.
4 mL 50 mL
. 3 mL
· (1 : 1) 0.5 mL
6 mL 50 mL
.
9 (KP IX) 2007
78

AT AS AT AS
(30 ppm ). ,
.
:
.
2) 0.5 g
50 mL . 1 mL
100 mL (1)
. (1) 10 mL
50 mL (2) .
.
, (1) (2) 10 Lμ
.
· · ·13.5 mol/L
(20 : 20 : 6 : 1)
.
· (1 : 99) 0.1 % 4-

(1)
. ,
(2) .
1.5 % (1 g, 100 ~ 105 , ).
0.1 % (1 g).
50 mg
200 mL . 5 mL
50 mL
. 50 mg

. 10 Lμ

AT AS .
S

: ( 254 nm )
: 4 mm, 30 cm
10 mμ
mL 100 mL
1000 mL .

6
2.0 % .

Desoximetasone
O
(C22H29FO4 ) 97.0 ~ 103.0 % .
.
,
.
1)

2) 0.1 g · (3 : 1)
10 mL .
0.1 g · (3 : 1)
10 mL .
.
20 Lμ
( ) .
· (1 : 1)
10 cm
. ( 254 nm)
p - (1 5)→

.
: +107 ~ -112° ( 0.1
g, , 20 mL, 100 mm).
1.0 g 2
9 (KP IX) [ 1 ]
79
(20 ppm ).
0.2 % ( 1 g).
40 mg
100 mL 10.0 mL
· (1 : 1)
100 mL .
20 mg
50 mL 10.0 mL ·
(1 : 1) 100 mL
. 10 Lμ

HT HS .
S

: ( 254 nm)
: 4.6 mm, 15 cm
3 ~ 10 μ m
.
: 1) , 6
.

1.5
.
5
2.0 % .
(C47H74O19 ) 90.0 ~ 102.0 % .
~
.
.
.
1 mg 10 mm
(1 →
10000) 1 mL 1 mL



.
g, , 25 mL, 100 mm)
1) 20 mg 10 mL
3 mL
100 mL .
2) 10 mg 5 mL
.
1.0 mg 5 mL
.
. 20 Lμ

. · ·
(84 : 15 : 1) 13 cm
.
110 10

.
9 (KP IX) 2007
80
4 ).
25 mL
5 mL (1 10) 0.5→
mL (1
4) 25 mL 18 ~ 22 25→
. (1 →
5) 5 mL
.
485 nm
AT AS .
S
T
.
110.0 % (C47H74O19 :
943.08) .
10 vol% .
. , 10 vol%
.
.
pH : 5.0 ~ 7.0
mg 1
mL 0.2 g
10 mL 3 .
. 15 mL

. 2) 1)
5 mL
. 1
mg 5 mL .
.
20 Lμ
.
· · (84 : 15 : 1)
13 cm .
110 10

.
.
.
(C47H74O19 ) 3 mg
5 mL
25 mL . .
4
×× S
T

(C25H46N6O8·CH4O3 S) 98.0 ~ 102.0 %
.
.
.
: 147 ( )
1) (1 500) 5 mL→
1
.
2) 50 mg 0.2 g
2 ~ 3
. 0.5 mL

.
81

.
pH 1.0 g 10 mL pH 3.5
~ 5.5 .
1) 1.0 g 10 mL
~ .
2) 1.0 g .
0.01 mol/L 0.90 mL (0.032 %
).
).
4) 2.0 g 4
. 2.0 mL
(10 ppm ).
5) 1.0 g 3
. (1 →
10) (2 ppm ).
6) 50 mg 50 mL
. 3 mL
50 mL .
20 Lμ
.


.
: ( 230 nm)
: 4 mm, 20 cm
10 mμ
: 40
: 1.32 g,
0.37 g 1-
1.08 g 950 mL .
pH 2.8 800 mL
100 mL .
.

: 16 mg
4 mg 50 mL . 20 Lμ
,
4 .
: 20 Lμ
5 ~ 20 mm .
:
2
0.1 % (1 g).
20 mL 0.05
mol/L 10 mL
50 mL . 5 mL
0.05 mol/L 5 mL
0.2 mL 50
mL .
0.2 mL 0.05 mol/L
50 mL

430 nm AT
AS .
.
(C24H34O5 ) 98.5 ~ 101.0 % .

.
.
.
1) 5 mg 1 mL 1
5 . 5
mL
.
82
2) 20 mg 1 mL
5
(1 8) 0.5 mL→
~ .
: 29 ~ 32°( 0.2
g, , 10 mL, 100 mm)
233 ~ 242
1) 2.0 g 100 mL
2 .
2) 0.10 g
30 mL 10
.
3) 2.0 g 100 mL 5
.
25 mL 6 mL 6

. 10 mL
50 mL .
. 0.01 mol/L 0.30
mL (0.021 % ).
4) 3) 25 mL 1 mL
6
. 10 mL
50 mL .
. 0.005 mol/L
0.50 mL (0.048 % ).
5) 1.0 g 2
. 2.0 mL
(20 ppm ).
6) 1) 2 mL 2
100 mL
. 10 mL 1 mL
.
0.2 % (1 g).
0.5 g
40 mL 20 mL
2 0.1 mol/L

100 mL .
0.1 mol/L 1 mL
~ 105.0 % (C24H34O5 :
402.52) .
.
~
.
g 10 mL
1 mL .
15 mL 3

105 1
235 ~ 242 .
1.0 g
2
. 2.0 mL (20
ppm ).
0.30 EU .
.
(C24H34O5 ) 0.5 g

50 mL . 5 mL
8.0 mL
50 mL .
50 mg
8.0 mL
50 mL .
10 Lμ

QT QS .
10(mg) =
×× S
T
83
3200)

: ( 280 nm)
: 4 mm, 30 cm
5 ~ 10 mμ
.
:
10 mL
: 12
.
,
5.0 .
6
2.0 % .
.
.

(C24H34O5 ) 99.0 ~ 101.0 % .

.
.
.
. : 29 ~ 32°( 0.2 g,
, 10 mL, 100 mm)
237 ~ 242
1.0 % (1 g, 105 , 2 ).
0.2 % (1 g).
0.1 mol/L 1 mL
Dexamethasone
H3C
(C22H29FO5 ) 97.0 ~ 102.0 % .
~
.
.
: 245 ( )
1) 10 mg 0.01 mol/L
0.5 mL 20 mL

.


.
.


.
84
1) 1.0 g 2
. 3.0
mL (30 ppm ).
2) 0.10 g 10 mL
. 2 mL
1.32 g 1000 mL pH
3.6 100 mL .
1 mL
100 mL . 10
Lμ
.




2 .

: 4.6 mm, 25 cm
5 mμ
.
: 1.32 g 1000 mL
pH 3.6 . 670 mL
330 mL .
.

: 1 mL
10 mL . 10 Lμ

8 ~ 12 % .
5000
1.5 .
6
1.0 % .
4 .
0.1 % (0.2 g, ).
10
mg (1 →
2) 70 mL 5 mL
(1 2) 100 mL→
. 10 Lμ


QT QS .
S
T

(1 2) (1 1000)→ →
: 4 mm, 30 cm
10 mμ
: 6
.

,
6 .
6

1.0 % .

Dexamethasone Tablets
(C22H29FO5 : 392.47) .
.

10 mL
1 mL .
1 mL
500 g .μ

. 10 L 20 Lμ μ
.
· (45 : 4)
15 cm .
9 (KP IX) [ 1 ]
85

.
1
(1 100) 500 mL 1→
100 . 45
200 μ
g 15 mL
3 .
20 mL
. 105 3
mL 10 gμ
. 20 mL
50 mL .

20 mL 50
mg 10 mL 2.0 mL
.
· (1 : 9) 2.0 mL
45 .
525 nm
AT AS
.
S
T
C : ( g/mL)μ
45 70 %
.

. 1 15 mL
. 10 mL
4
50 mL
.
200 g 50 mLμ

20.0 mL .
20 mL
.
.
C : ( g/mL)μ
20
. (C22H29FO5 ) 10
mg 100 mL
(1 2) 30 mL→
30 5 mL
(1 2)→
. .
10 mg 100 mL
(1 2) 30→
mL 5 mL
(1 2)→
. 10 Lμ


QT QS .
·

: 2 mg
4 mg · (1 : 1)
100 mL . 10 mL
,
5.0 .
: 10 mL
6

3.0 % .
86

(C22H28FNa2O8P) 97.0 ~

.


.
1) 20 mg 15 mL
5.0 mL
30 . 5.0
mL
. 15
mg 5 mL

.
. 10 Lμ

· · (180 : 15
: 1) 15 cm
. (
254 nm)
.
2)
.
pH (1 100) pH 7.5 ~ 10.5→
.
0.1 g, , 10 mL, 100 mm)
1) 0.5 g
10 mL 5 mL

. (1 50)→
25
4 mL
10 mL 5 mL

. 2 Lμ


QT QS .
S
T
S : (%)
W : (g)
· (1 100)→

:
: 4 mm, 1.8 m
80 ~ 100
:
2 1.5
.
6
4.0 % .
mL 10 mL
1 mol/L 5 mL
. A
B 1 mL
. 30
. 5 mL
.

730 nm

(PO4 1.0 % ).
143.3 mg 1000 mL (0.10 mg
PO4/mL).
A 5 g 0.5 mol/L 100 mL
B p - 0.35 g
50 mL 20 g
9 (KP IX) [ 1 ]
87
3) 20 Lμ

AT
AS (1.0 % ).
T1 A AC ××000=g)( )FOH(C 52922 µ
C : ( g/mL)μ
).
50 mg
100 mL . 5 mL
50 mL
. 40 , 0.67 kPa

1 mL 0.5 mg
(1 ). 105 3

· (1 : 1) 1 mL 50 gμ
(2 ). 1 10.0 mL 2
1.0 mL 100
mL . 20 Lμ

.
AT AS .
C : ( g/mL)μ
: ( 254 nm)
: 4.5 mm, 25 cm
5 mμ
: 7.5 mL 1000
mL pH 5.4 .
74 : 26 .
: 1.2 mL/


1.8 .
6
1.0 % .
.
.
3.1 g, 0.203 g
0.86 g 1000 mL (pH
9.0 ). 50 mL
50 mg 5 mL 5 mL
50 mL . 37
45 25 mL
2 .
. , 15 mL
.
3 mg 150 mL
. · 65 mL
.
45 mL 125 mL 1
100
mL . · 15
mL ,
.
·
. 40 , 0.67 kPa

· 1 mL
30 g .μ
. 20 Lμ

AT
9 (KP IX) 2007
88
C : ( g/mL)μ
: ( 254 nm)
: 4 mm, 30 cm
5 ~ 10 mμ
.
:
(52 : 48)
5
1.5 % .

(C22H30FO8 P : 472.45) 90.0 ~ 115.0 %
.
.
10 mg
100 mL
100 mL .
5 mL 125 mL
10 mL .
50 mL
50 mg pH 9.0 50 mL
5 mL 37
45 25 mL
. 15 mL
1 mL .

1 mL 300 g 5 Lμ μ

. (1 2)→
105
.
.
31.3 EU .
(C22H30FO8 P)
8 mg
100 mL .
40 , 0.67 kPa

1 mL 80 gμ
. . 20
Lμ
.
AT AS .
C : ( g/mL)μ
V : (mL)
: ( 254 nm)
: 4 mm, 30 cm
5 ~ 10 mμ
.
:
mol/L
: 20 Lμ
5
1.5 % .
9 (KP IX) [ 1 ]
89
(Lactobacillaceae )
40000 .
40 98.0 ~
102.0 % .

.
.
.
. (1 →
2) 1 mL 1 mL
.
pH 1.0 10 mL pH 5.0
~ 7.0 .
.
2) 2.0 .
0.01 mol/L 1.0 mL (0.018 % ).
3) 1.0 1
. 2.0 mL
(20 ppm ).
4) 1.5 g 1
(1.3 ppm ).
5) 2
(N : 14.007)
0.010 % . ,
10 mL , (2 5)→
45 mL .
6) 3.00
50 mL
. 0.450
500 mL
. 5 mL
50 mL .
5 mL 5
mL 15 .
(1 40) 1 mL→
1.5 mL 0.005 mol/L
( : 2 mL).
.
5.0 % (1 , 105 , 6 ).
0.1 % (1 ).
0.5 100 mL
. 25
1
0.16 ~ 0.19 .
25 ± 1
7 ~ 10 % (
80 ~ 90 mL) . 35

25 ± 1 15
.
1)
0.27 .
25 ± 1
90 ~ 93 % (
115 ~ 135 mL) . 25
.
1)
0.09 .
100 mL . 250
~ 300 g 4
1 3 , 5
1.0 mL .
0.10 mL .
15 2 , 22 2
, 0.2 mL
,
0.2 mL .
30 24 ,

. ,
4
3 .
100 mL .
3 g
50 mL
. 20 ± 1
100 mm α D .
40 (mg) = αD×253.8
.
90
~ 10.5 w/v% .
40
.

.
1) 1 mL 200 mL
1 mL 2 mL
.
(1 2) 1 mL→
1 mL .
2)
.
100 mL .
25
1 0.16 ~ 0.19 .
, ( /100 mL)
.
.
.
.
30 mL
50 mL .
20 ± 1
100 mm αD .
100 mL 40 (mg)
= αD×846.0
.
(Lactobacillaceae )
70000 .
70 98.0 ~
102.0 % .

.
.
.
40 . pH 3.0 50 mL pH 5.0
~ 7.0 .
.
2) 2.0 .
0.01 mol/L 1.0 mL (0.018 %
).
3) 1.0 1
. 2.0 mL
(20 ppm ).
4) 1.5 g 1
(1.3 ppm ).
5) 2
(N : 14.007)
0.010 % . ,
10 mL (2 5)→
45 mL .
6) 3.00
50 mL
. 0.300
500 mL
. 5 mL
50 mL .
5 mL 5 mL
15 .
(1 40) 1 mL 1.5→
mL 0.005 mol/L
( : 2 mL).
.
5.0 % (1 , 105 , 6 ).
0.1 % (1 ).
0.5 100 mL
. 25
9 (KP IX) [ 1 ]
91
0.21 ~ 0.26 .
25±1 7
~ 10 % (
75 ~ 85 mL) . 35
25
± 1 15
.
1)
0.35 .
25 ± 1
90 ~ 93 % (
110 ~ 130 mL) . 25
.
1)
0.10 .
100 mL .
40 . 6.0
100 mL .
3 g
50 mL
. 20 ± 1
100 mm α D .
70 (mg) = αD×253.8
.
~ 6.3 w/v% .
40
.

.
1) 1 mL 200 mL
1 mL 2 mL
.
(1 2) 1 mL→
1 mL .
2)
.
.
4 ~ 8 mL
100 mL .
25
1 0.21 ~ 0.26 .
, (g/100 mL)
.
= αD×507.6
.
(C18H25NO·HBr : 352.31)


9 (KP IX) 2007
92
3 )
(1 10000)→

.
2)
.
2
. 50 mL
40 mL 5 mL
.
: +26 ~ +30° ( ,
0.34 g, , 20 mL, 100 mm)
pH 1.0 g 100 mL pH 5.2
~ 6.5 .
1) 0.20 g 20 mL
.
2) 0.50 g 20 mL
2
mL, 1 mL 25 mL
.
0.10 g 400 mL
500 mL . 5 mL 200 mL
. 1.0 mL 2 mL,
1 mL 25 mL .
3) 1.0 g 4
. 2.0 mL
(20 ppm ).
1 mL 2
2 15
.
5) 0.25 g 10 mL
. 1 mL
200 mL
.
. 5 Lμ

: 13 : 10 : 2) 15 cm
.


.
4.0 ~ 5.5 % (0.2 g, , ).
0.1 % (1 g).
0.5 g
10 mL 40 mL
0.1 mol/L (
.
(C18H23NO3 ·HCl) 98.0 ~ 101.0 % .
~
.
.
(1 100) .→
1)

2) (1 50) 2)→
.
188 ~ 191
pH 1.0 g 100 mL pH 4.0
~ 5.5 .
1) 0.5 g 30 mL
.
2) 1.0 g 40 mL
2 mL
50 mL . .
9 (KP IX) [ 1 ]
93
3) 0.10 g 10 mL
. 1 mL
200 mL .

. 10 Lμ
.
· · (78 : 22 : 5)
12 cm
. 5

.
0.3 % (1 g, 105 , 3 ).
0.1 % (1 g).
50 mL
. 5 Lμ

QT
QS .
(1 125)→
: ( 280 nm)
: 4.0 mm, 15 cm
7 mμ
: (pH 3.0)· (7
: 3)
.

,
5 .
6
1.0
% .
1 mg
(C27H29NO11 ·HCl) 900 g ( )μ
.

.
1) 1 ~ 2 mg 1 mol/L
5 mL ~
.
2) 10 mg 1000
mL .
231 ~ 235
nm, 250 ~ 254 nm, 286 ~ 290 nm, 477 ~ 481
nm, 493 ~ 497 nm 527 ~ 531 nm
.
pH 50 mg 10 mL pH 4.0
~ 5.5 .
10 mg, , 500 mL)

.
. 1 mg
2.50 EU .

. , mL 2.0 mg

0.5 mL .
10 mg
( ) 25 mL
5 mL
100 mL .
9 (KP IX) 2007
94
AS .
µ
µ
(C8H11NO2 ·HCl) 98.5 ~ 101.0 % .
.

.

.
3) (1 50) 1)→
.
pH 1.0 g 50 mL pH 4.0
~ 5.5 .
1) 1.0 g 10 mL
.
2) 0.8 g .
0.005 mol/L 0.35 mL (0.021 %
).
3) 1.0 g 1
. 2.0 mL
(20 ppm ).
4) 1.0 g 1
(2 ppm ).
5) 0.10 g 10 mL
. 1 mL
250 mL .
.
5 Lμ
( ) .
· · (16 : 8 : 1)
10 cm
. (1 50)→
90 10

.
0.1 % (1 g).
0.2 g
5 mL 0.1 mol/L 15
mL 15 .
50 mL
0.1 mol/L (
).
.


(C24H30N2O2·HCl : 414.97) 98.0 ~101.0 %
.
,

.
9 (KP IX) [ 1 ]
95
.

.
218 ~ 222
pH 1.0 g 50 mL pH 3.5
~ 5.0 .
1) 1.0 g 50 mL
.
2) 1.0 g .
0.005 mol/L 0.50 mL (0.024 %
).
3) 2.0 g 2
. 2.0 mL
(10 ppm ).
4) 1.0 g 3
(2 ppm ).
5) 0.5 g 10 mL
. 3 mL
100 mL . 5 mL
50 mL
.
. 6 Lμ

(8 : 3 : 3 : 2) 10
cm .

.
3.5 ~ 4.5 % (0.5 g, , )
0.3 % (1 g).
0.8 g
· (7 : 3) 50 mL
0.1 mol/L (
.
1 mg
(C22H24N2O8 : 444.44) 880 ~ 980 gμ
( ) .

.
.


.
.
pH 0.1 g 10 mL pH
5.0 ~ 6.5 .
0.1 g (
) 0.1 mol/L 24 mL
100 mL
. 10 Lμ

AT AS
.
S
T
µ
µ

: ( 280 nm)
: 4.6 mm, 30 mm

300 mm 10 mμ
.
500 mL N,N-
3 mL pH 6.2 ~ 6.3
.
96

NH 2
1
mg (C22H24N2O8 : 444.44)
800 ~ 920 g ( ) .μ
~
.

.
1) 1 mg 1
.
2) 10 mg 10 mL
.
2
.
4)

.
.
pH 0.1 g 10 mL pH 2.0
~ 3.0 .
0.1 g( )

100 mL .
10 Lμ

AT AS .
S
T
µ
µ

: ( 280 nm)
: 4.6 mm, 30 mm

300 mm 10 mμ
.
500 mL N,N- - -
3 mL pH 6.2 ~ 6.3
.

(C22H24ClN5O2 ) 99.0 ~ 101.0 % .
.

.
1) 5 mg 3 mL
(II) 10 w/v%
0.1 mL 2 mol/L
0.1 mL
.

.
3) 20 mg 10 mL
. 20 mg 10 mL
(1) , 20 mg
20 mg 10 mL
(2) .
. , (1)
(2) 5 Lμ
9 (KP IX) [ 1 ]
97
15 cm
.

(1) ,
(2)
.
20 mL .
2) 1.0 g 4
. 2.0 mL
(20 ppm ).
3)
. 0.1 g 10 mL
. 1 mL
100 mL
5 mL
20 mL (1) .
( ), (1) 10
Lμ
.

(1) (0.25
%),
(1) 2
(0.5 %).
(1) 0.2

: 4.6 mm, 100cm
3 mμ
.
(70 : 30) 1.5 mL
10
2 .
: 1.5 mL/ . 30
[ (5
1000)· (70 : 30)] 5→
.
15 mg 100 mL
. (2) 10 Lμ

6.5 7 , 2.0
.
(linear gradient)
.
50 %
.
0.1% (1 g).
0.3 g
· (1 : 7)
50 mL 0.1 mol/L (
: - 0.2 mL ). ,α
.
0.1 mol/L 1 mL = 42.59 mg C22H24ClN5O2
.

(C22H24ClN5O2·C4H4O4 ) 99.0 ~ 101.0 % .
.

.
.
1) 0.1 g 10 mol/L
1 mL 3 mL
5 mL 3 . 0.1 mL
(1 300) 3 mL→
15 .
2 mL 15
.
0.1 mL (1 300) 3 mL→
15
.

9 (KP IX) 2007
98


.
3) 20 mg 10 mL
. 20 mg
10 mL (1) ,
20 mg 20 mg
10 mL (2) .
. ,
(1) (2) 5 Lμ
.
· · ·
.

(1)
, (2)
.
1) 0.2 g
20 mL ,
· ·1 w/v%
(6 : 24 : 70) 5.0 mL 1 w/v%
95.0 mL .
2) 1.0 g 4
. 2.0 mL
(20 ppm ).
3)
. 0.1 g 10 mL
. 1 mL
100 mL 5
mL
20 mL (1) .
( ), (1) 10 Lμ

.

(1)
(0.25 %),
2 (0.5 %).
(1)
0.2

: ( 280 nm)
: 4.6 mm, 100 cm
3 mμ
(70 : 30) 1.5 mL
10 100 %
2 .
: 1.5 mL/ . 30
[
(5 1000)· (70 : 30)] 5→
.
15 mg 100
mL (2) 10 Lμ
,
2.0 .
: (1) 10 Lμ
50 %
.
0.1 % (1 g).
0.4 g
50 mL 0.1 mol/L
( : -α
0.2 mL).
.
.

(C23H36O3 ) 97.0 ~ 103.0 % .
~
.

9 (KP IX) [ 1 ]
99
.
1) 20 mg 1 mL
1 mL 10
· 1 mL
1 mL .
2) 10 mg · 10
mL 5
.

.

.
: 22 ~ 28 ( 0.2
g, , 10 mL, 100 mm)
129 ~ 133
mL .
2) 1.0 g 2
. 2.0 mL
(20 ppm ).
. 1 mL
100 mL
.
. 10 Lμ
.
· (9 : 1)
10 cm
.
. ·
105 5

.
2 ).
25 mg
5 mL
10 mL .
2 Lμ

QT
QS .
(1 200)→
:
: 3 mm, 1 m
50 % 125
.
:
,
3 .
.

110.0 %
(C23H36O3 : 360.53) .
.
~ .

(C23H36O3 ) 50 mg
(4 5) 20 mL