1675
대한약전 제 8 개정 (KP VIII) [고 시]

대한약전 제 8 개정 (KP VIII) [고 시]Œ€한약전 8개정.pdf · 2015-09-08 · 대한약전 제 8 개정 (kp viii) [차 례

  • Upload
    others

  • View
    5

  • Download
    0

Embed Size (px)

Citation preview

8 2002-73
43 1 (
2002-15 )(2002. 03. 20) .
2002 12 30
1 () .
2 ()

.
8 (KP VIII) 2002
8 (KP VIII) [ ]

1958
10 10 1967 2, 1976
3 5 1997
7 .

.
8
.
,

.

.
2002 12 30

8 (KP VIII) [ ]

······································································································· ix
···································································································· xi
············································································································· 1
····································································································· 9
···························································································· 1601
() ···················································································
() ···················································································
8 (KP VIII) [ ]
ix

,

.
1958 10 10 25 1
632 .
2 1967
10 10 1 725 , 1968 7 15 2 457
1968 8 29 I, 1969 5 28 II, 1972
1 24 III .
1976 12 10 3 1
656 , 2 357 ,
1013 . 1978 2 1 I 146 , 1979
1 13 II 72 .
1982 3 1 4 1 785 , 2 427 ,
1212 1982 11 24 I .
1987 4 22 5 1 868 , 2 440 ,
1308 1988 3 16 8
I .
1992 4 7 6 1 986 , 2 442 ,
1428 1993 3 26
I .
8 (KP VIII) 2002
x
I .

2001 2 23 8

,
2001 3 16 8
, ,
.
,
, ,

.
2001 9 21 8
2001 11 8
. 2002 2 8
, , ,
8 2002 12 30
.
8 (KP VIII) []
xi

.
1. 8 7 1 2 1
, 2 , ,
1 , .
2. , , , .
3. , ,
.
4. .
1) ( ) 2)
3) 4)
5) 6)
7) 8)
9) 10)
11) 12)
17) , , 18)
19) 20) ,
21) 22)
23)
5.
.
9) 10)
11) 12)
13) 14)
15) 16)
19)
6. .
8 (KP VIII) 2002
xii
5) , ,
7. .
1) , , 2)
3) 4)
5) 6)
7) 8)
9) 10)
11) 12)
15)
.
1. , .
1) 3 .
2) 7 1999 .
3) 11 5
. 2
.
2. , .
1) .
3) .
7 8





7 8



4)
8 (KP VIII) []
xiii
.


( ) → ( )
5) 1 ()
.
6) 1 ()
.
7) , 8)
“ . ,

.” .
8) 4) “ ” “
” .
9) 4)
.
3) )
8) .
.
(3) 13)
.
3. .
1) 7 1,481 (1 1,007 , 2 474 : )
43 39 8 1,485 (1
1,018 , 2 467 ) .
2) . (43 )
, , , , ,
, , , , ,
, , L-, , , , ,
, , , , , ,
, , , , ,
8 (KP VIII) 2002
xiv
, , , , , , , ,
3) . (39)
, , , G-,
(123I), , ,
, , , , , ,
, , , , , , , ,
, ·, ·, ,
4) .
7 8

















(131I) (131I)
(133Xe) (133Xe)

xv
() ()
() ()

() ()

() ()
() ()
, , , ,
, , , ,
, , ,
, , ,
xvi
, , ,
, , , ,
, , ,
, , ,
, , ,
, , , , ,
, , , , , L-
, , , 10,
, ,
, , , , , ,
, , , , ,
, , , ,
, , , , , , ,
, , ,
, , , , ,
, , , , ,
, , , ,
, , , , , ,
, , , ,
, , , , ,
, , , , ,
, , , , ,
, , , ,
, , , , ,
, , , , , ,
, , , , ,
, , , ,
, , , , ,
, , , , ,
8 (KP VIII) []
xvii
, , , , ,
, , , , , ,
, , ,
, , ,
, , , ,
, , , , ,
, , , , ,
B, , , , ,
7) .
, , , ,
, , , ,
, , , ,
, , , L-, ,
(51Cr), , , ,
, , , , , ,
, , ,

, , , , ,
, , , , ,
, , , , , ,
, , , , ,
, , , , ,
, , ,
, , , , , , ,
, , ,
xviii
, , , ,
, , , , dl-,
, , , ,
, , , , ,
, , , , L-,
, , ,
, , ,
, L-, ,
, , , , , , , , , , ,
,
, , , ,
, , , , ,
, , , , 10,
, , , ,
, , , , L-,
, , , , , , , , ,

DL-, , , , ,
, , , ,
, , , , ,
,
11)
DL-, , , , ,
, ,
, , , ,
, , d-, dl-, , , ,
, , , ,
(3) .
, , , , ,
, , , , ,
8 (KP VIII) []
xix
, , , , ,
, , , ,
, , , , ,
(2) .
, , , , ,
, , , , ,
, , , , L-,
, , , ,
, ,
, , , ,
, , , , , l-
, , , , ,
, , , ,
, , , , , , ,
, L-, , ,
, , , , ,
, , , , , ,
200731, , , ,

, , ,

D-
, , 10%,
, , ,
, , ,
40, , , ,
xx
, , , ,
16) .
, , , ,
, , ,
(), , ,
, , , , , ,
,
, 220824
19)
, 220824
, , , , , ,
, , , ,
, , , , , ,
, , , ,
, , , ,
, , ,
, ,
, , ,
22) .
,
23)
, , , , , L-
, , , , DL-, L-
, , , , ,
, , , , ,
, , , , , ,
, , , ,
, , , , , ,
8 (KP VIII) []
xxi
, ,
, , , ,
, , , , , ,
, , , , , L-,
, , , ,
, , , ,
, , , , , ,
, , , ,
(2)
.
, , ,


,
, , , , , ,
, , , ,
, , , , ,
,





xxii



3) .
7 8






(1) ,
()
.
(2) 20.0
mm , .
.
(3)
“ A ” .
(4) ,
. , ,
, .
(5) () .
(6)
.
(8) ,
.
xxiii
















xxiv
1
2
. 8
KP VIII .
2. The Korean
Pharmacopoeia Eighth Edition

.

.
.
, ,

.
, , (
), ( ), , ,
, , , , ,
, , ,

.
,
.
6. ,


.

. 1999
.

.
95.0 105.0 % 95.0 110.0 %



,

.
,


.

.


.


, , ,
8 (KP VIII) [ ]
3

,
.
11.

.


, vol%

vol%
.
.
.
.
.


.

.
, 1 30 , 30
40 .
15 .
10 , 30 40 ,
60 70 , 100
.

100
. 15 25 ,
35 45 .
16. 20
20
0.90 1.10 .
17.

.
.
.
.
4
1 g 1 mL
4
→ 100)
1 g, 1 mL
6 mL, 10 mL,
100 mL
. (20 : 1) (5
: 2 : 1) 20
1 5
2 1
.


.
.
() 0.1
mg, 0.01 mg 0.001 mg
.

.
24. n
(n + 1)
(n + 1)
.

.


30
.
,
.

1 g

. 15
mm
30 mm
.

.

.

.
1 g
1 mL
.
.

20 ±
5 5 30
30
.
5
1 mL
10 mL
30 mL 100 mL
100 mL 1000 mL
1000 mL 10000 mL
10000 mL



.

.



.


, ,
.
.
33.
1


0.10 %
0.25 %
.
0.5 mg ,
0.05 mg ,
0.005
.
, ,

± 10
% .


%

101.0 % .
37.


.

.
8 (KP VIII) 2002
6
.
, , ,
.
.
.
, ,


.
, ,

.
. 60
.


.
, ,


.


.


.

, ,
.

.
.

.



.
.

.


.

8 (KP VIII) [ ]
7

.

.
53.

.
8
9
3. ()
5. () Liniments ·········································································
9. () Ophthalmic
14
15. () Fluid
Emulsions and Suspensions ·············17
Decoctions and Infusions ··················17
18. () Ophthalmic
20. () Suppositories ·······19
21. () Injections ········· 19
22. () Spirits ···············21
23. () Plasters and
Pressure Sensitive Adhesives ··········22
8 (KP VIII) 2002
10
11
.
, ,

.


.
.
, ,



.
.
4)
.

35 (500 ) 5
%
.
()

3. ()
.
, ,

.
.
3) .
4. ()


.
, ,
.
,
.
.
3)

.
4) .
12
.
, , , ,
, ,

.
.
3)

.
4) .
6. ()
.
1000 mL 15
12

1000 mL .
2 mL 2 g ,

1000 mL 10
.

1000
mL .
.
.
,
,

.
.
200 (74 )
10 %
.
()

8. ()

.
8 (KP VIII) []
13
.

,

.


.
, , , , ,
, .
3)
1 (
)

.


.

. ,

.
75 .
.

.

.
.
.
.
, ,
.


.
(),
, (),
.
, , , , ,
8 (KP VIII) 2002
14
.
.
) )

, 2)


.
.
, ()
.


.
.
5 .
5) .
13. ()

.
, ,


.
3) .
14. ()

.
, , , , ,
, , , ,
, , ,


.
.

.

.
5) .
15. ()
1 mL 1 g

8 (KP VIII) []
15
.
. 1
kg 1

2 .


2


2 3 0.5
1.0 mL
. 850 mL 1

2
2 .

.

.
1
3
10

1
(A), 2 1000 mL
2

.
(A)
2
.
.
.
5 .
5) .
)
.
.
.


.
.
.
3)
.
4) .
)
.
8 (KP VIII) 2002
16
) .
,
.
50 mL
15 900
mL 5

.

1000 mL .

.
3)
.

.



.
.

.
% w/v%
.

.

.

.
.
.
75 .
,
, , , ,
,
.

.

.

, pH

.
.
8 (KP VIII) []
17

.
.

.
.
10) .
19. ()
.
.
,



.



.
.

.
.
.

.
20. ()


.
.
,

,


.
.

.
.
5)
.

8 (KP VIII) 2002
18

, ,

.
,


, ,
,
8 .
% w/v%
.
.


.

.
3)


.
.
,

. ,


.
.
10 mL

.
10
0.56 ,
79 137, 185
200 .
.

7 .
,
.
, , , , ,

.

.

.

, pH

.


.
8 (KP VIII) []
19

.


9)
. 50 mL


.


.

.



.
.
.

.

.

.
0.9 w/v%
pH

.


.


.
17) 2 mL
2 mL
10 mL
,

,
,

.

8 (KP VIII) 2002
20

.
.
3)
.
() (
)
.




.
, , , , ,
, ,



.
3) .
24.
.
,

.
.
3)


.
4) .
25. ()

.





.


()

8 (KP VIII) []
21
.
.

26. ()

.
.

,
.
) ,



.





.



.
3)

28. ()
.

.
5

.


2

.
22





2 3
1 3 mL
.

2

.

.




.
.
.
, , ,

.
4)

.
5) .
30. ()
.
,

.
,

.
.
8 (KP VIII) []
23
8 (KP VIII) [ 1 ]
27

28
8 (KP VIII) [ 1 ]
29
Tilesius Theragra
chalcogramma Pallas (Gadidae)
.
5000 A .
.
.

.
mL 1 mL
3 mL

.
1.7
.
0.5 g
A 2
.

.


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

()
() .
. 5 mL
0.5 mL,
4 4

.
30
. 105

30 mg .
).
.)
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
(
.
0.21151 mg I
.
1 g
0.4 g [
(C12H17ClN4OSHCl : 337.27)] 100
.

6 12 μm
.
.


.
)
).
1) 50 mg

.
1 g (mg) = (N) (mg) × 6.25 × 1
(g)
1 mL 80 mL
80 85
30
100 mL
8 (KP VIII) [ 1 ]
31

45 50 3 .
2 mL
(40 110 μm
CM- (H
17 cm
.

.
0.5 mL 2
.
1 mL 1-
10 mg
. (

.) 15 mg
0.001 mol/L
100 mL . 1 mL

100 mL . 1 mL
1 mL
3 mL
. 200 μL

.

QT QS .
= (mg) × QT
Q S
100 mL . 1
mL (1 → 5)
100 mL .
30 cm 5 10
μm
.
1.6 g 200 mL
.
.

.
(C6H12O6) 98.0 % .

8 (KP VIII) 2002
32
.
.
.
.
2)

.
pH 4.0 g 20 mL
pH 4.0 6.5.
50 mL
.
:
3.0 mL 2.0
mL 10.0 mL
3.0 mL 50
mL .
50 mL
3 0.01 mol/L
0.60 mL
.
. 0.01 mol/L 1.0 mL
(0.018 % ).
. 0.005 mol/L 1.0
mL (0.024 % ).
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
).
g 100 mL .

0.32 .
, 3 ).
4 g
0.2 mL
80 mL 30
100 mL
20 ± 1
100 mm αD .
(C6H12O6) (mg) = αD × 1087.0
.
95.0 105.0 %
(C6H12O6 : 180.16) .
.
8 (KP VIII) [ 1 ]
33

.
1 g

20 mL .
2 3 5
mL .
2) 1) 10 mL 0.1 g
1 mL 3
.
pH 3.0 6.5
5.0 g
.
2
. 2.0 mL
.
1.5 g

5 mL 5 mL
1 mL
8) .
2.0 mg .
.
10 w/v%
10 w/v% .
(C6H12O6) 4 g

0.2 mL
100 mL 30

20 ± 1 100 mm
αD .
.
.
(KMnO4) 99.0 %
.
.
.
.
.
2.0 g 200 mL


105 2
4 mg .
2) 0.40 g 10 mL
1 mL

5 mL
.

(5 ppm ).


2.0 mL 5 mL
8 (KP VIII) 2002
34
.
).
200
mL . 0.05 mol/L
25 mL 500 mL
(1 →
20) 200 mL 30 35

23 mL

. 55 60 30

.
KMnO4
34.01) 2.5 3.5 w/v% .
0.05 %
.

.
.
.
.
d 20 20 : 1.01
1 mL 1
10 mL
2 mL 1


.
2 0.1 mol/L
2.5 mL
.
2 mL
2 mL
50
mL .
. 2.5 mL
2 mL 50 mL
(5 ppm ).
10
.
mL (3


() 2
.
105
1 30 mg
.
20 mL
20 mL 0.02
mol/L .
8 (KP VIII) [ 1 ]
35
1.7005 mg H2O2
.

(99mTc)
.

(C7H7KO5S)
98.5 % .

.

,
.
.
100 mL .

234 238 nm 277 280 nm
282 287
nm 254
258 nm .
.
pH 1.0 g 20 mL
pH 4.0 5.5.
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 μL


.
8 (KP VIII) 2002
36

25 cm 5 10 μ
m



,
.

:
3.0 4.5 % (0.3 g,
, )
0.3 g
2.0 mL
50 mL 0.1 mol/L
(
).
C7H7KO5S

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


.
.
1 mL
.

.

743 cm-1 .
80 83
pH 1.0 g 100 mL
pH 5.0 7.0.
8 (KP VIII) [ 1 ]
37
.

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 ).
1000 mL . 3 mL
22 mL
.
1.0 mL 4-
(1 → 200) 5.0 mL
. (1 → 1200)
4-



.

200 mL .


(40 : 10 :
.
p-


.
3 )
60 mg

100 mL . 5 mL
100 mL
.
273 nm
A
× 20000
H2O) 99.5 % .
38

.

.


.
. 0.005 mol/L
0.50 mL (0.048 % ).
2) 1.0 g 2
mL
0.2 mL
1
.
3) 2.0 g 2
.
2.0 mL (10 ppm
).
4) 1.0 g 10 mL

1 mL
.
5) 2.0 g 1
(1 ppm ).
6) 0.50 g 105
3
10 mL
.
. 5 μL
n-
(8 : 3 : 2)
25 cm
. pH 7.0

.
30 mL 50
. n- 20 mL
3 .
2500 3000 10

1 2 mL
n-
10 mL .
30 mL


260 350 nm 0.05
.
. 90 1
. K
.
1.5 g
25 mL 1 mol/L
( :
mg C6H8O7H2O
8 (KP VIII) [ 1 ]
39
(C6H807) 99.5 %
.

.

.
.
.
).

.
mg C6H8O7
.
(67Ga)
.
(C6H5Na3O7 : 258.07) 97.0 103.0
% .

.
.

.
pH 1.0 g 20 mL
pH 7.5 8.5.
10 mL .
2) 0.6 g
. 0.01 mol/L 0.25
mL (0.015 % ).
40 mL .
3.0 mL 50 mL
. 0.005 mol/L
0.50 mL (0.048 % ).
4) 2.5 g 2
.
2.5 mL (10 ppm
).
5) 1.0 g 1
(2 ppm ).
6) 1.0 g 2 mL,
1 mL 1 mL
8 (KP VIII) 2002
40
.
7) 1.0 g 1 mL
3 mL 4
mL 0.2 mL 1
.
8) 0.5 g
. 90 1
. K
.
)

10 mL
100 mL
.
0.1 g
10 mL
100 mL
.
20 μL


(C 6H 5Na 3O 7) (mg)
= (mg) × QT
Q S
30 cm
2 mL 1000 mL
pH 2.5 .
:
5 .

,
.
(C6H5Na3O72H2O : 294.10)
100
.
.

.
pH 7.0 8.5
.
25 mL
10 mL
. 180
2 30 mL
. 0.1
8 (KP VIII) [ 1 ]
41
.
C6H5Na3O72H2O
w/v% .
38
.
.

.
pH 7.0 8.5
5 mL
.
0.1 mol/L
( : 3
.
C6H5Na3O72 H2O
(C10H21N3OC6H8O7)
98.0 % .
.

,
.
.
10 mL
5 mL 4
.

.

42
4 mL

105 4
151 155 .

2) 3)
.
4 .
4.0 mL (20
ppm ).
).
0.75 g
50 mL
. 0.1 mol/L
(
.
C10H21N3OC6H8O7
105.0 %
(C10H21N3OC6H8O7 : 391.42)

.
0.5 g
10 mL

10 mL
1)
.
0.8 g

. 5 mL
5 mL
20 mL 2 .

2) 3)
.
20
.
(C10H21N3O
10 mL
5 mL
20 mL
10

.
50 mg 10
mL
5 mL


8 (KP VIII) [ 1 ]
43
QT QS .
(C 10H 21N 3OC 6H 8O 7) (mg)
= (mg) × Q T
Q S
m
35 %
3 %

,
.
(C26H28ClNOC6H8O7) 98.0 %
.
.
.
: 115
200) 2 mL 2 mL
.
2) 0.1 mol/L (1
→ 50000)
233 237 nm 290 294 nm
.
1) 1.0 g
30 mL
.
2) 2.0 g 2
.
2.0 mL (10 ppm
).
, 3 ).
0.10 g 10 mL
1 mL 15
mL 3 .
20 mL
10 g 1

. 10 mL
. 2 μL

44
Ab) 0.3 0.5.

1 %
.
: 195 .
: 2 μL
2
1.3 .
1 g
50 mL
0.1 mol/L
( : 2
.
C26H28ClNOC6H8O7

107.0 %
(C26H28ClNOC6H8O7 : 598.09)
.

1 g
100 mL
.


.

.
20
.
(C26H28ClNOC6H8O7)
50 mL 10
100
mL .
4 mL
100 mL
.
50 mg
100 mL
. 4 mL
100 mL
.

AS .
(C 26H 28ClNOC 6H 8O 7) (mg)
= (mg) × A T
A S
8 (KP VIII) [ 1 ]
45
C
CH2CO2H
CH2CO2H
(C22H28N2OC6H8O7)
.
.
10 mL 100
mL

261 265 nm
.

.
3) (1 → 100)
1) .
pH 0.10 g 10 mL
pH 3.0 5.0.
2 .
1.0 mL
(20 ppm ).

100 mL .


10 cm
.

.
0.5 % (0.2 g, ,
, 60 , 2 ).
75 mg
50 mL 0.02 mol/L
(
.
C26H28N2OC6H8O7

(C20H31NO3C6H8O7) 98.5 %
46
.

.
10 mL
.
2)

1726 cm-1, 1580 cm-1, 1214 cm-1
734 cm-1 .
3) (1 → 10)
1) 2) .
92 95
10 mL .
2) 2.0 g 2
.
2.0 mL (10 ppm
).
3) 1.0 g 3
(2 ppm ).
4) 0.20 g 10
mL . 1 mL

200 mL .

L

(25 :
cm
. 10


.
, 60 , 4 ).
0.5 g
30 mL
30 mL 0.1 mol/L
( :
.
.
C20H31NO3C6H8O7
[(C4H10N2)3
.
.
.
8 (KP VIII) [ 1 ]
47
.
5 mL
(1 → 2) 1 mL
. 15


10 mL 105 .
N,N'-
3)
.
0.5 g 10 mL 2.5
mol/L 1 mL,
1 mL 1 mL
10

520 nm
600 nm A1 A2
A2/A1 0.5 .

(
0.7 % ).
12.0 % (0.3 g,
, ).
0.2 g
100 mL .
0.1 mol/L
( :
.
(C4H10N2)32C6H8O7
60.08) 45.0 %
(MgO : 40.30) 20.0 %
(%)
.
.
mL


.

()

.
150 mL 60
150 mL
75
mL 100 mL
. 25 mL
700
2 20
mg .
2 0.1 mol/L
1.0 mL
.
6 mL 50 mL
. .
8 (KP VIII) 2002
48
(0.053 % ).
mL 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 ).
).
0.6 g

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) .
(SiO 2) (%) = a-b
(g) × 100
50 mL
0.5 mol/L 10 mL
15 .
100 mL

100 mL .
50 mL 50
mL (1 →
2.0 mL pH 10.7
10 mL
0.05 mol/L
.
8 (KP VIII) [ 1 ]
49

.
.
20 mL
.
1) 0.5 g
(1 → 3) 3 mL
20 mL
.
.

()

.
mL
.
15
100 mL
. 10 mL
6 mL 50
mL .
. 0.01 mol/L 0.30
mL (0.021 % ).
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



.
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 mL
.
10 mL

5 mL .
(2 ppm ).
6) 1) 50 mL
700
2 40 mg
.
.
.
8 (KP VIII) 2002
50

C :
H :
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 .
1 10 mL .
170 mL
C
200
mL .

.
= 5 mL (mg) × A T
A S
× 200 V
20.0 % (1 g, 105 , 3
).
. 1.0
mL 200 mL
50 mL


.
50 mL .
8 (KP VIII) [ 1 ]
51
.
.
20 mL
.
mL
.
2) .
1 mL 50 mL
.
. 0.005 mol/L 1.0
mL (0.480 % ).
4)
.
3.0 mL (30 ppm ).
5) 1.0 g 10
mL
5) (2 ppm
).
).
0.5 g
1 g 0.1 mol/L
50.0 mL .
.
.
.
.
.
.


.
(C17H17ClO6 :
8 (KP VIII) 2002
52
.
(C12H22FeO14 :



.
.
1) 10 mg 10
mL .
60 .
10 mg 10
mL .


cm 110 20
.
1.0 g 1
mol/L 100 mL
110 10

, Rf .
2) (1 → 200)

.
. 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
.
4) 1.0 g 50 mL
9 mol/L 10
mL, 10 mL,
20 mL
(5
.


.
5 mL
100 mL 2 mL
50 mL

.

.
8 (KP VIII) [ 1 ]
53
4.5 mol/L 40
mL (3 → 10) 2 mL

.
. 25 mL
(3 ppm ).
100 mL 10 mL
3.0 g
. 5
0.1
mol/L
.
5.585 mg Fe3
.
mL
1 mL
.
30
5 mL 2

2 mL
.

10 mL
. 5
mL 20 mL
100 mL .
5 mL 2 mL 1
1
.
)
1.5 g
300 mL 75
mL 15 mL
. 0.25 g

20
.

10
mL 10 mL . o-

.
.
44.61 mg C12H22FeO14
107.0 %
(C12H22FeO142H2O : 482.18) .
.

1 g
100 mL .


.
8 (KP VIII) 2002
54
900 mL 1
150 .
80
.

.
.



.
.
20
.
(C12H22FeO142H2O)
300 mL 75 mL
15 mL

.
48.22 mg C12H22FeO142H2O
.
(C12H22CaO14H2O) 99.0 104.0
% .
.

.
1) 0.5 g 5 mL
0.65 mL
1 mL
30

. 10 mL

.

10 mL 3
187 199 ().
2) (1 → 40)
.
50 mL .
2) 0.50 g
20 mL
0.01 mol/L 0.10 mL
2
. 0.01 mol/L
0.30 mL
.
. 0.01 mol/L 0.80
mL (0.071 % ).
. 0.005 mol/L 1.0
8 (KP VIII) [ 1 ]
55
5) 1.0 g 30 mL
2 mL
50 mL .
.
2.0 mL 2 mL
50 mL (20 ppm
).
6) 0.6 g 5 mL
5 mL
1 mL
5 mL .
(3.3 ppm ).
7) 0.5 g
10 mL 2 mL 2
5
mL 5
20 mL . 5 mL
2 mL 1

.
).
100 mL 8
mol/L 2 mL NN
0.1 g 0.05 mol/L

.
0.05 mol/L
95.0 105.0 %
(Ca : 40.08) .
.

.

.
1) 5 mL
0.7 mL
1 mL 30

1)
.
.
0.17 EU .
3 mol/L 2 mL
150 mL .
0.05 mol/L
20 mL
1 mol/L 15 mL
0.3 g

56
.
21.0 w/v% .
.
.
1 mL 5 mL
3 mL
.
.
d 20 20 : 1.06 1.07
1) 0.05 mL 5
mL 1 mL 8 mol/L
1 mL
.
2) 0.5 mL 10 mL
0.5 mL

.
3) 10 mL 5 mL

5 mL
.
(7 → 10)
105 30
130 134 .
4) 3) 5 mol/L
5 mL
0.65 mL
1 mL 30

.
10 mL
.

195 ()
.
pH 5.5 7.0.
100 mL .
5 mL 20
mL 1 mol/L 5 mL
0.3 mL
2
4 mL 1
. N-(1-)-N'-
10 1 mL
50 mL
.
mol/L 10 mL ,
100 mL . 5
mL
100 mL . 5 mL
20 mL 1 mol/L 5 mL
.
0.10 % (2 g, ).
2 mL

60 mL 0.1 mol/L
(
C22H30Cl2N102C6H12O7
8 (KP VIII) [ 1 ]
57

Glibenclamide
(C23H28CIN3O5S) 98.5 %
.


.
10000)
273 275 nm 297 301 nm
270 272 nm
276 279 nm
.

.
.
168 173
.
2) 1.0 g 2
.
2.0 mL (20 ppm
).
3) 1.0 g 3
(2 ppm ).
4) 0.20 g
20 mL .
1 mL
50 mL . 2.5
mL
10 mL
.
.
10 μL
. n-
(4 →
12 cm
. ( 254 nm)


.
).
0.9 g
50 mL
0.1 mol/L
( : 3
18 mL
.
mg C23H28ClN3O5S
58

Glycerin
% ( ).
.
.
.
.
.
d 20 20 : 1.221 1.230

.
.
( ).
.
.
.
.
.
d 20 20 : 1.258 .
1) 50 mL

.
:
50 mL .
2) 2 mL 8 mL
.
. 0.01 mol/L 0.30
mL (0.001 % ).
. 0.005 mol/L 0.40
mL (0.002 % ).
(1 → 10) 5 mL

.
6) 5.0 g 1
.
2.5 mL (5 ppm
).
3
.
8) 1.0 g 1
(2 ppm).
9) ,
1.0 g 1
mL 60 5

.
3 5

.
8 (KP VIII) [ 1 ]
59
0.1 mol/L 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 % .
.
CO2 -
: 196.97) 49.0 52.5 % .

.

.
.
1) (1 → 10) 2
mL (1 → 10) 1 mL

.

.
3 mL

.
1 mL
1 mL
. 20
mL


.
pH 1.0 g 10 mL
pH 5.8 6.5.
10 mL
.
2) 1.0 g 2
.
3.0 mL (30 ppm
).
3) 1.0 g 3
(2 ppm ).
8.0 % (1 g, ,
, 80 , 4 ).
2 mL

100 mL . 2 mL
25
mL .
5 mL, 10 mL 15
mL
25 mL
.
8 (KP VIII) 2002
60
:

(C27H37FO6) 97.0 103.0 %
.

.
: 190 ()
mol/L 0.5 mL
20 mL


.
[α] 20 D : 77 83° (
0.10 g, , 20 mL, 100 mm)

. 20 mg
(9 :
1 mL
(9 : 1) 50
mL .


(9 : 1)
.

.
0.5 % (1 g, 105 , 3
).
).

100 mL . 10 mL
10 mL

. 10 μL

= (mg) × Q T
Q S
8 (KP VIII) [ 1 ]
61
25 cm 7 μm


,
.



.

.


105

.
[α]20D : 41 47° (0.25
g, , 10 mL, 100 mm)
143 150 ( 1 )
1) 50 mg
10 mL
. 5 mg
100 mL
.
.
5 μL
(7 : 3)
. (3 → 10)
90 30



(1.0 % ).
mL
. 0.50
g
0.01 mol/L
( 0.5
% ).
1.0213 mg C5H10O2
62
10 mL .
10 mg
10 mL .
0.1 mL, 0.5 mL, 1 mL 2 mL

10 mL (1),
(2), (3) (4)
.
. , (1),
(2), (3) (4) 20
μL
(4 : 1)
15 cm
.
(1 → 10)
( 254 nm 366
nm)


2.0 % .
)
25
mL .
10 μL

= (mg) × QT
Q S
cm 5 10 μm

.
:
mL 700 mL
.
,
.
6

1.5 % .

90.0 115.0 %
(C23H32O3 : 356.50)

.
80 % 10 mL
2
8 (KP VIII) [ 1 ]
63
(1 → 5) 3 mL
.
30 %

10 mL
.

L

(3.0 % ).
(C23H32O3) 20 mg


25 mL
.
5.0 mL
25 mL
.
.
= (mg) × QT

Naproxen
(C14H14O3) 98.5 % .

.


.
2 mL
(1 → 100) 5 mL
.
5 mL

.
mL
1 mL
1 mL

.

264 nm, 270 273 nm, 316 319
nm 330 333 nm
8 (KP VIII) 2002
64
.

.
0.1 g, , 10 mL, 100
mm)

0.070 .
2) 2.0 g 2
.
2.0 mL (10 ppm
).
3) 2.0 g 3
(1 ppm ).
4)
. 0.10 g
(1 : 1) 10 mL
. 2 mL
(1
5 mL
(1 : 1)
.
.
10 μL
.
cm
. ( 254 nm)


.
)
0.5 g
(4 → 5)
100 mL
0.1 mol/L
( :
.
mg C14H14O3

Naproxen Tablets
110.0 % (C14H14O3 :
230.26) .
.
(1 : 1)

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


8 (KP VIII) [ 1 ]
65
.


.
.
2.62 g
1000 mL .
20
.
(C14H14O3) 0.25 g

.

(90 : 10) 1 mL
2.5 mg .
(C 14H 14O 3) (mg) = 10 × C × QT
Q S
(C14H13NaO3) 98.0 102.0 %
.
.

.
(1 → 40000)

.

.
, 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
8 (KP VIII) 2002
66
.
. ,
(1), (2) (3) 10 μL


cm
. ( 254 nm)
Rf
Rf

(3)
.
(1), (2)
(3) ( 0.1 %,
0.3 % 0.5 % )
2.0 % .
3) 5.0 g
25 mL
15 mL 3
.


0.1 mol/L
2.2
mL (1.0 % ).
3 ).
p-
50 mL
0.1 mol/L
.
C14H13NaO3
%
(C14H13NaO3 : 252.25) .
.
1)
0.25 g

12 mL 1 mL
.


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




.


.
8 (KP VIII) [ 1 ]
67
.
2.62 g
1000 mL .
20
.
(C14H13NaO3) 0.275 g
100
mL 10 mL

.

1 mL
2.0 mL
100 mL .

. 1 mL
2.0 mL
100 mL
. 20 μL



(C 14H 13NaO 3) (mg) = 10 × C × QT
Q S
cm 5 μm

,
.
6

1.5 % .
(C33H44N4O10) 98.5 %
.

.
8 (KP VIII) 2002
68
.


.
(3 → 20)
(3 → 20)(1 : 1) 2
8 mL
.


A1, A2, A3
A1/A3 2.47 2.77, A1/A2 3.50
3.90 A2/A3 0.65 0.75.
146 150
10 .
10 mL
. 25 mL
50 mL 1
mL 5
.
: 25 mL 1
mL 10
. 5 mL 4
0.01 mol/L
0.30 mL 50 mL
1 mL (0.021
% ).
2) 2.0 g 2
.
2.0 mL (10 ppm
).
50 mL
. 25 mL 0.01 mol/L
0.50 mL
2
.
10 mL .
1 mL
50 mL . 5
mL
20 mL
.
.
10 μL
.
(9 : 1)
. (
254 nm)

.
, 4 ).

. 40 mg

500 mL . 10 mL
50
mL .
105 2
50 mg
(2 → 75) 150 mL
500
8 (KP VIII) [ 1 ]
69
50 mL
.

AT As .
= (mg) × A T
A S

(C25H36O6) 96.0 104.0 %
.

.


. (
254 nm)
. 10 mL


.
1 mL
.
3) 50 mg
2 mL 5
. (2 →
7) 2 mL 1
.

1181 cm-1, 1085 cm-1 905 cm-1
.
0.1 g, , 10 mL, 100
mm)
2 .
2.0 mL
(20 ppm ).
5 mL
. 2 mL




(470 : 30
70
.

.
).
50 mg

100 mL . 2 mL

50 mL .

A .
× 25000
(C12H12N2O3) 98.5 %
.
.



.
100 mL
. 1 mL 0.01 mol/L
200 mL .

260 nm 333 337 nm
.
A1 A2
A2/A1 0.42 0.47.
2) 20 mg 2.0 mL
1.0 mL 20
mg 2
.

30
.

.
70 5
. 25 mL
6 mL 50 mL .
.
0.01 mol/L 0.35 mL
(0.012 % ).
3) 1.0 g 2
.
2.0 mL (20 ppm
).
4) 0.40 g 3
(5 ppm
8 (KP VIII) [ 1 ]
71
).
25 mL .
1 mL
200 mL
.
.
10 μL
(7 : 2 :
.
( 254 nm)

.
0.20 % (1 g, 105 , 3
).
0.3 g
50 mL
0.1 mol/L
( :
. 50
mL (17 : 3) 13
mL
.
mL = 23.224 mg C12H12N2O3
.
(C21H28O2) 98.0 %
.
.


.
1 mL
. ( 365
nm) .
2)

cm-1 .
206 212
.
(1 → 10) 10
1 mL 4
.
2.0 mL (20 ppm
).
5 mL
. 1 mL
100 mL
.
8 (KP VIII) 2002
72
( )
(2 : 1)
.
( 254 nm)

.
).
0.2 g
40 mL
(1 → 20) 10 mL
0.1 mol/L
(
.
mg C21H28O2
(C20H26O2) 97.0 103.0 %
.
.



.
1) 2 mg 2 mL

. 10 mL

.
mg 50 mg
25 mL 3.5 mL
5
. 15 mL
. 1 2
mL
(, ) 5
112 118
.
mm)
, 4 ).
0.2 g
40 mL
(1 → 20) 10 mL
0.1 mol/L
(
.
8 (KP VIII) [ 1 ]
73
mg C20H26O2

Norethisterone Tablets

110.0 %
.

50 mg
15 mL 15
.
. 10 mL
2
.
25 mL 1 2
. 3
mL

.

.
.
20
.
(C20H26O2) 0.7 mg
50 mL

10.0 mL

.
10.0 mL
2.0 mL
. 10.0 mL

30
.
mL 14 μg
10.0 mL
2.0 mL
30
.
380
nm
,
,
AT, AB AS .
(C 20H 26O 2) (mg) = 0.05 × C × A T - A B
A S
74
HO
HO
CCH2NH2
OHH



(C8H11NO3) 98.0 %
.

.

.
.
.
mL . 5 mL
1
.
1 mL A
pH 3.5 10 mL
, B pH 6.5 10 mL
. 1.0 mL
5
2.0 mL A
B
.
100 mL
.
mol/L 100 mL
.
310 nm
0.1 .
10 mL .
(1 → 100) 0.3 mL 1

.
:
mL 1 mL
(1 → 2) 1.0 mL
10 mL
.
, 18 ).
0.3 g
50 mL
0.1 mol/L
( :

.
.
C8H11NO3
.

Norepinephrine Injection
8 (KP VIII) [ 1 ]
75
90.0 110.0 % dl-
(C8H11NO3 : 169.18)
.
.
pH : 2.3 5.0
1 mg
1)
.
1 mg A
B
2) .
10 mg
20 mL
.
310
nm 0.10 .
5 mg
(1 → 2) 1 mL
10 mL
3)
.

25 mL
. 5 mL
0.2 mL

. 0.05 mol/L
pH 6.5
pH 6.5 10 mL
3 .


50 mL .
5
515 nm
AT AS .
= ( mg) × A T
A S

Norfloxacin
N
C2H5
COOH
O
F
N
HN
(C16H18FN3O3) 99.0 %
.
76
.

.
.
10 mg (1 →
5 mL (1 → 250)

.

.


.
mol/L 7 mL
23 mL 1
(1 → 3)

0.5 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 ).
4)
. 0.10 g
(1 : 1) 50 mL
. 1 mL
(1 : 1)
100 mL . 2
mL
(1 : 1) 10 mL
.

( 5 7 μ
m, )
.
: 7 : 4) 9 cm
.
( 254 nm 366
nm)
2
.
1.0 % ( 1 g, 105 , 2
)
0.5 g
50 mL
0.1 mol/L (
).
.
8 (KP VIII) [ 1 ]
77
C16H18FN3O3

Noscapine
N
O
O
O
(C22H23NO7) 98.5 %
.
.


.
20000)
.

.
0.5 g, 0.1 mol/L , 25 mL,
100 mm)
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--β- 5 mL
(1 →
. (1 →
10 mL


.

50 mL . 5 mL

100 mL .



10 cm
.

.
8 (KP VIII) 2002
78
)
0.8 g
30 mL
0.1 mol/L (
: 3 ).
.
0.1 mol/L 1 mL = 41.34 mg
C22H23NO7

Nystatin
.
.

.

Nystatin Tablets
120.0 %
.
.

120.0 %
.
.

(C34H32N4O9) 98.0 % .
.
.
20 mg
2 mL 5
4
mL
.
5
.
8 (KP VIII) [ 1 ]
79
100000)
.

cm-1 .
181 185
mol/L 10 mL
.
50 mL 5
. 25 mL 0.01 mol/L
0.60 mL
2
.
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).
6) 0.20 g
20 mL .
1 mL
20 mL . 2
mL
20 mL
.
.
10 μL
.
. ( 254 nm)


.
).
1.5 g
0.5 mol/L
40 mL
()
0.25
mol/L ( :
3 ).
.
mg C34H32N4O9
105.0 % (C34H32N4O9 :
640.64) .
.
0.5 g
8 (KP VIII) 2002
80
.
.
2 75
. 60
20 mL 0.8 μ
m .
10 mL 2
mL 1
25 mL .
105 4
0.1 g
1 100 mL .
2 mL 1
100 mL
.

AS .
.
(C 34H 32N 4O 9) (%) = WS × A T
A S
(mg)
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
.

AT AS .
(C 34H 32N 4O 9) (mg) = (mg) × AT
A S
× 25 2
(C6H5NO2) 99.5 % .


.
.

.
8 (KP VIII) [ 1 ]
81
4 mL
.
2) 20 mg 1000 mL
.

, 235 239 nm
.
A1,
A2/A1 0.35 0.39.
pH 0.20 g 20 mL
pH 3.0 4.0 .
234 238
2) 0.5 g .
0.01 mol/L 0.30 mL
(0.021 % ).
.
0.005 mol/L 0.40 mL
3 mL 50 mL
(0.019 % ).
8 mL 20
mL A
.
5) 1.0 g 2
.
2.0 mL (20 ppm
).
).
0.3 g
50 mL 0.1
mol/L (
: 5 ).
mg C6H5NO2
95.0 110.0 %
(C6H5NO2 : 123.11) .
.

pH : 5.0 7.0
0.1 g
0.3 mL
2 mL .


105 1
234 238 .

.
100 mL
. 10 mL
10 mL
100 mL
. 105
1 0.1 g
8 (KP VIII) 2002
82
100 mL . 10 mL
10 mL
100 mL
.
10 μL


QT, QS .
( C 6H 5NO 2) (mg) = (mg) × QT
Q S
cm 5 μm

(4 : 1)
.
,
6


1.0 % .
.
(C6H6N2O) 98.0 102.0 %
.
.

.

4 mL
.

mL .

243 247 nm
.
A1,
A2/A1 0.63 0.67 .
pH 1.0 g 20 mL
pH 6.0 7.5 .
128 131
8 (KP VIII) [ 1 ]
83
20 mL .
2) 0.5 g
. 0.01 mol/L 0.30
mL (0.021 % ).
. 0.005 mol/L 0.40
mL (0.019 % ).
4) 1.0 g 1
.
3.0 mL (30 ppm
).
.
A .
, 4 ).
50 mg

100 mL . 5 mL
8 mL
100 mL
.
50 mg
100 mL .
5 mL 8 mL
100 mL
.
20 μL


.
(C 6H 6N 2O) (mg) = (mg) × QT
Q S
.

30 cm 5 10 μ
m
.
:
mL 10 mL .
:
: 20 μL

,
.
(C6H6N2O : 122.13)
.
.
pH : 5.0 7.0
6 mL


8 (KP VIII) 2002
84
100
mL .
(

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

2 mL

398 nm
AT AS
.
(C 6H 6N 2O) (mg) = (mg) × AT
A S
(C15H11N3O3) 99.0 %
.
.

,


.
500) 3 mL 0.1 mL
.
2) 20 mg 15 mL
5
.

.
257 261 nm 308 312 nm
.
A1 A2
A1/A2 1.45 1.65.
1) 0.10 g
20 mL
.
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
8 (KP VIII) [ 1 ]
85
2 mL
(1 : 1) 50
mL .

(
(17 :
.
( 254 nm)

.
0.5 % (1 g, 105 , 4
).
0.4 g
40 mL
0.1 mol/L (
).
.
C15H11N3O3

Nitroglycerin Tablets
120.0 %
.
1)
(C3H5N3O9) 6
mg 12 mL

. 5 mL
1
2 1

.
5

0.1 mL .
20 mg
.


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


. 20 mL
30 mL
60 mg
30

.
.
86
V mL
1

. ,
1

0.05 mL
1
mL (C3H5N3O9)
30 μg
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) × 0.7487 × A T
A S

(%) 25.0 %
. 25.0 %
30.0 % 1
20 . 2
30
(%) 25.0 %
30.0 % 1
30.0 %
.
20

. (C3H5N3O9)
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 .
(C 3H 5N 3O 9) (mg)
= (mg) × 0.7487 × A T
A S
× 1 20
.
8 (KP VIII) [ 1 ]
87

Nifedipine
(C17H18N2O6) 98.0 102.0
% .
.
,

.
1) 50 mg 5
mL 5 mL 2
g 5 .


356 nm
.

.
.
.
10 mL 5 mL
6 mL 50
mL .
. 0.01 mol/L 0.30
mL (0.021 % ).
1 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 ).
6)
. 5.0 g
(5 : 3) 80 mL
0.02 mol/L (
).
mol/L 1.9 mL
.
g
10 mL .

. 1 mL

.
8 (KP VIII) 2002
88
10 μL
.
.
0.5 % (0.5 g, 105 , 2
).

. 0.12 g
200 mL
. 5 mL
100 mL .

A .
142.3 × 40000

Nifedipine Capsules
110.0 % (C17H18N2O6
: 346.33) .
.
0.1 mol/L
20 mL
25 mL

. 1
2000 2500
10
.

.

.
.

(1 : 1)
.
( 254 nm)
Rf 0.3
.


.
30 g 3 mol/L 10
mL 100 mL
. 10 mL
3 mol/L 10 mL
100 mL .
2)

.
2 50
. 20


.
8 (KP VIII) [ 1 ]
89

.

.
.
.
.
1
mL 1 mg
.
1 mL 0.3 mg
.

1 mL 1 mg
.
1 mL 6 μg
(1) .

mL 1 mg
.
1 mL 1.5 μg
(2) .
(1) (2) 5 mL
5 mL
.
25 μL

.
25 μL

,
.
6

10 %
. 5

1 mL 0.1
mg
V mL
.
1 mL
1 mg .

1 mL 0.1 mg
.
25 μL

.
(C 17H 18N 2O 6) (mg) = V × C
5 ×
90

cm 5 μm

1.5 .
6

1.0 % .
25 .
NNa
O
O

(C14H9N4NaO5 :

.


,
100000)
223 227 nm, 305 309 nm
377 381 nm
.

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

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

8 (KP VIII) [ 1 ]
91
cm 5 μm

.
0.1 g
100 mL .
10 mL
100 mL . 10
μL
,
6 .
: 10 μL

:
14.5 17.0 % (0.2 g,
, )
0.7 g
(1 : 1)
(
.
C14H9N4NaO5
(C12H12N2O2S) 99.0 %
.
.
1) (1 →
200000)
260 nm 295 nm
.
→ 1000)
Rf
.
50 mL
. 1 mL
100 mL
(1) . 10 mL
50 mL
(2) .
8 (KP VIII) 2002
92

n-13.5 mol/L
(20 : 20 : 6 : 1)

. (1 :

(1) .
2
(2)
.
).
0.1 g
2 mol/L 50 mL
3 g
0.1 mol/L
(
).
mg C12H12N2O2S

Deslanoside
O
O
O
CH3
(C47H74O19) 90.0 102.0 %
.

.
.
mm
(1 → 10000) 1 mL
1 mL 2




.
10 mL 3 mL
8 (KP VIII) [ 1 ]
93
mL .
2) 10 mg
5 mL
. 1.0
mg 5 mL
.


.
13 cm
.
110 10


.
[α] 20D : 6.5 8.5° (
0.5 g, , 25 mL, 100
mm)
, 60 , 4 ).

12 mg
20 mL
100 mL
. 5 mL
25
mL
mL
(1 → 4) 25 mL
18 22 25
.
(1 → 5) 5 mL

.
.
(C 47H 74O 19) (mg) (mg) × AT
A S
90.0 110.0 %
(C47H74O19 : 943.08) .
10 vol%
.
10 vol%

.
pH : 5.0 7.0
2 mg
1 mL
0.2 g
10 mL 3 .



.

. 1 mg
8 (KP VIII) 2002
94


(84 :
.
110
10

Rf .
5 mL
25 mL .

.
(C 47H 74O 19) (mg) (mg) × AT
A S
× 1 4

(C24H34O5) 98.5 %
.
.

.
1 5
. 5 mL

.
m-
0.5 mL

.
0.2 g, , 10 mL, 100 mm)
233 242
mL 2
.
0.10 g 30 mL
10
.
5
25 mL 6 mL
6
.
10 mL
50 mL
. .
0.01 mol/L 0.30 mL
(0.021 % ).
8 (KP VIII) [ 1 ]
95

. 10 mL
50
mL .
. 0.005 mol/L 0.50
mL (0.048 % ).
5) 1.0 g 2
.
2.0 mL (20 ppm
).
2
100 mL .
10 mL 1 mL
.
).
0.5 g
40 mL
20 mL
2 0.1 mol/L

.
mg C24H34O5
95.0 105.0 %
(C24H34O5 : 402.52) .

.

.
10 mL
1 mL .
15 mL 3

105 1
235 242 .

1.0 g

2
.
1 mg 0.30 EU
.
(C24H34O5) 0.5 g

50 mL . 5 mL
8.0 mL
50 mL
.
. 10 μL



8 (KP VIII) 2002
96
(mg) × QT
cm 510 μm



,
6

2.0 % .

(C24H34O5) 99.0 %
.
.

.
0.2 g, , 10 mL, 100 mm)
237 242

).

.
mg C24H34O5
8 (KP VIII) [ 1 ]
97
Dexamethasone
H3C
(C22H29FO5) 97.0 102.0 %
.
.
, ,

.
mL 2, 6-- 3 -p-
5 mL 5
mL
20
.
1 mL
.
3) 10 mg 0.01 mol/L
0.5 mL 20 mL

.
. 2.0 mL
10 mL
60 20 .
2.0 mL


5)

.
[α] 20 D : 72 80° (
0.1 g, , 10 mL, 100
mm)
2 .
3.0 mL
(30 ppm ).
10 mL .
2 mL
100 mL
.
.
10 μL
.
(45 : 4)
. (
254 nm)

.
).
).
10 mg
8 (KP VIII) 2002
98
100 mL
. 10 μL


QT QS .
(C 22H 29FO 5) (mg) = (mg) × QT
Q S

cm 10 μm

.
:
. 10 μL

.

Dexamethasone Tablets
110.0 %
.


.


(45 : 4)
. (
254 nm)
Rf
.
(1 → 100) 500 mL
1 100
. 45

15 mL 3
.
20 mL
.
105 3
1 mL 10
μg
. 20 mL 50 mL
8 (KP VIII) [ 1 ]
99

20 mL
50 mg
10 mL 2.0 mL
.

AT AS .
(C 22H 29FO 5) (mg) = 10 × C × 1 V ×
AT
.
mL
.
10 mL 4

50 mL
.
0.2 mg
50 mL

.
20 mL
.
.
AT
(mL)
20
.
(C22H29FO5) 5 mg
50 mL
(1 → 2)
30 mL 30
(1 → 2)
.
.
(1 →
2) 1 mL 0.1 mg
.
10 μL

HT HS .
(C 22H 29FO 5) (mg) = 50 × C × HT
HS
cm 5 10 μm

.
:
8 (KP VIII) 2002
100
6
3.0 %
.
40000
.
40 98.0 102.0 % .

.
.
.
mL 2 mL

. (1
→ 2) 1 mL 1 mL
.
pH 1.0 10 mL
pH 5.0 7.0.
10 mL
.
. 0.01 mol/L 1.0 mL
(0.018 % ).
.
2.0 mL (20 ppm
).
4) 1.5 g 1
(1.3 ppm
).

(N : 14.01) 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
( :
.
).
1) 40
0.2 0.5
100 mL
. 25
1
0.16 0.19.

100 mL 25
± 1 7
8 (KP VIII) [ 1 ]
101
. 35
25
± 1 15

.
1)
0.27 .
3) 6

100 mL 25
± 1 90
93 %
( 115 135 mL)
. 25
.
. 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 .
10.0
100 mL
.
3 g
50 mL
.
20 ± 1
100 mm αD
.
.
.


.

.
.
(1 → 2) 1 mL
1 mL
.
102
.
100 mL
.
25
1
0.16 0.19.
(/100 mL)
.
.
50 mL
.
20 ± 1
100 mm αD .
100 mL 40 (mg) = αD × 846.0
.
.
70000
.
70 98.0 102.0 % .

.
.
.
.
pH 3.0 50 mL
pH 5.0 7.0.
10 mL
.
. 0.01 mol/L 1.0 mL
(0.018 % ).
.
2.0 mL (20 ppm
).
4) 1.5 g 1
(1.3 ppm
).

(N : 14.01) 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
8 (KP VIII) [ 1 ]
103
.
).
1) 70
0.2 0.5
100 mL
. 25
1
0.21 0.26.

100 mL 25
± 1 7
10 %
( 75 85 mL)
. 35
25
± 1 15

.
1)
0.35 .
3) 6

100 mL 25
± 1 90
93 %
( 110 130 mL)
. 25
.
100 mL
.
40 .
6.0
100 mL
.
3 g
50 mL
.
20 ± 1
100 mm αD
.
.
.


.

.
.
(1 → 2) 1 mL
1 mL
.
.
104
100 mL
.
25
1
0.21 0.26.
(g/100 mL) .

20 ± 1 100 mm
αD .
100 mL 70 (mg) = αD × 507.6
.
.
O O O OH

.


.

120.0 %
(C22H24N2O8 : 444.43) .

90.0 120.0 %
(C22H24N2O8 :

8 (KP VIII) [ 1 ]
105
(C22H24ClN5O2) 99.0 %
.
.

.
(II)
10 w/v% 0.1 mL
2 mol/L
0.1 mL
.

.
.
20 mg 10 mL
(1) 20 mg
20 mg
10 mL (2) .

(2) 5 μL

(20 :
.


(1)
Rf (2)

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


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

100cm 3 μm

10

8 (KP VIII) 2002
106
: 1.5 mL/. 30

[(5 →
.

100 mL
,

2.0 .

.
, )
0.3 g

mol/L ( :

.
C22H24ClN5O2

Droperidol
(C22H22FN3O2) 98.0 %
.
.

.
1) (1
→ 10000) 10 mL
5 mL

.
5 mL
0.1 mol/L 10 mL
100 mL

nm, 243 247 nm 278 282 nm
.

.
8 (KP VIII) [ 1 ]
107
2
. 2.0
mL (20 ppm ).
2)
.
50 mg 5 mL
. 1 mL


(

pH 4.7
15 cm
. ( 254 nm)


.
, 70 , 4 ).
).
50 mL
0.1 mol/L (
).
.
C22H22FN3O2

(C41H64O14) 96.0 106.0 % .


.
.
mm
(1 → 10000) 1 mL
1 mL 2




.
(1 : 1) 50 mL
8 (KP VIII) 2002
108


10 cm
.
110 10

Rf .
[α] 25 546.1 : 13.3 14.3°
( 1 g, , 10 mL, 100
mm).
(4 → 5) 15 mL
70
.
105 1
10.0 mg
(2 : 1)
100 mL . 10 mL

. 1 mL 10 μ
g . .
)
.
20 .
50 mL T S

.
20
28 .
30

355 nm,
465 nm FT FS
FT FS .
1.0 % (0.5 g, , 105
, 1 ).

25 mg
50 mL
100 mL
.
10 mL
100 mL
.
5 mL


. m-

620 nm
1 AT
AS .
(C 41H 64O 14) (mg) = (mg) × AT
A S

Digoxin Tablets
8 (KP VIII) [ 1 ]
109
110.0 % (C41H64O14 :
780.94) .
.
.
m-
.
2) . )
1 mL
10 mL
.

(3 → 500) 500 mL 1
100 .
60 30 mL
0.8 μm
10 mL
.
105 1
25 mg

(4 → 5)
500 mL . 5 mL
500
mL . ,
2 mL
T,
S B . 0.12 mg/mL
10 mL
.
1 mL
25 30
45 .

360 nm, 485 nm
FT, FS FB .
60 65 %
.
.
(C 41H 64O 14) (%) = WS × FT - FB
F S - FB

0.5 mL 30
mL 15 1
mL (C41H64O14) 5 μg

V mL .
10 mL
. 105
1 10 mg
50 mL
100
mL . 5 mL
50 mL 1 mL
100 mL
. ,
(47 → 50) 2 mL

T, S B .
0.12 mg/mL
10 mL
1 mL
30
45 .

8 (KP VIII) 2002
110
(C 41H 64O 14) (mg) = (mg) × FT - F B
F S - FB
20
.
(C41H64O14) 2.5 mg
n- 5
mL
20
20 mL
n-(5 :
5 mL
100
mL .
105 1
25 mg
50 mL
100 mL
. 10 mL
100 mL
. 10
mL


5 mL
10 .
.


590 nm 2
AT As
.
(C 41H 64O 14) (mg) = (mg) × A T
A S
× 1 10

Digoxin Injection
90.0 110.0 %
(C41H64O14 : 780.94) .
vol%
.
2 mL
.
m-

.
2) . )
1 mL
10 mL
.
mg
50 mL
1 mL
n-(5 : 1) 35 mL, 30
mL 30 mL .
5 mL
100 mL
.
.
8 (KP VIII) [ 1 ]
111
(C 41H 64O 14) (mg) = (mg) × A T
A S
× 1 10

Digitoxin
O
O
O
CH3
(C41H64O13) 90.0 % .

.

.
mm
(1 → 10000) 1 mL
1 mL 2




.
(1 → 100) 25 mL
. 2
mL
.
(1 : 1) 50 mL
.


10 cm
.
110
10
Rf .
[α] 20 D : 16 18° (
0.5 g, , 20 mL, 200
mm)
mL
(1 → 200) 2 mL
10
.
, 2 ).

20 mg
200
mL . 5 mL
10 mL
12.5 mL
50 mL
8 (KP VIII) 2002
112
μL


QT QS .
(C 41H 64O 14) (mg) = (mg) × QT
Q S
20 cm 5 μm

.
,


Digitoxin Tablets
110.0 % (C41H64O13 :
764.94) .
.
(C41H64O13) 2 mg

30 mL
30 mL
.
.
10 mL
. 5 mL
10 mm
.
1) .

(1 → 100) 10 mL
. 2 mL
2)
.

(3 → 500) 500 mL 1
100 .
30 α 15
mL 37 ± 0.5

. α 15 mL 0.8 μm
.
.
(C41H64O13) 2 μg
α mL
T30 37 ± 0.5
30 .
60 α 15 mL
α
mL
T60 .
100 2
8 (KP VIII) [ 1 ]
113
. 1 mL
500 mL
37 ± 0.5 60
0.8 μm
10 mL
.
α mL
TS TB .
T30,
T60, TS TB 7 mL
10
.
5 mL
T'30, T'60, T'S
T'B
0.5 mg/mL
4 mL
10 .
0.5 mL
25 30
45 .

395 nm, 560 nm
F30, F60, Fs FB
.
60 85 %
.
.
30 (C 41H 64O 13) (%)
= W S × F 30 FB
F S FB
60 (C 41H 64O 13) (%)
= WS × ( F 60 FB
F S F B
(mg)
0.5 mL
5 mL
5
.
A 30
mL, 20 mL
A
.
B


. A
30 mL 2

B

.

1 mL (C41H64O13) 5
μg
(4 → 5) V mL
20
.
mg
(4 → 5) 100 mL
. 5 mL
(4 → 5)
100 mL
. , (4
→ 5) 2 mL
8 (KP VIII) 2002
114
. 0.2 mg/mL
10 mL

1 mL
25 30 45
.
400
nm, 570 nm
FT, Fs FB .
(C 41H 64O 13) ( mg)
= ( mg) × F T F B
F S F B
20
.
(C41H64O13) 0.5 mg
12.5 mL
10 .
10 mL 20
50
mL .
.
100 2
20 mg
200 mL . 5
mL 10
mL 12.5 mL
50 mL
.
.
= (mg) × Q T
Q S

Digitoxin Injection
90.0 110.0 %
(C41H64O13 : 764.94) .
vol%
.
.
.
1) .
.

m- (1 →
. 2 mL
2) .

.
111.0 EU .

1 mL 40 μg
8 (KP VIII) [ 1 ]
115
50 μL

As .
(C 41H 64O 13) (μg/mL) = 25 × C V ×
A T
A S

cm 5 10 μm

.
:
1 mL
40 μg 50 μL

,
6

2.0 % .


.

.


.

. 5.0 mL

.
15 mg 5 mL


.
.
10 μL
(180 : 15

8 (KP VIII) 2002
116
Rf
Rf
.
.
pH (1 → 100) pH
7.5 10.5.
0.1 g, , 10 mL, 100
mm).
10 mL
5 mL

.
(1 → 50) 25

4 mL
10 mL
5 mL

. 2 μL



(C 2H 5OH) (%) = 4 × S W
× HT
HS
W : (g)
(1
m 149 177 μm 4-


.
6

4.0 % .
.
25 mL
10 mL 1 mol/L
5 mL
. A
B 1 mL
.
30
. 5 mL

.



(PO4 1.0 % ).
:
mL (0.10 mg PO4/mL).
A : 5 g
0.5 mol/L
100 mL .
8 (KP VIII) [ 1 ]
117
20 g
100 mL .
3)
20 μL

AT AS (1.0 % )
(C 22H 29FO 5) (μg) = 1000 × C × A T
A S
, 0.4 g, , ).
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 μg
2 . 1 10.0 mL
2 1.0 mL
100 mL
. 20 μL

.
= 516.41 472.45
× C × AT
A S
cm 5 μm

.
1000 mL
pH 5.4 .
74 : 26 .
: 1.2 mL/

6

1.0 % .
115.0 %
118

.
g 0.86 g
1000 mL (pH 9.0 ).
50 mL
5 mL 50 mL
. 37 45
25 mL
2 .

. 15 mL
.
65 mL
.
45 mL 125 mL
1

100 mL .
15 mL 2


.
( 40 ,

1 mL 30 μg
.
.
20 μL

AS .
(C 22H 30FO 8P) (mg) = 0.1 × C × AT
A S
cm 5 10 μm

.
:
6
1.5
% .

Dexamethasone Disodium
Phosphate Injection
90.0 115.0 %
(C22H30FO8P : 472.45)

.
mL 100
mL . 5
mL 125 mL
8 (KP VIII) [ 1 ]
119
2 . 50
mL
50 mg pH 9.0
50 mL
5 mL 37 45
25 mL
. 15
mL

1 mL 300 μg
5 μL

.
15 cm
. (1
→ 2) 105
.
Rf
.
31.3 EU .

100 mL .
( 40 , 0.67
kPa )
80 μg
. .
20 μL

(C 22H 30FO 8P) (mg/mL) = 0.1C V
× AT
cm 5 10 μm

.
:
6
1.5
% .

Dinoprost
CH3
CO2H
H
HO
(C20H34O5) 98.5 %
.
120

,
.
1) 5 mg 2 mL
5
.
30 mL
.

330 nm .

cm-1, 2920 cm-1, 2855 cm-1, 1705 cm-1,
1405 cm-1 965 cm-1
.
, 10 mL, 100 mm)
1) 0.20 g
5 mL
.