医薬発1304_局外規第三部改正_.PDF
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2 Aldioxa Powder C 4 H 7 AlN 4 O g 900 ml ml 0.45 m 10 ml V ml 1 ml C 4 H 7 AlN 4 O 5 22 g ph V ' ml g 25 ml 1 ml ph ml 223 nm A T A S C 4 H 7 AlN 4 O 5 W S A T V ' 1 72 W T A S V C W S W T g C 1 g C 4 H 7 AlN 4 O mg/g 15 85%
3 Aldioxa Fine Granules C 4 H 7 AlN 4 O g 900 ml ml 0.45 m 10 ml V ml 1 ml C 4 H 7 AlN 4 O 5 22 g ph V ' ml g 25 ml 1 ml ph ml 223 nm A T A S C 4 H 7 AlN 4 O 5 W S A T V ' 1 72 W T A S V C W S W T g C 1 g C 4 H 7 AlN 4 O mg/g 15 85%
4 Aldioxa Granules C 4 H 7 AlN 4 O g 900 ml ml 0.45 m 10 ml V ml 1 ml C 4 H 7 AlN 4 O 5 22 g ph V ' ml g 25 ml 1 ml ph ml 223 nm A T A S C 4 H 7 AlN 4 O 5 W S A T V ' 1 72 W T A S V C W S W T g C 1 g C 4 H 7 AlN 4 O mg/g 15 85% 200 mg/g 15 85% 250 mg/g 15 85% 500 mg/g 15 85%
5 Aldioxa Tablets ml ml 0.45 m 10 ml V ml 1 ml C 4 H 7 AlN 4 O 5 22 g ph V ' ml g 25 ml 1 ml ph ml 223 nm A T A S C 4 H 7 AlN 4 O 5 A T V ' 1 W S 72 A S V C W s C 1 C 4 H 7 AlN 4 O 5 50 mg 15 80% 100 mg 30 70%
6 Ubenimex Capsules 1 900mL mL 0.45 m 10mL V ml 1 C 16 H 24 N 2 O 4 11 g 7 3 V ml V g mL 5mL mL 50 L A T A S C 16 H 24 N 2 O 4 A T V 1 Ws 45 A S V W S C 1 C 16 H 24 N 2 O 4 C 200nm 4mm 15cm 5 m L L mg 30 75% 30 mg 30 70%
7 C 16 H 24 N 2 O %
8 Benexate Hydrochloride Betadex Capsules 1 900mL mL 0.5 m 10mL V ml 1 C 23 H 27 N 3 O 4 HCl C 42 H 70 O g V ml 0.033g 10mL 1mL 50mL 100 L A T A S C 23 H 27 N 3 O 4 HCl C 42 H 70 O 35 A T V 1 W S A S V C W S C 1 C 23 H 27 N 3 O 4 HCl C 42 H 70 O nm 4mm 15cm 5 m 25 ph L L mg 20 85%
9 Lomefloxacin Hydrochloride Tablets 1 900mL ml 0.8 m 10 ml V 1 ml C 17 H 19 F 2 N 3 O V ml g 200 ml 2 ml 1 50 ml 288 nm A T A S C 17 H 19 F 2 N 3 O 3 (%) A T V 1 = W S A S V C W S C 1 C 17 H 19 F 2 N 3 O 3 * 200 mg 30 75% * C 17 H 19 F 2 N 3 O 3 HCl ( )-1- -6,8- -1,4- -7-( ) g 150 ml cm cm cm cm cm cm g ph mL
10 1mL ph mL 7 L 1/10 280nm 4mm 15cm 5 m 25 ph mL g mL g 0.01 mol/l 50mL 5mL ph mL 10mL ph mL ph mL 7 L 9 7 L 5 15mm g g 1 : 1 20 ml 0.1 mol/l ml 50 ml 0.1 mol/l 0.1mol/L 1mL mg C 17 H 19 F 2 N 3 O 3 HCl ph g 1000mL ph 2.5
11 Lomefloxacin Hydrochloride Capsules ml ml 0.8 m 10 ml V ml 1 C 17 H 19 F 2 N 3 O V ml g 200 ml 2 ml 1 50 ml 288 nm A T A S C 17 H 19 F 2 N 3 O 3 (%) A T V 1 = W S A S V C W S C 1 C 17 H 19 F 2 N 3 O 3 * 100 mg 30 75% * C 17 H 19 F 2 N 3 O 3 HCl ( )-1- -6,8- -1,4- -7-( ) g 150 ml cm cm cm cm cm cm -1
12 0.010g ph mL 1mL ph mL 7 L 1/10 280nm 4mm 15cm 5 m 25 ph mL g mL g 0.01mol/L 50mL 5mL ph mL 10mL ph mL ph mL 7 L 9 7 L 5 15mm g g 1 : 1 20 ml 0.1 mol/l ml 50 ml 0.1 mol/l ) 0.1mol/L 1mL mg C 17 H 19 F 2 N 3 O 3 HCl ph g 1000mL ph 2.5
13 Auranofin Tablets ml ml 0.45 m 10 ml ml 5 ml 100 ml 10 ml 100 ml 50 L A T A S C 20 H 34 AuO 9 PS A T 1 W S 9 A S C W S C 1 C 20 H 34 AuO 9 PS 230 nm 4 mm 15 cm 5 m L L % 3 mg 15 85%
14 Cinoxacin Capsules 1 ph mL mL 0.45 m 10mL V ml 1 ml C 12 H 10 N 2 O 5 11 ph V ml g ph mL 5mL ph mL 351nm A T A S C 12 H 10 N 2 O 5 A T V 1 W S 45 A S V W S C 1 C 12 H 10 N 2 O 5 C 200 mg 90 70% C 12 H 10 N 2 O %
15 Cimetidine Fine Granules C 10 H 16 N 6 S 0.4 g 900 ml ml 0.8 m 10 ml V ml 1 ml C 10 H 16 N 6 S 66 g V ' ml g 100 ml 6 ml 20 ml 242 nm A T A S C H N S W A T V ' W A S V W S W T g C 1 g C 10 H 16 N 6 S C 200 mg/g 15 85% 400 mg/g 15 80%
16 Sofalcone Fine Granules C 27 H 30 O g 80 ph mL mL 0.45 m 10mL 5mL 80 ph mL V g 50mL 1mL 80 ph mL 346nm A T A S C 27 H 30 O 6 W S A T W T A S C W S W T g C 1g C 27 H 30 O mg/g 45 75% C 27 H 30 O
17 Sofalcone Tablets 1 80 ph mL mL 0.45 m 10mL V ml 1 ml C 27 H 30 O ph V ml V g 50mL 1mL 80 ph mL 346nm A T A S C 27 H 30 O 6 A T V 1 Ws A S V W S C 1 C 27 H 30 O 6 C 50 mg 60 75% C 27 H 30 O
18 Sofalcone Capsules 1 80 ph mL mL 0.45 m 10mL V 1 ml C 27 H 30 O ph V ml V g 50mL 1mL 80 ph mL 346nm A T A S C 27 H 30 O 6 A T V 1 Ws 18 A S V C W S C 1 C 27 H 30 O mg 45 70% C 27 H 30 O
19 Tosufloxacin Tosilate Tablets ml ml 0.5 m 10 ml V 1 ml C 19 H 15 F 3 N 4 O 3 C 7 H 8 O 3 S H 2 O 17 ph mol/l V ml g N,N- 50 ml 2 ml ph mol/l 100 ml ph mol/l 346 nm A T A S C 19 H 15 F 3 N 4 O 3 C 7 H 8 O 3 S H 2 O A T V 1 W S A S V C W S C 1 C 19 H 15 F 3 N 4 O 3 C 7 H 8 O 3 S H 2 O 75 mg 90 70% 150 mg 90 65% C 19 H 15 F 3 N 4 O 3 C 7 H 8 O 3 S H 2 O p- p cm cm cm cm cm cm cm g 4 ml 1
20 ml L cm 254 nm Rf 0.4 p- Rf g g N,N- 50 ml 0.1 mol/l 1,4-2 N,N- 50 ml 1, ml 0.1mol/L 1,4-1mL mg C 19 H 15 F 3 N 4 O 3 C 7 H 8 O 3 S H 2 O p g 0.1 mol/l 20 ml 100 ml 0.1mol/L 3 0.1mol/L 1mL mg C 7 H 8 O 3 S 0.05 mol/l ph g 1000 ml 3.4 g 500 ml ph
21 Niceritrol Tablets mL mL 0.5 m 10mL V ml 1 ml C 29 H 24 N 4 O V ml g 1 100mL 5mL 1 100mL 261nm A T A S C 29 H 24 N 4 O 8 A T V 1 W S 45 A S V C W S C 1 C 29 H 24 N 4 O mg 90 75% 250 mg 90 70%
22 Famotidine Powder C 8 H 15 N 7 O 2 S g ph mol/l 900 ml ml 0.5 m 10 ml V g ph mol/l 100 ml 5 ml ph mol/l 100 ml 266 nm A T A S C 8 H 15 N 7 O 2 S 3 ( ) W S A T 1 45 W T A S C W S W T g C 1 g C 8 H 15 N 7 O 2 S 3 20 mg/g 15 80% 100 mg/g 15 85% C 8 H 15 N 7 O 2 S % 0.05 mol/l ph g 1000 ml 3.4 g 500 ml ph
23 Famotidine Tablets 1 ph mol/l 900 ml ml 0.5 m 10 ml V ph mol/l 100 ml 5 ml ph mol/l 100 ml 266 nm A T A S C 8 H 15 N 7 O 2 S 3 A T 1 W S 45 A S C W S C 1 C 8 H 15 N 7 O 2 S 3 10 mg 45 70% 20 mg 60 70% C 8 H 15 N 7 O 2 S mol/l ph g 1000 ml 3.4 g 500 ml ph
24 Fluorouracil Dry Syrup C 4 H 3 FN 2 O g 900 ml ml 0.45 m 10 ml 2 ml 20 ml g 100 ml 2 ml 50 ml 266 nm A T A S C 4 H 3 FN 2 O 2 W S A T W T A S C W S W T g C 1g C 4 H 3 FN 2 O 2 50 mg / g 15 85%
25 Irsogladine Maleate Fine Granules C H 7 Cl 2 N 5 C 4 H 4 O 4 4 mg 900 ml ml 0.5 m 10 ml g 20 ml 2 ml 20 ml 2 ml 100 ml 210 nm A T A S C 9 H 7 Cl 2 N 5 C 4 H 4 O 4 W S A T 1 9 W T A S C W S W T g C 1 g C 9 H 7 Cl 2 N 5 C 4 H 4 O 4 8 mg/g 30 70% C 9 H 7 Cl 2 N 5 C 4 H 4 O 4 2,4- -6-(2,5- )-S- 10 g 1 g ml cm cm cm cm g 10 ml 1 ml 50 ml 1 ml 20 ml
26 5 L : : 250 nm : 4 mm 15 cm 5 m : 40 : ( ) 4 1 : 16 : 0.05 g 0.01 g 20 ml 1 ml 20 ml 5 L 8 : 5 L 5 15 % : g % 0.3 g ml 25 ml 0.05 mol/l 0.05 mol/l 1 ml = mg C 9 H 7 Cl 2 N 5 C 4 H 4 O 4
27 Irsogladine Maleate Tablets ml ml 0.5 m 10 ml ml 2 20 ml 2 ml 100 ml 210 nm A T A S C 9 H 7 Cl 2 N 5 C 4 H 4 O 4 A T 1 W S 9 A S C W S C 1 C 9 H 7 Cl 2 N 5 C 4 H 4 O 4 2 mg 30 80% 4 mg 30 80% C 9 H 7 Cl 2 N 5 C 4 H 4 O 4 2,4- -6-(2,5- )-S- 10 g 1 g ml cm cm cm cm g 10 ml 1 ml 50 ml 1 ml 20 ml 5 L
28 : : 250 nm : 4 mm 15 cm 5 m : 40 : : 16 : 0.05 g 0.01 g 20 ml 1 ml 20 ml 5 L 8 : 5 L 5 15 % : g % 0.3 g ml 25 ml 0.05 mol/l 0.05mol/L 1mL = mg C 9 H 7 Cl 2 N 5 C 4 H 4 O 4
29 Methotrexate Tablets 1 900mL mL 0.45 m 10mL Vml 1mL C 20 H 22 N 8 O g V ml 0.028g 100mL 1mL 100mL 50 L A T A S C 20 H 22 N 8 O 5 A T V 1 W S 9 A S V C W S C 1 C 20 H 22 N 8 O 5 302nm 4mm 15cm 5 m mol/L 250mL 0.2mol/L 29mL 1000mL 890mL 110mL 4 50 L L mg 45 85%
30 Mercaptopurine Powder C 5 H 4 N 4 S H 2 O 0.1g 900mL mL 0.45 m 10mL 4 ml 100 ml 0.028g 250mL 4mL 100mL 323nm A T A S C 5 H 4 N 4 S H 2 O W S A T W T A S C W S W T g C 1g C 5 H 4 N 4 S H 2 O 100 mg/g 30 75% C 5 H 4 N 4 S 99.0
31 Rebamipide Tablets 1 ph ml ml ml V ml 1 ml C 19 H 15 ClN 2 O 4 22 g ph V ' ml 0.05 g N,N- 25 ml 2 ml ph ml 326 nm A T As C 19 H 15 ClN 2 O 4 A T V 1 Ws 36 As V C Ws C 1 C 19 H 15 ClN 2 O mg 60 75% C 19 H 15 ClN 2 O 4 ( )-2-(4- )-3-[2(1H)- -4- ] cm cm cm cm cm cm g N,N- 5 ml N,N ml 2 ml N,N ml 5 ml N,N ml
32 20 L nm 4 mm 15 cm 5 m g N,N- 5 ml N,N ml 5 ml N,N ml 20 L L 5 10 mm g g N,N- 60 ml 0.1 mol/l mol/l 1 ml mg C 19 H 15 ClN 2 O 4
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