诺氟沙星胶囊项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号130450-201907对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100
标示量(mg)100 供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 10.184114858411369241109644112397411342441130670.04
2 10.144113017411449241137540.03
单位质量响应值RSD%判断
404034.09405695.660.30数据可信
供试品溶液-24122601批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min14070172-407017290.11790.024.8490.1290.024.84
23846737-384673785.17085.17
34346604-434660496.23796.24
44027064-402706489.16289.16
53872694-387269485.74585.74
64230790-423079093.67393.67
10min14574198-4574198101.276100.760.58101.43100.910.59
24532969-4532969100.364100.51
34540829-4540829100.538100.70
44526590-4526590100.222100.37
54537002-4537002100.453100.60
64592531-4592531101.682101.84
15min14578898-4578898101.381100.830.58101.70101.150.58
24538390-4538390100.484100.79
34535753-4535753100.425100.75
44545834-4545834100.648100.96
54531577-4531577100.333100.64
64594422-4594422101.724102.05
20min14574602-4574602101.285100.890.87101.77101.370.87
24531315-4531315100.327100.80
34526829-4526829100.228100.72
44603983-4603983101.936102.42
54508680-450868099.826100.30
64593972-4593972101.714102.21
30min14564512-4564512101.062100.660.65101.72101.310.65
24534445-4534445100.396101.04
34522089-4522089100.123100.79
44544702-4544702100.623101.28
54516580-4516580100.001100.64
64594595-4594595101.728102.39
诺氟沙星胶囊项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号130450-201907对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100
标示量(mg)100 供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 10.184104653410311641038544103363410357641037120.02
2 10.144112540410713341098360.10
单位质量响应值RSD%判断
403115.13405309.270.39数据可信
供试品溶液-24122602批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min13893054-389305486.33585.887.0186.3385.887.01
24392152-439215297.40397.40
33834334-383433485.03385.03
43626915-362691580.43380.43
53780639-378063983.84283.84
63707365-370736582.21782.22
10min14533223-4533223100.532100.940.59100.68101.090.59
24565019-4565019101.237101.40
34584965-4584965101.679101.82
44535859-4535859100.590100.72
54574246-4574246101.441101.58
64517725-4517725100.188100.32
15min14530324-4530324100.467101.100.54100.78101.410.54
24560427-4560427101.135101.47
34587517-4587517101.736102.05
44556196-4556196101.041101.34
54584804-4584804101.676101.98
64533648-4533648100.541100.85
20min14529414-4529414100.447100.770.46100.93101.250.46
24544818-4544818100.789101.29
34582976-4582976101.635102.12
44539957-4539957100.681101.15
54540673-4540673100.697101.18
64524819-4524819100.345100.82
30min14529763-4529763100.455101.320.84101.10101.970.84
24559601-4559601101.117101.78
34636316-4636316102.818103.47
44553716-4553716100.986101.62
54587460-4587460101.734102.38
64546896-4546896100.835101.47
诺氟沙星胶囊项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号130450-201907对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数100
标示量(mg)100 供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 10.184119064411932841182924119222411933541190480.02
2 10.144115402411432741148640.02
单位质量响应值RSD%判断
404621.61405805.130.21数据可信
供试品溶液-24122603批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min13604479-360447979.73782.864.8079.7482.874.80
23834572-383457284.82784.83
33787914-378791483.79583.80
43566856-356685678.90578.91
53638448-363844880.48980.49
64042760-404276089.43389.43
10min14429633-442963397.99198.310.5198.1298.440.51
24476355-447635599.02599.17
34463165-446316598.73398.87
44444650-444465098.32398.45
54431802-443180298.03998.17
64417444-441744497.72197.87
15min14453776-445377698.52598.780.7098.8299.080.70
24516711-451671199.917100.22
34487054-448705499.26199.57
44451585-445158598.47798.77
54448828-444882898.41698.71
64432779-443277998.06198.37
20min14464337-446433798.75998.741.1299.2299.211.11
24518061-451806199.947100.42
34526950-4526950100.144100.61
44429106-442910697.97998.44
54438739-443873998.19398.65
64404286-440428697.43097.91
30min14459349-445934998.64898.630.9499.2799.260.94
24499083-449908399.527100.17
34517133-451713399.927100.56
44437138-443713898.15798.78
54424897-442489797.88698.51
64413680-441368097.63898.28
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