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%
110.174091878408693840897604085213408671040881000.07
210.134097077408796140925190.16
单位质量响应值RSD%判断
401976.40403999.900.36数据可信
加速6月-供试品溶液-25031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%
5min12571550-257155057.20147.0820.9057.2047.0820.90
22447665-244766554.44654.45
31755234-175523439.04339.04
42371509-237150952.75252.75
52120153-212015347.16147.16
61433932-143393231.89631.90
10min14216674-421667493.79696.642.9393.8996.722.93
24375848-437584897.33697.43
34431416-443141698.57298.64
44525871-4525871100.673100.76
54321916-432191696.13796.22
64194804-419480493.30993.36
15min14400014-440001497.87499.521.9798.1399.761.97
24535167-4535167100.880101.13
34488391-448839199.840100.07
44579987-4579987101.877102.13
54341935-434193596.58296.82
64497579-4497579100.044100.25
20min14417684-441768498.26799.681.6298.68100.081.61
24523925-4523925100.630101.05
34487578-448757899.822100.22
44566512-4566512101.577102.00
54373356-437335697.28197.68
64517242-4517242100.481100.86
30min14408404-440840498.06099.521.6698.64100.091.65
24512058-4512058100.366100.95
34483329-448332999.727100.29
44562576-4562576101.490102.08
54364111-436411197.07597.64
64514276-4514276100.415100.96
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%
110.174108513408819240863884090095408574840917870.24
210.134088551409088240897160.05
单位质量响应值RSD%判断
402338.94403723.200.25数据可信
加速6月-供试品溶液-25032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%
5min12162293-216229348.09350.7230.7748.0950.7230.77
23113288-311328869.24469.24
32159441-215944148.02948.03
42772428-277242861.66361.66
51063711-106371123.65923.66
62412202-241220253.65153.65
10min14394546-439454697.74199.782.8997.8299.862.91
24662119-4662119103.693103.81
34352655-435265596.81096.89
44633433-4633433103.055103.16
54438282-443828298.71498.75
64435492-443549298.65298.74
15min14534426-4534426100.853101.641.80101.10101.901.82
24676476-4676476104.012104.30
34481339-448133999.67299.91
44662024-4662024103.691103.97
54565265-4565265101.538101.74
64500482-4500482100.098100.35
20min14553627-4553627101.280101.561.73101.69101.981.75
24664462-4664462103.745104.21
34461761-446176199.23699.64
44651421-4651421103.455103.90
54553420-4553420101.275101.65
64512065-4512065100.355100.78
30min14539081-4539081100.956101.531.69101.54102.121.71
24659539-4659539103.635104.27
34451518-445151899.00999.58
44641399-4641399103.232103.85
54570511-4570511101.655102.20
64527570-4527570100.700101.29
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%
110.174083152408285340844414078781409286540844180.13
210.134088305409346740908860.09
单位质量响应值RSD%判断
401614.36403838.700.40数据可信
中间条件6月-供试品溶液-25031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%
5min11478034-147803432.89935.5517.1732.9035.5517.17
21639210-163921036.48636.49
32082700-208270046.35846.36
41256933-125693327.97727.98
51617551-161755136.00436.00
61508842-150884233.58433.58
10min14303529-430352995.79096.342.4295.8496.402.42
24358473-435847397.01397.07
34284259-428425995.36195.44
44179182-417918293.02293.07
54496915-4496915100.094100.15
64347289-434728996.76496.82
15min14450781-445078199.067100.281.1299.28100.501.12
24519515-4519515100.597100.82
34484425-448442599.816100.05
44453591-445359199.13099.33
54556666-4556666101.424101.65
64565552-4565552101.622101.84
20min14438068-443806898.785100.101.1499.16100.481.15
24486018-448601899.852100.24
34489124-448912499.921100.32
44453947-445394799.13899.50
54568368-4568368101.685102.08
64546739-4546739101.203101.59
30min14433475-443347598.682100.021.1699.23100.571.16
24490789-449078999.958100.51
34480933-448093399.739100.31
44446199-444619998.96599.50
54552368-4552368101.329101.89
64557010-4557010101.432101.99
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%
110.174084074408255440826914082639408391940831750.02
210.134070820407336440720920.05
单位质量响应值RSD%判断
401492.13401983.420.09数据可信
中间条件6月-供试品溶液-25032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%
5min14120298-412029891.93761.1636.7391.9461.1636.73
21881588-188158841.98441.98
31972222-197222244.00644.01
43286429-328642973.33073.33
53455776-345577677.10977.11
61728523-172852338.56938.57
10min14690087-4690087104.650102.982.39104.80103.082.41
24482202-4482202100.012100.08
34524312-4524312100.951101.02
44578285-4578285102.156102.28
54780161-4780161106.660106.79
64637509-4637509103.477103.54
15min14694233-4694233104.743104.321.98105.07104.601.98
24734254-4734254105.636105.87
34547280-4547280101.464101.71
44590401-4590401102.426102.72
54797077-4797077107.038107.34
64688995-4688995104.626104.86
20min14684563-4684563104.527104.192.00105.03104.642.00
24733211-4733211105.612106.03
34541373-4541373101.332101.74
44587199-4587199102.354102.82
54795085-4795085106.993107.48
64676449-4676449104.346104.76
30min14677244-4677244104.364103.942.13105.04104.562.13
24725089-4725089105.431106.02
34532349-4532349101.131101.71
44559859-4559859101.744102.38
54794864-4794864106.988107.65
64659725-4659725103.973104.56
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