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(%)99.60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%
110.304001786400589840273334035520404569040232450.48
210.244018844401690040178720.04
单位质量响应值RSD%判断
390606.31392370.310.32数据可信
长期18月-供试品溶液-22101批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1637887-63788714.60614.2612.7814.6114.2612.78
2578974-57897413.25713.26
3623874-62387414.28514.29
4698421-69842115.99215.99
5705731-70573116.15916.16
6492667-49266711.28111.28
10min11740113-174011339.84438.068.8039.8738.088.80
21554083-155408335.58435.61
31668638-166863838.20738.23
41783059-178305940.82740.85
51799707-179970741.20941.24
61426388-142638832.66132.68
15min12588478-258847859.26957.446.5659.3657.526.56
22365365-236536554.16154.24
32522545-252254557.76057.85
42641497-264149760.48360.58
52674649-267464961.24261.34
62258225-225822551.70751.78
20min13247784-324778474.36671.545.5974.5671.725.60
22997616-299761668.63768.81
33113822-311382271.29871.48
43246468-324646874.33674.53
53293795-329379575.41975.62
62846388-284638865.17565.33
30min13957178-395717890.60987.743.6890.9288.043.69
23731291-373129185.43785.72
33809178-380917887.22087.52
43895564-389556489.19889.52
53982136-398213691.18091.50
63616882-361688282.81783.09
45min14228824-422882496.82995.762.5697.2996.202.58
24083724-408372493.50693.93
34161735-416173595.29395.74
44284362-428436298.10198.57
54297027-429702798.39198.87
64036332-403633292.42192.83
60min14264847-426484797.65497.112.1698.2897.722.18
24146655-414665594.94795.53
34194646-419464696.04696.65
44310760-431076098.70599.34
54374974-4374974100.175100.81
64154708-415470895.13295.69
极限14362326-436232699.88699.201.29100.6799.981.31
24271780-427178097.81298.55
34288250-428825098.19098.96
44407915-4407915100.930101.73
54373043-4373043100.131100.94
64292197-429219798.28099.00
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(%)99.60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%
110.304034380403582340462914042582404272040403590.13
210.243934678393599339353360.03
单位质量响应值RSD%判断
392267.86384310.161.45数据可信
长期18月-供试品溶液-22102批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1552334-55233412.75214.1512.3412.7514.1512.36
2640798-64079814.79514.79
3659443-65944315.22515.23
4487335-48733511.25211.25
5672672-67267215.53115.53
6664294-66429415.33715.34
10min11703001-170300139.31940.094.8539.3440.124.86
21804957-180495741.67341.70
31816233-181623341.93441.96
41586157-158615736.62236.64
51756329-175632940.55140.58
61752171-175217140.45540.48
15min12656502-265650261.33460.964.3161.4261.054.31
22719287-271928762.78462.88
32763806-276380663.81263.91
42441956-244195656.38156.46
52589587-258958759.78959.88
62671324-267132461.67661.77
20min13322096-332209676.70276.062.9376.8976.262.93
23341341-334134177.14677.34
33422305-342230579.01579.22
43135012-313501272.38272.56
53253165-325316575.11075.30
63292852-329285276.02676.22
30min14086002-408600294.33992.552.4594.6692.872.45
24003287-400328792.42992.76
34134237-413423795.45395.79
43895380-389538089.93890.23
53896461-389646189.96390.28
64035085-403508593.16393.49
45min14465552-4465552103.102100.012.29103.58100.492.29
24341813-4341813100.245100.73
34377722-4377722101.074101.57
44232317-423231797.71798.16
54200354-420035496.97997.45
64373004-4373004100.965101.44
60min14488648-4488648103.635101.121.89104.28101.761.89
24378620-4378620101.095101.74
34441617-4441617102.549103.21
44315635-431563599.641100.25
54261610-426161098.39399.02
64392760-4392760101.421102.07
极限14522709-4522709104.422102.051.70105.24102.861.70
24399459-4399459101.576102.39
34457929-4457929102.926103.76
44364397-4364397100.767101.54
54314914-431491499.624100.42
64460651-4460651102.989103.80
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(%)99.60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%
110.304101923410626541013404102437410436241032650.05
210.244054058404932640516920.09
单位质量响应值RSD%判断
398375.24395673.050.49数据可信
长期18月-供试品溶液-22103批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1681001-68100115.37612.7717.4815.3812.7717.47
2439650-4396509.9279.93
3543400-54340012.26912.27
4640037-64003714.45114.45
5624649-62464914.10314.10
6464974-46497410.49810.50
10min11894606-189460642.77739.207.6542.8039.227.65
21617189-161718936.51336.53
31759277-175927739.72139.74
41852781-185278141.83341.86
51742334-174233439.33939.36
61550327-155032735.00435.02
15min12859067-285906764.55360.675.1864.6560.765.19
22574225-257422558.12158.20
32719715-271971561.40661.49
42817935-281793563.62463.72
52652530-265253059.88959.98
62499997-249999756.44656.52
20min13533339-353333979.77775.614.8279.9875.804.82
23313611-331361174.81574.99
33384767-338476776.42276.61
43482993-348299378.64078.84
53300073-330007374.51074.70
63078842-307884269.51569.68
30min14211798-421179895.09592.003.6295.4392.313.62
24110857-411085792.81693.11
34103510-410351092.65092.97
44181257-418125794.40594.74
54038724-403872491.18791.50
63801100-380110085.82286.11
45min14528018-4528018102.23599.432.68102.7399.902.68
24483807-4483807101.236101.69
34370732-437073298.68399.15
44464234-4464234100.795101.28
54377279-437727998.83199.30
64199150-419915094.80995.24
60min14555436-4555436102.854100.752.15103.52101.382.16
24540241-4540241102.511103.13
34459114-4459114100.679101.31
44499410-4499410101.589102.24
54425667-442566799.924100.55
64293988-429398896.95197.54
极限14567006-4567006103.115101.691.50103.95102.491.51
24575338-4575338103.303104.10
34488035-4488035101.332102.13
44505337-4505337101.723102.55
54498133-4498133101.560102.36
64389059-438905999.09799.85
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