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%
110.344093418409078140916514093334408440240907170.10
210.324084240409476940895040.19
单位质量响应值RSD%判断
395620.60396269.770.12数据可信
供试品溶液-24040201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%
5min14255417-425541796.34191.505.0796.3491.505.07
23765314-376531485.24585.24
34264930-426493096.55696.56
44067218-406721892.08092.08
53848968-384896887.13987.14
64047200-404720091.62791.63
10min14366889-436688998.86498.651.1599.0298.801.15
24355001-435500198.59598.74
34439285-4439285100.503100.66
44370234-437023498.94099.09
54293348-429334897.19997.34
64319804-431980497.79897.95
15min14374960-437496099.04798.601.1999.3798.911.20
24351888-435188898.52598.83
34424138-4424138100.160100.49
44376175-437617599.07499.39
54269534-426953496.66096.97
64333964-433396498.11998.43
20min14370855-437085598.95498.730.9299.4499.210.93
24355839-435583998.61499.08
34427523-4427523100.237100.73
44370767-437076798.95299.44
54318168-431816897.76198.23
64321637-432163797.84098.32
30min14365421-436542198.83198.590.7199.4999.240.72
24340341-434034198.26398.90
34403281-440328199.688100.35
44369678-436967898.92799.58
54316668-431666897.72798.36
64334202-433420298.12498.77
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%
110.344057611404725140600584061138404979840551710.16
210.324061799405670840592540.09
单位质量响应值RSD%判断
392182.88393338.570.21数据可信
供试品溶液-24040201批-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13453171-345317178.81284.124.6178.8184.124.61
23714913-371491384.78684.79
33595518-359551882.06182.06
43749510-374951085.57585.58
53959041-395904190.35890.36
63642344-364234483.13083.13
10min14130552-413055294.27295.952.4894.4096.092.49
24199096-419909695.83695.98
34056197-405619792.57592.71
44283393-428339397.76097.90
54348015-434801599.23599.39
64206340-420634096.00296.14
15min14152941-415294194.78396.942.2795.0797.242.27
24298790-429879098.11298.41
34107273-410727393.74194.03
44323794-432379498.68298.99
54341610-434161099.08999.41
64261447-426144797.25997.56
20min14128241-412824194.21996.972.4994.6797.432.49
24305066-430506698.25598.72
34104025-410402593.66794.11
44316556-431655698.51798.99
54356152-435615299.42199.90
64281496-428149697.71798.18
30min14194070-419407095.72297.352.5796.3397.982.57
24308721-430872198.33898.97
34105102-410510293.69194.29
44315384-431538498.49099.12
54420951-4420951100.900101.55
64248993-424899396.97597.60
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