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(%)99.70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%
110.324107593411266441125884114252411539641124990.08
210.344079539407861540790770.02
单位质量响应值RSD%判断
398497.97394494.870.72数据可信
影响因素10天-供试品溶液-24041601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%
5min11218110-121811027.56730.9616.0027.5730.9615.99
21150956-115095626.04826.05
31645550-164555037.24137.24
41212846-121284627.44827.45
51629737-162973736.88336.88
61351408-135140830.58430.58
10min13264302-326430273.87579.457.8573.9279.507.85
23437868-343786877.80377.85
34017195-401719590.91490.98
43620983-362098381.94881.99
53360371-336037176.05076.11
63361866-336186676.08376.13
15min14276906-427690696.79298.422.2896.9698.602.29
24406165-440616599.71799.89
34509014-4509014102.045102.26
44307130-430713097.47697.66
54359505-435950598.66198.85
64234336-423433695.82996.01
20min14427577-4427577100.202101.002.51100.53101.352.51
24460528-4460528100.948101.29
34516932-4516932102.224102.61
44321126-432112697.79398.14
54649165-4649165105.217105.57
64402791-440279199.64199.98
30min14424106-4424106100.123100.852.68100.62101.362.68
24439632-4439632100.475100.98
34510957-4510957102.089102.64
44311571-431157197.57698.08
54659644-4659644105.454105.98
64391096-439109699.37699.88
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(%)99.70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%
110.324137226413372941329574134368413795541352470.06
210.344091899409390040929000.04
单位质量响应值RSD%判断
400702.23395831.720.87数据可信
影响因素10天-供试品溶液-24041601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%
5min13857728-385772886.91881.844.6786.9281.844.67
23758014-375801484.67284.67
33536353-353635379.67779.68
43466540-346654078.10478.10
53452719-345271977.79377.79
63722794-372279483.87883.88
10min14529022-4529022102.04399.622.06102.1999.762.06
24410710-441071099.37899.52
34430527-443052799.82499.96
44361220-436122098.26298.39
54510313-4510313101.622101.75
64287009-428700996.59096.73
15min14550248-4550248102.521100.112.08102.84100.422.08
24443683-4443683100.120100.43
34446318-4446318100.180100.48
44393812-439381298.99799.29
54529432-4529432102.052102.35
64297108-429710896.81897.12
20min14554495-4554495102.617100.032.11103.10100.492.11
24433001-443300199.880100.35
34443474-4443474100.116100.58
44390847-439084798.93099.39
54521873-4521873101.882102.35
64293281-429328196.73297.19
30min14547953-4547953102.470100.052.06103.13100.682.06
24447680-4447680100.210100.85
34431204-443120499.839100.47
44405503-440550399.26099.88
54519995-4519995101.840102.48
64290594-429059496.67197.29
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(%)99.70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%
110.324090543409086240834834089145409078540889640.08
210.344096700410083240987660.08
单位质量响应值RSD%判断
396217.44396399.030.04数据可信
影响因素10天-供试品溶液-24041601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%
5min13488227-348822778.97974.8411.8378.9874.8411.83
23150114-315011471.32371.32
32999914-299991467.92267.92
42855436-285543664.65164.65
53938726-393872689.17989.18
63399590-339959076.97276.97
10min14405728-440572899.75299.390.7899.8899.510.78
24369096-436909698.92399.04
34343335-434333598.33998.45
44431207-4431207100.329100.44
54418079-4418079100.032100.18
64370309-437030998.95099.08
15min14419865-4419865100.072100.121.27100.37100.411.27
24383138-438313899.24199.52
34363506-436350698.79699.07
44517187-4517187102.276102.55
54453648-4453648100.837101.15
64395200-439520099.51499.81
20min14402222-440222299.67399.941.19100.14100.401.18
24383555-438355599.25099.70
34354516-435451698.59399.03
44507511-4507511102.057102.50
54428851-4428851100.276100.76
64407079-440707999.783100.24
30min14393286-439328699.47099.941.29100.10100.561.29
24377682-437768299.11799.73
34350674-435067498.50699.11
44514714-4514714102.220102.84
54424292-4424292100.172100.82
64423477-4423477100.154100.78
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