依折麦布片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
110.393430483430213430223432713432243431170.04
210.413424823422693423760.05
单位质量响应值RSD%判断
33023.7732889.150.29数据可信
影响因素30天-包装高温-供试品溶液-2024012321批-pH4.5(内含%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1135003-13500340.96452.7113.5940.9652.7113.59
2197139-19713959.81859.82
3175412-17541253.22653.23
4179820-17982054.56354.56
5195763-19576359.40159.40
6159196-15919648.30548.31
10min1252999-25299976.76883.854.8676.8984.004.87
2293716-29371689.12389.30
3273533-27353382.99983.16
4275988-27598883.74483.91
5282240-28224085.64185.82
6279462-27946284.79884.94
15min1289080-28908087.71690.931.9988.0791.342.01
2304535-30453592.40692.85
3302682-30268291.84392.25
4296126-29612689.85490.27
5302909-30290991.91292.35
6302775-30277591.87292.27
20min1300001-30000191.03092.731.4491.6593.411.46
2307293-30729393.24393.97
3308807-30880793.70294.39
4300428-30042891.15991.84
5310473-31047394.20794.92
6306619-30661993.03893.71
30min1307292-30729293.24293.531.4194.1394.491.41
2307442-30744293.28894.29
3311206-31120694.43095.40
4301398-30139891.45492.41
5314273-31427395.36096.35
6307827-30782793.40594.36
45min1308882-30888293.72578.4748.4594.8979.7147.68
23067-30670.9312.21
3312810-31281094.91796.17
4301525-30152591.49292.72
5316975-31697596.18097.46
6308399-30839993.57894.81
60min1308675-30867593.66293.961.8095.1195.431.81
2307837-30783793.40894.69
3313275-31327595.05896.59
4301415-30141591.45992.97
5317881-31788196.45598.02
6308821-30882193.70695.22
极限1333038-333038101.054100.360.92102.79102.120.94
2328977-32897799.822101.39
3332139-332139100.782102.60
4331996-331996100.738102.52
5332922-332922101.019102.88
6325357-32535798.724100.52
依折麦布片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
110.393444513426083418573424623424123427580.29
210.413421663419943420800.04
单位质量响应值RSD%判断
32989.2232860.710.28数据可信
影响因素30天-包装高湿-供试品溶液-2024012321批-pH4.5(内含%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1146977-14697744.64056.3715.4344.6456.3615.43
2165350-16535050.22050.22
3191872-19187258.27658.28
4174418-17441852.97552.97
5215989-21598965.60165.60
6218893-21889366.48366.48
10min1292254-29225488.76491.913.3288.9092.083.34
2295112-29511289.63289.78
3299258-29925890.89191.07
4298881-29888190.77790.94
5314281-31428195.45495.65
6315941-31594195.95896.16
15min1318708-31870896.79995.982.2397.2096.422.24
2307803-30780393.48793.91
3311286-31128694.54494.99
4310890-31089094.42494.86
5325620-32562098.89899.38
6321707-32170797.71098.20
20min1323651-32365198.30096.352.1598.9997.082.16
2309189-30918993.90894.61
3311470-31147094.60095.33
4312883-31288395.02995.74
5324848-32484898.66499.44
6321290-32129097.58398.36
30min1325526-32552698.86996.662.0899.8597.682.08
2311246-31124694.53295.51
3311728-31172894.67995.69
4314344-31434495.47396.47
5325194-32519498.76999.84
6321547-32154797.66198.73
45min1327289-32728999.40596.702.17100.6998.012.17
2312036-31203694.77296.04
3311293-31129394.54795.85
4313731-31373195.28796.57
5324549-32454998.57399.94
6321317-32131797.59198.96
60min1327389-32738999.43596.562.21101.0298.162.20
2311995-31199594.76096.31
3310446-31044694.28995.87
4313187-31318795.12296.69
5323832-32383298.355100.02
6320737-32073797.41599.07
极限1338914-338914102.936101.780.91104.81103.680.90
2334371-334371101.556103.39
3330210-330210100.292102.16
4336326-336326102.150104.01
5336998-336998102.354104.32
6333920-333920101.419103.37
依折麦布片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
110.393454053433883434183430563433613437260.28
210.413435733439923437820.09
单位质量响应值RSD%判断
33082.3933024.210.13数据可信
影响因素30天-包装光照-供试品溶液-2024012321批-pH4.5(内含%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1174826-17482652.89252.2519.9152.8952.2419.91
2156070-15607047.21847.22
3197724-19772459.82059.82
4128615-12861538.91138.91
5154139-15413946.63446.63
6224775-22477568.00468.00
10min1293589-29358988.82383.935.6188.9884.085.62
2270169-27016981.73781.88
3282575-28257585.49185.67
4249600-24960075.51475.63
5284552-28455286.08986.23
6283933-28393385.90286.11
15min1320264-32026496.89392.844.6097.3293.254.58
2302336-30233691.46991.86
3299241-29924190.53390.97
4294208-29420889.01089.35
5328533-32853399.39599.79
6296648-29664889.74890.21
20min1326533-32653398.79095.204.6199.5195.894.59
2309851-30985193.74394.40
3302611-30261191.55392.26
4308191-30819193.24193.85
5338216-338216102.325103.02
6302643-30264391.56292.29
30min1327046-32704698.94596.304.3599.9697.284.33
2313628-31362894.88695.83
3306614-30661492.76493.75
4312824-31282494.64295.53
5342298-342298103.559104.56
6307495-30749593.03094.04
45min1328108-32810899.26696.634.22100.5897.894.20
2314634-31463495.19096.42
3307571-30757193.05394.31
4314685-31468595.20596.38
5342485-342485103.616104.93
6308793-30879393.42394.71
60min1327412-32741299.05696.574.09100.6698.124.06
2314665-31466595.19996.71
3307199-30719992.94194.48
4315714-31571495.51796.98
5341455-341455103.304104.93
6308747-30874793.40994.97
极限1328420-32842099.361101.501.85101.26103.341.84
2340927-340927103.145104.94
3334653-334653101.247103.07
4328112-32811299.268101.01
5342517-342517103.626105.56
6338304-338304102.351104.20
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