托伐普坦口崩片项目信息
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101242-202302对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
116.601965071964271966031964461961541964270.09
216.661981011987561984280.24
单位质量响应值RSD%判断
11832.9511910.440.47数据可信
加速6月-供试品溶液-2批-shui(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%
5min1186376-18637694.10295.141.6594.1095.141.65
2190487-19048796.17896.18
3184945-18494593.37993.38
4193127-19312797.51197.51
5189273-18927395.56595.56
6186324-18632494.07694.08
10min1195487-19548798.70298.941.0798.8699.101.07
2196158-19615899.04199.20
3192742-19274297.31697.47
4199274-199274100.614100.78
5196341-19634199.13399.29
6195722-19572298.82198.98
15min1196103-19610399.01399.421.0699.3399.741.06
2197498-19749899.717100.04
3193647-19364797.77398.09
4200026-200026100.994101.32
5197160-19716099.54799.87
6196976-19697699.45499.78
20min1196602-19660299.26599.761.1999.75100.261.20
2198622-198622100.285100.78
3193995-19399597.94998.43
4201042-201042101.507102.01
5198234-198234100.089100.58
6197051-19705199.49299.98
30min1197166-19716699.550100.061.13100.20100.721.13
2198665-198665100.307100.97
3194607-19460798.25898.90
4201435-201435101.705102.37
5198758-198758100.354101.01
6198440-198440100.193100.85
45min1197432-19743299.684100.561.09100.50101.381.09
2199543-199543100.750101.58
3196423-19642399.17599.98
4202683-202683102.335103.17
5199705-199705100.832101.66
6199208-199208100.581101.40
60min1198070-198070100.006100.461.07100.99101.451.08
2200011-200011100.986101.98
3195711-19571198.81599.79
4202074-202074102.028103.04
5199461-199461100.709101.70
6198468-198468100.207101.19
极限1198233-198233100.089100.681.44101.24101.841.44
2200180-200180101.072102.23
3194596-19459698.25299.39
4203270-203270102.632103.81
5199953-199953100.957102.12
6200223-200223101.093102.25
托伐普坦口崩片项目信息
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101242-202302对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
116.603963423966723966073966873961953965010.06
216.663981813976333979070.10
单位质量响应值RSD%判断
23885.6023883.970.01数据可信
加速6月-供试品溶液-1批-shui(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%
5min1357658-35765889.75691.902.0489.7691.902.03
2363555-36355591.23691.24
3379117-37911795.14195.14
4361732-36173290.77890.78
5369319-36931992.68292.68
6365912-36591291.82791.83
10min1381878-38187895.83496.561.8695.9896.711.86
2381912-38191295.84395.99
3398492-398492100.003100.16
4378094-37809494.88495.04
5385607-38560796.77096.92
6382618-38261896.02096.17
15min1384347-38434796.45497.051.9496.7697.361.93
2381290-38129095.68796.00
3400933-400933100.616100.94
4380260-38026095.42895.74
5386724-38672497.05097.37
6386719-38671997.04997.36
20min1383575-38357596.26097.261.9096.7397.741.90
2382143-38214395.90196.37
3401222-401222100.689101.18
4381642-38164295.77596.24
5388309-38830997.44897.93
6388461-38846197.48697.96
30min1384505-38450596.49397.641.9797.1298.281.97
2382418-38241895.97096.60
3402655-402655101.048101.71
4383113-38311396.14496.77
5390606-39060698.02498.66
6391190-39119098.17198.81
45min1385688-38568896.79097.861.7497.5898.661.74
2384056-38405696.38197.17
3402843-402843101.095101.92
4386746-38674697.05697.84
5390208-39020897.92598.73
6390239-39023997.93298.73
60min1385916-38591696.84797.992.0897.8098.962.08
2384881-38488196.58897.54
3405798-405798101.837102.83
4384050-38405096.37997.33
5391144-39114498.15999.13
6391119-39111998.15399.12
极限1388486-38848697.49298.221.8898.6199.341.88
2385969-38596996.86197.97
3405435-405435101.746102.91
4385520-38552096.74897.86
5390940-39094098.10899.24
6391869-39186998.34199.47
托伐普坦口崩片项目信息
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101242-202302对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
116.603999623999003999464004614000804000700.06
216.664012054009094010570.06
单位质量响应值RSD%判断
24100.6024073.050.09数据可信
加速6月-供试品溶液-1批-shui(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%
5min1379873-37987394.53193.104.3994.5393.104.38
2371391-37139192.42192.42
3390654-39065497.21497.21
4376008-37600893.57093.57
5383362-38336295.40095.40
6343459-34345985.47085.47
10min1395482-39548298.41698.661.9398.5798.811.93
2396822-39682298.74998.90
3407469-407469101.399101.56
4392984-39298497.79497.95
5401101-40110199.81499.97
6384854-38485495.77195.91
15min1398228-39822899.09999.402.0199.4299.722.02
2399712-39971299.46899.79
3411753-411753102.465102.80
4394941-39494198.28198.60
5403831-403831100.493100.82
6388097-38809796.57896.88
20min1399324-39932499.37299.721.8799.86100.211.87
2402162-402162100.078100.56
3412150-412150102.563103.07
4396857-39685798.75899.24
5404106-404106100.562101.05
6389849-38984997.01497.48
30min1405872-405872101.001100.211.94101.65100.861.94
2402166-402166100.079100.73
3413203-413203102.825103.50
4398691-39869199.21499.86
5406048-406048101.045101.71
6390209-39020997.10397.73
45min1402814-402814100.240100.501.92101.06101.311.93
2404770-404770100.727101.54
3412980-412980102.770103.61
4399074-39907499.309100.12
5411256-411256102.341103.17
6392156-39215697.58898.37
60min1402597-402597100.186100.421.74101.17101.411.74
2404763-404763100.725101.71
3413347-413347102.861103.88
4399456-39945699.405100.38
5408021-408021101.536102.54
6393087-39308797.82098.77
极限1402960-402960100.277100.481.70101.43101.641.70
2404252-404252100.598101.75
3414137-414137103.058104.24
4399647-39964799.452100.60
5407650-407650101.444102.61
6394103-39410398.07299.18
托伐普坦口崩片项目信息
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101242-202302对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
116.603942233954163954373953493953943951640.14
216.664025154021164023160.08
单位质量响应值RSD%判断
23805.0624148.621.02数据可信
加速6月-供试品溶液-1批-shui(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%
5min1366893-36689391.72588.226.3891.7288.226.38
2360645-36064590.16390.16
3311885-31188577.97377.97
4371295-37129592.82592.83
5342036-34203685.51085.51
6364573-36457391.14591.14
10min1397455-39745599.36597.181.8599.5297.331.85
2391345-39134597.83897.99
3378502-37850294.62794.76
4395007-39500798.75398.91
5385766-38576696.44396.59
6384141-38414196.03796.19
15min1401704-401704100.42898.451.33100.7598.761.33
2393745-39374598.43898.75
3391511-39151197.87998.17
4397689-39768999.42499.74
5390939-39093997.73698.04
6387119-38711996.78197.09
20min1403797-403797100.95198.811.34101.4499.281.34
2393931-39393198.48498.96
3393173-39317398.29598.75
4398261-39826199.567100.05
5393854-39385498.46598.93
6388299-38829997.07697.55
30min1405117-405117101.28199.131.46101.9499.761.46
2396002-39600299.00299.64
3395073-39507398.77099.38
4400849-400849100.214100.86
5393259-39325998.31698.95
6388749-38874997.18997.82
45min1407839-407839101.96199.551.48102.78100.351.48
2395624-39562498.90899.71
3396531-39653199.13499.91
4401881-401881100.472101.29
5396353-39635399.09099.88
6390853-39085397.71598.51
60min1406027-406027101.50899.491.30102.50100.461.30
2396423-39642399.107100.08
3396314-39631499.080100.02
4402191-402191100.549101.53
5394702-39470298.67799.64
6392124-39212498.03398.99
极限1406393-406393101.60099.631.23102.76100.761.24
2395740-39574098.937100.07
3395779-39577998.946100.06
4402781-402781100.697101.85
5396116-39611699.031100.15
6394215-39421598.55599.68
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