依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号RSF-703-230318-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(%)98.9对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.561732901740351740151738921743061739080.22
2 11.511745171745311745240.01
单位质量响应值RSD%判断
15043.9415162.810.56数据可信
供试品溶液-2024030821批-瑞舒伐他汀钙-pH4.5(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1149333-14933384.48985.884.1684.4985.884.17
2155108-15510887.75687.76
3152169-15216986.09386.09
4156593-15659388.59688.60
5157142-15714288.90788.91
6140376-14037679.42179.42
10min1172025-17202597.32798.731.7497.8099.211.74
2173875-17387598.37498.86
3172963-17296397.85898.34
4175497-17549799.29299.78
5180154-180154101.926102.42
6172497-17249797.59498.04
15min1175047-17504799.037100.421.52100.05101.441.51
2176198-17619899.688100.72
3174503-17450398.72999.75
4178655-178655101.078102.12
5181416-181416102.640103.70
6179101-179101101.331102.31
20min1175413-17541399.244100.300.99100.80101.880.98
2175405-17540599.240100.83
3176665-17666599.952101.52
4179451-179451101.529103.13
5177696-177696100.536102.17
6179037-179037101.294102.84
30min1173790-17379098.32699.320.88100.44101.460.90
2175163-17516399.103101.24
3175209-17520999.129101.25
4176091-17609199.628101.80
5178300-178300100.877103.07
6174713-17471398.848100.96
45min1175855-17585599.49499.310.94102.15102.000.94
2173846-17384698.357101.05
3174657-17465798.816101.49
4175370-17537099.220101.94
5178581-178581101.036103.79
6174905-17490598.957101.61
60min1176022-17602299.58998.331.09102.80101.581.06
2172826-17282697.780101.02
3171616-17161697.096100.32
4172314-17231497.491100.76
5175972-17597299.560102.87
6174063-17406398.480101.69
极限1176286-17628699.73897.781.38103.50101.571.33
2172706-17270697.712101.49
3169371-16937195.82699.59
4171467-17146797.011100.83
5174336-17433698.635102.50
6172766-17276697.746101.50
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.491952921953001956041955161961781955780.19
211.461960241959861960050.02
单位质量响应值RSD%判断
17021.5817103.400.34数据可信
供试品溶液-2024030821批-依折麦布-pH4.5(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min172439-7243938.11454.7117.9838.1154.7017.99
2111501-11150158.66758.67
3112332-11233259.10459.10
4124057-12405765.27365.27
5112085-11208558.97458.97
691437-9143748.11048.11
10min1157784-15778483.01989.994.6283.2390.294.66
2175310-17531092.24192.57
3179536-17953694.46494.79
4176568-17656892.90393.27
5169446-16944689.15589.48
6167543-16754388.15488.42
15min1179285-17928594.33297.951.8495.0198.751.88
2187675-18767598.74799.58
3187424-18742498.61499.47
4187902-18790298.86699.74
5186508-18650898.13398.96
6188118-18811898.98099.74
20min1183415-18341596.50599.141.6897.70100.491.72
2187927-18792798.879100.27
3191728-191728100.879102.28
4190691-190691100.333101.76
5186379-18637998.06599.43
6190449-190449100.206101.51
30min1184920-18492097.29799.001.0299.03100.901.06
2189941-18994199.939101.88
3189446-18944699.678101.64
4186984-18698498.383100.37
5189342-18934299.624101.54
6188308-18830899.080100.94
45min1187778-18777898.80199.050.90101.07101.500.87
2187025-18702598.405100.90
3189528-18952899.721102.24
4185952-18595297.840100.37
5190529-190529100.248102.71
6188750-18875099.312101.73
60min1186669-18666998.21798.070.69101.04101.070.65
2186709-18670998.238101.28
3186864-18686498.320101.39
4183795-18379596.70599.78
5187063-18706398.425101.45
6187205-18720598.499101.47
极限1184937-18493797.30697.360.54100.67100.900.51
2185754-18575497.736101.32
3185062-18506297.372100.99
4183263-18326396.425100.04
5185067-18506797.374100.94
6186133-18613397.935101.45
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号RSF-703-230318-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(%)98.9对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.561768931774581770741763901766101768850.24
2 11.511730921741441736180.43
单位质量响应值RSD%判断
15301.4715084.101.02数据可信
供试品溶液-2024030921批-瑞舒伐他汀钙-pH4.5(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1153086-15308686.10580.5710.9486.1180.5710.94
2157202-15720288.42088.42
3141457-14145779.56479.56
4126506-12650671.15571.16
5122764-12276469.05069.05
6158487-15848789.14389.14
10min1172554-17255497.05598.402.1997.5398.842.21
2178631-178631100.474100.96
3172146-17214696.82697.27
4172373-17237396.95497.35
5173008-17300897.31197.69
6180909-180909101.755102.25
15min1174617-17461798.21699.531.7499.23100.521.74
2176992-17699299.552100.60
3175598-17559898.76899.75
4173356-17335697.50798.44
5179868-179868101.169102.09
6181256-181256101.950103.01
20min1172031-17203196.76199.902.4198.32101.442.38
2175877-17587798.925100.53
3174648-17464898.23399.76
4180990-180990101.800103.28
5178427-178427100.359101.85
6183648-183648103.295104.92
30min1170619-17061995.96798.652.1098.07100.752.06
2173645-17364597.66999.82
3172951-17295197.27999.35
4175911-17591198.944100.98
5179756-179756101.106103.15
6179433-179433100.925103.13
45min1168966-16896695.03797.761.8997.67100.411.86
2171846-17184696.65799.35
3172789-17278997.18899.80
4175875-17587598.923101.51
5175276-17527698.586101.19
6178142-178142100.198102.96
60min1167609-16760994.27497.782.2497.44100.972.20
2173495-17349597.585100.82
3172151-17215196.82999.98
4173981-17398197.858101.00
5177275-17727599.711102.86
6178496-178496100.398103.72
极限1167781-16778194.37196.361.8698.06100.091.86
2171141-17114196.261100.03
3170192-17019295.72799.42
4169021-16902195.06898.75
5173088-17308897.356101.06
6176641-17664199.354103.23
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.491964971983001984991989261985641981570.49
211.461945801949871947840.15
单位质量响应值RSD%判断
17246.0416996.861.03数据可信
供试品溶液-2024030921批-依折麦布-pH4.5(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1128761-12876167.51848.0829.8367.5248.0829.83
2115583-11558360.60860.61
392474-9247448.49148.49
467213-6721335.24435.24
557247-5724730.01930.02
688908-8890846.62146.62
10min1181354-18135495.09789.095.6995.4789.365.76
2176495-17649592.54992.89
3169587-16958788.92689.20
4162044-16204484.97185.17
5155426-15542681.50181.67
6174488-17448891.49691.76
15min1187208-18720898.16697.111.8299.0797.871.88
2187048-18704898.08298.93
3186947-18694798.02998.79
4179114-17911493.92294.59
5183345-18334596.14196.76
6187530-18753098.33599.10
20min1187481-18748198.30999.230.9399.76100.530.91
2189420-18942099.326100.72
3188536-18853698.863100.17
4190333-19033399.805100.99
5187613-18761398.37999.53
6192015-192015100.687102.00
30min1185892-18589297.47699.201.0199.47101.050.90
2188769-18876998.985100.93
3189569-18956999.404101.26
4189257-18925799.241100.98
5191697-191697100.520102.22
6189911-18991199.584101.46
45min1182122-18212295.49998.121.5298.04100.521.41
2186124-18612497.598100.10
3187964-18796498.563100.97
4190175-19017599.722102.02
5187192-18719298.158100.42
6189111-18911199.164101.59
60min1182172-18217295.52698.161.4398.59101.111.31
2186594-18659497.844100.88
3188727-18872798.963101.92
4187693-18769398.421101.27
5189636-18963699.439102.24
6188369-18836998.775101.75
极限1182853-18285395.88396.521.0599.48100.011.02
2182659-18265995.78199.36
3184163-18416396.570100.08
4182699-18269995.80299.20
5184309-18430996.646100.00
6187701-18770198.425101.95
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号RSF-703-230318-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(%)98.9对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数0.96
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.561755621748501752481763191758641755690.33
2 11.511776101792801784450.67
单位质量响应值RSD%判断
15187.6315503.481.46数据可信
供试品溶液-2024031021批-瑞舒伐他汀钙-pH4.5(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1141031-14103178.53971.8114.3378.5471.8114.33
2131442-13144273.19973.20
3136028-13602875.75375.75
4138371-13837177.05877.06
591829-9182951.13951.14
6134985-13498575.17375.17
10min1170458-17045894.92793.732.9595.3694.132.99
2168985-16898594.10794.51
3172006-17200695.78996.21
4172197-17219795.89696.32
5158940-15894088.51388.80
6167304-16730493.17193.59
15min1172288-17228895.94697.361.3896.9198.281.38
2176126-17612698.08499.01
3176893-17689398.51199.46
4177719-17771998.97199.93
5173640-17364096.69997.48
6172253-17225395.92796.86
20min1173372-17337296.55097.691.4298.0599.151.45
2174880-17488097.39098.86
3178493-17849399.402100.90
4177838-17783899.037100.55
5172109-17210995.84797.16
6175817-17581797.91299.38
30min1173629-17362996.69397.980.7898.7399.980.79
2177125-17712598.640100.66
3176460-17646098.270100.32
4177302-17730298.739100.80
5175397-17539797.67899.52
6175674-17567497.83299.84
45min1174728-17472897.30597.790.6999.88100.340.71
2176255-17625598.156100.72
3175932-17593297.976100.57
4177500-17750098.849101.46
5174970-17497097.44099.83
6174201-17420197.01299.57
60min1174651-17465197.26297.570.66100.37100.660.70
2174060-17406096.933100.04
3176644-17664498.372101.51
4175918-17591897.968101.13
5173898-17389896.84399.77
6176060-17606098.047101.14
极限1172808-17280896.23696.391.0099.89100.031.01
2175205-17520597.571101.22
3175110-17511097.518101.21
4172568-17256896.10299.81
5171063-17106395.26498.73
6171784-17178495.66699.30
依折麦布瑞舒伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.491957561974511975701979541993761976210.66
211.461971671992141981900.74
单位质量响应值RSD%判断
17199.3917294.070.39数据可信
供试品溶液-2024031021批-依折麦布-pH4.5(内含0.2%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min187757-8775745.68136.7116.2545.6836.7116.25
259309-5930930.87330.87
359208-5920830.82030.82
475320-7532039.20739.21
564363-6436333.50333.50
677173-7717340.17140.17
10min1159299-15929982.92179.094.3583.1779.304.37
2143437-14343774.66474.84
3145610-14561075.79575.97
4159009-15900982.77082.99
5151361-15136178.78978.98
6152968-15296879.62679.85
15min1173994-17399490.57090.922.4391.2891.562.44
2170052-17005288.51889.10
3170686-17068688.84889.44
4180482-18048293.94894.63
5178857-17885793.10293.73
6173890-17389090.51691.18
20min1179278-17927893.32194.021.1994.5495.161.21
2177453-17745392.37193.45
3180230-18023093.81694.90
4183193-18319395.35996.56
5180882-18088294.15695.30
6182632-18263295.06796.24
30min1181349-18134994.39995.811.2596.1497.481.24
2182763-18276395.13596.73
3182582-18258295.04196.65
4184324-18432495.94897.68
5187563-18756397.63499.30
6185725-18572596.67798.37
45min1183572-18357295.55696.010.6597.8298.220.65
2184551-18455196.06698.19
3183064-18306495.29297.43
4185154-18515496.38098.64
5186386-18638697.02199.23
6183977-18397795.76798.00
60min1181349-18134994.39995.421.0797.1998.161.06
2180540-18054093.97896.63
3184347-18434795.96098.62
4183438-18343895.48698.28
5184943-18494396.27099.02
6185272-18527296.44199.21
极限1179375-17937593.37194.550.8596.6997.820.76
2183014-18301495.26698.44
3183049-18304995.28498.48
4180412-18041293.91197.24
5182672-18267295.08898.37
6181294-18129494.37097.67
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