依折麦布阿托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对照品来源工作对照品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%
19.821689891688071688421685131685531687410.12
29.841692471692161692320.02
单位质量响应值RSD%判断
17183.4017198.370.07数据可信
长期24月-供试品溶液-2023120821批-依折麦布-pH6.8(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min131871-3187116.64427.2334.6716.6427.2334.68
269564-6956436.32836.33
337559-3755919.61419.61
468146-6814635.58835.59
537855-3785519.76919.77
667818-6781835.41635.42
10min1134148-13414870.05574.938.2370.1575.088.27
2149035-14903577.83078.03
3126708-12670866.17066.28
4152246-15224679.50779.70
5140700-14070073.47773.59
6158047-15804782.53682.73
15min1167329-16732987.38390.073.1487.8690.643.19
2170838-17083889.21689.85
3165484-16548486.42086.90
4175435-17543591.61692.26
5177057-17705792.46392.98
6178705-17870593.32493.98
20min1175965-17596591.89394.922.2492.8695.982.26
2180203-18020394.10695.24
3179453-17945393.71594.67
4182724-18272495.42396.57
5187239-18723997.78198.81
6184960-18496096.59197.76
30min1182008-18200895.04995.870.9696.5397.470.95
2182078-18207895.08696.74
3183568-18356895.86497.34
4183662-18366295.91397.59
5186810-18681097.55799.13
6183361-18336195.75697.47
45min1182305-18230595.20497.181.8497.2199.311.81
2181965-18196595.02797.21
3187990-18799098.173100.18
4186815-18681597.55999.77
5190845-19084599.664101.78
6186620-18662097.45899.70
60min1180237-18023794.12496.211.7796.6698.881.73
2182325-18232595.21597.92
3186510-18651097.40099.96
4182833-18283395.48098.23
5189321-18932198.868101.54
6184128-18412896.15698.94
极限1182149-18214995.12396.332.4298.1899.532.34
2177686-17768692.79296.03
3186972-18697297.641100.74
4185227-18522796.730100.01
5190815-19081599.648102.87
6183865-18386596.01999.34
依折麦布阿托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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.981555141556281554461553321553781554600.08
210.891561861564911563380.14
单位质量响应值RSD%判断
14158.4714356.110.99数据可信
长期24月-供试品溶液-2023120821批-阿托伐他汀钙-pH6.8(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1122291-12229171.00277.2210.6571.0077.2210.66
2149187-14918786.61886.62
3144072-14407283.64883.65
4118591-11859168.85468.85
5144073-14407383.64983.65
6119832-11983269.57569.57
10min1161639-16163993.84896.123.4594.2496.553.47
2165238-16523895.93796.42
3172666-172666100.250100.71
4157754-15775491.59291.97
5171447-17144799.542100.01
6164588-16458895.56095.95
15min1166508-16650896.67598.222.4497.5999.182.44
2164738-16473895.64796.66
3173067-173067100.483101.50
4166133-16613396.45797.35
5174929-174929101.564102.58
6169675-16967598.51499.43
20min1165623-16562396.16198.642.0997.61100.152.10
2167094-16709497.01598.56
3172311-172311100.044101.62
4168615-16861597.89899.33
5175256-175256101.754103.34
6170503-17050398.994100.46
30min1165699-16569996.20596.931.2598.1998.981.23
2163971-16397195.20297.29
3167591-16759197.30499.44
4169573-16957398.454100.43
5168705-16870597.950100.10
6166115-16611596.44798.46
45min1165625-16562596.16297.582.6798.68100.182.64
2162264-16226494.21196.82
3168377-16837797.760100.44
4167828-16782897.44199.96
5175837-175837102.091104.78
6168514-16851497.840100.39
60min1162739-16273994.48795.901.3897.5499.041.40
2162763-16276394.50097.64
3167007-16700796.965100.18
4164493-16449395.50598.56
5168312-16831297.722100.98
6165723-16572396.21999.31
极限1164142-16414295.30197.722.5798.88101.392.55
2169414-16941498.362102.02
3167065-16706596.998100.76
4166836-16683696.865100.46
5176396-176396102.416106.22
6166019-16601996.391100.02
依折麦布阿托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对照品来源工作对照品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%
19.821685701691091692941697311697771692960.30
29.841696231700841698540.20
单位质量响应值RSD%判断
17239.9217261.590.09数据可信
长期24月-供试品溶液-2023120821批-依折麦布-pH6.8(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min130566-3056615.90721.8528.4415.9121.8528.44
251674-5167426.89226.89
355994-5599429.14029.14
432669-3266917.00117.00
530484-3048415.86415.86
650545-5054526.30426.30
10min1112198-11219858.38962.2610.7158.4862.3810.75
2133908-13390869.68769.84
3133274-13327469.35769.52
4107059-10705955.71555.81
5106042-10604255.18655.27
6125309-12530965.21265.36
15min1153324-15332479.79281.125.7480.2081.585.79
2165853-16585386.31286.85
3166814-16681486.81287.36
4148571-14857177.31877.72
5144923-14492375.42075.81
6155773-15577381.06681.57
20min1170100-17010088.52289.353.1089.3890.273.15
2176895-17689592.05893.07
3179602-17960293.46794.50
4169072-16907287.98788.82
5166184-16618486.48487.30
6168310-16831087.59188.55
30min1180369-18036993.86694.741.3495.2196.161.40
2185016-18501696.28597.81
3184935-18493596.24297.79
4179939-17993993.64294.96
5182256-18225694.84896.14
6179829-17982993.58595.03
45min1182154-18215494.79596.891.2296.6698.831.27
2188842-18884298.276100.34
3187517-18751797.58699.67
4185691-18569196.63698.48
5186505-18650597.05998.88
6186328-18632896.96798.93
60min1181683-18168394.55096.221.1796.9598.701.23
2187749-18774997.707100.32
3186548-18654897.08299.71
4185331-18533196.44998.83
5184187-18418795.85398.21
6183806-18380695.65598.16
极限1181362-18136294.38396.531.1597.3099.541.17
2186681-18668197.151100.30
3186091-18609196.844100.01
4185194-18519496.37799.29
5187108-18710897.373100.27
6186434-18643497.023100.06
依折麦布阿托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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.981584291594231589441591041591691590140.24
210.891589731595591592660.27
单位质量响应值RSD%判断
14482.1514624.980.70数据可信
长期24月-供试品溶液-2023120821批-阿托伐他汀钙-pH6.8(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1132533-13253375.38171.957.9375.3871.957.93
2125434-12543471.34371.34
3137890-13789078.42778.43
4124778-12477870.97070.97
5129785-12978573.81873.82
6108565-10856561.74861.75
10min1157980-15798089.85492.912.8990.2793.312.87
2158690-15869090.25890.65
3167703-16770395.38495.82
4161240-16124091.70892.10
5165456-16545694.10694.52
6169041-16904196.14596.49
15min1162322-16232292.32495.892.3993.2496.812.36
2167526-16752695.28496.18
3169763-16976396.55697.52
4167110-16711095.04795.95
5170531-17053196.99397.93
6174320-17432099.148100.02
20min1164204-16420493.39496.241.6994.8297.681.68
2168797-16879796.00697.43
3170755-17075597.12098.62
4168171-16817195.65097.08
5171435-17143597.50798.98
6171846-17184697.74199.17
30min1164465-16446593.54395.571.6995.4997.551.68
2168505-16850595.84097.80
3168842-16884296.03298.07
4164731-16473193.69495.66
5171159-17115997.35099.36
6170468-17046896.95798.93
45min1161527-16152791.87195.652.3294.3498.172.28
2170189-17018996.79899.29
3168273-16827395.70898.28
4166263-16626394.56597.05
5170127-17012796.76399.32
6172665-17266598.206100.72
60min1160548-16054891.31594.491.9794.2997.541.94
2167961-16796195.53198.56
3167485-16748595.26098.37
4164275-16427593.43496.44
5166790-16679094.86597.96
6169723-16972396.53399.59
极限1160609-16060991.34994.452.1294.8498.022.09
2167598-16759895.32498.89
3166092-16609294.46898.10
4163590-16359093.04596.57
5167946-16794695.52299.14
6170544-17054497.000100.59
依折麦布阿托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对照品来源工作对照品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%
19.821705921710741712331712021711691710540.16
29.841697721697711697720.01
单位质量响应值RSD%判断
17418.9417253.250.68数据可信
长期24月-供试品溶液-2023120822批-依折麦布-pH6.8(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min154378-5437828.16030.3015.7128.1630.3015.71
266641-6664134.51134.51
345693-4569323.66323.66
454386-5438628.16428.16
571069-7106936.80436.80
658876-5887630.49030.49
10min1133004-13300468.87870.506.1969.0370.676.21
2149952-14995277.65477.85
3125843-12584365.16965.30
4135807-13580770.32970.49
5140981-14098173.00973.21
6131237-13123767.96368.13
15min1163612-16361284.72884.432.8985.2784.992.91
2171702-17170288.91889.54
3160491-16049183.11283.61
4161033-16103383.39383.94
5163275-16327584.55485.16
6158103-15810381.87682.42
20min1178031-17803192.19590.382.5593.2191.422.57
2181864-18186494.18095.30
3170670-17067088.38489.34
4172182-17218289.16790.18
5173140-17314089.66390.74
6171316-17131688.71889.72
30min1182722-18272294.62594.271.1396.1595.801.17
2183414-18341494.98396.62
3180370-18037093.40794.85
4182232-18223294.37195.88
5184557-18455795.57597.15
6178963-17896392.67894.17
45min1183154-18315494.84895.770.6996.9097.820.70
2185112-18511295.86298.03
3184330-18433095.45797.42
4186841-18684196.75898.79
5185732-18573296.18498.29
6184433-18443395.51197.52
60min1184124-18412495.35195.621.1297.9398.201.04
2181196-18119693.83596.54
3184439-18443995.51498.01
4185670-18567096.15198.72
5184935-18493595.77198.41
6187440-18744097.06899.61
极限1184317-18431795.45195.360.4198.5698.480.38
2183051-18305194.79598.02
3183593-18359395.07698.10
4185237-18523795.92799.03
5184181-18418195.38098.56
6184453-18445395.52198.60
依折麦布阿托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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.981572101578191573301573851575201574530.15
210.891562261554671558460.35
单位质量响应值RSD%判断
14339.9814310.930.15数据可信
长期24月-供试品溶液-2023120822批-阿托伐他汀钙-pH6.8(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1142233-14223382.18482.566.0082.1882.566.00
2146749-14674984.79384.79
3129534-12953474.84674.85
4148839-14883986.00186.00
5136940-13694079.12679.13
6153008-15300888.41088.41
10min1166131-16613195.99294.951.8396.4595.411.84
2166389-16638996.14296.61
3161376-16137693.24593.66
4167902-16790297.01697.49
5160382-16038292.67193.11
6163773-16377394.63095.12
15min1168111-16811197.13796.101.6198.1397.091.59
2166523-16652396.21997.22
3169159-16915997.74298.68
4167756-16775696.93197.95
5162097-16209793.66294.62
6164240-16424094.90095.92
20min1170830-17083098.70897.182.53100.2498.702.52
2169853-16985398.14399.68
3167957-16795797.04898.52
4173519-173519100.261101.82
5161516-16151693.32694.80
6165418-16541895.58097.12
30min1167323-16732396.68196.481.3498.7698.541.32
2167353-16735396.69998.78
3167455-16745596.75798.77
4169717-16971798.064100.18
5167165-16716596.59098.58
6162864-16286494.10596.18
45min1165746-16574695.77096.411.5598.3999.011.55
2167064-16706496.53299.15
3167494-16749496.78099.33
4171482-17148299.084101.74
5164016-16401694.77097.30
6165341-16534195.53698.13
60min1166606-16660696.26795.921.4499.4199.041.43
2163738-16373894.61097.77
3166358-16635896.12499.21
4168995-16899597.647100.85
5162645-16264593.97897.03
6167643-16764396.86699.99
极限1166573-16657396.24895.471.2299.9399.131.22
2165511-16551195.63499.32
3165491-16549195.62399.25
4167639-16763996.864100.61
5161861-16186193.52597.10
6164268-16426894.91698.58
依折麦布阿托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对照品来源工作对照品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%
19.821699661709781714711716991718361711900.45
29.841687841689251688540.06
单位质量响应值RSD%判断
17432.7917159.961.12数据可信
长期24月-供试品溶液-2023120822批-依折麦布-pH6.8(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min164407-6440733.43226.5123.7833.4326.5123.78
230075-3007515.61115.61
349356-4935625.61925.62
460352-6035231.32731.33
554987-5498728.54228.54
647291-4729124.54724.55
10min1142894-14289474.17270.597.5574.3670.747.58
2122028-12202863.34163.43
3126452-12645265.63865.78
4149639-14963977.67377.85
5136318-13631870.75970.92
6138594-13859471.94072.08
15min1170783-17078388.64987.173.4189.2587.713.44
2160805-16080583.46983.91
3160709-16070983.41983.93
4171427-17142788.98389.59
5169924-16992488.20388.75
6173960-17396090.29890.83
20min1182331-18233194.64392.741.5195.7393.761.56
2176269-17626991.49692.40
3175915-17591591.31292.28
4181275-18127594.09595.19
5179080-17908092.95594.00
6177071-17707191.91392.95
30min1183788-18378895.39995.570.5097.0297.110.54
2182911-18291194.94496.35
3184646-18464695.84597.32
4184778-18477895.91397.54
5185255-18525596.16197.72
6183359-18335995.17696.72
45min1185960-18596096.52797.201.2098.6799.271.16
2187109-18710997.12399.06
3187233-18723397.18799.20
4185277-18527796.17298.33
5191556-19155699.431101.52
6186383-18638396.74698.82
60min1184715-18471595.88096.430.6798.5699.040.65
2185054-18505496.05698.53
3187858-18785897.512100.06
4186088-18608896.59399.28
5186329-18632996.71899.36
6184616-18461695.82998.44
极限1182358-18235894.65796.110.8697.8799.250.84
2184929-18492995.99199.00
3185163-18516396.11399.20
4187095-18709597.116100.34
5186095-18609596.59799.78
6185263-18526396.16599.31
依折麦布阿托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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.981587061594951601021598831599411596250.36
210.891555661559211557440.17
单位质量响应值RSD%判断
14537.8014301.561.16数据可信
长期24月-供试品溶液-2023120822批-阿托伐他汀钙-pH6.8(内含0.2%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1140776-14077680.81676.009.4580.8276.009.45
2113000-11300064.87064.87
3141314-14131481.12581.12
4136300-13630078.24678.25
5142418-14241881.75881.76
6120540-12054069.19969.20
10min1162656-16265693.37792.622.8393.8393.042.84
2161356-16135692.63092.99
3165092-16509294.77595.23
4155597-15559789.32489.76
5166919-16691995.82496.28
6156424-15642489.79990.18
15min1166508-16650895.58895.182.1496.5696.112.12
2166511-16651195.59096.46
3168275-16827596.60297.58
4158749-15874991.13492.06
5166647-16664795.66896.65
6168045-16804596.47097.35
20min1170054-17005497.62495.481.6699.1296.951.65
2168315-16831596.62598.03
3167475-16747596.14397.66
4162972-16297293.55895.00
5165309-16530994.90096.42
6163803-16380394.03595.45
30min1166439-16643995.54895.000.7597.5997.000.76
2165866-16586695.21997.16
3167032-16703295.88997.94
4163607-16360793.92395.88
5164808-16480894.61296.66
6165191-16519194.83296.77
45min1167791-16779196.32495.771.2698.9098.291.26
2167401-16740196.10198.57
3166983-16698395.86198.44
4163175-16317593.67596.15
5169438-16943897.27099.84
6166153-16615395.38497.85
60min1166401-16640195.52795.090.7598.6398.140.76
2165903-16590395.24198.25
3167526-16752696.17299.29
4164138-16413894.22797.23
5165020-16502094.73497.85
6164808-16480894.61297.61
极限1163603-16360393.92094.680.4997.5698.260.43
2165371-16537194.93598.47
3165158-16515894.81398.46
4165974-16597495.28198.80
5164596-16459694.49098.13
6164867-16486794.64698.17
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