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DJ333-221017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(%)99.67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%
19.431630891630451629141630331630131630190.04
29.481642041643771642900.08
单位质量响应值RSD%判断
17287.2717330.170.18数据可信
供试品溶液-2022091403批-依折麦布-pH6.8(钾盐内含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%
5min137469-3746919.41823.1625.6119.4223.1625.61
234944-3494418.11018.11
346325-4632524.00824.01
436639-3663918.98818.99
565504-6550433.94833.95
647261-4726124.49324.49
10min1120956-12095662.68664.576.9662.7964.706.99
2112583-11258358.34758.45
3131153-13115367.97168.10
4118728-11872861.53161.64
5135892-13589270.42770.62
6128187-12818766.43366.57
15min1162646-16264684.29284.243.5484.7584.733.57
2153792-15379279.70380.13
3161453-16145383.67484.18
4159803-15980382.81983.27
5169611-16961187.90288.48
6167969-16796987.05187.56
20min1179005-17900592.77092.611.8793.6993.561.92
2172597-17259789.44990.32
3178723-17872392.62493.60
4178960-17896092.74793.65
5182740-18274094.70695.77
6180111-18011193.34394.33
30min1191179-19117999.07999.411.03100.52100.881.07
2189160-18916098.03399.40
3190176-19017698.559100.05
4192786-19278699.912101.33
5193417-193417100.239101.83
6194195-194195100.642102.15
45min1187977-18797797.42098.980.8299.41101.010.82
2191453-19145399.221101.13
3192113-19211399.563101.60
4191414-19141499.201101.18
5190823-19082398.895101.05
6192197-19219799.607101.67
60min1189949-18994998.44299.530.89100.97102.100.89
2192259-19225999.639102.10
3191810-19181099.406102.00
4191656-19165699.326101.86
5191499-19149999.245101.95
6195126-195126101.125103.74
极限1191735-19173599.36799.670.67102.45102.800.63
2192687-19268799.861102.87
3194219-194219100.655103.80
4193122-193122100.086103.17
5191598-19159899.296102.55
6190584-19058498.771101.95
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100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.551567871568411568641568981568731568530.03
210.541580831581201581020.02
单位质量响应值RSD%判断
14867.5815000.190.63数据可信
供试品溶液-2022091403批-阿托伐他汀钙-pH6.8(钾盐内含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%
5min1115321-11532163.78666.946.1263.7966.946.12
2116040-11604064.18464.18
3118600-11860065.59965.60
4123910-12391068.53768.54
5134796-13479674.55874.56
6117445-11744564.96164.96
10min1150849-15084983.43785.283.2783.7985.653.27
2148955-14895582.38982.75
3149988-14998882.96183.33
4159830-15983088.40488.79
5160324-16032488.67889.09
6155114-15511485.79686.16
15min1162254-16225489.74590.832.8790.5691.672.87
2159803-15980388.39089.20
3158528-15852887.68488.51
4168915-16891593.43094.30
5169558-16955893.78594.69
6166217-16621791.93792.77
20min1166371-16637192.02292.782.3493.3494.132.35
2164907-16490791.21392.52
3163454-16345490.40991.72
4173004-17300495.69197.08
5172139-17213995.21396.64
6166598-16659892.14893.50
30min1170622-17062294.37494.911.5896.2096.771.61
2169195-16919593.58495.40
3168380-16838093.13494.95
4175048-17504896.82298.74
5174342-17434296.43198.39
6171919-17191995.09196.95
45min1164583-16458391.03392.861.2693.3995.261.28
2166857-16685792.29194.62
3167905-16790592.87195.20
4170537-17053794.32796.79
5169656-16965693.83996.33
6167798-16779892.81295.20
60min1164921-16492191.22092.961.3294.0895.861.34
2166411-16641192.04594.89
3167106-16710692.42995.28
4170013-17001394.03797.02
5169876-16987693.96196.97
6170021-17002194.04196.95
极限1165647-16564791.62292.891.4894.9996.321.49
2166126-16612691.88795.24
3168925-16892593.43596.80
4171586-17158694.90798.41
5169657-16965793.84097.38
6165705-16570591.65495.08
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DJ333-221017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(%)99.67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%
19.431637381639061638801640871640711639360.09
29.481644691646211645450.07
单位质量响应值RSD%判断
17384.5217357.070.12数据可信
供试品溶液-2022091403批-依折麦布-pH6.8(钠盐内含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%
5min153406-5340627.57929.9910.6627.5829.9910.66
266209-6620934.19034.19
365437-6543733.79233.79
456525-5652529.19029.19
554729-5472928.26228.26
652117-5211726.91326.91
10min1161608-16160883.45572.457.7683.6172.627.74
2140126-14012672.36172.55
3138703-13870371.62671.81
4131400-13140067.85568.02
5134838-13483869.63169.79
6135112-13511269.77269.92
15min1161251-16125183.27086.091.9583.8986.661.92
2169500-16950087.53088.12
3168947-16894787.24587.83
4164637-16463785.01985.56
5166786-16678686.12986.67
6169104-16910487.32687.86
20min1175288-17528890.51992.511.2891.6093.561.25
2180118-18011893.01394.09
3179182-17918292.53093.60
4179743-17974392.82093.83
5178323-17832392.08693.11
6182201-18220194.08995.11
30min1187980-18798097.07397.580.4498.6699.150.42
2188282-18828297.22998.82
3189488-18948897.85299.44
4190070-19007098.15299.68
5188496-18849697.34098.87
6189507-18950797.86299.41
45min1195069-195069100.73499.611.24102.86101.711.21
2192485-19248599.400101.53
3189613-18961397.916100.04
4191411-19141198.845100.92
5196156-196156101.295103.37
6192612-19261299.465101.55
60min1195079-195079100.73999.511.28103.42102.171.25
2192726-19272699.524102.21
3190259-19025998.250100.92
4193253-19325399.796102.42
5189432-18943297.823100.46
6195480-195480100.946103.59
极限1192631-19263199.47599.230.80102.72102.440.78
2190968-19096898.616101.86
3193172-19317299.754102.97
4193644-19364499.998103.17
5189655-18965597.938101.12
6192917-19291799.623102.82
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100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.551565371567431569871570071570911568730.15
210.541577331578861578100.07
单位质量响应值RSD%判断
14869.4814972.490.49数据可信
供试品溶液-2022091403批-阿托伐他汀钙-pH6.8(钠盐内含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%
5min1104411-10441157.80168.228.1457.8068.228.14
2126359-12635969.95169.95
3129907-12990771.91571.92
4132468-13246873.33373.33
5125234-12523469.32869.33
6120988-12098866.97866.98
10min1161149-16114989.21086.761.9889.5387.141.95
2151587-15158783.91784.31
3157640-15764087.26887.67
4156256-15625686.50286.91
5156143-15614386.43986.82
6157565-15756587.22687.60
15min1160851-16085189.04591.051.8489.8691.911.85
2160467-16046788.83389.69
3166331-16633192.07992.96
4165245-16524591.47892.37
5166604-16660492.23093.10
6167307-16730792.61993.48
20min1165996-16599691.89492.701.5193.2194.071.51
2163079-16307990.27991.63
3168112-16811293.06594.46
4168842-16884293.46994.87
5168643-16864393.35994.74
6170059-17005994.14395.51
30min1170048-17004894.13793.971.3295.9695.861.32
2165346-16534691.53493.38
3170786-17078694.54596.46
4170441-17044194.35496.27
5171683-17168395.04296.94
6170205-17020594.22496.12
45min1172139-17213995.29494.361.9497.6496.761.90
2166759-16675992.31694.67
3168287-16828793.16295.60
4168969-16896993.53995.98
5176044-17604497.45699.88
6170513-17051394.39496.81
60min1171485-17148594.93293.981.2697.8196.911.23
2166765-16676592.31995.19
3168261-16826193.14896.10
4169929-16992994.07197.03
5169537-16953793.85496.82
6172652-17265295.57898.52
极限1168565-16856593.31693.491.2296.7296.941.21
2164890-16489091.28194.67
3170452-17045294.36097.83
4169846-16984694.02597.51
5169680-16968093.93397.42
6169870-16987094.03897.51
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