培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.274047841057411164106141043409510.65
210.184133541378413560.08
单位质量响应值RSD%判断
3987.444062.481.32数据可信
供试品溶液-2022082101批-培哚普利-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min148341-48341102.481101.901.36102.48101.901.36
247425-47425100.539100.54
347610-47610100.931100.93
448293-48293102.379102.38
549137-49137104.168104.17
647599-47599100.908100.91
10min149063-49063104.012101.931.35105.15103.061.35
247583-47583100.874101.99
347408-47408100.503101.62
447621-47621100.955102.09
548486-48486102.788103.95
648320-48320102.436103.56
15min148373-48373102.549100.581.56104.84102.841.54
246646-4664698.888101.13
346519-4651998.618100.86
447432-47432100.554102.81
547968-47968101.690103.99
647720-47720101.164103.42
20min147537-47537100.77699.561.30104.21102.941.29
246396-4639698.358101.69
346264-4626498.078101.41
447531-47531100.764104.14
547455-47455100.603104.03
646597-4659798.784102.17
30min146835-4683599.28897.241.44103.84101.721.42
245846-4584697.192101.62
345045-4504595.49499.92
445932-4593297.374101.87
546282-4628298.116102.66
645259-4525995.947100.43
45min146252-4625298.05295.783.01103.71101.352.82
245867-4586797.236102.75
345744-4574496.975102.46
445511-4551196.481102.06
542507-4250790.11395.75
645193-4519395.807101.35
极限145591-4559196.65195.391.00103.40102.020.98
244299-4429993.912100.50
345299-4529996.032102.59
444916-4491695.220101.87
545111-4511195.633102.27
644752-4475294.872101.48
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.471687961688271689171689911691851689430.10
214.321686741690491688620.16
单位质量响应值RSD%判断
11675.4011792.040.71数据可信
供试品溶液-2022082101批-氨氯地平-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1134732-13473274.43774.331.0574.4474.331.04
2134029-13402974.04974.05
3133168-13316873.57373.57
4133698-13369873.86673.87
5137168-13716875.78375.78
6134446-13444674.27974.28
10min1157581-15758187.06185.061.6187.8985.891.60
2152342-15234284.16684.99
3150770-15077083.29884.12
4152849-15284984.44685.27
5155763-15576386.05686.90
6154438-15443885.32486.15
15min1161049-16104988.97787.581.1790.7789.351.16
2157836-15783687.20288.96
3155581-15558185.95687.70
4158658-15865887.65689.41
5159698-15969888.23090.03
6158340-15834087.48089.25
20min1162663-16266389.86888.311.3392.6591.061.32
2158126-15812687.36290.09
3157148-15714886.82189.52
4161534-16153489.24591.98
5160652-16065288.75791.54
6158930-15893087.80690.55
30min1161480-16148089.21587.821.0493.0091.551.04
2158298-15829887.45791.15
3157249-15724986.87790.54
4159141-15914187.92391.65
5160148-16014888.47992.24
6157436-15743686.98190.70
45min1163348-16334890.24788.980.9495.0293.680.90
2162005-16200589.50594.17
3160994-16099488.94693.57
4160390-16039088.61393.31
5158904-15890487.79292.54
6160737-16073788.80493.49
极限1163945-16394590.57789.201.3196.3594.901.26
2157983-15798387.28392.95
3162991-16299190.05095.67
4160252-16025288.53694.22
5161892-16189289.44295.17
6161697-16169789.33595.01
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.274093141620414984165541601414610.73
210.184160841397415020.36
单位质量响应值RSD%判断
4037.104076.820.70数据可信
供试品溶液-2批-培哚普利
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min145872-4587296.474100.492.0996.47100.492.10
247945-47945100.833100.83
347617-47617100.144100.14
448226-48226101.424101.42
548553-48553102.112102.11
648484-48484101.967101.97
10min146937-4693798.713101.331.7099.79102.451.70
247454-4745499.801100.92
348482-48482101.963103.08
448350-48350101.685102.81
548849-48849102.735103.87
649025-49025103.105104.24
15min145093-4509394.83598.982.5397.00101.222.51
246838-4683898.505100.73
346769-4676998.360100.61
447097-4709799.050101.31
548273-48273101.523103.80
648321-48321101.624103.90
20min145762-4576296.24297.602.0699.46100.942.04
246197-4619797.157100.48
346334-4633497.445100.78
445145-4514594.94598.30
547734-47734100.390103.79
647272-4727299.418102.83
30min144281-4428193.12896.762.1297.42101.192.10
246097-4609796.947101.35
345549-4554995.794100.22
446592-4659297.988102.40
546855-4685598.541103.06
646682-4668298.177102.69
45min144473-4447393.53194.723.1798.86100.223.05
242408-4240889.18894.67
345380-4538095.439100.92
445791-4579196.303101.80
545937-4593796.610102.22
646237-4623797.241102.84
极限142324-4232489.01293.522.9595.38100.082.88
243896-4389692.31898.79
344559-4455993.712100.26
444403-4440393.38499.96
545895-4589596.522103.21
645739-4573996.194102.88
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.471705151701051700341696261696891699940.22
214.321693161690411691780.12
单位质量响应值RSD%判断
11748.0311814.110.40数据可信
供试品溶液-2批-氨氯地平
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1126322-12632269.50973.032.8369.5173.042.83
2132559-13255972.94172.94
3132562-13256272.94372.94
4135067-13506774.32174.32
5132295-13229572.79672.80
6137567-13756775.69775.70
10min1147425-14742581.12184.102.3281.8984.912.32
2149966-14996682.51983.33
3155359-15535985.48786.30
4154689-15468985.11885.94
5152878-15287884.12184.93
6156728-15672886.24087.08
15min1149520-14952082.27485.242.3283.9586.992.32
2153271-15327184.33886.07
3155026-15502685.30387.06
4154773-15477385.16486.94
5156455-15645586.09087.83
6160422-16042288.27390.07
20min1153139-15313984.26586.251.5086.8588.941.52
2154942-15494285.25787.92
3156657-15665786.20188.91
4157925-15792586.89989.62
5158423-15842387.17389.87
6159360-15936087.68890.47
30min1150803-15080382.98086.382.1186.5090.032.11
2156761-15676186.25889.87
3157201-15720186.50090.17
4158383-15838387.15190.83
5158124-15812487.00890.68
6160601-16060188.37192.13
45min1153479-15347984.45286.972.0388.9091.582.03
2155723-15572385.68790.26
3158514-15851487.22391.85
4159149-15914987.57292.22
5158661-15866187.30491.94
6162849-16284989.60894.34
极限1154260-15426084.88287.812.4690.2793.392.42
2156201-15620185.95091.47
3160243-16024388.17493.77
4159255-15925587.63093.26
5163098-16309889.74595.35
6164464-16446490.49796.23
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