比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
19.828186281881818408188081877818680.03
29.858179281844818180.05
单位质量响应值RSD%判断
8336.868306.400.26数据可信
影响因素30天-供试品溶液-2024021621批-比索洛尔-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%
5min187755-8775594.71994.842.9194.7294.842.91
289532-8953296.63796.64
387881-8788194.85594.86
486523-8652393.38993.39
591489-9148998.75098.75
684020-8402090.68890.69
10min188294-8829495.30196.743.3695.4696.903.36
291117-9111798.34898.51
390094-9009497.24497.40
487807-8780794.77594.93
594521-94521102.022102.19
685918-8591892.73692.89
15min188271-8827195.27697.023.5895.5997.343.57
291328-9132898.57698.90
390307-9030797.47497.79
488010-8801094.99495.31
595276-95276102.837103.17
686131-8613192.96693.27
20min188152-8815295.14896.963.6195.6297.443.61
291298-9129898.54399.03
390173-9017397.32997.81
487953-8795394.93395.40
595310-95310102.874103.38
686099-8609992.93293.39
30min187860-8786094.83397.123.8495.4797.763.83
292498-9249899.839100.49
390079-9007997.22897.87
487911-8791194.88895.52
595397-95397102.968103.65
686110-8611092.94493.56
45min187625-8762594.57996.823.7895.3797.623.77
291307-9130798.55399.37
390129-9012997.28298.09
487734-8773494.69795.48
595411-95411102.983103.83
686006-8600692.83193.60
极限188214-8821495.21596.783.7896.1697.743.78
290960-9096098.17999.16
390030-9003097.17598.14
487571-8757194.52195.47
595460-95460103.036104.06
685733-8573392.53793.46
比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
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)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.801067381067341067281066021065831066770.08
213.761063201062331062760.06
单位质量响应值RSD%判断
7730.227723.550.07数据可信
影响因素30天-供试品溶液-2024021621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%
5min155548-5554846.60245.064.9446.6045.064.94
256028-5602847.00547.01
351092-5109242.86442.86
453749-5374945.09345.09
549896-4989641.86141.86
655937-5593746.92946.93
10min185086-8508671.38368.955.9671.4669.035.96
285641-8564171.84971.93
377925-7792565.37665.45
482273-8227369.02369.10
574824-7482462.77462.84
687393-8739373.31973.40
15min194840-9484079.56776.345.6679.7676.535.66
294581-9458179.34979.55
385276-8527671.54371.72
491533-9153376.79276.98
584001-8400170.47370.65
695760-9576080.33880.54
20min199397-9939783.39080.104.8783.7280.424.87
297975-9797582.19782.53
389918-8991875.43775.74
495645-9564580.24280.56
589733-8973375.28275.57
6100193-10019384.05784.39
30min199889-9988983.80283.334.4784.2783.784.47
2103416-10341686.76187.23
393285-9328578.26278.69
4100302-10030284.14984.60
594873-9487379.59480.01
6104225-10422587.44087.91
45min1104514-10451487.68385.334.0888.2985.924.08
2103576-10357686.89687.51
396429-9642980.90081.46
4103602-10360286.91787.51
596479-9647980.94281.49
6105657-10565788.64289.26
极限1110667-11066792.84592.932.9593.6093.662.96
2112624-11262494.48795.24
3105438-10543888.45889.15
4111011-11101193.13393.87
5109647-10964791.98992.67
6115241-11524196.68297.45
比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
19.828165681644816358166981667816540.02
29.858168381768817260.08
单位质量响应值RSD%判断
8315.078297.060.16数据可信
影响因素30天-供试品溶液-2024021621批-比索洛尔-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%
5min187702-8770294.83994.340.8694.8494.340.86
286920-8692093.99493.99
387791-8779194.93594.94
486929-8692994.00394.00
586045-8604593.04793.05
688058-8805895.22495.22
10min190817-9081798.20898.241.3698.3798.401.36
291682-9168299.14399.30
392881-92881100.440100.60
489713-8971397.01497.17
590214-9021497.55697.71
689800-8980097.10897.27
15min191227-9122798.65199.051.4998.9799.371.49
293034-93034100.605100.93
393545-93545101.158101.48
490384-9038497.73998.06
591010-9101098.41698.73
690374-9037497.72998.05
20min190809-9080998.19999.311.9298.6999.791.91
294254-94254101.924102.41
393928-93928101.572102.07
490607-9060797.98198.46
590818-9081898.20998.69
690578-9057897.94998.43
30min191077-9107798.48999.211.5799.1499.861.57
293346-93346100.942101.60
393818-93818101.453102.12
490606-9060697.98098.62
590942-9094298.34398.99
690686-9068698.06698.71
45min191529-9152998.97899.271.6299.79100.081.62
293448-93448101.053101.88
393849-93849101.486102.32
490452-9045297.81398.62
590740-9074098.12498.93
690758-9075898.14498.95
极限190565-9056597.93599.261.7698.91100.241.76
294016-94016101.667102.66
393569-93569101.184102.19
490301-9030197.65098.62
590772-9077298.15999.13
691494-9149498.94099.91
比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
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)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.801061261058791060561059901059191059940.10
213.761061241061201061220.01
单位质量响应值RSD%判断
7680.727712.350.30数据可信
影响因素30天-供试品溶液-2024021621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%
5min152675-5267544.36640.417.3844.3740.417.38
250082-5008242.18242.18
342550-4255035.83835.84
445532-4553238.35038.35
548766-4876641.07441.07
648239-4823940.63040.63
10min183873-8387370.64365.614.1970.7265.684.20
278732-7873266.31366.38
375536-7553663.62163.68
477393-7739365.18665.25
574657-7465762.88162.95
677196-7719665.02065.09
15min192035-9203577.51871.935.0077.7172.115.00
285732-8573272.20972.39
383820-8382070.59970.76
488007-8800774.12574.30
583120-8312070.00970.18
679710-7971067.13767.31
20min192780-9278078.14574.713.8178.4775.003.81
290257-9025776.02076.32
384764-8476471.39471.68
491902-9190277.40677.70
586368-8636872.74573.03
686115-8611572.53272.82
30min199860-9986084.10978.054.7684.5678.484.75
291941-9194177.43977.87
394026-9402679.19579.60
493676-9367678.90079.33
589531-8953175.40975.82
686997-8699773.27573.68
45min1100739-10073984.84980.245.3685.4480.795.34
294738-9473879.79580.35
398649-9864983.08983.62
497630-9763082.23082.79
593527-9352778.77579.31
686333-8633372.71573.25
极限1111455-11145593.87590.472.9194.6191.152.92
2109222-10922291.99492.68
3105666-10566688.99989.67
4109120-10912091.90892.60
5106240-10624089.48290.15
6102741-10274186.53587.19
比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
19.828211582104822148218682223821680.07
29.858180381812818080.01
单位质量响应值RSD%判断
8367.418305.380.53数据可信
影响因素30天-供试品溶液-2024021621批-比索洛尔-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%
5min184425-8442590.96493.861.6990.9693.861.69
287573-8757394.35694.36
388148-8814894.97694.98
487036-8703693.77893.78
588598-8859895.46195.46
686894-8689493.62593.62
10min187862-8786294.66896.080.9794.8296.240.97
289383-8938396.30696.46
389470-8947096.40096.56
490133-9013397.11597.27
589765-8976596.71896.88
688431-8843195.28195.44
15min188830-8883095.71196.690.9796.0297.000.97
290378-9037897.37997.70
389788-8978896.74397.06
491039-9103998.09198.41
589512-8951296.44596.77
688873-8887395.75796.07
20min188855-8885595.73896.691.0596.2197.171.05
290504-9050497.51497.99
389810-8981096.76797.25
491134-9113498.19398.67
589402-8940296.32796.81
688740-8874095.61496.09
30min188745-8874595.61996.551.3296.2597.181.32
290485-9048597.49498.14
389805-8980596.76197.40
491317-9131798.39099.04
589164-8916496.07196.71
688115-8811594.94095.57
45min188730-8873095.60396.431.1796.3997.231.16
290587-9058797.60498.41
389365-8936596.28797.09
490935-9093597.97998.79
589025-8902595.92196.72
688351-8835195.19595.99
极限188477-8847795.33096.181.0396.2897.141.03
290207-9020797.19498.16
389066-8906695.96596.93
490478-9047897.48698.46
589152-8915296.05897.02
688187-8818795.01895.97
比索洛尔氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
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)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.801066941064921065551065401066711065900.09
213.761058991060131059560.08
单位质量响应值RSD%判断
7723.917700.290.22数据可信
影响因素30天-供试品溶液-2024021621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%
5min159877-5987750.33152.525.0150.3352.525.02
261791-6179151.93951.94
366332-6633255.75655.76
458463-5846349.14249.14
565756-6575655.27255.27
662678-6267852.68552.68
10min180648-8064867.79069.573.9867.8769.663.98
281348-8134868.37868.46
386322-8632272.55972.65
478141-7814165.68365.76
586285-8628572.52872.62
683874-8387470.50270.59
15min188692-8869274.55176.393.6274.7576.593.62
289514-8951475.24275.44
394309-9430979.27379.49
486425-8642572.64672.84
594798-9479879.68479.90
691510-9151076.92077.13
20min191641-9164177.03079.223.4577.3579.553.45
292115-9211577.42977.75
398025-9802582.39682.74
490701-9070176.24076.55
597960-9796082.34282.69
695044-9504479.89180.22
30min194648-9464879.55881.873.5180.0182.333.51
294569-9456979.49179.95
3101383-10138385.21985.70
494107-9410779.10379.54
5101296-10129685.14685.63
698369-9836982.68683.15
45min198539-9853982.82884.053.1983.4184.653.19
296230-9623080.88881.48
3102853-10285386.45587.08
497189-9718981.69482.27
5104170-10417087.56288.19
6100986-10098684.88585.49
极限1108183-10818390.93591.591.6591.6692.331.66
2107281-10728190.17790.90
3110644-11064493.00493.77
4106694-10669489.68390.39
5110535-11053592.91293.68
6110424-11042492.81993.56
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