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%
19.828303683095830448310882982830530.07
29.858307283116830940.04
单位质量响应值RSD%判断
8457.548435.940.19数据可信
影响因素30天-供试品溶液-2024021621批-比索洛尔-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min195868-95868101.94397.072.95101.9497.072.95
291221-9122197.00297.00
389334-8933494.99595.00
490206-9020695.92295.92
592666-9266698.53898.54
688422-8842294.02594.03
10min196571-96571102.69197.922.84102.8698.082.84
291665-9166597.47497.64
390610-9061096.35296.51
491055-9105596.82596.99
593460-9346099.38399.55
689155-8915594.80594.96
15min196745-96745102.87697.902.89103.2298.232.89
291858-9185897.67998.00
390369-9036996.09696.41
491035-9103596.80497.13
593175-9317599.08099.41
689223-8922394.87795.19
20min196372-96372102.47997.692.84102.9998.182.84
291456-9145697.25297.74
390373-9037396.10096.58
490972-9097296.73797.22
593147-9314799.05099.54
688908-8890894.54295.02
30min196177-96177102.27297.422.81102.9698.082.82
291164-9116496.94197.59
390055-9005595.76296.40
490707-9070796.45597.10
592741-9274198.61899.28
688864-8886494.49595.13
45min195829-95829101.90297.262.78102.7698.082.78
291149-9114996.92597.74
389912-8991295.61096.41
490345-9034596.07096.87
592839-9283998.72299.55
688731-8873194.35495.14
极限195847-95847101.92196.912.91102.9497.882.91
290622-9062296.36597.34
389617-8961795.29696.25
490123-9012395.83496.80
592271-9227198.11899.11
688311-8831193.90794.85
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%
113.801057241059541054301051781055571055690.28
213.761054941052931053940.14
单位质量响应值RSD%判断
7649.937659.450.09数据可信
影响因素30天-供试品溶液-2024021621批-氨氯地平-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1114648-11464897.09295.072.3297.0995.062.32
2109844-10984493.02393.02
3114916-11491697.31997.32
4112686-11268695.43095.43
5112993-11299395.69095.69
6108450-10845091.84391.84
10min1116639-11663998.77898.021.6698.9498.181.66
2113480-11348096.10396.26
3118894-118894100.688100.85
4115862-11586298.12098.28
5115433-11543397.75797.92
6114171-11417196.68896.84
15min1117604-11760499.59597.951.6099.9298.281.60
2113918-11391896.47496.79
3117752-11775299.720100.05
4116329-11632998.51598.84
5114889-11488997.29697.62
6113492-11349296.11396.43
20min1116806-11680698.91997.711.7799.4198.191.77
2113108-11310895.78896.26
3118008-11800899.937100.43
4116401-11640198.57699.06
5114839-11483997.25497.74
6113089-11308995.77296.25
30min1116888-11688898.98997.491.7999.6598.141.79
2112563-11256395.32695.96
3117625-11762599.613100.28
4115718-11571897.99898.65
5114971-11497197.36598.01
6112950-11295095.65496.29
45min1115844-11584498.10597.061.5898.9397.871.59
2112301-11230195.10495.90
3116992-11699299.07799.91
4115364-11536497.69898.51
5114296-11429696.79497.60
6112837-11283795.55896.35
极限1115389-11538997.71996.621.7198.7197.591.71
2111739-11173994.62895.58
3116815-11681598.92799.92
4114813-11481397.23298.21
5113585-11358596.19297.16
6112195-11219595.01495.97
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%
19.828290182889829408288782928829090.03
29.858316183112831360.05
单位质量响应值RSD%判断
8442.878440.200.03数据可信
影响因素30天-供试品溶液-2024021621批-比索洛尔-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min191745-9174597.61997.802.3097.6297.802.30
291933-9193397.81997.82
394615-94615100.673100.67
493352-9335299.32999.33
588344-8834494.00094.00
691498-9149897.35697.36
10min192310-9231098.22099.132.5098.3899.292.50
293640-9364099.63599.80
396439-96439102.613102.78
494491-94491100.541100.71
589532-8953295.26495.42
692570-9257098.49798.66
15min192749-9274998.68798.942.4499.0199.272.44
293590-9359099.58299.91
396277-96277102.441102.78
493732-9373299.733100.07
589346-8934695.06695.38
692246-9224698.15298.48
20min192402-9240298.31898.862.3998.8199.352.39
293328-9332899.30399.80
396041-96041102.190102.70
494194-94194100.225100.72
589454-8945495.18195.66
692047-9204797.94098.43
30min191829-9182997.70898.402.2998.3699.062.29
293085-9308599.04599.71
395354-95354101.459102.14
493745-9374599.747100.41
589155-8915594.86395.50
691722-9172297.59498.25
45min191880-9188097.76398.672.5098.5899.502.50
292958-9295898.91099.74
396028-96028102.176103.03
493796-9379699.801100.63
588979-8897994.67695.47
692767-9276798.70699.52
极限192673-9267398.60698.312.3799.5999.302.37
292603-9260398.53299.52
395461-95461101.573102.59
493514-9351499.501100.50
589000-8900094.69895.65
691116-9111696.95097.93
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%
113.801051941056821050661051411052951052760.23
213.761054271054581054420.03
单位质量响应值RSD%判断
7628.707662.940.32数据可信
影响因素30天-供试品溶液-2024021621批-氨氯地平-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1114177-11417796.80694.473.4696.8194.473.46
2105209-10520989.20289.20
3111810-11181094.79994.80
4108419-10841991.92491.92
5114133-11413396.76896.77
6114797-11479797.33197.33
10min1114853-11485397.37996.892.8097.5497.052.81
2110118-11011893.36493.51
3115472-11547297.90498.06
4110750-11075093.90094.05
5116196-11619698.51798.68
6118271-118271100.277100.44
15min1115615-11561598.02596.783.1698.3597.103.16
2109603-10960392.92793.23
3116077-11607798.41698.74
4109630-10963092.95093.26
5115959-11595998.31698.64
6117967-117967100.019100.35
20min1114824-11482497.35496.532.8697.8497.012.86
2109196-10919692.58293.04
3114945-11494597.45797.94
4110563-11056393.74194.21
5116161-11616198.48898.98
6117431-11743199.564100.06
30min1114530-11453097.10596.462.3597.7597.102.35
2110561-11056193.74094.35
3114349-11434996.95197.60
4110599-11059993.77294.39
5115394-11539497.83798.49
6117168-11716899.341100.00
45min1114539-11453997.11296.452.8397.9297.252.83
2109830-10983093.12093.89
3115504-11550497.93198.74
4109857-10985793.14393.92
5115110-11511097.59798.41
6117681-11768199.776100.60
极限1114513-11451397.09096.172.5298.0697.132.52
2109726-10972693.03293.96
3114663-11466397.21898.19
4109944-10994493.21794.15
5115340-11534097.79298.77
6116353-11635398.65099.64
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%
19.828287382898828558280582785828430.06
29.858302382992830080.03
单位质量响应值RSD%判断
8436.158427.210.08数据可信
影响因素30天-供试品溶液-2024021621批-比索洛尔-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min194845-94845101.03599.182.30101.0499.182.30
289497-8949795.33895.34
394128-94128100.272100.27
494573-94573100.746100.75
591486-9148697.45797.46
694087-94087100.228100.23
10min195558-95558101.795100.111.97101.96100.281.97
290941-9094196.87797.04
395077-95077101.283101.45
494575-94575100.748100.92
592509-9250998.54798.71
695223-95223101.438101.61
15min195798-95798102.051100.162.03102.39100.502.03
291002-9100296.94297.26
395424-95424101.652101.99
494697-94697100.878101.21
592362-9236298.39098.72
694870-94870101.062101.40
20min195703-95703101.94999.801.98102.46100.301.97
290985-9098596.92397.41
394952-94952101.149101.65
494030-94030100.167100.67
591903-9190397.90198.39
694568-94568100.740101.24
30min195564-95564101.80199.711.99102.48100.381.99
290554-9055496.46497.11
394874-94874101.066101.74
494212-94212100.361101.03
592233-9223398.25398.91
694185-94185100.332101.00
45min194940-94940101.13799.572.03101.98100.402.03
290453-9045396.35797.16
395049-95049101.253102.10
493958-93958100.090100.93
591852-9185297.84798.66
694583-94583100.756101.60
极限195600-95600101.84099.432.18102.86100.432.18
290221-9022196.11097.07
394536-94536100.706101.72
493376-9337699.471100.48
591689-9168997.67398.65
694595-94595100.769101.78
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%
113.801050671051121052081053211053931052200.14
213.761051861049561050710.16
单位质量响应值RSD%判断
7624.647635.970.11数据可信
影响因素30天-供试品溶液-2024021621批-氨氯地平-0.005hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1110935-11093594.24895.111.4994.2595.111.49
2111218-11121894.48894.49
3109774-10977493.26193.26
4113638-11363896.54496.54
5114097-11409796.93496.93
6112040-11204095.18695.19
10min1113771-11377196.65797.281.8896.8197.441.88
2114572-11457297.33797.49
3110913-11091394.22994.38
4114682-11468297.43197.59
5117354-11735499.70199.86
6115741-11574198.33198.49
15min1113697-11369796.59497.241.3896.9197.561.38
2114676-11467697.42697.75
3111671-11167194.87395.19
4115475-11547598.10598.43
5116044-11604498.58898.92
6115177-11517797.85198.17
20min1113508-11350896.43496.911.5796.9197.391.57
2114576-11457697.34197.82
3110842-11084294.16994.64
4115056-11505697.74998.24
5116058-11605898.60099.09
6114347-11434797.14697.63
30min1113261-11326196.22496.901.5196.8697.541.51
2114408-11440897.19897.84
3111473-11147394.70595.33
4115001-11500197.70298.35
5116549-11654999.01799.67
6113625-11362596.53397.18
45min1112830-11283095.85896.721.2796.6697.531.27
2114271-11427197.08297.89
3111545-11154594.76695.55
4114664-11466497.41698.23
5115594-11559498.20699.03
6114178-11417897.00397.81
极限1113739-11373996.63096.161.5497.5997.131.53
2114521-11452197.29498.26
3109743-10974393.23594.18
4113534-11353496.45697.43
5114126-11412696.95997.94
6113487-11348796.41697.39
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