比索洛尔左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)1.5
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%
110.318957689401893648941189299894100.12
210.408926589135892000.11
单位质量响应值RSD%判断
8672.168576.920.79数据可信
加速6月-供试品溶液-2024010421批-比索洛尔-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min195023-9502398.96497.152.0098.9697.152.00
291783-9178395.59095.59
395399-9539999.35699.36
490646-9064694.40694.41
592900-9290096.75396.75
693917-9391797.81397.81
10min194795-9479598.72798.031.9598.8998.191.95
292888-9288896.74196.90
396372-96372100.369100.53
491303-9130395.09095.25
593936-9393697.83297.99
695471-9547199.43199.59
15min195990-9599099.97198.332.03100.3098.652.03
292810-9281096.66096.98
396674-96674100.684101.02
491680-9168095.48395.80
594128-9412898.03298.36
695179-9517999.12799.46
20min195694-9569499.66397.762.41100.1698.252.41
291197-9119794.98095.46
396289-96289100.283100.78
491082-9108294.86095.33
593922-9392297.81898.31
695020-9502098.96199.46
30min195067-9506799.01097.791.8199.6798.441.81
292255-9225596.08296.72
396171-96171100.160100.83
491819-9181995.62796.26
593406-9340697.28097.93
694648-9464898.57499.23
45min195201-9520199.15097.611.8099.9898.421.80
292366-9236696.19797.00
395945-9594599.925100.76
491488-9148895.28396.08
593408-9340897.28298.10
693909-9390997.80498.63
极限195297-9529799.25097.641.91100.2498.621.91
292096-9209695.91696.88
395851-9585199.827100.83
491420-9142095.21296.16
593250-9325097.11898.09
694621-9462198.54699.53
比索洛尔左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)1.5
对照品批号100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
113.774848248521489904826348761486030.58
213.784864848488485680.24
单位质量响应值RSD%判断
3529.633524.530.11数据可信
加速6月-供试品溶液-2024010421批-左氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min154771-5477198.04598.582.3198.0598.582.31
255926-55926100.113100.11
357205-57205102.402102.40
453841-5384196.38096.38
554584-5458497.71097.71
654105-5410596.85396.85
10min151095-5109591.46598.354.0691.6398.514.05
256833-56833101.736101.90
357382-57382102.719102.89
454944-5494498.35598.52
554271-5427197.15097.31
655110-5511098.65298.81
15min154733-5473397.97799.782.6598.29100.112.65
257286-57286102.547102.88
357804-57804103.475103.82
454335-5433597.26597.59
554640-5464097.81198.14
655638-5563899.59799.92
20min155110-5511098.65298.661.2599.1399.161.25
255917-55917100.097100.60
355837-5583799.953100.47
454248-5424897.10997.60
554458-5445897.48597.97
655120-5512098.67099.16
30min154159-5415996.95097.222.0697.5997.882.05
252666-5266694.27794.95
355877-55877100.025100.71
454752-5475298.01198.66
553562-5356295.88196.53
654861-5486198.20698.86
45min153973-5397396.61797.822.8597.4298.642.85
256440-56440101.033101.86
356817-56817101.708102.56
453277-5327795.37196.18
553569-5356995.89496.70
653806-5380696.31897.14
极限153335-5333595.47597.512.2596.4498.502.25
255826-5582699.934100.93
356127-56127100.473101.49
453290-5329095.39496.36
554035-5403596.72897.70
654234-5423497.08498.06
比索洛尔左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)1.5
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%
110.318908189007891648900489118890750.08
210.408943189329893800.09
单位质量响应值RSD%判断
8639.678594.230.38数据可信
长期6月-供试品溶液-2024010421批-比索洛尔-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min191570-9157095.45095.591.7395.4595.591.73
290746-9074694.59194.59
393800-9380097.77497.77
490943-9094394.79694.80
593380-9338097.33797.34
689771-8977193.57593.57
10min191849-9184995.74196.532.1895.9096.692.17
290363-9036394.19294.35
395273-9527399.31099.47
493005-9300596.94697.10
594503-9450398.50798.67
690671-9067194.51394.67
15min192259-9225996.16896.422.1296.4996.742.12
290396-9039694.22694.54
394902-9490298.92399.25
492720-9272096.64996.97
594461-9446198.46398.79
690268-9026894.09394.41
20min192005-9200595.90396.261.9496.3896.741.94
291281-9128195.14995.62
394997-9499799.02299.52
492119-9211996.02296.50
593738-9373897.71098.20
689964-8996493.77694.25
30min191857-9185795.74996.321.9696.3996.961.96
291280-9128095.14895.78
394816-9481698.83399.49
492588-9258896.51197.15
593988-9398897.97098.62
689876-8987693.68494.31
45min191533-9153395.41196.152.0796.2196.952.07
291242-9124295.10895.90
394816-9481698.83399.66
492354-9235496.26797.07
593935-9393597.91598.73
689567-8956793.36294.14
极限191490-9149095.36795.802.0496.3296.762.04
290874-9087494.72495.67
394201-9420198.19299.18
492038-9203895.93896.90
593702-9370297.67298.65
689138-8913892.91593.85
比索洛尔左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)1.5
对照品批号100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
113.774872748570484894822748661485350.41
213.784879548508486520.42
单位质量响应值RSD%判断
3524.693530.620.12数据可信
长期6月-供试品溶液-2024010421批-左氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min154925-5492598.30597.232.9298.3097.232.92
254313-5431397.20997.21
356409-56409100.961100.96
452140-5214093.32093.32
555284-5528498.94798.95
652864-5286494.61694.62
10min154855-5485598.17997.862.2898.3498.022.28
253581-5358195.89996.06
356697-56697101.476101.64
453914-5391496.49596.65
555463-5546399.26899.43
653563-5356395.86796.02
15min155768-5576899.81498.362.40100.1498.682.40
254614-5461497.74898.07
356450-56450101.034101.37
453864-5386496.40696.72
555955-55955100.148100.48
653088-5308895.01795.33
20min155206-5520698.80897.843.2999.3098.333.28
254192-5419296.99397.48
356479-56479101.086101.59
454017-5401796.68097.16
556417-56417100.975101.47
651695-5169592.52493.00
30min154305-5430597.19597.861.6497.8598.521.65
254577-5457797.68298.33
356084-56084100.379101.05
454362-5436297.29797.94
555268-5526898.91999.58
653477-5347795.71396.34
45min154761-5476198.01197.082.4098.8397.902.40
253831-5383196.34797.16
356014-56014100.254101.10
453593-5359395.92196.72
554982-5498298.40799.24
652265-5226593.54494.33
极限154882-5488298.22897.112.4099.2198.082.40
253850-5385096.38197.35
355788-5578899.849100.86
453473-5347395.70696.67
555267-5526798.91799.91
652275-5227593.56294.51
比索洛尔左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)1.5
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%
110.318871188832887808870688633887320.09
210.408908488968890260.10
单位质量响应值RSD%判断
8606.408560.190.39数据可信
中间条件6月-供试品溶液-2024010421批-比索洛尔-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min192629-9262996.93296.050.9896.9396.050.98
292689-9268996.99597.00
390332-9033294.52994.53
491421-9142195.66895.67
592165-9216596.44796.45
691481-9148195.73195.73
10min193548-9354897.89497.300.5898.0697.460.58
293567-9356797.91498.08
392193-9219396.47696.63
492661-9266196.96697.13
593059-9305997.38297.54
692855-9285597.16997.33
15min193861-9386198.22297.230.6698.5597.560.66
293128-9312897.45597.78
392021-9202196.29696.61
492769-9276997.07997.40
593062-9306297.38697.71
692654-9265496.95997.28
20min193668-9366898.02097.020.8298.5197.500.81
293383-9338397.72198.21
391748-9174896.01096.49
492200-9220096.48396.97
592985-9298597.30597.79
692275-9227596.56297.05
30min193419-9341997.75996.870.9398.4197.520.93
293313-9331397.64898.30
391036-9103695.26595.90
492457-9245796.75297.40
592711-9271197.01897.67
692469-9246996.76597.41
45min193356-9335697.69396.830.7798.5197.640.77
293246-9324697.57898.39
391457-9145795.70696.50
492120-9212096.40097.20
592508-9250896.80697.62
692487-9248796.78497.59
极限192860-9286097.17496.570.7898.1597.540.78
293021-9302197.34398.32
391049-9104995.27996.24
491976-9197696.24997.21
592576-9257696.87797.85
692196-9219696.47997.45
比索洛尔左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)1.5
对照品批号100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5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%
113.774814348190481324822048178481730.08
213.784836548316483400.08
单位质量响应值RSD%判断
3498.403507.980.20数据可信
中间条件6月-供试品溶液-2024010421批-左氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min155324-5532499.71197.563.0899.7197.563.08
253853-5385397.05997.06
352393-5239394.42894.43
452340-5234094.33294.33
556599-56599102.008102.01
654281-5428197.83197.83
10min155300-5530099.66798.202.7599.8398.362.75
254341-5434197.93998.10
353294-5329496.05296.21
452478-5247894.58194.74
556711-56711102.210102.38
654780-5478098.73098.89
15min155825-55825100.61399.102.94100.9599.422.94
254761-5476198.69699.02
353214-5321495.90896.23
453089-5308995.68296.00
557196-57196103.084103.42
655811-55811100.588100.92
20min155075-5507599.26298.662.5399.7699.152.53
254609-5460998.42298.91
353542-5354296.49996.98
453139-5313995.77296.25
557061-57061102.841103.35
655007-5500799.13999.63
30min155009-5500999.14397.551.9199.8198.201.92
254089-5408997.48598.14
352834-5283495.22395.86
452970-5297095.46896.10
555294-5529499.656100.34
654554-5455498.32398.98
45min154804-5480498.77396.842.8199.6097.662.81
253971-5397197.27298.09
352667-5266794.92295.72
451272-5127292.40893.20
555357-5535799.770100.62
654331-5433197.92198.75
极限154740-5474098.65896.583.2199.6597.563.20
253392-5339296.22897.21
351627-5162793.04794.00
451498-5149892.81593.76
555570-55570100.154101.17
654698-5469898.58299.57
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