托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101242-201201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(%)100.0对照品水分(%)0对照品稀释倍数10000
标示量(mg)15供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.764956049652495804960749627496050.08
216.735018450232502080.07
单位质量响应值RSD%判断
2959.733001.080.99数据可信
供试品溶液-2J95SDC1批-shui(内含0.22%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min134012-3401268.47569.203.7868.4769.203.78
234510-3451069.47769.48
332209-3220964.84564.84
434632-3463269.72369.72
536230-3623072.94072.94
634647-3464769.75369.75
10min143677-4367787.93389.581.4388.3189.971.44
244942-4494290.47990.87
343957-4395788.49688.86
444471-4447189.53189.92
545422-4542291.44691.85
644511-4451189.61290.00
15min146656-4665693.93094.550.5794.8095.440.57
246702-4670294.02394.91
346995-4699594.61395.46
447254-4725495.13496.02
546897-4689794.41595.33
647287-4728795.20196.09
20min148037-4803796.71096.920.4398.1098.320.43
248174-4817496.98698.40
348118-4811896.87498.25
447892-4789296.41997.83
548108-4810896.85398.29
648511-4851197.66599.08
30min147570-4757095.77096.491.2497.7098.431.23
247696-4769696.02497.97
347501-4750195.63197.55
448122-4812296.88298.83
549049-4904998.748100.72
647621-4762195.87397.83
45min145490-4549091.58395.902.2294.0498.392.18
248135-4813596.90899.39
347963-4796396.56199.01
448023-4802396.68299.17
548208-4820897.05599.58
648001-4800196.63899.13
60min147082-4708294.78895.721.0697.7698.731.05
247144-4714494.91397.93
347508-4750895.64598.63
447401-4740195.43098.45
548464-4846497.570100.63
647668-4766895.96898.99
极限147172-4717294.96995.371.1598.4698.921.10
246924-4692494.47098.02
347545-4754595.72099.23
447807-4780796.24799.80
546685-4668593.98997.59
648099-4809996.835100.39
托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101242-201201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(%)100.0对照品水分(%)0对照品稀释倍数10000
标示量(mg)15供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.764946249446494254944649433494420.03
216.734984849920498840.11
单位质量响应值RSD%判断
2950.002981.710.76数据可信
供试品溶液-2J95SDC1批-shui(内含0.22%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min129723-2972360.13266.916.2860.1366.916.28
233429-3342967.63067.63
334505-3450569.80669.81
431471-3147163.66863.67
534095-3409568.97768.98
635204-3520471.22171.22
10min143280-4328087.55987.802.4987.8988.172.48
242997-4299786.98787.36
341850-4185084.66685.05
443416-4341687.83488.19
543664-4366488.33688.72
645175-4517591.39391.79
15min146181-4618193.42893.301.1994.2594.161.19
246483-4648394.03994.90
345611-4561192.27593.13
445632-4563292.31793.16
545807-4580792.67193.55
646992-4699295.06995.97
20min145702-4570292.45994.251.4893.8095.631.48
246680-4668094.43895.82
346758-4675894.59595.97
446909-4690994.90196.26
545912-4591292.88494.27
647571-4757196.24097.67
30min148397-4839797.91196.231.0499.7698.141.00
247495-4749596.08697.99
347848-4784896.80098.70
447323-4732395.73897.62
546993-4699395.07196.98
647349-4734995.79197.76
45min148268-4826897.65096.151.01100.0598.590.98
247773-4777396.64999.09
346900-4690094.88397.32
447230-4723095.55097.96
547343-4734395.77998.21
647656-4765696.41298.91
60min147329-4732995.75194.761.7298.6997.731.68
247108-4710895.30398.28
346851-4685194.78397.74
446818-4681894.71797.66
545316-4531691.67894.64
647608-4760896.31599.35
极限146797-4679794.67495.391.2698.1598.881.24
246419-4641993.91097.42
347332-4733295.75799.24
447337-4733795.76799.24
546886-4688694.85498.33
648123-4812397.357100.93
托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101242-201201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(%)100.0对照品水分(%)0对照品稀释倍数10000
标示量(mg)15供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.769962699692995019946199438995440.12
216.731010331013041011680.19
单位质量响应值RSD%判断
5939.386047.101.28数据可信
供试品溶液-2K72SDB2批-shui(内含0.22%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min170592-7059270.67772.101.4970.6872.101.49
272063-7206372.15072.15
371246-7124671.33271.33
473264-7326473.35373.35
571717-7171771.80471.80
673219-7321973.30873.31
10min192353-9235392.46592.560.9992.8692.961.00
293343-9334393.45693.86
390749-9074990.85991.25
493065-9306593.17793.59
592761-9276192.87393.27
692431-9243192.54392.95
15min197662-9766297.78097.190.5798.6998.110.56
297737-9773797.85598.78
396845-9684596.96297.86
496321-9632196.43797.36
597095-9709597.21298.13
696801-9680196.91897.84
20min198349-9834998.46898.931.9099.92100.391.88
298391-9839198.51099.97
396998-9699897.11598.55
4102446-102446102.570104.03
598716-9871698.835100.29
697983-9798398.10199.56
30min199188-9918899.30898.731.27101.30100.731.25
297882-9788298.000100.01
398064-9806498.183100.16
4100390-100390100.511102.54
596875-9687596.99299.00
699262-9926299.382101.39
45min197025-9702597.14297.951.1899.69100.501.16
297288-9728897.40699.96
397537-9753797.655100.18
499213-9921399.333101.92
599297-9929799.417101.96
696603-9660396.72099.28
60min197174-9717497.29197.410.88100.38100.510.83
298429-9842998.548101.64
398167-9816798.286101.35
496204-9620496.32099.46
596997-9699797.114100.21
696800-9680096.917100.01
极限196738-9673896.85596.601.03100.48100.240.97
295378-9537895.49399.14
398011-9801198.129101.74
495708-9570895.82499.50
595986-9598696.10299.74
697108-9710897.225100.86
托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号101242-201201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(%)100.0对照品水分(%)0对照品稀释倍数10000
标示量(mg)15供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.761007251008691007021005761005401006820.14
216.731023661025211024440.11
单位质量响应值RSD%判断
6007.286123.371.36数据可信
供试品溶液-2K72SDB2批-shui(内含0.22%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min171979-7197971.21073.082.4071.2173.072.40
274448-7444873.65373.65
375965-7596575.15475.15
474932-7493274.13274.13
571436-7143670.67370.67
674425-7442573.63073.63
10min192011-9201191.02892.331.0591.4292.731.05
293778-9377892.77693.19
394888-9488893.87594.29
493139-9313992.14492.56
592746-9274691.75692.15
693379-9337992.38292.79
15min195591-9559194.57096.961.5195.4797.881.50
298022-9802296.97597.90
398867-9886797.81198.75
497831-9783196.78697.71
5100056-10005698.98799.89
697648-9764896.60597.53
20min196135-9613595.10897.551.9896.5499.011.96
297351-9735196.31197.77
399935-9993598.868100.35
499585-9958598.52199.98
597370-9737096.33097.78
6101262-101262100.181101.64
30min196721-9672195.68897.131.6597.6499.141.63
298178-9817897.12999.13
3101321-101321100.239102.27
497721-9772196.67798.69
597731-9773196.68798.67
697430-9743096.38998.41
45min197288-9728896.24997.441.8098.7499.981.77
297927-9792796.88199.42
399705-9970598.640101.23
497230-9723096.19298.74
597272-9727296.23398.76
6101543-101543100.459103.01
60min196434-9643495.40496.650.8898.4399.730.87
297347-9734796.30799.38
398413-9841397.362100.50
498800-9880097.745100.83
597833-9783396.78899.85
697315-9731596.27699.38
极限195397-9539794.37897.192.0397.93100.811.99
298944-9894497.887101.50
399698-9969898.633102.31
498032-9803296.985100.61
596614-9661495.58299.18
6100763-10076399.687103.33
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