达格列净片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号D5551-23-012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(%)19.2对照品稀释倍数1000
标示量(mg)10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%
1 12.159941999290991599930999081992520.14
2 12.219900499028990160.02
单位质量响应值RSD%判断
8168.898109.420.52数据可信
供试品溶液-25030602批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min185409-8540984.62079.034.6384.6279.024.63
281020-8102080.27180.27
379165-7916578.43478.43
480546-8054679.80279.80
574155-7415573.47073.47
678283-7828377.56077.56
10min197758-9775896.85594.483.0696.9894.603.06
295026-9502694.14894.27
397298-9729896.39996.52
497466-9746696.56596.69
590089-9008989.25789.37
694515-9451593.64293.76
15min199846-9984698.92397.341.7499.2097.601.74
297785-9778596.88197.14
399743-9974398.82199.08
499216-9921698.29998.56
595429-9542994.54794.79
697497-9749796.59696.85
20min1100512-10051299.58398.211.68100.0098.621.68
298931-9893198.01798.42
3100700-10070099.770100.18
4100065-10006599.14099.55
596380-9638095.48995.88
698176-9817697.26997.67
30min1100779-10077999.84899.371.94100.4299.931.94
2100327-10032799.40099.95
3103239-103239102.285102.85
4100435-10043599.507100.07
597193-9719396.29596.82
699821-9982198.89999.45
45min1103669-103669102.711100.501.62103.43101.201.62
2102037-102037101.094101.80
3101961-101961101.019101.73
4100813-10081399.881100.59
598721-9872197.80998.48
6101429-101429100.492101.19
60min1102000-102000101.058100.931.04101.93101.791.04
2102469-102469101.522102.38
3102619-102619101.671102.54
4101586-101586100.647101.51
599905-9990598.98299.80
6102678-102678101.729102.58
极限1102019-102019101.076101.780.87102.10102.780.84
2102755-102755101.806102.81
3102043-102043101.100102.12
4101946-101946101.004102.01
5103952-103952102.991103.96
6103641-103641102.683103.68
达格列净片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号D5551-23-012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(%)19.2对照品稀释倍数1000
标示量(mg)10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%
1 12.151000691001271002321002221000961001490.08
2 12.211003391002191002790.09
单位质量响应值RSD%判断
8242.728212.860.26数据可信
供试品溶液-25030602批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min191590-9159089.76589.993.1889.7789.993.18
289283-8928387.50487.50
390794-9079488.98588.99
497492-9749295.55095.55
591547-9154789.72389.72
690206-9020688.40988.41
10min199256-9925697.27998.101.1497.4198.231.14
299824-9982497.83597.97
3100002-10000298.01098.14
4102316-102316100.278100.42
599840-9984097.85197.99
699302-9930297.32497.46
15min199841-9984197.85298.311.0998.1398.591.09
2100435-10043598.43498.71
399891-9989197.90198.18
4102450-102450100.409100.70
599631-9963197.64697.93
699595-9959597.61197.89
20min199853-9985397.86498.211.2398.2998.641.23
299898-9989897.90898.33
399866-9986697.87698.30
4102686-102686100.640101.08
599455-9945597.47497.90
699505-9950597.52397.95
30min199512-9951297.52998.061.2798.1098.641.27
299519-9951997.53698.11
399447-9944797.46698.04
4102626-102626100.581101.18
599756-9975697.76998.34
699456-9945697.47598.05
45min199217-9921797.24098.071.5097.9698.791.50
299839-9983997.85098.57
399521-9952197.53898.26
4103085-103085101.031101.78
599269-9926997.29198.01
699427-9942797.44698.16
60min199376-9937697.39697.851.4398.2698.721.43
299363-9936397.38398.25
399462-9946297.48098.35
4102716-102716100.670101.57
599206-9920697.23098.10
698931-9893196.96097.82
极限198967-9896796.99597.521.3998.0198.541.39
299359-9935997.37998.39
398959-9895996.98798.00
4102268-102268100.231101.28
598697-9869796.73197.74
698746-9874696.77997.79
达格列净片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号D5551-23-012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(%)19.2对照品稀释倍数1000
标示量(mg)10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%
1 12.159919099104990339901099311991300.13
2 12.211011851011461011660.03
单位质量响应值RSD%判断
8158.858285.501.09数据可信
供试品溶液-25030602批-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%
5min178162-7816276.66179.014.6676.6679.014.66
287247-8724785.57285.57
380985-8098579.43079.43
480400-8040078.85678.86
576119-7611974.65874.66
680434-8043478.89078.89
10min193214-9321491.42492.313.3391.5492.433.33
298292-9829296.40596.53
395533-9553393.69993.82
495166-9516693.33993.46
588886-8888687.17987.29
693599-9359991.80291.92
15min194789-9478992.96994.182.7693.2294.442.76
297682-9768295.80796.08
397447-9744795.57695.84
497840-9784095.96296.22
591140-9114089.39089.63
697241-9724195.37495.63
20min195519-9551993.68594.922.8594.0895.322.85
298395-9839596.50696.92
398213-9821396.32796.73
498672-9867296.77897.18
591671-9167189.91190.29
698203-9820396.31896.72
30min196152-9615294.30695.482.7094.8496.022.70
298126-9812696.24296.80
399120-9912097.21797.76
499307-9930797.40097.95
592546-9254690.76991.28
698853-9885396.95597.50
45min197214-9721495.34896.222.4196.0296.902.42
298908-9890897.00997.71
399578-9957897.66698.36
499679-9967997.76598.46
593665-9366591.86792.51
699568-9956897.65698.35
60min197477-9747795.60696.792.4196.4297.612.41
2100491-10049198.56299.41
399583-9958397.67198.51
499863-9986397.94698.79
594377-9437792.56593.35
6100293-10029398.36799.20
极限1101434-10143499.48798.910.52100.4599.880.53
2100958-10095899.020100.02
3100370-10037098.44399.43
4100823-10082398.88799.87
5100129-10012998.20799.13
6101334-10133499.388100.37
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