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101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0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%
112.781056381054891054261056301053781055120.12
212.901037451038731038090.09
单位质量响应值RSD%判断
8256.038047.211.82数据可信
供试品溶液-2025080621批-5mg规格-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%
5min183630-8363082.49880.192.4282.5080.192.42
279294-7929478.22178.22
380750-8075079.65779.66
479617-7961778.54078.54
583786-8378682.65282.65
680638-8063879.54779.55
10min192208-9220890.96090.001.8391.0890.121.83
290490-9049089.26689.38
390916-9091689.68689.81
488421-8842187.22587.34
592450-9245091.19991.32
692951-9295191.69391.81
15min195294-9529494.00593.012.2594.2693.272.25
293402-9340292.13892.39
393462-9346292.19792.45
490895-9089589.66589.91
596173-9617394.87295.13
696514-9651495.20895.46
20min196690-9669095.38294.512.3695.7894.912.36
294970-9497093.68594.07
394935-9493593.65094.04
492180-9218090.93391.32
597856-9785696.53296.94
698227-9822796.89897.30
30min1100484-10048499.12496.452.6999.6796.982.69
297147-9714795.83396.36
396077-9607794.77795.31
493680-9368092.41292.93
599963-9996398.61099.16
699283-9928397.94098.48
45min199719-9971998.37097.112.3499.0697.792.34
298357-9835797.02697.70
396971-9697195.65996.33
494653-9465393.37294.03
5100626-10062699.26499.96
6100320-10032098.96399.65
极限1101333-10133399.96299.362.50100.80100.192.50
2100339-10033998.98199.80
398419-9841997.08797.91
497577-9757796.25797.05
5104403-104403102.990103.84
6102261-102261100.877101.72
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101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0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%
112.781034801031431035081032301035271033780.18
212.901051441044271047860.49
单位质量响应值RSD%判断
8089.058122.950.30数据可信
供试品溶液-2025080621批-5mg规格-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%
5min181131-8113180.47179.822.2980.4779.822.29
278194-7819477.55877.56
383181-8318182.50482.50
480089-8008979.43779.44
581475-8147580.81280.81
678788-7878878.14778.15
10min192696-9269691.94291.161.5192.0691.281.51
289797-8979789.06689.18
392720-9272091.96692.09
493011-9301192.25492.37
592716-9271691.96292.08
690520-9052089.78389.90
15min196322-9632295.53894.141.7295.8094.391.71
292530-9253091.77792.03
394448-9444893.67993.94
496139-9613995.35795.61
596378-9637895.59495.85
693632-9363292.87093.12
20min197418-9741896.62595.692.1097.0396.092.10
293987-9398793.22293.61
395512-9551294.73595.14
499591-9959198.78199.18
597296-9729696.50496.91
695051-9505194.27894.67
30min198685-9868597.88296.671.4998.4397.211.49
296347-9634795.56396.09
395719-9571994.94095.48
499154-9915498.34798.90
598383-9838397.58298.13
696471-9647195.68696.22
45min199140-9914098.33397.621.6299.0398.311.62
297238-9723896.44797.12
396378-9637895.59496.28
4100770-10077099.950100.65
599248-9924898.44099.13
697775-9777596.97997.66
极限199486-9948698.67698.502.0399.5299.332.02
297330-9733096.53897.35
397043-9704396.25397.08
4102583-102583101.748102.59
599631-9963198.82099.66
699775-9977598.96399.78
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101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0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%
112.781046641044881044651043151042111044290.17
212.901046671044491045580.15
单位质量响应值RSD%判断
8171.288105.270.58数据可信
供试品溶液-2025080721批-5mg规格-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%
5min175297-7529774.38979.453.4174.3979.453.41
281032-8103280.05580.05
382300-8230081.30781.31
482208-8220881.21781.22
582193-8219381.20281.20
679467-7946778.50978.51
10min190263-9026389.17491.872.0089.2991.992.00
291624-9162490.51990.64
393885-9388592.75392.87
493521-9352192.39392.51
593043-9304391.92192.04
695606-9560694.45394.57
15min194008-9400892.87494.861.3293.1295.111.32
295437-9543794.28694.54
396222-9622295.06295.32
497245-9724596.07296.33
595749-9574994.59494.85
697425-9742596.25096.51
20min195955-9595594.79897.291.9295.1897.691.92
297307-9730796.13496.53
3101193-10119399.973100.38
499817-9981798.61399.02
597660-9766096.48296.88
698922-9892297.72998.13
30min197997-9799796.81598.081.5897.3498.621.58
298575-9857597.38697.93
398300-9830097.11597.67
4102021-102021100.791101.34
598487-9848797.29997.85
6100277-10027799.06899.62
45min199321-9932198.12398.911.5798.8099.601.57
299529-9952998.32999.02
398936-9893697.74398.44
4102904-102904101.663102.37
598967-9896797.77398.47
6101053-10105399.834100.53
极限1101319-101319100.09799.641.69100.92100.481.68
2100509-10050999.297100.13
399306-9930698.10898.95
4103606-103606102.357103.21
598910-9891097.71798.56
6101499-101499100.275101.12
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101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0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%
112.781038421039001037881041781042231039860.20
212.901069401069131069260.02
单位质量响应值RSD%判断
8136.628288.841.32数据可信
供试品溶液-2025080721批-5mg规格-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%
5min184490-8449082.72079.155.9382.7279.165.93
282463-8246380.73680.74
379412-7941277.74877.75
484399-8439982.63182.63
571826-7182670.32170.32
682497-8249780.76980.77
10min195711-9571193.70692.282.3893.8392.402.38
295273-9527393.27793.40
392583-9258390.64490.76
493887-9388791.92092.04
590960-9096089.05589.16
697096-9709695.06295.18
15min198309-9830996.25094.671.5196.5194.931.51
297721-9772195.67495.93
395541-9554193.54093.79
497890-9789095.83996.10
595906-9590693.89794.14
694808-9480892.82293.09
20min1100179-10017998.08096.321.3998.4996.721.39
298542-9854296.47896.88
396907-9690794.87795.27
499792-9979297.70298.11
597321-9732195.28295.66
697518-9751895.47595.88
30min1102039-10203999.90297.961.51100.4698.501.51
299071-9907196.99697.54
398487-9848796.42496.96
4101619-10161999.490100.04
5100289-10028998.18898.71
698825-9882596.75597.30
45min1107302-107302105.05499.762.87105.76100.452.86
299253-9925397.17497.87
399921-9992197.82898.51
4102742-102742100.590101.29
5101507-10150799.381100.05
6100621-10062198.51399.20
极限1103346-103346101.18199.321.89102.04100.161.88
298634-9863496.56897.41
3101096-10109698.97899.80
4102879-102879100.724101.58
5102879-102879100.724101.54
699860-9986097.76898.61
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101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0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%
112.781054131040431040441042181042811044000.56
212.901058551060061059300.11
单位质量响应值RSD%判断
8169.018211.630.37数据可信
供试品溶液-2025080722批-5mg规格-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%
5min174742-7474273.37176.146.3373.3776.146.33
278471-7847177.03177.03
382661-8266181.14481.14
479554-7955478.09478.09
580835-8083579.35279.35
669138-6913867.87067.87
10min185204-8520483.64188.112.6783.7588.222.67
289447-8944787.80687.92
391933-9193390.24690.37
491227-9122789.55389.67
590666-9066689.00389.12
690050-9005088.39888.50
15min189699-8969988.05392.742.5188.2992.992.51
295219-9521993.47293.72
395846-9584694.08894.34
495384-9538493.63493.89
594899-9489993.15893.41
695822-9582294.06494.30
20min191602-9160289.92195.212.8790.2995.592.87
297282-9728295.49795.88
397512-9751295.72396.12
498629-9862996.81997.21
597352-9735295.56695.96
699538-9953897.71298.09
30min194380-9438092.64897.542.7593.1598.062.74
2100227-10022798.38898.92
399804-9980497.97398.51
4101406-10140699.546100.08
598459-9845996.65397.19
6101887-101887100.018100.54
45min196434-9643494.66598.832.6695.3199.512.65
2100954-10095499.10299.78
3100553-10055398.70899.40
4103087-103087101.196101.88
599263-9926397.44298.12
6103793-103793101.889102.56
极限1100764-10076498.915100.281.6399.70101.101.62
2101607-10160799.743100.57
3101682-10168299.816100.65
4104024-104024102.115102.95
5100467-10046798.62499.45
6104369-104369102.454103.28
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101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0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%
112.781039131042441041631044151044181042310.21
212.901058771045781052280.88
单位质量响应值RSD%判断
8155.798157.210.02数据可信
供试品溶液-2025080722批-5mg规格-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%
5min176562-7656275.46879.143.6875.4779.143.68
277820-7782076.70876.71
382552-8255281.37381.37
479342-7934278.20978.21
584406-8440683.20083.20
681024-8102479.86779.87
10min190451-9045189.15991.282.0589.2791.402.05
291391-9139190.08690.20
391322-9132290.01890.14
493139-9313991.80991.93
595524-9552494.16094.28
693776-9377692.43792.56
15min197507-9750796.11495.721.4896.3695.971.48
296943-9694395.55895.81
394911-9491193.55593.81
496396-9639695.01995.27
599209-9920997.79298.06
697667-9766796.27296.53
20min199781-9978198.35697.091.5498.7597.491.54
298370-9837096.96597.36
396389-9638995.01295.41
497162-9716295.77496.17
5100334-10033498.90199.31
698975-9897597.56197.96
30min1101174-10117499.72998.681.65100.2799.221.65
299211-9921197.79498.33
397939-9793996.54097.08
498906-9890697.49398.03
5102123-102123100.664101.23
6101307-10130799.860100.41
45min1101379-10137999.93199.511.70100.62100.211.70
2100395-10039598.96199.65
398573-9857397.16597.85
499762-9976298.33799.02
5102498-102498101.034101.75
6103133-103133101.660102.36
极限1102176-102176100.71799.971.14101.55100.811.14
2100726-10072699.287100.12
399606-9960698.18399.01
4101108-10110899.664100.50
5102647-102647101.181102.04
6102251-102251100.791101.64
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