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%
112.601038261037211037151035661036571036970.10
212.661043181041761042470.10
单位质量响应值RSD%判断
8229.928234.360.04数据可信
供试品溶液-2025080621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%
5min182407-8240780.48477.791.9380.4877.791.93
278204-7820476.37976.38
380441-8044178.56378.56
478895-7889577.05477.05
578878-7887877.03777.04
679075-7907577.22977.23
10min188457-8845786.39285.661.2286.5185.781.21
288796-8879686.72386.84
387298-8729885.26085.38
487609-8760985.56485.68
585859-8585983.85583.97
688251-8825186.19186.31
15min190819-9081988.69988.871.7588.9589.121.74
293470-9347091.28891.53
389555-8955587.46587.71
490986-9098688.86289.11
589172-8917287.09187.33
691991-9199189.84490.09
20min192949-9294990.78090.912.1491.1691.292.14
296303-9630394.05594.44
391493-9149389.35889.73
493472-9347291.29091.67
590568-9056888.45488.83
693708-9370891.52191.90
30min194648-9464892.43992.932.3392.9693.442.32
298944-9894496.63597.16
393667-9366791.48191.99
495958-9595893.71894.23
592521-9252190.36290.87
695162-9516292.94193.46
45min196258-9625894.01194.572.2194.6795.222.20
2100436-10043698.09298.76
395582-9558293.35194.00
497726-9772695.44596.10
594177-9417791.97992.62
696787-9678794.52895.18
极限199290-9929096.97396.831.7197.7797.631.71
2101812-10181299.436100.25
397628-9762895.34996.14
4100330-10033097.98898.79
597474-9747495.19995.98
698334-9833496.03996.84
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%
112.601045191046971045231043581044991045190.12
212.661047601046631047120.07
单位质量响应值RSD%判断
8295.168271.090.21数据可信
供试品溶液-2025080621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%
5min177234-7723474.96775.882.5974.9775.882.59
280986-8098678.60978.61
376112-7611273.87873.88
479693-7969377.35477.35
576058-7605873.82673.83
678993-7899376.67576.67
10min187971-8797185.38985.812.4685.5085.922.46
292379-9237989.66889.79
385919-8591983.39783.51
488082-8808285.49785.61
587301-8730184.73984.85
688746-8874686.14186.26
15min191727-9172789.03589.282.6389.2889.522.63
296651-9665193.81494.07
389612-8961286.98287.22
491131-9113188.45688.70
591001-9100188.33088.57
691742-9174289.04989.29
20min193526-9352690.78191.372.3291.1691.752.31
298204-9820495.32295.71
391945-9194589.24689.61
494325-9432591.55791.93
592758-9275890.03690.41
694045-9404591.28591.66
30min195083-9508392.29293.331.9292.8093.841.92
299718-9971896.79197.33
394778-9477891.99692.50
495519-9551992.71693.23
595360-9536092.56193.07
696461-9646193.63094.14
45min196540-9654093.70794.661.6394.3695.321.63
2100605-10060597.65298.33
396419-9641993.58994.23
496859-9685994.01694.67
596919-9691994.07494.72
697823-9782394.95295.61
极限198683-9868395.78796.191.8396.5896.981.83
2101312-10131298.33999.17
397061-9706194.21294.99
497337-9733794.48095.27
5101113-10111398.14598.93
699057-9905796.15096.95
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%
112.601037921036971036721038241037301037430.07
212.661057631058721058180.08
单位质量响应值RSD%判断
8233.578358.451.07数据可信
供试品溶液-2025080721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%
5min174934-7493472.62674.845.2772.6374.845.27
281249-8124978.74678.75
377590-7759075.20075.20
474882-7488272.57572.58
572052-7205269.83269.83
682588-8258880.04480.04
10min187477-8747784.78285.652.8184.8985.762.81
290367-9036787.58387.70
385889-8588983.24383.36
489597-8959786.83786.95
585421-8542182.79082.89
691461-9146188.64488.76
15min191464-9146488.64689.333.0088.8889.573.00
295023-9502392.09692.35
389497-8949786.74086.98
493758-9375890.87091.11
588533-8853385.80686.03
694724-9472491.80692.06
20min193750-9375090.86291.302.8891.2391.672.88
297448-9744894.44694.83
392035-9203589.20089.57
495362-9536292.42492.80
590280-9028087.49987.86
696331-9633193.36493.75
30min195933-9593392.97893.562.4893.4894.072.48
299190-9919096.13496.66
395516-9551692.57493.08
497121-9712194.12994.64
592691-9269189.83690.32
698750-9875095.70896.24
45min197690-9769094.68195.262.3095.3395.912.30
2100649-10064997.54998.22
398077-9807795.05695.70
498452-9845295.41996.07
594421-9442191.51292.14
6100419-10041997.32698.00
极限199030-9903095.97997.211.3896.7798.001.38
2101542-10154298.41499.23
3101534-10153498.40699.19
4100458-10045897.36398.16
598239-9823995.21395.97
6101006-10100697.89598.71
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%
112.601050561050161050391052521052351051200.11
212.661061381062001061690.05
单位质量响应值RSD%判断
8342.868386.180.37数据可信
供试品溶液-2025080721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%
5min172511-7251169.69872.085.3769.7072.085.37
275190-7519072.27372.27
372052-7205269.25769.26
479459-7945976.37776.38
580144-8014477.03577.04
670556-7055667.81967.82
10min183054-8305479.83283.623.0579.9483.733.05
288469-8846985.03785.15
384553-8455381.27381.38
489363-8936385.89786.01
589412-8941285.94486.06
687105-8710583.72683.83
15min186483-8648383.12887.982.7983.3588.222.79
291675-9167588.11988.35
392250-9225088.67288.90
492468-9246888.88189.12
592833-9283389.23289.48
693489-9348989.86390.09
20min190209-9020986.71090.202.2387.0690.562.22
293733-9373390.09790.47
394793-9479391.11691.47
493359-9335989.73890.11
594429-9442990.76691.14
696496-9649692.75393.11
30min192338-9233888.75692.342.3989.2492.852.38
296059-9605992.33392.84
398065-9806594.26194.76
494786-9478691.10991.62
596588-9658892.84193.36
698592-9859294.76895.27
45min194869-9486991.18993.862.0491.8094.502.04
298004-9800494.20294.84
399951-9995196.07496.71
495747-9574792.03392.68
597939-9793994.14094.79
699362-9936295.50896.15
极限1100234-10023496.34695.741.4697.0996.521.45
2100112-10011296.22997.01
3100916-10091697.00197.78
496758-9675893.00593.79
599832-9983295.95996.75
699774-9977495.90496.69
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%
112.601044561046021045861046691046991046020.10
212.661061921060401061160.11
单位质量响应值RSD%判断
8301.758381.990.69数据可信
供试品溶液-2025080722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%
5min175795-7579573.05474.864.9873.0574.864.98
275615-7561572.88072.88
382062-8206279.09479.09
481341-8134178.39978.40
572017-7201769.41369.41
679170-7917076.30776.31
10min188083-8808384.89785.552.9585.0185.662.95
285068-8506881.99282.10
391522-9152288.21288.33
492023-9202388.69588.81
587471-8747184.30884.41
688377-8837785.18185.30
15min191299-9129987.99788.682.9088.2388.922.90
287549-8754984.38384.62
394675-9467591.25191.50
494772-9477291.34591.60
591527-9152788.21788.45
692208-9220888.87389.12
20min193213-9321389.84290.542.4990.2190.922.49
290503-9050387.23087.59
397047-9704793.53793.93
495747-9574792.28492.67
592633-9263389.28389.65
694477-9447791.06091.44
30min195139-9513991.69892.822.1992.2093.332.19
294039-9403990.63891.13
399150-9915095.56496.09
497978-9797894.43594.96
594311-9431190.90091.40
697193-9719393.67894.19
45min196396-9639692.91094.271.8993.5594.921.90
296672-9667293.17693.80
3100038-10003896.42097.09
499301-9930195.71096.38
595511-9551192.05792.69
698939-9893995.36196.01
极限1101657-10165797.98196.531.2298.7697.321.21
298483-9848394.92195.69
3100250-10025096.62497.44
499699-9969996.09396.90
599424-9942495.82896.60
6101399-10139997.73298.53
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%
112.601052161054831054641053111054411053830.11
212.661046921047921047420.07
单位质量响应值RSD%判断
8363.738273.460.77数据可信
供试品溶液-2025080722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%
5min183107-8310780.32676.774.3980.3376.774.39
279854-7985477.18277.18
380191-8019177.50877.51
472927-7292770.48770.49
581409-8140978.68578.68
679056-7905676.41176.41
10min192529-9252989.43388.462.1689.5588.582.16
293832-9383290.69290.81
393039-9303989.92690.04
488698-8869885.73085.84
589897-8989786.88987.01
691136-9113688.08688.20
15min195189-9518992.00492.482.2492.2692.732.24
297591-9759194.32594.58
398567-9856795.26995.52
495821-9582192.61592.85
592814-9281489.70889.96
694112-9411290.96391.21
20min196595-9659593.36394.282.7793.7694.662.76
299715-9971596.37896.77
3101462-10146298.06798.46
497597-9759794.33194.70
593976-9397690.83191.21
695916-9591692.70693.09
30min197618-9761894.35195.662.8694.8896.192.86
2101442-10144298.04898.59
3103260-10326099.805100.35
498757-9875795.45295.97
596391-9639193.16693.68
696349-9634993.12593.65
45min198815-9881595.50896.612.7096.1897.282.69
2102567-10256799.13599.82
3103957-103957100.478101.17
499233-9923395.91296.57
598027-9802794.74795.41
697146-9714693.89594.56
极限1100799-10079997.42697.722.3998.2498.542.39
2103505-103505100.041100.88
3104439-104439100.944101.79
4100030-10003096.68397.48
599763-9976396.42597.23
698071-9807194.78995.59
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