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%
112.319958199513993949930499154993890.18
212.2910001899781999000.17
单位质量响应值RSD%判断
8073.848128.560.48数据可信
供试品溶液-STGY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%
5min175965-7596575.39273.418.1175.3973.428.11
267112-6711266.60666.61
383910-8391083.27783.28
476040-7604075.46675.47
570507-7050769.97569.98
670293-7029369.76369.76
10min190620-9062089.93687.973.9490.0588.093.94
285402-8540284.75884.86
393709-9370993.00293.13
490488-9048889.80589.92
585012-8501284.37184.48
686627-8662785.97486.08
15min193078-9307892.37691.893.8592.6292.143.86
288304-8830487.63887.86
395810-9581095.08795.35
497416-9741696.68196.93
589402-8940288.72888.96
691549-9154990.85891.09
20min194554-9455493.84194.133.2394.2394.513.23
291222-9122290.53490.89
397048-9704896.31696.72
499043-9904398.29698.69
591618-9161890.92791.29
695612-9561294.89195.26
30min197892-9789297.15497.511.1197.6898.031.12
296624-9662495.89596.39
398704-9870497.95998.51
499043-9904398.29698.84
597598-9759896.86297.36
699621-9962198.87099.38
45min198829-9882998.08498.431.5798.7699.101.55
2102097-102097101.327101.97
398471-9847197.72898.43
498914-9891498.16898.86
597489-9748996.75497.40
699294-9929498.54599.21
极限198321-9832197.57998.181.6498.4099.001.61
2101924-101924101.155101.95
398168-9816897.42798.27
498690-9869097.94698.78
597218-9721896.48597.28
699244-9924498.49599.30
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%
112.319989699914998069965799681997910.12
212.291007231008311007770.08
单位质量响应值RSD%判断
8106.508199.920.82数据可信
供试品溶液-STGY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%
5min175580-7558074.53375.493.9774.5375.493.97
280743-8074379.62479.62
378788-7878877.69777.70
477440-7744076.36776.37
574266-7426673.23773.24
672489-7248971.48571.48
10min190590-9059089.33589.671.7389.4589.791.73
292846-9284691.56091.68
390845-9084589.58789.70
492602-9260291.31991.43
589985-8998588.73888.85
688733-8873387.50487.61
15min194078-9407892.77592.961.4293.0293.211.42
295514-9551494.19194.45
394725-9472593.41393.66
495497-9549794.17494.43
593869-9386992.56992.81
691942-9194290.66890.91
20min196435-9643595.09995.570.7295.4895.960.72
297301-9730195.95396.35
396457-9645795.12195.51
496570-9657095.23295.63
598178-9817896.81897.20
696564-9656495.22695.60
30min199003-9900397.63298.371.2598.1698.901.24
299213-9921397.83998.38
3100017-10001798.63199.17
498549-9854997.18497.72
5102067-102067100.653101.18
699674-9967498.29398.81
45min198957-9895797.58698.861.3598.2699.541.34
299028-9902897.65698.34
399916-9991698.53299.21
4101680-101680100.271100.95
5102152-102152100.737101.41
699783-9978398.40199.07
极限198740-9874097.37298.771.7198.1999.591.70
298695-9869597.32898.16
399486-9948698.10898.94
4101676-101676100.268101.10
5102849-102849101.424102.25
699488-9948898.11098.92
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%
112.319960199494994969959499620995610.07
212.291002971002931002950.01
单位质量响应值RSD%判断
8087.818160.700.64数据可信
供试品溶液-STGC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%
5min166251-6625165.56563.866.1865.5763.866.19
265752-6575265.07165.07
368881-6888168.16868.17
463788-6378863.12863.13
565345-6534564.66964.67
657125-5712556.53456.53
10min187674-8767486.76686.833.4486.8686.923.43
288893-8889387.97388.07
386516-8651685.62085.72
482746-8274681.88981.98
591798-9179890.84890.94
688801-8880187.88287.97
15min191127-9112790.18491.673.5090.4191.903.50
292474-9247491.51791.75
389629-8962988.70188.93
490010-9001089.07889.30
598261-9826197.24497.48
694260-9426093.28493.50
20min193389-9338992.42293.592.6792.7993.952.67
294655-9465593.67594.04
391630-9163090.68291.05
493365-9336592.39992.75
599007-9900797.98298.36
695345-9534594.35894.71
30min197232-9723296.22695.811.1496.7396.321.15
296169-9616995.17495.68
395740-9574094.74995.25
496028-9602895.03495.52
598732-9873297.71098.24
696989-9698995.98596.48
45min198267-9826797.25096.410.9597.9097.060.95
296338-9633895.34195.99
397621-9762196.61197.25
496404-9640495.40696.04
598536-9853697.51698.19
697360-9736096.35296.99
极限198157-9815797.14196.461.3997.9397.261.40
296095-9609595.10095.89
397365-9736596.35797.14
496259-9625995.26396.04
599761-9976198.72899.55
697206-9720696.20096.99
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%
112.3110000799785996589967399502997250.19
212.291007651007801007720.02
单位质量响应值RSD%判断
8101.148199.510.86数据可信
供试品溶液-STGC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%
5min170486-7048669.53464.3410.5869.5364.3410.58
263477-6347762.62062.62
376158-7615875.13075.13
457035-5703556.26556.27
562841-6284161.99361.99
661354-6135460.52660.53
10min182636-8263681.52083.445.2881.6283.545.28
284761-8476183.61783.71
390220-9022089.00289.11
485276-8527684.12584.21
587461-8746186.28086.37
677157-7715776.11576.21
15min188164-8816486.97488.452.8387.2088.672.84
289520-8952088.31188.53
393090-9309091.83392.08
489372-8937288.16588.38
591811-9181190.57290.79
686004-8600484.84385.05
20min191896-9189690.65592.502.0191.0192.862.00
293365-9336592.10592.46
394672-9467293.39493.78
491346-9134690.11390.46
595920-9592094.62594.98
695397-9539794.10994.44
30min195808-9580894.51596.161.1195.0196.661.10
297969-9796996.64697.14
396791-9679195.48496.01
498551-9855197.22197.70
598524-9852497.19497.69
697227-9722795.91496.39
45min199794-9979498.44796.791.2799.0897.431.26
297613-9761396.29596.93
396734-9673495.42896.10
498763-9876397.43098.05
598958-9895897.62298.27
696841-9684195.53496.15
极限1100003-10000398.65396.781.2899.4497.561.27
297879-9787996.55897.34
396995-9699595.68696.50
498699-9869997.36798.14
598492-9849297.16297.95
696562-9656295.25896.02
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