恩格列净片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DC033-12306002对照品来源分装对照品使用方法直接使用
对照品含量(%)98.99对照品水分(%)0对照品稀释倍数200
标示量(mg)50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%
110.212819481281984828202082820072281896928197160.02
210.292824558282448928245240.01
单位质量响应值RSD%判断
276171.99274492.130.44数据可信
供试品溶液-2024052411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%
5min11787111-178711157.82758.804.4857.8358.804.49
21833525-183352559.32959.33
31919964-191996462.12662.13
41878487-187848760.78460.78
51797331-179733158.15858.16
61685961-168596154.55454.55
10min12357008-235700876.26875.952.6676.3676.042.67
22369275-236927576.66576.76
32401343-240134377.70377.81
42412922-241292278.07778.18
52270895-227089573.48273.58
62270944-227094473.48373.57
15min12508709-250870981.17780.971.9881.4081.191.98
22505892-250589281.08681.31
32533938-253393881.99382.23
42551436-255143682.55982.79
52408933-240893377.94878.17
62504283-250428381.03381.25
20min12557260-255726082.74883.262.1783.1183.622.16
22551588-255158882.56482.93
32608408-260840884.40384.77
42607104-260710484.36184.73
52480250-248025080.25680.61
62634728-263472885.25485.60
30min12607580-260758084.37685.402.8084.8785.902.78
22605132-260513284.29784.80
32664582-266458286.22086.73
42657474-265747485.99086.50
52541414-254141482.23582.72
62759444-275944489.29089.78
45min12638191-263819185.36687.003.9786.0087.643.95
22635653-263565385.28485.92
32730863-273086388.36589.02
42688117-268811786.98287.63
52564621-256462182.98683.61
62873780-287378092.99093.63
60min12984697-298469796.57996.641.0297.3697.421.01
23044603-304460398.51799.30
32980006-298000696.42797.23
42984727-298472796.58097.38
52960718-296071895.80396.56
62964534-296453495.92696.72
极限13014156-301415697.53297.501.1198.4798.451.10
23075460-307546099.516100.46
33008221-300822197.34098.30
43012711-301271197.48598.44
52984437-298443796.57097.49
62984584-298458496.57597.53
恩格列净片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DC033-12306002对照品来源分装对照品使用方法直接使用
对照品含量(%)98.99对照品水分(%)0对照品稀释倍数200
标示量(mg)50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%
110.212814287281365628131672812354281202328130970.04
210.292817210281785728175340.02
单位质量响应值RSD%判断
275523.70273812.830.45数据可信
供试品溶液-2024052811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%
5min12180891-218089170.74071.003.8370.7471.003.84
22314307-231430775.06775.07
32257138-225713873.21373.21
42151020-215102069.77169.77
52080448-208044867.48267.48
62150252-215025269.74669.75
10min12706895-270689587.80186.472.5787.9286.592.57
22764679-276467989.67689.80
32668386-266838686.55286.67
42630174-263017485.31385.43
52562925-256292583.13183.24
62662223-266222386.35286.47
15min12832805-283280591.88590.932.7292.1591.202.72
22921055-292105594.74895.02
32783763-278376390.29590.56
42793495-279349590.61090.87
52685743-268574387.11587.37
62803544-280354490.93691.20
20min12902035-290203594.13193.033.0594.5593.453.05
22993704-299370497.10497.54
32836677-283667792.01192.43
42875925-287592593.28493.69
52726136-272613688.42588.82
62874667-287466793.24393.65
30min12959712-295971296.00294.983.1096.5895.553.09
23049243-304924398.90699.50
32889247-288924793.71694.29
42933547-293354795.15395.72
52777268-277726890.08490.63
62960786-296078696.03796.60
45min13021004-302100497.99096.473.0398.7297.203.03
23063068-306306899.354100.11
32960168-296016896.01796.74
42983507-298350796.77497.50
52804738-280473890.97591.67
63012317-301231797.70898.44
60min13027977-302797798.21698.740.8199.1199.630.81
23055378-305537899.105100.03
33031188-303118898.32099.21
43013424-301342497.74498.63
53055899-305589999.12299.97
63081458-308145899.951100.84
极限13054208-305420899.06799.530.75100.13100.590.74
23088932-3088932100.193101.28
33057626-305762699.178100.23
43037963-303796398.54099.59
53074883-307488399.737100.75
63097989-3097989100.487101.54
恩格列净片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DC033-12306002对照品来源分装对照品使用方法直接使用
对照品含量(%)98.99对照品水分(%)0对照品稀释倍数200
标示量(mg)50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%
110.212814044281555228138302814210281163228138540.06
210.292808406280789428081500.02
单位质量响应值RSD%判断
275597.85272900.870.70数据可信
供试品溶液-304468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%
5min11845235-184523559.94562.132.7659.9462.132.77
21852650-185265060.18660.19
31909272-190927262.02562.02
41947648-194764863.27263.27
51965332-196533263.84663.85
61954722-195472263.50163.50
10min12469940-246994080.23981.081.2780.3481.191.27
22475144-247514480.40880.51
32557016-255701683.06883.17
42485338-248533880.73980.84
52490783-249078380.91681.02
62497379-249737981.13081.24
15min12709262-270926288.01487.911.7988.2588.151.79
22724855-272485588.52088.75
32785778-278577890.49990.74
42649710-264971086.07986.32
52663437-266343786.52586.77
62703439-270343987.82488.07
20min12828709-282870991.89491.112.0092.2791.491.99
22834977-283497792.09892.48
32882194-288219493.63194.02
42748389-274838989.28589.67
52735014-273501488.85089.24
62797544-279754490.88291.27
30min12962309-296230996.23494.592.1596.7795.132.14
22959972-295997296.15896.69
32975314-297531496.65797.21
42879142-287914293.53294.06
52823042-282304291.71092.24
62871122-287112293.27293.81
45min13026671-302667198.32596.802.1099.0297.492.09
23028021-302802198.36999.06
33015735-301573597.97098.68
43008141-300814197.72398.41
52895929-289592994.07894.76
62903849-290384994.33595.03
60min13049845-304984599.07897.581.9699.9498.441.95
23047787-304778799.01199.87
33030666-303066698.45599.33
43035835-303583598.62399.47
52941691-294169195.56496.41
62916990-291699094.76295.61
极限13073006-307300699.83099.080.82100.85100.100.82
23060819-306081999.434100.46
33056925-305692599.308100.35
43068175-306817599.673100.69
53034277-303427798.57299.57
63007156-300715697.69198.70
恩格列净片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DC033-12306002对照品来源分装对照品使用方法直接使用
对照品含量(%)98.99对照品水分(%)0对照品稀释倍数200
标示量(mg)50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%
110.212810131281069028100952810775281209328107570.03
210.292830539283024328303910.01
单位质量响应值RSD%判断
275294.52275062.290.06数据可信
供试品溶液-304468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%
5min12023071-202307165.49862.347.8265.5062.347.83
21917483-191748362.08062.08
31963142-196314263.55863.56
42065670-206567066.87866.88
51638586-163858653.05053.05
61944632-194463262.95962.96
10min12584315-258431583.66981.743.9383.7881.853.93
22514130-251413081.39781.50
32605370-260537084.35184.46
42583510-258351083.64383.75
52336267-233626775.63875.73
62525673-252567381.77181.88
15min12779309-277930989.98288.772.7490.2389.012.75
22731609-273160988.43888.68
32858963-285896392.56192.81
42737558-273755888.63088.88
52632178-263217885.21985.43
62711542-271154287.78888.03
20min12863961-286396192.72392.172.1893.1292.562.18
22878878-287887893.20693.59
32946954-294695495.41095.81
42813336-281333691.08491.48
52783577-278357790.12090.48
62794915-279491590.48790.87
30min12956059-295605995.70595.391.9796.2695.931.97
22970466-297046696.17196.71
33044572-304457298.57099.13
42905689-290568994.07494.62
52917177-291717794.44694.95
62883596-288359693.35993.90
45min13012743-301274397.54097.171.7498.2597.871.74
23002571-300257197.21097.91
33091200-3091200100.080100.80
42995072-299507296.96897.67
52970945-297094596.18796.85
62935651-293565195.04495.74
60min13033597-303359798.21597.811.4999.0998.681.49
23014142-301414297.58598.45
33099895-3099895100.361101.25
43022301-302230197.84998.72
52979129-297912996.45197.28
62978342-297834296.42697.28
极限13054748-305474898.90098.761.0399.9499.791.04
23062641-306264199.155100.18
33104879-3104879100.523101.58
43036747-303674798.31799.35
53020272-302027297.78498.77
63023983-302398397.90498.92
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