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400
标示量(mg)25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%
110.241425323142533714258181426696142559614257540.04
210.251429308142869914290040.04
单位质量响应值RSD%判断
139233.79139415.020.10数据可信
供试品溶液-24032201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%
5min1987501-98750163.14654.2515.2363.1554.2515.23
2942496-94249660.26860.27
3613488-61348839.23039.23
4846829-84682954.15154.15
5849134-84913454.29854.30
6850987-85098754.41654.42
10min11332625-133262585.21581.506.0985.3281.596.11
21339043-133904385.62585.73
31127134-112713472.07572.14
41277954-127795481.71981.81
51267757-126775781.06781.16
61302840-130284083.31083.40
15min11429397-142939791.40389.952.6991.6590.172.71
21439073-143907392.02292.26
31333432-133343285.26685.45
41405654-140565489.88590.11
51420367-142036790.82591.05
61412009-141200990.29190.52
20min11459742-145974293.34392.462.0693.7492.832.09
21467993-146799393.87194.27
31387081-138708188.69789.02
41445631-144563192.44192.82
51461388-146138893.44993.83
61453278-145327892.93093.31
30min11469187-146918793.94793.722.1394.5094.252.14
21481623-148162394.74295.30
31403654-140365489.75790.23
41470317-147031794.01994.55
51484564-148456494.93095.46
61484117-148411794.90295.44
45min11491083-149108395.34794.562.2596.0695.252.26
21486999-148699995.08695.80
31412786-141278690.34190.97
41488765-148876595.19995.89
51486334-148633495.04495.73
61506596-150659696.33997.03
60min11483133-148313394.83994.572.1695.7195.422.17
21486558-148655895.05895.93
31416600-141660090.58591.36
41492110-149211095.41396.26
51486811-148681195.07495.92
61508754-150875496.47797.33
极限11548965-154896599.049101.541.56100.08102.541.53
21597861-1597861102.175103.20
31592012-1592012101.801102.73
41614407-1614407103.233104.24
51605703-1605703102.677103.68
61568234-1568234100.281101.30
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400
标示量(mg)25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%
110.241420182142003214209241421212142111714206930.04
210.251426189142662014264040.03
单位质量响应值RSD%判断
138739.55139161.370.22数据可信
供试品溶液-24032201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%
5min11032038-103203866.17160.686.5866.1760.686.58
2978675-97867562.75062.75
3874499-87449956.07056.07
4888012-88801256.93756.94
5918204-91820458.87358.87
6986674-98667463.26363.26
10min11431165-143116591.76286.343.7991.8786.443.79
21368667-136866787.75587.86
31315265-131526584.33184.42
41283176-128317682.27482.37
51352379-135237986.71186.81
61328571-132857185.18485.29
15min11492739-149273995.71091.582.5795.9791.822.58
21430892-143089291.74592.00
31388727-138872789.04189.28
41420525-142052591.08091.31
51437687-143768792.18192.42
61398934-139893489.69689.94
20min11499695-149969596.15693.292.2496.5893.692.24
21464505-146450593.90094.30
31419733-141973391.02991.41
41471701-147170194.36194.75
51460031-146003193.61394.01
61414449-141444990.69191.09
30min11519925-151992597.45394.642.8098.0495.202.80
21488962-148896295.46896.03
31430345-143034591.71092.24
41520548-152054897.49398.03
51468679-146867994.16894.72
61428098-142809891.56692.11
45min11503183-150318396.38094.682.9497.1395.402.93
21491486-149148695.63096.35
31432219-143221991.83092.52
41538359-153835998.63599.34
51469869-146986994.24494.95
61425313-142531391.38792.09
60min11502702-150270296.34994.702.9197.2695.572.90
21491068-149106895.60396.48
31432245-143224591.83292.67
41539520-153952098.71099.58
51467936-146793694.12094.99
61428280-142828091.57792.43
极限11569156-1569156100.610100.061.23101.68101.081.24
21570189-1570189100.676101.71
31532801-153280198.27999.27
41587818-1587818101.807102.84
51550288-155028899.400100.42
61553148-155314899.584100.59
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400
标示量(mg)25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%
110.241427998142831214291321428169142787014282960.04
210.251426777142628414265300.03
单位质量响应值RSD%判断
139482.03139173.660.16数据可信
供试品溶液-24032201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%
5min1913707-91370758.42653.596.7158.4353.596.71
2886535-88653556.68856.69
3791437-79143750.60750.61
4858620-85862054.90354.90
5776245-77624549.63649.64
6801944-80194451.27951.28
10min11289737-128973782.47079.943.8082.5780.033.80
21308191-130819183.65083.74
31192563-119256376.25776.34
41271275-127127581.29081.38
51201259-120125976.81376.90
61237829-123782979.15179.24
15min11390670-139067088.92487.612.1389.1687.832.13
21416808-141680890.59690.83
31334857-133485785.35585.57
41361764-136176487.07687.30
51355223-135522386.65886.87
61360965-136096587.02587.24
20min11439408-143940892.04191.531.4992.4291.901.49
21465765-146576593.72694.11
31425654-142565491.16191.52
41404523-140452389.81090.18
51436933-143693391.88392.24
61416454-141645490.57390.94
30min11478778-147877894.55895.451.6295.0995.971.61
21511432-151143296.64697.19
31499257-149925795.86896.37
41449896-144989692.71193.23
51506292-150629296.31896.83
61510327-151032796.57697.09
45min11501784-150178496.02997.311.7896.7297.981.76
21529801-152980197.82198.52
31530872-153087297.88998.55
41478935-147893594.56895.24
51534395-153439598.11598.78
61554907-155490799.426100.10
60min11506553-150655396.33497.721.6297.1998.571.60
21536740-153674098.26599.13
31540897-154089798.53099.36
41490727-149072795.32296.16
51537327-153732798.30299.13
61557501-155750199.592100.43
极限11527977-152797797.70499.270.9898.72100.280.97
21563151-156315199.953100.98
31555678-155567899.476100.47
41544432-154443298.75699.75
51552096-155209699.246100.24
61571428-1571428100.483101.49
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