二甲双胍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对照品来源中检院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2000
标示量(mg)5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%
19.949177891918920529187692088919420.14
29.899187992283920810.32
单位质量响应值RSD%判断
9249.709310.520.47数据可信
供试品溶液-1批-恩格列净-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%
5min135707-3570734.28038.205.3834.2838.205.38
239297-3929737.72637.73
340726-4072639.09839.10
441646-4164639.98139.98
540705-4070539.07839.08
640667-4066739.04239.04
10min170526-7052667.70772.344.0067.7672.414.00
273752-7375270.80470.87
375386-7538672.37372.44
479439-7943976.26476.33
576383-7638373.33073.40
676637-7663773.57473.64
15min189129-8912985.56787.601.5185.7487.791.51
291146-9114687.50387.68
391027-9102787.38987.57
492893-9289389.18089.37
592613-9261388.91189.10
690697-9069787.07287.26
20min194605-9460590.82491.650.6491.1491.980.64
295128-9512891.32691.65
396160-9616092.31792.65
495544-9554491.72592.07
596113-9611392.27292.61
695229-9522991.42391.76
30min195734-9573491.90892.250.6292.3792.730.63
295640-9564091.81792.30
397115-9711593.23393.72
496200-9620092.35592.85
596321-9632192.47192.96
695524-9552491.70692.19
45min195271-9527191.46392.090.5192.0892.720.52
295833-9583392.00392.63
396738-9673892.87293.51
496109-9610992.26892.92
595869-9586992.03792.68
695694-9569491.86992.51
60min195806-9580691.97792.340.5192.7593.130.52
295766-9576691.93892.72
397044-9704493.16593.96
496060-9606092.22193.02
596468-9646892.61293.41
695970-9597092.13492.93
极限195861-9586192.03092.980.7392.9593.920.73
296554-9655492.69593.63
397886-9788693.97494.92
496844-9684492.97393.93
597367-9736793.47594.43
696604-9660492.74393.69
二甲双胍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DA-11412209074对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数10
标示量(mg)850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%
110.249472069469499469919470209464949469320.03
210.179487679496469492060.07
单位质量响应值RSD%判断
92473.8393333.920.66数据可信
供试品溶液-1批-二甲双胍-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%
5min1465557-46555753.06157.894.3053.0657.894.31
2504913-50491357.54657.55
3518835-51883559.13359.13
4525711-52571159.91659.92
5514343-51434358.62158.62
6518131-51813159.05359.05
10min1813953-81395392.76898.013.3092.8698.113.30
2849494-84949496.81996.91
3856762-85676297.64797.75
4898948-898948102.455102.55
5865670-86567098.66298.76
6875018-87501899.72899.83
15min1979481-979481111.634113.821.17111.88114.081.17
21003721-1003721114.396114.65
3995291-995291113.436113.70
41008594-1008594114.952115.22
51010838-1010838115.207115.47
6994192-994192113.310113.57
20min11022385-1022385116.524117.390.49116.95117.840.49
21033456-1033456117.785118.23
31034419-1034419117.895118.35
41026246-1026246116.964117.43
51034457-1034457117.899118.35
61028815-1028815117.256117.71
30min11027305-1027305117.084117.600.47117.71118.250.47
21034657-1034657117.922118.57
31038542-1038542118.365119.01
41028441-1028441117.214117.87
51034963-1034963117.957118.61
61027128-1027128117.064117.71
45min11024714-1024714116.789117.410.55117.61118.250.55
21034443-1034443117.898118.74
31038255-1038255118.332119.18
41025159-1025159116.840117.69
51031932-1031932117.612118.46
61026276-1026276116.967117.81
60min11023862-1023862116.692117.280.54117.70118.320.54
21032799-1032799117.710118.75
31037106-1037106118.201119.24
41024452-1024452116.759117.81
51031156-1031156117.523118.57
61024811-1024811116.800117.84
极限11022098-1022098116.491116.990.57117.70118.220.57
21030196-1030196117.414118.65
31035111-1035111117.974119.21
41021579-1021579116.432117.67
51029096-1029096117.288118.53
61020956-1020956116.361117.59
二甲双胍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对照品来源中检院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2000
标示量(mg)5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%
19.949184091765915819212991844918320.22
29.899158091802916910.18
单位质量响应值RSD%判断
9238.639271.080.25数据可信
供试品溶液-2批-恩格列净-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%
5min155847-5584753.76147.7411.4053.7647.7411.40
242418-4241840.83340.83
351072-5107249.16449.16
446883-4688345.13245.13
545308-4530843.61543.62
655999-5599953.90753.91
10min186116-8611682.89979.903.7582.9979.983.76
278933-7893375.98476.05
382554-8255479.47079.55
481470-8147078.42778.50
581718-8171878.66578.74
687232-8723283.97384.06
15min193837-9383790.33290.571.4390.5690.781.43
292267-9226788.82089.01
393429-9342989.93990.15
493995-9399590.48490.69
594731-9473191.19291.40
696255-9625592.65992.89
20min194515-9451590.98491.801.0091.3692.160.99
295097-9509791.54591.89
394396-9439690.87091.23
495306-9530691.74692.10
595994-9599492.40892.76
696890-9689093.27193.65
30min194492-9449290.96291.961.0491.4992.481.04
295405-9540591.84192.34
394453-9445390.92591.44
495706-9570692.13192.64
596051-9605192.46392.97
697069-9706993.44393.98
45min194300-9430090.77791.840.9291.4692.510.91
295165-9516591.61092.26
394560-9456091.02891.69
495823-9582392.24392.91
596067-9606792.47893.14
696494-9649492.88993.58
60min194609-9460991.07591.910.8091.9192.740.80
295416-9541691.85292.65
394548-9454891.01691.84
496372-9637292.77293.59
595935-9593592.35193.17
695998-9599892.41293.26
极限195514-9551491.94692.640.9592.9393.610.94
296581-9658192.97393.93
395017-9501791.46792.44
495997-9599792.41193.38
597522-9752293.87994.85
696754-9675493.14094.14
二甲双胍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DA-11412209074对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数10
标示量(mg)850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%
110.249467049467029467889617299479409499730.70
210.179473789466969470370.06
单位质量响应值RSD%判断
92770.8093120.650.27数据可信
供试品溶液-2批-二甲双胍-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%
5min1685345-68534578.07470.139.7578.0770.139.75
2538633-53863361.36061.36
3631940-63194071.99071.99
4587077-58707766.87966.88
5570955-57095565.04365.04
6679914-67991477.45577.46
10min1959095-959095109.259105.612.90109.39105.722.91
2889196-889196101.296101.40
3927975-927975105.714105.83
4912690-912690103.973104.08
5917264-917264104.494104.60
6956021-956021108.909109.04
15min11016426-1016426115.790115.730.80116.10116.020.80
21005741-1005741114.573114.84
31008311-1008311114.866115.16
41015049-1015049115.633115.92
51025784-1025784116.856117.14
61023998-1023998116.653116.96
20min11017187-1017187115.877116.530.75116.38117.020.75
21020600-1020600116.266116.73
31012278-1012278115.318115.81
41025876-1025876116.867117.34
51032782-1032782117.653118.13
61028825-1028825117.203117.71
30min11015714-1015714115.709116.420.74116.41117.100.73
21021066-1021066116.319116.97
31011318-1011318115.208115.89
41026051-1026051116.887117.56
51031589-1031589117.517118.19
61026202-1026202116.904117.60
45min11013903-1013903115.503116.260.76116.39117.130.75
21020538-1020538116.259117.11
31009476-1009476114.998115.87
41024279-1024279116.685117.55
51030517-1030517117.395118.26
61024351-1024351116.693117.59
60min11013274-1013274115.431116.050.75116.51117.120.74
21017831-1017831115.950116.99
31008088-1008088114.840115.90
41021366-1021366116.353117.41
51029947-1029947117.330118.40
61021765-1021765116.398117.49
极限11013521-1013521115.459115.910.72116.74117.170.71
21015589-1015589115.695116.93
31007182-1007182114.737115.99
41021173-1021173116.331117.59
51028508-1028508117.166118.43
61018797-1018797116.060117.34
二甲双胍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对照品来源中检院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2000
标示量(mg)5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%
19.949203791938921949219692021920770.13
29.899207891994920360.07
单位质量响应值RSD%判断
9263.289305.970.33数据可信
供试品溶液-3批-恩格列净-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%
5min152050-5205049.94546.0911.2149.9546.0911.22
251014-5101448.95148.95
354375-5437552.17652.18
447183-4718345.27545.27
541195-4119539.52939.53
642362-4236240.64940.65
10min188222-8822284.65480.316.1684.7480.396.17
284466-8446681.05081.13
389395-8939585.78085.87
484700-8470081.27581.35
575917-7591772.84772.91
679478-7947876.26476.33
15min195627-9562791.76090.901.4091.9891.101.41
295290-9529091.43691.65
395806-9580691.93292.16
495027-9502791.18491.39
592235-9223588.50588.69
694380-9438090.56390.76
20min196453-9645392.55292.210.2492.9392.570.26
296059-9605992.17492.54
396068-9606892.18392.57
496246-9624692.35492.72
595969-9596992.08892.42
695792-9579291.91892.26
30min196571-9657192.66692.290.4593.2092.800.45
296407-9640792.50893.03
396134-9613492.24692.78
495800-9580091.92692.44
595560-9556091.69592.18
696580-9658092.67493.17
45min195951-9595192.07192.100.1492.7692.770.14
295914-9591492.03592.71
396196-9619692.30693.00
495815-9581591.94092.61
595982-9598292.10092.74
696023-9602392.14092.79
60min196830-9683092.91492.150.6593.7592.970.66
296457-9645792.55693.39
396446-9644692.54693.39
495421-9542191.56292.39
595366-9536691.50992.30
695682-9568291.81392.62
极限197526-9752693.58293.470.5994.5894.450.59
297970-9797094.00894.99
397824-9782493.86894.87
497309-9730993.37494.35
597457-9745793.51694.46
696368-9636892.47193.43
二甲双胍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DA-11412209074对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数10
标示量(mg)850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%
110.249482789481879480579495099491559486370.07
210.179467279464079465670.03
单位质量响应值RSD%判断
92640.3393074.430.34数据可信
供试品溶液-3批-二甲双胍-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%
5min1634810-63481072.38668.059.1072.3968.059.10
2626195-62619571.40371.40
3661452-66145275.42475.42
4592174-59217467.52467.52
5526803-52680360.07060.07
6539216-53921661.48561.49
10min1966797-966797110.241106.444.55110.36106.564.56
2944235-944235107.669107.79
3979248-979248111.661111.79
4943842-943842107.624107.74
5866809-86680998.84098.94
6899861-899861102.609102.71
15min11023720-1023720116.732116.240.86117.04116.530.87
21025813-1025813116.971117.27
31024654-1024654116.839117.15
41020523-1020523116.368116.66
51002291-1002291114.289114.55
61019290-1019290116.227116.50
20min11026781-1026781117.081116.850.27117.58117.330.29
21028541-1028541117.282117.78
31025370-1025370116.920117.43
41023095-1023095116.661117.15
51020914-1020914116.412116.87
61023582-1023582116.716117.18
30min11023852-1023852116.747116.650.23117.44117.330.24
21026896-1026896117.094117.78
31023611-1023611116.720117.42
41020089-1020089116.318117.00
51021501-1021501116.479117.13
61022252-1022252116.565117.23
45min11020801-1020801116.399116.380.22117.29117.260.23
21024636-1024636116.837117.72
31021007-1021007116.423117.32
41019687-1019687116.272117.15
51018560-1018560116.144116.99
61019208-1019208116.218117.07
60min11021278-1021278116.454116.140.40117.54117.200.41
21023160-1023160116.668117.75
31020286-1020286116.341117.43
41011857-1011857115.380116.45
51016142-1016142115.868116.91
61018164-1018164116.099117.15
极限11016095-1016095115.863116.020.29117.14117.280.29
21022399-1022399116.582117.85
31017144-1017144115.982117.27
41015113-1015113115.751117.01
51019071-1019071116.202117.43
61014857-1014857115.722116.96
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