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%
110.281436460143634314360771436433143831714367260.07
210.211439527144012914398280.03
单位质量响应值RSD%判断
139759.34141021.350.64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%
5min1930236-93023659.03356.008.8359.0356.008.83
2900385-90038557.13957.14
3826619-82661952.45852.46
4901811-90181157.23057.23
5976862-97686261.99261.99
6758692-75869248.14748.15
10min11254245-125424579.59578.582.3079.6978.672.31
21264205-126420580.22780.32
31212961-121296176.97577.06
41220142-122014277.43177.53
51271472-127147280.68980.79
61205982-120598276.53376.61
15min11383118-138311887.77486.471.4888.0086.691.48
21391250-139125088.29088.52
31347445-134744585.51085.73
41340960-134096085.09885.32
51358077-135807786.18586.42
61354226-135422685.94086.15
20min11445307-144530791.72090.061.5692.1090.421.56
21443590-144359091.61191.99
31403776-140377689.08589.44
41392830-139283088.39088.76
51404945-140494589.15989.54
61424020-142402090.36990.72
30min11489611-148961194.53293.231.2595.0693.741.25
21482094-148209494.05594.58
31453407-145340792.23492.74
41443578-144357891.61192.12
51463777-146377792.89293.42
61481912-148191294.04394.54
45min11511028-151102895.89195.241.4296.5895.921.42
21494353-149435394.83395.52
31478765-147876593.84494.50
41475383-147538393.62994.30
51526022-152602296.84397.53
61519400-151940096.42297.08
60min11517370-151737096.29396.231.6097.1497.061.59
21500368-150036895.21596.06
31496863-149686394.99295.81
41494255-149425594.82795.65
51554489-155448998.64999.50
61534460-153446097.37898.20
极限11516896-151689696.26396.991.7097.2797.981.69
21499695-149969595.17296.17
31512278-151227895.97096.95
41525250-152525096.79497.77
51571708-157170899.742100.75
61544472-154447298.01398.99
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%
110.281437403143721214372411437317143701214372370.02
210.211441708144153814416230.01
单位质量响应值RSD%判断
139809.05141197.160.70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%
5min11018212-101821264.56555.8911.4664.5655.8911.46
2808675-80867551.27851.28
3740192-74019246.93646.94
4855954-85595454.27654.28
5908412-90841257.60357.60
6956564-95656460.65660.66
10min11300156-130015682.44377.206.0782.5577.296.08
21141877-114187772.40772.49
31125624-112562471.37671.45
41229338-122933877.95278.04
51212016-121201676.85476.95
61295729-129572982.16282.26
15min11359342-135934286.19682.734.3586.4482.954.36
21248908-124890879.19379.40
31233186-123318678.19678.39
41322256-132225683.84484.06
51292867-129286781.98182.20
61371329-137132986.95687.19
20min11375910-137591087.24784.493.7287.6484.863.73
21280892-128089281.22281.56
31277844-127784481.02881.36
41349246-134924685.55685.92
51314252-131425283.33783.70
61396788-139678888.57088.95
30min11390362-139036288.16386.113.2088.7086.623.21
21306302-130630282.83383.31
31320236-132023683.71684.18
41379695-137969587.48787.99
51335905-133590584.71085.21
61415664-141566489.76790.30
45min11398074-139807488.65287.063.0989.3387.703.09
21315170-131517083.39584.01
31341175-134117585.04485.65
41399305-139930588.73089.38
51356072-135607285.98986.63
61427581-142758190.52391.20
60min11408597-140859789.31987.423.0190.1588.213.02
21321490-132149083.79684.55
31354394-135439485.88286.63
41401797-140179788.88889.68
51355142-135514285.93086.71
61430885-143088590.73391.56
极限11518014-151801496.25796.392.0597.2497.322.06
21478317-147831793.74094.63
31522653-152265396.55297.44
41523441-152344196.60297.55
51504783-150478395.41896.35
61573137-157313799.753100.74
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%
110.281436039143585014374851436321143626014363910.05
210.211436234143602114361280.02
单位质量响应值RSD%判断
139726.75140658.960.48数据可信
供试品溶液-2024052511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%
5min1914373-91437358.10856.728.1058.1156.728.10
2868237-86823755.17655.18
3861195-86119554.72954.73
41019855-101985564.81164.81
5804146-80414651.10351.10
6887783-88778356.41856.42
10min11312388-131238883.40281.036.5683.5081.136.56
21219290-121929077.48577.58
31282055-128205581.47481.57
41400284-140028488.98789.10
51153926-115392673.33273.42
61282612-128261281.50981.60
15min11404807-140480789.27587.875.6289.5188.105.62
21327035-132703584.33384.55
31423055-142305590.43590.66
41473458-147345893.63893.89
51256838-125683879.87280.08
61410849-141084989.65989.89
20min11454107-145410792.40890.934.8992.7991.304.89
21394277-139427788.60688.97
31475710-147571093.78194.16
41494110-149411094.95095.36
51305922-130592282.99183.33
61460870-146087092.83893.22
30min11496172-149617295.08194.092.6095.6294.622.61
21481651-148165194.15894.67
31496157-149615795.08095.61
41508774-150877495.88296.45
51404189-140418989.23689.71
61496474-149647495.10095.63
45min11510817-151081796.01295.520.8096.7196.200.83
21507041-150704195.77296.44
31492614-149261494.85595.55
41514598-151459896.25296.98
51483959-148395994.30594.93
61508999-150899995.89696.59
60min11513455-151345596.17995.920.6397.0496.770.66
21513937-151393796.21097.04
31509775-150977595.94696.80
41514424-151442496.24197.13
51490464-149046494.71895.50
61514533-151453396.24897.10
极限11519693-151969396.57696.180.5297.5997.180.54
21516599-151659996.37997.37
31512437-151243796.11597.13
41514505-151450596.24697.30
51498509-149850995.23096.17
61518861-151886196.52397.54
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%
110.281436345143615514365701436526143717014365530.03
210.211430123142915414296380.05
单位质量响应值RSD%判断
139742.51140023.310.15数据可信
供试品溶液-2024052611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%
5min11117251-111725171.15758.3811.6871.1658.3811.68
2847957-84795754.00654.01
3959783-95978361.12861.13
4853008-85300854.32854.33
5869409-86940955.37255.37
6852152-85215254.27354.27
10min11385895-138589588.26779.126.0588.3979.226.06
21198822-119882276.35376.44
31265713-126571380.61380.71
41202071-120207176.56076.65
51204735-120473576.72976.82
61196784-119678476.22376.31
15min11443464-144346491.93484.724.6992.2084.954.70
21298271-129827182.68782.90
31356638-135663886.40486.64
41312304-131230483.58083.80
51301462-130146282.89083.11
61268893-126889380.81581.03
20min11464898-146489893.29986.874.7993.7287.244.80
21321506-132150684.16684.52
31408929-140892989.73490.11
41376464-137646487.66788.02
51321245-132124584.15084.51
61290985-129098582.22382.57
30min11492044-149204495.02889.005.5195.6089.525.51
21338796-133879685.26885.76
31457196-145719692.80893.34
41447362-144736292.18292.69
51341042-134104285.41185.91
61308393-130839383.33183.82
45min11527394-152739497.27990.685.9698.0191.345.96
21359834-135983486.60887.24
31487887-148788794.76395.45
41482186-148218694.40095.06
51357545-135754586.46287.10
61327853-132785384.57185.20
60min11536624-153662497.86791.436.1498.7692.246.13
21381389-138138987.98088.76
31498338-149833895.42996.27
41505799-150579995.90496.72
51362520-136252086.77987.56
61328671-132867184.62385.39
极限11535380-153538097.78897.351.3798.8598.311.37
21546629-154662998.50499.43
31519358-151935896.76897.77
41537700-153770097.93698.91
51490111-149011194.90595.83
61541371-154137198.17099.08
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