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101566-202301对照品来源中检所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%
110.061406954140452214058501403902140754214057540.12
210.001405824140262414042240.17
单位质量响应值RSD%判断
139736.98140422.400.35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%
5min11316538-131653884.58783.671.6084.5983.671.60
21282772-128277282.41782.42
31292811-129281183.06283.06
41313452-131345284.38984.39
51277764-127776482.09682.10
61329948-132994885.44985.45
10min11469588-146958894.42092.961.7294.5693.091.72
21431564-143156491.97792.11
31428176-142817691.76091.90
41469027-146902794.38494.52
51414584-141458490.88691.02
61467833-146783394.30894.45
15min11503466-150346696.59795.261.7196.9095.561.71
21467430-146743094.28294.57
31462955-146295593.99494.29
41511097-151109797.08797.39
51450639-145063993.20393.49
61500558-150055896.41096.71
20min11512523-151252397.17995.951.5897.6496.401.58
21478010-147801094.96195.41
31473334-147333494.66195.11
41520897-152089797.71798.18
51466043-146604394.19394.64
61509173-150917396.96497.42
30min11521407-152140797.75096.551.5698.3797.161.56
21485650-148565095.45296.06
31485663-148566395.45396.06
41529664-152966498.28098.90
51474601-147460194.74295.34
61519136-151913697.60498.23
45min11530568-153056898.33897.091.5499.1297.871.54
21490706-149070695.77796.54
31493376-149337695.94996.71
41538249-153824998.83299.62
51486825-148682595.52896.29
61527465-152746598.13998.92
60min11531219-153121998.38097.291.4999.3398.221.49
21495015-149501596.05496.98
31497737-149773796.22997.15
41540264-154026498.96199.91
51489529-148952995.70296.62
61531393-153139398.39199.34
极限11532468-153246898.46097.361.3999.5798.461.39
21497592-149759296.22097.30
31500460-150046096.40497.49
41540442-154044298.973100.09
51492062-149206295.86496.94
61529276-152927698.25599.37
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101566-202301对照品来源中检所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%
110.061407516141127714110531409037141208214101930.14
210.001398782140163014002060.15
单位质量响应值RSD%判断
140178.23140020.600.08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%
5min11347399-134739986.55783.012.9586.5683.012.95
21277074-127707482.03982.04
31250989-125098980.36480.36
41270935-127093581.64581.65
51331351-133135185.52685.53
61275444-127544481.93581.93
10min11474198-147419894.70392.801.7294.8592.941.72
21420516-142051691.25491.39
31439870-143987092.49792.63
41438473-143847392.40892.54
51474965-147496594.75294.89
61419486-141948691.18891.32
15min11508798-150879896.92595.091.6897.2395.381.68
21453481-145348193.37293.66
31470461-147046194.46394.75
41483235-148323595.28395.57
51509480-150948096.96997.27
61456009-145600993.53493.82
20min11518891-151889197.57496.051.4198.0496.501.41
21481749-148174995.18895.63
31482493-148249395.23695.68
41496694-149669496.14896.60
51521094-152109497.71598.18
61470380-147038094.45794.90
30min11540473-154047398.96096.751.8299.5997.371.82
21476228-147622894.83395.44
31495209-149520996.05296.66
41510092-151009297.00897.62
51534888-153488898.60199.23
61479832-147983295.06595.67
45min11554433-155443399.85797.421.91100.6598.191.91
21487066-148706695.52996.29
31501400-150140096.45097.21
41522135-152213597.78298.55
51545371-154537199.275100.06
61488411-148841195.61696.38
60min11548222-154822299.45897.571.86100.4298.511.86
21488705-148870595.63596.55
31502424-150242496.51697.44
41535068-153506898.61399.55
51548208-154820899.457100.41
61490780-149078095.76896.69
极限11549272-154927299.52597.491.84100.6598.581.83
21489203-148920395.66796.75
31501720-150172096.47197.56
41526706-152670698.07699.17
51548412-154841299.470100.59
61489862-148986295.70996.79
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101566-202301对照品来源中检所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%
110.061407539140705314082731408637140966514082330.08
210.001411109141259114118500.08
单位质量响应值RSD%判断
139983.40141185.000.61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%
5min11310121-131012183.87484.531.0883.8784.541.08
21310626-131062683.90683.91
31326157-132615784.90084.90
41344228-134422886.05786.06
51306841-130684183.66483.66
61324690-132469084.80684.81
10min11469451-146945194.07494.370.8594.2194.510.85
21452816-145281693.00993.15
31472977-147297794.30094.44
41477354-147735494.58094.72
51488510-148851095.29495.43
61483491-148349194.97395.11
15min11496127-149612795.78296.300.9896.0896.600.98
21481496-148149694.84595.14
31504349-150434996.30896.61
41506644-150664496.45596.76
51525286-152528697.64897.95
61511270-151127096.75197.05
20min11512689-151268996.84296.960.9497.3097.420.94
21490247-149024795.40595.86
31516512-151651297.08797.55
41514672-151467296.96997.43
51534465-153446598.23698.70
61518658-151865897.22497.68
30min11519754-151975497.29497.350.9997.9197.970.99
21494733-149473395.69296.30
31518995-151899597.24697.87
41520797-152079797.36197.98
51539697-153969798.57199.20
61529681-152968197.93098.55
45min11520652-152065297.35297.700.7198.1398.480.71
21516342-151634297.07697.85
31518400-151840097.20897.99
41528040-152804097.82598.61
51545977-154597798.97399.76
61527292-152729297.77798.56
60min11522177-152217797.44997.861.2598.3998.811.25
21498422-149842295.92996.86
31519680-151968097.29098.23
41536574-153657498.37199.32
51548628-154862899.143100.10
61546230-154623098.98999.94
极限11519051-151905197.24997.350.9798.3598.450.97
21496240-149624095.78996.88
31519148-151914897.25598.36
41520972-152097297.37298.48
51541783-154178398.70599.82
61526371-152637197.71898.83
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101566-202301对照品来源中检所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%
110.061438969143664714383941437312143606114374770.09
210.001404242140436714043040.01
单位质量响应值RSD%判断
142890.36140430.401.23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%
5min11305133-130513382.92484.031.4182.9284.031.41
21341778-134177885.25385.25
31294088-129408882.22282.22
41331992-133199284.63184.63
51331962-133196284.62984.63
61330301-133030184.52384.52
10min11494849-149484994.97894.461.0995.1294.601.09
21490122-149012294.67894.82
31463138-146313892.96393.10
41493732-149373294.90795.05
51506526-150652695.72095.86
61471651-147165193.50493.65
15min11527862-152786297.07696.370.9297.3796.660.92
21520814-152081496.62896.93
31494551-149455194.95995.25
41522464-152246496.73397.03
51529547-152954797.18397.48
61505126-150512695.63195.93
20min11537887-153788797.71396.910.9398.1797.370.92
21525735-152573596.94197.40
31507115-150711595.75896.21
41530545-153054597.24697.71
51540395-154039597.87298.33
61509795-150979595.92896.38
30min11544881-154488198.15797.101.4898.7897.721.47
21534138-153413897.47598.10
31510708-151070895.98696.60
41538588-153858897.75798.38
51549784-154978498.46999.09
61491424-149142494.76195.38
45min11547389-154738998.31697.540.9999.1098.330.99
21538623-153862397.76098.54
31511958-151195896.06596.84
41541687-154168797.95498.74
51549888-154988898.47599.27
61521882-152188296.69697.47
60min11549487-154948798.45097.611.0799.4098.561.07
21545411-154541198.19199.14
31512475-151247596.09897.03
41543309-154330998.05799.01
51548577-154857798.39299.35
61518366-151836696.47297.41
极限11549756-154975698.46797.151.6899.5898.261.67
21530777-153077797.26198.37
31508847-150884795.86896.96
41549464-154946498.44899.56
51547360-154736098.31599.43
61487941-148794194.53995.64
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