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%
110.12 9576695934957899560295541957260.17
210.099622896260962440.03
单位质量响应值RSD%判断
9459.099538.550.60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%
5min144763-4476341.98536.5525.6241.9836.5525.62
241287-4128738.72438.72
345372-4537242.55642.56
442165-4216539.54839.55
518904-1890417.73117.73
641316-4131638.75238.75
10min180398-8039875.40873.634.5575.4873.694.56
276906-7690672.13372.20
384666-8466679.41179.48
478020-7802073.17873.24
574681-7468170.04670.08
676342-7634271.60471.67
15min195077-9507789.17689.352.6689.3789.532.66
293735-9373587.91788.10
399991-9999193.78593.99
494705-9470588.82789.01
595413-9541389.49189.64
692643-9264386.89387.08
20min199039-9903992.89293.151.1193.2493.491.11
298176-9817692.08292.41
3101210-10121094.92895.29
499229-9922993.07093.41
599819-9981993.62493.92
698427-9842792.31892.65
30min1100245-10024594.02394.300.6094.5294.790.61
2100099-10009993.88694.37
3101501-10150195.20195.72
4100016-10001693.80894.30
5100346-10034694.11894.57
6101057-10105794.78595.27
45min1100285-10028594.06194.070.7194.7294.720.72
299420-9942093.24993.89
3101571-10157195.26795.94
499981-9998193.77594.42
5100356-10035694.12794.74
6100161-10016193.94494.58
60min1100361-10036194.13294.310.7594.9495.110.75
299586-9958693.40594.20
3101713-10171395.40096.24
4100179-10017993.96194.76
5101081-10108194.80795.57
6100372-10037294.14294.94
极限1101611-10161195.30496.181.1496.2797.131.14
2101649-10164995.34096.29
3104714-10471498.21599.21
4102000-10200095.66996.63
5102501-10250196.13997.06
6102763-10276396.38597.34
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)1000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%
110.208942808952188964568961568967438957710.12
210.099004599005989005280.02
单位质量响应值RSD%判断
87820.6989249.551.15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%
5min1523176-52317653.18743.4944.9453.1943.4944.94
2486749-48674949.48349.48
3529838-52983853.86453.86
4500478-50047850.87950.88
537050-370503.7673.77
6489503-48950349.76349.76
10min1832230-83223084.60583.233.6984.6983.303.71
2806240-80624081.96382.05
3871020-87102088.54988.64
4816382-81638282.99483.08
5784419-78441979.74579.75
6801642-80164281.49681.58
15min1943982-94398295.96696.261.7096.2096.481.71
2936386-93638695.19495.41
3977021-97702199.32599.56
4947194-94719496.29396.52
5946334-94633496.20596.34
6930558-93055894.60294.82
20min1970523-97052398.66599.010.5299.0599.390.52
2967087-96708798.31598.69
3981717-98171799.803100.21
4975616-97561699.18299.57
5975882-97588299.20999.51
6972990-97299098.91599.29
30min1972743-97274398.89099.540.4499.44100.080.45
2979504-97950499.578100.12
3982296-98229699.861100.43
4977995-97799599.42499.97
5977427-97742799.36699.83
6985121-985121100.149100.69
45min1971621-97162198.77699.050.3699.5099.760.36
2969757-96975798.58799.29
3979737-97973799.601100.34
4974374-97437499.05699.77
5975645-97564599.18599.82
6974828-97482899.10299.81
60min1967693-96769398.37798.840.5399.2699.710.51
2966618-96661898.26899.14
3977272-97727299.351100.25
4971043-97104398.71799.60
5979307-97930799.558100.35
6971752-97175298.78999.66
极限1964192-96419298.02198.841.0499.0799.871.04
2963343-96334397.93598.97
3991247-991247100.771101.84
4969930-96993098.60499.65
5972171-97217198.83299.79
6972414-97241498.85799.89
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%
110.12 9621596281964309615596108962380.14
210.099641296595965040.14
单位质量响应值RSD%判断
9509.689564.320.41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%
5min135354-3535433.02735.077.3233.0335.077.32
239872-3987237.24737.25
333231-3323131.04331.04
438012-3801235.51035.51
538422-3842235.89335.89
640357-4035737.70037.70
10min173074-7307468.26370.665.2068.3270.725.20
279793-7979374.54074.60
369977-6997765.37065.42
474266-7426669.37769.44
576882-7688271.82171.88
679867-7986774.60974.67
15min193937-9393787.75387.152.3487.9287.322.35
294630-9463088.40088.59
389542-8954283.64783.81
492229-9222986.15786.33
593614-9361487.45187.63
695786-9578689.48089.67
20min198861-9886192.35391.570.8992.6791.890.90
298557-9855792.06992.40
397090-9709090.69891.00
497895-9789591.45091.77
596891-9689190.51390.84
698822-9882292.31692.65
30min199698-9969893.13592.410.8193.6092.880.82
299389-9938992.84693.33
398152-9815291.69192.14
498339-9833991.86592.34
598121-9812191.66292.14
699815-9981593.24493.73
45min199866-9986693.29292.680.8593.9293.310.86
299558-9955893.00493.65
398685-9868592.18892.79
498894-9889492.38493.01
597994-9799491.54392.17
6100274-10027493.67394.32
60min1100283-10028393.68192.990.8094.4693.780.80
2100146-10014693.55394.35
399072-9907292.55093.31
499319-9931992.78193.56
598296-9829691.82592.61
6100152-10015293.55994.36
极限1101820-10182095.11794.930.4796.0595.860.48
2101642-10164294.95195.90
3101004-10100494.35595.27
4101606-10160694.91795.85
5101255-10125594.58995.52
6102379-10237995.63996.60
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)1000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%
110.208995048986128978938974558970938981110.11
210.098991928992208992060.01
单位质量响应值RSD%判断
88050.1089118.530.86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%
5min1429718-42971843.66045.766.2643.6645.766.26
2475358-47535848.29748.30
3404423-40442341.09041.09
4455822-45582246.31246.31
5460424-46042446.78046.78
6476326-47632648.39648.40
10min1771417-77141778.37780.904.4578.4580.984.45
2832475-83247584.58184.66
3744419-74441975.63475.70
4786039-78603979.86379.94
5809998-80999882.29782.38
6833036-83303684.63884.72
15min1936059-93605995.10594.981.8195.3195.191.82
2942182-94218295.72795.95
3904225-90422591.87192.07
4931128-93112894.60494.81
5941016-94101695.60995.82
6954346-95434696.96397.19
20min1968333-96833398.38498.170.5898.7598.540.58
2966603-96660398.20998.59
3959777-95977797.51597.86
4971300-97130098.68699.05
5959247-95924797.46197.84
6971802-97180298.73799.12
30min1970587-97058798.61398.370.4899.1498.900.49
2968330-96833098.38498.93
3962758-96275897.81898.33
4971157-97115798.67199.20
5962449-96244997.78798.32
6973709-97370998.93199.48
45min1968629-96862998.41498.190.4099.1098.890.40
2965833-96583398.13098.84
3962372-96237297.77998.45
4968816-96881698.43399.13
5961741-96174197.71598.41
6971203-97120398.67699.39
60min1967530-96753098.30398.040.4199.1698.900.41
2964179-96417997.96298.83
3961212-96121297.66198.50
4967827-96782798.33399.19
5959558-95955897.49398.36
6969103-96910398.46399.34
极限1963880-96388097.93297.960.3298.9598.990.33
2962111-96211197.75298.79
3959371-95937197.47498.47
4965755-96575598.12299.15
5966900-96690098.23999.26
6967146-96714698.26499.31
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%
110.12 9661096376963129619696312963610.16
210.099652896160963440.28
单位质量响应值RSD%判断
9521.849548.460.20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%
5min140217-4021737.57734.4816.1037.5834.4816.09
239201-3920136.62736.63
328357-2835726.49526.50
444341-4434141.43041.43
537932-3793235.44235.44
631366-3136629.30729.31
10min185267-8526779.66971.9310.2179.7371.9910.21
279991-7999174.73974.80
364550-6455060.31260.36
483421-8342177.94478.01
577617-7761772.52172.58
671087-7108766.42066.47
15min197472-9747291.07288.663.6391.2788.843.65
297994-9799491.56091.75
389524-8952483.64683.79
495839-9583989.54789.75
596727-9672790.37690.56
691758-9175885.73485.89
20min199325-9932592.80492.401.3593.1592.731.36
2100531-10053193.93194.27
397888-9788891.46191.75
499077-9907792.57292.92
599702-9970293.15693.49
696834-9683490.47690.78
30min199792-9979293.24093.550.9093.7494.030.90
2101383-10138394.72795.22
3100270-10027093.68794.12
499817-9981793.26393.77
5100716-10071694.10394.59
698759-9875992.27592.73
45min1100406-10040693.81494.030.8494.4794.660.84
2102029-10202995.33095.98
3100895-10089594.27194.86
4100104-10010493.53294.19
5100843-10084394.22294.86
699559-9955993.02293.63
60min1100525-10052593.92594.481.0394.7495.271.04
2102466-10246695.73996.55
3100963-10096394.33495.08
4101232-10123294.58695.40
5101974-10197495.27996.08
699561-9956193.02493.79
极限1102430-10243095.70596.230.8396.6897.180.82
2104338-10433897.48898.46
3103583-10358396.78297.69
4102220-10222095.50996.48
5103083-10308396.31597.27
6102282-10228295.56796.48
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)1000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%
110.208959548962118957308964288961598960960.03
210.098935328943468939390.07
单位质量响应值RSD%判断
87852.5588596.530.60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%
5min1481582-48158249.12845.2813.5749.1345.2813.58
2465523-46552347.49047.49
3356750-35675036.39436.39
4516554-51655452.69652.70
5455843-45584346.50246.50
6387142-38714239.49439.49
10min1881064-88106489.88182.458.5089.9682.528.50
2831986-83198684.87484.95
3699867-69986771.39671.46
4864153-86415388.15688.24
5816351-81635183.27983.36
6755895-75589577.11277.18
15min1965159-96515998.46096.692.6998.6996.902.71
2969207-96920798.87399.09
3910977-91097792.93393.11
4953366-95336697.25797.49
5967326-96732698.68198.90
6920984-92098493.95394.15
20min1975304-97530499.49599.240.9499.8999.620.95
2982462-982462100.225100.61
3971930-97193099.15199.49
4972844-97284499.24499.64
5978462-97846299.817100.20
6956106-95610697.53697.89
30min1975627-97562799.52899.600.86100.09100.140.86
2983717-983717100.353100.91
3982968-982968100.277100.78
4974110-97411099.37399.94
5980119-98011999.986100.53
6961254-96125498.06298.58
45min1974915-97491599.45599.540.80100.18100.240.80
2983976-983976100.380101.10
3982156-982156100.194100.86
4972721-97272199.23199.96
5978132-97813299.783100.50
6962364-96236498.17598.85
60min1973043-97304399.26499.620.93100.16100.500.94
2983682-983682100.350101.24
3980178-98017899.992100.83
4978002-97800299.770100.66
5984346-984346100.417101.30
6960026-96002697.93698.78
极限1970200-97020098.97499.180.70100.03100.220.70
2982083-982083100.186101.24
3976679-97667999.635100.64
4967549-96754998.70499.76
5973730-97373099.334100.38
6963273-96327398.26899.27
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