恩格列净二甲双胍片项目信息
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对照品来源中检院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%
19.668877489057887438893988981888990.16
29.658935589362893580.01
单位质量响应值RSD%判断
9202.809259.900.44数据可信
加速6月-供试品溶液-2024112921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%
5min131039-3103930.26139.1418.7930.2639.1418.79
237989-3798937.03737.04
341093-4109340.06440.06
437651-3765136.70836.71
539196-3919638.21438.21
653879-5387952.52952.53
10min165372-6537263.73475.729.8863.7875.789.88
279674-7967477.67877.74
381770-8177079.72279.79
473217-7321771.38371.44
578181-7818176.22276.29
687754-8775485.55685.64
15min187658-8765885.46292.623.9885.6292.813.99
296760-9676094.33694.53
396868-9686894.44194.64
495144-9514492.76092.94
595305-9530592.91793.11
698252-9825295.79196.02
20min195020-9502092.64095.801.7092.9496.141.72
298462-9846295.99596.34
399229-9922996.74397.10
498354-9835495.89096.22
599735-9973597.23697.58
698759-9875996.28596.67
30min195954-9595493.55095.961.3294.0096.461.34
298885-9888596.40896.92
398987-9898796.50797.03
498279-9827995.81796.31
599701-9970197.20397.71
698736-9873696.26396.81
45min196396-9639693.98196.031.2794.5996.691.28
299075-9907596.59397.26
399246-9924696.76097.44
497995-9799595.54096.19
599964-9996497.46098.13
698281-9828195.81996.53
60min196276-9627693.86496.081.3194.6396.911.32
299024-9902496.54397.37
399092-9909296.61097.45
498443-9844395.97796.79
5100122-10012297.61498.45
698361-9836195.89796.77
极限196792-9679294.36796.341.4095.2997.331.41
298950-9895096.47197.46
399776-9977697.27698.28
497965-9796595.51196.48
5100737-10073798.21399.21
698690-9869096.21897.25
恩格列净二甲双胍片项目信息
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100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
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%
110.159240259246809264099261459268529256220.14
210.229254809255489255140.01
单位质量响应值RSD%判断
91194.2990559.100.50数据可信
加速6月-供试品溶液-2024112921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%
5min1361575-36157535.80944.0915.8935.8144.0915.88
2423600-42360041.95241.95
3453732-45373244.93644.94
4423864-42386441.97841.98
5433460-43346042.92842.93
6575087-57508756.95556.95
10min1685877-68587767.92778.198.2667.9978.278.27
2803902-80390279.61679.69
3824361-82436181.64281.72
4753700-75370074.64474.71
5791541-79154178.39178.46
6877822-87782286.93687.03
15min1878505-87850587.00492.613.1287.1892.823.14
2949229-94922994.00894.21
3950804-95080494.16494.38
4938033-93803392.90093.09
5934726-93472692.57292.77
6959414-95941495.01795.26
20min1939015-93901592.99795.211.1993.3195.561.20
2963661-96366195.43895.80
3965951-96595195.66496.03
4966161-96616195.68596.03
5971360-97136096.20096.56
6961792-96179295.25395.65
30min1944508-94450893.54195.260.9694.0195.770.98
2963093-96309395.38195.90
3965162-96516295.58696.11
4964283-96428395.49996.01
5972202-97220296.28396.80
6961779-96177995.25195.81
45min1944006-94400693.49195.241.0094.1295.921.01
2965948-96594895.66496.34
3965379-96537995.60896.29
4962759-96275995.34896.02
5972046-97204696.26896.95
6960077-96007795.08395.80
60min1945075-94507593.59795.351.0294.3896.181.04
2961385-96138595.21296.05
3965309-96530995.60196.45
4961362-96136295.21096.04
5971850-97185096.24997.09
6971439-97143996.20897.08
极限1943882-94388293.47994.960.9294.4295.960.93
2959671-95967195.04296.04
3963576-96357695.42996.43
4958377-95837794.91495.90
5970501-97050196.11597.11
6957322-95732294.81095.84
恩格列净二甲双胍片项目信息
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对照品来源中检院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%
19.668886988641883938846188639886010.21
29.658926289379893200.10
单位质量响应值RSD%判断
9171.959255.960.65数据可信
加速6月-供试品溶液-2024112921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%
5min144685-4468543.64838.4215.8043.6538.4215.80
241787-4178740.81840.82
343410-4341042.40342.40
440445-4044539.50739.51
527547-2754726.90826.91
638095-3809537.21137.21
10min187234-8723485.21076.6311.9685.2876.7011.97
284361-8436182.40482.47
381656-8165679.76279.83
481853-8185379.95480.02
561496-6149660.06960.11
674123-7412372.40372.47
15min197886-9788695.61592.324.9695.8392.514.97
298775-9877596.48396.69
395034-9503492.82993.03
495971-9597193.74493.94
585746-8574683.75783.90
693653-9365391.48091.66
20min198520-9852096.23495.521.1096.6195.861.13
299123-9912396.82397.19
398263-9826395.98396.34
497640-9764095.37595.73
596220-9622093.98894.27
696939-9693994.69095.03
30min198712-9871296.42295.800.8796.9696.310.89
298948-9894896.65297.18
398833-9883396.54097.06
497566-9756695.30295.82
597331-9733195.07395.51
697065-9706594.81395.31
45min198199-9819995.92195.650.6396.6296.320.64
298422-9842296.13996.83
398583-9858396.29696.98
497628-9762895.36396.04
597749-9774995.48196.08
696940-9694094.69195.34
60min198385-9838596.10295.700.7096.9696.520.72
298598-9859896.31197.16
398679-9867996.39097.23
497580-9758095.31696.15
597592-9759295.32896.09
696983-9698394.73395.54
极限198952-9895296.65696.060.8197.6797.040.83
299211-9921196.90997.92
398941-9894196.64697.65
497806-9780695.53796.53
597843-9784395.57396.49
697295-9729595.03896.00
恩格列净二甲双胍片项目信息
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100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
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%
110.159223399224199220449211619215199218960.06
210.229275939283869279900.07
单位质量响应值RSD%判断
90827.1990801.370.03数据可信
加速6月-供试品溶液-2024112921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%
5min1491953-49195348.75443.3713.7048.7543.3713.70
2463620-46362045.94645.95
3471607-47160746.73846.74
4446677-44667744.26744.27
5323584-32358432.06832.07
6428013-42801342.41842.42
10min1872098-87209886.42878.8110.1486.5178.8810.14
2846044-84604483.84683.92
3821533-82153381.41781.49
4823404-82340481.60281.68
5649670-64967064.38464.44
6758744-75874475.19475.26
15min1960362-96036295.17592.433.4395.4092.643.45
2961305-96130595.26995.48
3934912-93491292.65392.87
4940940-94094093.25093.46
5874642-87464286.68086.84
6923878-92387891.55991.76
20min1966485-96648595.78294.820.9096.1795.180.93
2964847-96484795.62095.99
3961168-96116895.25595.62
4953305-95330594.47694.84
5946062-94606293.75894.06
6948732-94873294.02394.37
30min1964636-96463695.59994.900.7196.1495.420.73
2964169-96416995.55296.09
3961162-96116295.25495.78
4953065-95306594.45294.97
5954802-95480294.62495.09
6947840-94784093.93494.44
45min1963261-96326195.46294.860.6696.1795.530.67
2962326-96232695.37096.06
3961798-96179895.31796.00
4952604-95260494.40695.09
5955074-95507494.65195.27
6947841-94784193.93494.60
60min1960760-96076095.21595.000.4696.0895.830.47
2963340-96334095.47096.32
3962211-96221195.35896.20
4952155-95215594.36295.20
5955009-95500994.64595.42
6958029-95802994.94495.76
极限1962573-96257395.39494.710.7596.4195.700.76
2961897-96189795.32796.34
3961233-96123395.26196.26
4949597-94959794.10895.10
5952835-95283594.42995.36
6946118-94611893.76394.74
恩格列净二甲双胍片项目信息
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对照品来源中检院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%
19.668840288601885318854188529885210.09
29.658878588637887110.12
单位质量响应值RSD%判断
9163.669192.850.23数据可信
加速6月-供试品溶液-2024120221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%
5min138261-3826137.51838.3221.3337.5238.3221.33
255099-5509954.02954.03
338935-3893538.17938.18
431000-3100030.39830.40
535101-3510134.41934.42
636094-3609435.39335.39
10min176848-7684875.35673.8910.3375.4273.9610.34
289773-8977388.03088.12
374866-7486673.41273.48
467303-6730365.99666.05
571939-7193970.54270.60
671387-7138770.00170.06
15min193940-9394092.11691.783.6592.3091.973.67
2100265-10026598.31898.55
392591-9259190.79390.98
491576-9157689.79889.96
592187-9218790.39790.57
691053-9105389.28589.46
20min198409-9840996.49896.811.2096.8497.151.22
2100858-10085898.89999.30
397999-9799996.09696.43
497553-9755395.65995.97
599216-9921697.28997.61
698347-9834796.43796.76
30min198941-9894197.02097.530.9197.5298.030.93
2101166-10116699.20199.77
399027-9902797.10497.60
499076-9907697.15297.62
599752-9975297.81598.30
698812-9881296.89397.38
45min198492-9849296.57997.520.8197.2498.180.83
2100848-10084898.89099.62
399221-9922197.29497.95
499141-9914197.21697.85
599797-9979797.85998.51
699199-9919997.27397.92
60min198702-9870296.78597.690.7697.6198.520.78
2100890-10089098.93199.83
399439-9943997.50898.33
499461-9946197.53098.32
5100005-10000598.06398.88
699249-9924997.32298.13
极限199068-9906897.14497.910.7798.1398.900.78
2100885-10088598.92699.99
399799-9979997.86198.84
499710-9971097.77498.73
5100585-10058598.63299.61
699042-9904297.11998.09
恩格列净二甲双胍片项目信息
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100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
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%
110.159198289201789203189198439196209199570.04
210.229215129206509210810.07
单位质量响应值RSD%判断
90636.1690125.340.40数据可信
加速6月-供试品溶液-2024120221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%
5min1435871-43587143.40443.5517.9643.4043.5517.95
2587620-58762058.51558.51
3433693-43369343.18743.19
4361212-36121235.96935.97
5398657-39865739.69839.70
6406873-40687340.51640.52
10min1777354-77735477.40976.338.4677.4876.408.47
2887267-88726788.35488.45
3761816-76181675.86175.93
4700188-70018869.72469.78
5740272-74027273.71673.78
6732197-73219772.91272.98
15min1926360-92636092.24691.882.9792.4592.082.98
2975255-97525597.11597.36
3911510-91151090.76890.97
4906454-90645490.26490.44
5917033-91703391.31891.51
6899539-89953989.57689.76
20min1961302-96130295.72695.871.0996.0896.221.11
2979388-97938897.52797.93
3955086-95508695.10795.46
4957076-95707695.30595.63
5971141-97114196.70697.05
6952524-95252494.85295.19
30min1961574-96157495.75396.290.7496.2796.810.76
2977857-97785797.37597.94
3963017-96301795.89796.40
4965562-96556296.15096.64
5973735-97373596.96497.47
6960284-96028495.62596.12
45min1961177-96117795.71496.310.7396.3996.980.75
2977905-97790597.37998.11
3964210-96421096.01696.68
4965653-96565396.15996.80
5973530-97353096.94497.61
6960431-96043195.63996.30
60min1961415-96141595.73796.260.7296.5797.090.74
2976896-97689697.27998.17
3963691-96369195.96496.79
4965932-96593296.18796.99
5972943-97294396.88597.71
6959049-95904995.50296.32
极限1958262-95826295.42396.241.1696.4297.241.17
2987068-98706898.29299.35
3961134-96113495.70996.70
4963515-96351595.94696.91
5970789-97078996.67197.66
6958048-95804895.40296.38
恩格列净二甲双胍片项目信息
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对照品来源中检院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%
19.668779488308884258810888274881820.28
29.658917589286892300.09
单位质量响应值RSD%判断
9128.579246.630.91数据可信
加速6月-供试品溶液-2024120221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%
5min136267-3626735.52842.7216.8235.5342.7216.82
245340-4534044.41644.42
356580-5658055.42755.43
443923-4392343.02843.03
537106-3710636.35036.35
642421-4242141.55741.56
10min172319-7231970.84579.077.6570.9079.147.65
284480-8448082.75882.83
388684-8868486.87786.97
483907-8390782.19782.27
575146-7514673.61573.68
679777-7977778.15178.22
15min194443-9444392.51894.692.4492.7094.892.46
298148-9814896.14896.36
399949-9994997.91298.15
497673-9767395.68395.89
593791-9379191.88092.06
695934-9593493.97994.18
20min1100728-10072898.67597.441.6699.0197.801.67
299775-9977597.74298.11
3101455-10145599.38799.79
499452-9945297.42597.79
596770-9677094.79895.13
698650-9865096.64097.00
30min1100041-10004198.00297.381.2098.5097.901.22
299528-9952897.50098.03
3100832-10083298.77799.34
499960-9996097.92398.45
597486-9748695.49995.99
698604-9860496.59597.11
45min199684-9968497.65397.281.0198.3197.961.03
299786-9978697.75398.45
3100616-10061698.56699.30
499397-9939797.37198.07
597763-9776395.77196.42
698565-9856596.55697.23
60min199875-9987597.84097.320.9598.6698.160.96
299450-9945097.42398.28
3100416-10041698.37099.26
499388-9938897.36398.22
597622-9762295.63396.45
699309-9930997.28598.12
极限1100488-10048898.44097.751.1299.4398.761.14
2100199-10019998.15799.18
3101028-10102898.969100.03
499766-9976697.73398.75
597825-9782595.83196.80
699397-9939797.37198.37
恩格列净二甲双胍片项目信息
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100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
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%
110.159182759186949191759195669190959189610.06
210.229276619278149277380.02
单位质量响应值RSD%判断
90538.0390776.710.19数据可信
加速6月-供试品溶液-2024120221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%
5min1413167-41316741.01747.5213.8641.0247.5213.86
2495722-49572249.21349.21
3596549-59654959.22259.22
4481503-48150347.80147.80
5421500-42150041.84441.84
6463405-46340546.00546.00
10min1743305-74330573.79280.646.2573.8680.726.26
2848933-84893384.27884.36
3875672-87567286.93287.03
4837312-83731283.12483.20
5767522-76752276.19676.27
6801184-80118479.53879.61
15min1930871-93087192.41293.891.7692.6094.101.77
2961375-96137595.44195.66
3966450-96645095.94496.19
4951623-95162394.47294.69
5926136-92613691.94292.14
6938061-93806193.12693.34
20min1983736-98373697.66096.121.3498.0196.491.34
2970642-97064296.36196.74
3981212-98121297.41097.81
4964575-96457595.75896.13
5950460-95046094.35794.71
6958704-95870495.17595.54
30min1974017-97401796.69695.910.8797.2096.440.88
2968797-96879796.17796.72
3973509-97350996.64597.21
4968915-96891596.18996.72
5955211-95521194.82995.34
6956129-95612994.92095.44
45min1971989-97198996.49495.790.7597.1696.480.76
2968426-96842696.14196.84
3971976-97197696.49397.22
4963400-96340095.64296.34
5954451-95445194.75395.42
6958830-95883095.18895.87
60min1970726-97072696.36996.090.9997.2096.940.99
2967840-96784096.08296.95
3971717-97171796.46797.36
4961210-96121095.42496.28
5954196-95419694.72895.55
6982017-98201797.49098.33
极限1975576-97557696.85095.650.9297.8496.660.92
2967033-96703396.00297.03
3969176-96917696.21597.26
4959083-95908395.21396.23
5950932-95093294.40495.38
6958865-95886595.19196.19
恩格列净二甲双胍片项目信息
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对照品来源中检院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%
19.668863988763885738835488561885780.17
29.658813088276882030.12
单位质量响应值RSD%判断
9169.579140.210.23数据可信
加速6月-供试品溶液-2024120321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%
5min143188-4318842.45742.8619.4542.4642.8619.45
242839-4283942.11442.11
351854-5185450.97750.98
435697-3569735.09335.09
533340-3334032.77632.78
654671-5467153.74653.75
10min174935-7493573.66777.2410.4073.7477.3110.41
280971-8097179.60179.67
386347-8634784.88684.97
471447-7144770.23870.30
568774-6877467.61167.67
688936-8893687.43287.52
15min189603-8960388.08792.944.9688.2893.144.97
2100258-10025898.56298.76
397943-9794396.28696.51
491441-9144189.89490.07
590053-9005388.53088.70
697936-9793696.27996.51
20min194652-9465293.05195.622.4793.3995.982.49
2100928-10092899.22199.59
398251-9825196.58996.98
495055-9505593.44793.77
596205-9620594.57894.89
698511-9851196.84597.24
30min194904-9490493.29995.932.0793.7996.442.09
2100829-10082999.12399.66
398124-9812496.46497.01
496545-9654594.91295.39
596746-9674695.10995.58
698324-9832496.66197.22
45min194652-9465293.05195.632.1393.7096.312.14
2100463-10046398.76499.46
397283-9728395.63796.35
496923-9692395.28395.92
595748-9574894.12894.76
698613-9861396.94597.66
60min194805-9480593.20196.102.0694.0196.942.08
2100249-10024998.55399.42
398712-9871297.04297.91
496654-9665495.01995.82
596855-9685595.21796.00
699265-9926597.58698.47
极限193929-9392992.34095.952.2693.3096.952.27
2100327-10032798.63099.66
398075-9807596.41697.45
497295-9729595.64996.61
596840-9684095.20296.15
699168-9916897.49098.53
恩格列净二甲双胍片项目信息
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100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
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%
110.159252379270559288359288359295939279110.19
210.229289019276639282820.10
单位质量响应值RSD%判断
91419.8090829.940.46数据可信
加速6月-供试品溶液-2024120321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%
5min1498625-49862549.24748.1816.7649.2548.1816.75
2473856-47385646.80146.80
3568021-56802156.10256.10
4410930-41093040.58640.59
5385889-38588938.11338.11
6589493-58949358.22258.22
10min1789710-78971077.99780.218.5678.0880.298.57
2826159-82615981.59781.67
3878789-87878986.79586.89
4753770-75377074.44774.51
5723796-72379671.48771.55
6900502-90050288.94089.04
15min1909730-90973089.85193.303.7490.0693.513.75
2982878-98287897.07697.29
3974679-97467996.26696.50
4921173-92117390.98191.17
5907727-90772789.65389.84
6971781-97178195.98096.22
20min1951248-95124893.95295.481.9694.3195.851.98
2989572-98957297.73798.11
3980075-98007596.79997.20
4943595-94359593.19693.54
5955553-95555394.37794.71
6980330-98033096.82497.23
30min1961238-96123894.93895.781.0695.4696.301.08
2985881-98588197.37297.91
3971731-97173195.97596.53
4961311-96131194.94595.44
5961517-96151794.96695.46
6976726-97672696.46897.03
45min1957161-95716194.53695.621.2595.2196.301.27
2985532-98553297.33898.04
3973550-97355096.15496.87
4961651-96165194.97995.64
5954894-95489494.31294.96
6975765-97576596.37397.10
60min1960346-96034694.85095.751.2095.6896.601.22
2983573-98357397.14498.01
3979537-97953796.74697.63
4960099-96009994.82695.64
5957006-95700694.52095.33
6976193-97619396.41597.30
极限1945949-94594993.42895.461.4194.4296.471.43
2982020-98202096.99198.02
3976376-97637696.43397.47
4960836-96083694.89995.87
5958853-95885394.70395.67
6975181-97518196.31597.36
恩格列净二甲双胍片项目信息
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对照品来源中检院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%
19.668882288982887458896189283889590.24
29.658945889646895520.15
单位质量响应值RSD%判断
9209.019280.000.55数据可信
加速6月-供试品溶液-2024120321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%
5min132974-3297432.10236.438.5332.1036.438.53
235656-3565634.71334.71
341805-4180540.70040.70
438562-3856237.54337.54
535862-3586234.91434.91
639672-3967238.62338.62
10min171291-7129169.40673.434.2169.4673.484.22
272245-7224570.33570.39
377888-7788875.82975.90
478391-7839176.31976.38
574537-7453772.56772.62
678166-7816676.10076.16
15min191785-9178589.35991.391.3089.5391.571.31
293893-9389391.41191.59
394453-9445391.95692.15
495411-9541192.88993.08
593427-9342790.95791.14
694247-9424791.75691.95
20min196748-9674894.19195.590.9594.5195.920.96
299396-9939696.76997.10
397883-9788395.29695.64
498855-9885596.24296.59
598477-9847795.87496.20
697747-9774795.16395.51
30min198298-9829895.70095.961.1096.1796.461.09
2100548-10054897.89098.38
397680-9768095.09895.60
498534-9853495.92996.43
598769-9876996.15896.65
697576-9757694.99795.50
45min198505-9850595.90195.970.9096.5496.630.90
2100172-10017297.52498.18
397982-9798295.39296.06
498458-9845895.85596.52
598757-9875796.14696.80
697592-9759295.01295.67
60min197966-9796695.37696.010.9396.1796.820.92
2100235-10023597.58598.40
398025-9802595.43496.26
498977-9897796.36197.19
598669-9866996.06196.87
697816-9781695.23096.05
极限198561-9856195.95696.461.3496.9197.441.33
2101471-10147198.78999.77
398216-9821695.62096.60
499744-9974497.10798.09
598494-9849495.89096.86
697999-9799995.40896.39
恩格列净二甲双胍片项目信息
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100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
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%
110.159329929323809330379316239312649322590.09
210.229402999404599403790.02
单位质量响应值RSD%判断
91848.1892013.600.13数据可信
加速6月-供试品溶液-2024120321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%
5min1384339-38433937.62742.067.6537.6342.067.65
2410052-41005240.14440.14
3473824-47382446.38746.39
4441662-44166243.23943.24
5413644-41364440.49640.50
6454129-45412944.45944.46
10min1736374-73637472.09176.284.5572.1576.354.55
2738726-73872672.32172.39
3802607-80260778.57578.65
4811419-81141979.43879.51
5772356-77235675.61375.68
6813433-81343379.63579.71
15min1915169-91516989.59591.851.4389.7892.041.44
2935521-93552191.58791.77
3941949-94194992.21792.42
4953017-95301793.30093.50
5934634-93463491.50091.69
6948945-94894592.90193.11
20min1960319-96031994.01595.150.7994.3595.500.79
2981532-98153296.09296.43
3969597-96959794.92395.29
4979178-97917895.86196.22
5970574-97057495.01995.36
6970224-97022494.98595.35
30min1972616-97261695.21995.290.8095.7195.800.79
2982585-98258596.19596.70
3963724-96372494.34894.87
4980533-98053395.99496.51
5975355-97535595.48795.99
6965501-96550194.52295.04
45min1969946-96994694.95795.110.5295.6195.780.51
2976755-97675595.62496.28
3967353-96735394.70495.38
4977913-97791395.73796.42
5965597-96559794.53295.20
6971301-97130195.09095.77
60min1967449-96744994.71395.200.8495.5296.020.84
2983572-98357296.29197.11
3962068-96206894.18695.02
4980311-98031195.97296.81
5968779-96877994.84395.66
6972406-97240695.19896.03
极限1967133-96713394.68295.050.8195.6596.040.80
2980096-98009695.95196.93
3958062-95806293.79494.79
4974992-97499295.45196.45
5969286-96928694.89395.87
6975718-97571895.52396.52
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