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%
19.669115990808906719066190882908360.23
29.659054390519905310.02
单位质量响应值RSD%判断
9403.319381.450.17数据可信
中间条件6月-供试品溶液-2024120421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%
5min140986-4098639.27456.1123.8239.2756.1123.83
262427-6242759.81959.82
367301-6730164.48964.49
440830-4083039.12439.12
570417-7041767.47567.48
669387-6938766.48866.49
10min177492-7749274.25587.5410.9174.3287.6310.92
298260-9826094.15594.25
396808-9680892.76492.87
479579-7957976.25576.32
597994-9799493.90094.01
697992-9799293.89894.01
15min195717-9571791.71894.001.3491.9194.241.37
299558-9955895.39995.66
398474-9847494.36094.62
497657-9765793.57793.77
598659-9865994.53794.81
698527-9852794.41194.68
20min198428-9842894.31695.040.7794.6695.430.76
299891-9989195.71896.13
398497-9849794.38294.80
4100285-10028596.09696.44
599145-9914595.00395.43
698839-9883994.71095.13
30min199408-9940895.25595.140.8995.7595.690.86
299652-9965295.48996.06
398211-9821194.10894.68
4100738-10073896.53097.04
599001-9900194.86595.45
698698-9869894.57595.16
45min199409-9940995.25695.160.9495.9195.870.91
299558-9955895.39996.13
398036-9803693.94194.67
4100872-10087296.65897.33
599030-9903094.89395.64
698954-9895494.82095.56
60min199500-9950095.34395.170.9996.1696.040.95
299495-9949595.33996.23
398447-9844794.33495.22
4101100-10110096.87797.71
598688-9868894.56595.47
698707-9870794.58395.48
极限199962-9996295.78695.711.2396.7696.741.21
2101568-10156897.32598.38
399034-9903494.89795.94
4101129-10112996.90497.90
598980-9898094.84595.90
698620-9862094.50095.56
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%
110.024933504939134938874938084937774937470.05
210.034920324924034922180.06
单位质量响应值RSD%判断
49276.1549074.580.29数据可信
中间条件6月-供试品溶液-2024120421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%
5min1246725-24672545.15561.0120.8545.1661.0220.85
2353619-35361964.71964.72
3376625-37662568.93068.93
4243903-24390344.63944.64
5392813-39281371.89271.89
6386557-38655770.74770.75
10min1424314-42431477.65888.859.1677.7388.959.17
2516610-51661094.55094.66
3509631-50963193.27293.39
4432232-43223279.10779.18
5514862-51486294.23094.35
6515130-51513094.27994.40
15min1505341-50534192.48794.241.0192.6994.491.04
2520303-52030395.22595.49
3515597-51559794.36494.63
4513698-51369894.01794.22
5517345-51734594.68494.96
6517327-51732794.68194.96
20min1516397-51639794.51194.890.8094.8795.300.78
2519882-51988295.14895.57
3515036-51503694.26294.69
4526212-52621296.30796.67
5517077-51707794.63595.07
6516148-51614894.46594.90
30min1518358-51835894.86994.790.7395.3995.360.70
2519215-51921595.02695.61
3514904-51490494.23794.82
4524561-52456196.00596.53
5516000-51600094.43895.03
6514630-51463094.18794.78
45min1518005-51800594.80594.670.7195.4895.400.68
2518125-51812594.82795.57
3513383-51338393.95994.70
4523700-52370095.84796.53
5515522-51552294.35095.10
6514961-51496194.24895.00
60min1517409-51740994.69694.560.7295.5395.440.69
2517471-51747194.70795.61
3513389-51338993.96094.86
4523307-52330795.77596.62
5514736-51473694.20795.11
6513827-51382794.04094.94
极限1516515-51651594.53295.051.7495.5296.091.72
2536284-53628498.15099.21
3516198-51619894.47495.53
4521950-52195095.52796.53
5513245-51324593.93495.00
6511774-51177493.66494.73
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%
19.668943289330895998913389248893480.20
29.658893088565887480.30
单位质量响应值RSD%判断
9249.289196.680.41数据可信
中间条件6月-供试品溶液-2024120421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%
5min137965-3796537.04747.8430.1237.0547.8430.12
233628-3362832.81532.82
335543-3554334.68434.68
465361-6536163.78163.78
561991-6199160.49360.49
659691-5969158.24858.25
10min176832-7683274.97583.2916.1175.0483.3716.13
269350-6935067.67467.73
372928-7292871.16571.22
499576-9957697.16997.28
595800-9580093.48593.59
697621-9762195.26295.36
15min195932-9593293.61394.423.6893.8094.643.72
291246-9124689.04189.21
394493-9449392.20992.39
4100863-10086398.42598.69
598767-9876796.38096.64
699258-9925896.85997.11
20min1100861-10086198.42397.211.1398.7797.591.13
298071-9807195.70196.02
3100025-10002597.60897.94
4100777-10077798.34198.77
598980-9898096.58897.01
699002-9900296.60997.03
30min1101521-10152199.06797.661.4199.5798.201.39
298878-9887896.48896.96
3101793-10179399.33399.83
4100645-10064598.21398.81
598880-9888096.49097.07
698774-9877496.38796.97
45min1102080-10208099.61397.941.40100.2898.641.39
299188-9918896.79197.43
3100895-10089598.45799.11
4101812-10181299.351100.11
598950-9895096.55997.30
699297-9929796.89797.64
60min1101708-10170899.25097.631.17100.0998.491.15
299551-9955197.14597.94
3100763-10076398.32899.15
4100607-10060798.17599.10
598783-9878396.39697.30
698873-9887396.48397.38
极限1101873-10187399.41197.921.10100.4198.951.08
299749-9974997.33898.30
3101192-10119298.74699.73
4100774-10077498.33899.43
599054-9905496.66097.72
699435-9943597.03298.09
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%
110.024879594874544873454869444865724872550.11
210.034875474873714874590.03
单位质量响应值RSD%判断
48628.2448600.100.05数据可信
中间条件6月-供试品溶液-2024120421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%
5min1232005-23200542.95152.9525.7842.9552.9525.78
2208753-20875338.64738.65
3217869-21786940.33440.33
4367567-36756768.04868.05
5349846-34984664.76764.77
6339915-33991562.92962.93
10min1430423-43042379.68585.3413.3579.7685.4313.36
2387241-38724171.69071.75
3401898-40189874.40474.47
4521460-52146096.53996.65
5505372-50537293.56093.67
6519577-51957796.19096.29
15min1506911-50691193.84594.192.4594.0594.422.48
2488620-48862090.45990.64
3501828-50182892.90493.10
4523040-52304096.83197.11
5514531-51453195.25695.52
6517571-51757195.81996.08
20min1527352-52735297.62996.391.0297.9996.781.01
2516303-51630395.58495.92
3525184-52518497.22897.57
4523409-52340996.89997.34
5514645-51464595.27795.70
6517076-51707695.72796.15
30min1527771-52777197.70796.631.5098.2397.181.47
2518906-51890696.06696.56
3534131-53413198.88499.39
4522139-52213996.66497.26
5513703-51370395.10295.68
6515206-51520695.38195.97
45min1528889-52888997.91496.681.3498.6097.391.33
2519087-51908796.09996.75
3525462-52546297.27997.95
4530314-53031498.17898.94
5513428-51342895.05295.79
6516164-51616495.55896.30
60min1526570-52657097.48596.261.0398.3397.121.00
2518084-51808495.91496.73
3524938-52493897.18298.02
4521353-52135396.51997.44
5512975-51297594.96895.87
6515644-51564495.46296.36
极限1526760-52676097.52096.071.1398.5397.101.10
2517272-51727295.76396.74
3524100-52410097.02798.02
4519902-51990296.25097.33
5511234-51123494.64595.70
6514456-51445695.24296.30
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%
19.668939989041897158952889345894060.28
29.658927589280892780.01
单位质量响应值RSD%判断
9255.289251.610.03数据可信
中间条件6月-供试品溶液-2024120521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%
5min143664-4366442.46852.1725.1842.4752.1725.18
249165-4916547.81847.82
334883-3488333.92833.93
467906-6790666.04666.05
557719-5771956.13856.14
668475-6847566.60066.60
10min180924-8092478.70886.1012.4078.7886.1912.41
285951-8595183.59783.68
371689-7168969.72669.78
499093-9909396.37996.49
594866-9486692.26892.36
698638-9863895.93696.05
15min198900-9890096.19195.482.6196.3995.712.63
299474-9947496.75096.97
393028-9302890.48090.65
499735-9973597.00397.27
598553-9855395.85496.10
699343-9934396.62296.89
20min199783-9978397.05096.950.2397.4197.340.25
299887-9988797.15197.53
399320-9932096.60096.92
499856-9985697.12197.55
599772-9977297.03997.45
699489-9948996.76497.20
30min1100592-10059297.83797.251.1998.3697.801.18
299434-9943496.71197.25
3100320-10032097.57298.06
4101844-10184499.05599.65
598491-9849195.79396.36
699247-9924796.52997.12
45min1100296-10029697.54996.880.8198.2497.600.78
299997-9999797.25897.96
3100329-10032997.58198.23
499695-9969596.96497.72
598261-9826195.57096.30
699076-9907696.36297.12
60min199990-9999097.25196.790.7998.1097.660.76
299462-9946296.73897.60
3100582-10058297.82798.64
499735-9973597.00397.92
598389-9838995.69496.58
698912-9891296.20397.12
极限1100451-10045197.70097.181.0298.7198.220.98
299646-9964696.91797.94
3101601-10160198.81899.79
499773-9977397.04098.12
598634-9863495.93396.98
699398-9939896.67697.75
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%
110.024875094868514876894876274874124874180.07
210.034920164924144922150.06
单位质量响应值RSD%判断
48644.5149074.280.63数据可信
中间条件6月-供试品溶液-2024120521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%
5min1260852-26085248.05057.0222.3148.0557.0222.31
2288716-28871653.18353.18
3211551-21155138.96938.97
4382740-38274070.50370.50
5328334-32833460.48160.48
6385097-38509770.93770.94
10min1439793-43979381.01287.3810.6481.0987.4810.65
2466321-46632185.89985.99
3395421-39542172.83972.90
4523686-52368696.46696.58
5500940-50094092.27692.38
6520092-52009295.80495.92
15min1519303-51930395.65995.212.3195.8795.452.33
2526537-52653796.99197.22
3494610-49461091.11091.30
4524753-52475396.66296.94
5513026-51302694.50294.76
6522909-52290996.32396.60
20min1523688-52368896.46696.320.6296.8496.720.61
2527245-52724597.12197.51
3522368-52236896.22396.56
4524268-52426896.57397.01
5517456-51745695.31895.73
6522339-52233996.21896.66
30min1524716-52471696.65696.521.4497.1997.081.44
2526058-52605896.90397.46
3525912-52591296.87697.37
4534604-53460498.47799.08
5511515-51151594.22494.79
6521183-52118396.00596.60
45min1522207-52220796.19396.021.0396.8996.741.01
2525233-52523396.75197.47
3525471-52547196.79597.45
4523181-52318196.37397.14
5511003-51100394.13094.86
6520532-52053295.88596.64
60min1521878-52187896.13395.910.9896.9996.790.96
2524095-52409596.54197.42
3524855-52485596.68197.50
4522566-52256696.26097.18
5510990-51099094.12795.01
6519616-51961695.71696.63
极限1520981-52098195.96895.671.0896.9896.711.06
2523176-52317696.37297.41
3523637-52363796.45797.44
4521021-52102195.97597.06
5508563-50856393.68094.72
6518803-51880395.56696.64
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%
19.668881988697886748867788540886810.12
29.659007190131901010.05
单位质量响应值RSD%判断
9180.239336.891.20数据可信
中间条件6月-供试品溶液-2024120521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%
5min134562-3456233.59939.3114.5233.6039.3114.52
235733-3573334.73834.74
350589-5058949.18049.18
437701-3770136.65136.65
542058-4205840.88640.89
641964-4196440.79540.80
10min175590-7559073.48475.745.2173.5475.805.22
275059-7505972.96873.03
385257-8525782.88282.96
474899-7489972.81372.87
576691-7669174.55574.62
679967-7996777.73977.81
15min198193-9819395.45894.672.3095.6494.862.31
296563-9656393.87394.05
3101276-10127698.45598.67
495451-9545192.79292.97
595194-9519492.54292.73
697623-9762394.90495.10
20min199065-9906596.30597.210.9796.6497.560.99
2100288-10028897.49497.83
3101719-10171998.88599.27
499697-9969796.92097.26
5100046-10004697.25997.61
699168-9916896.40596.76
30min199536-9953696.76397.820.8697.2698.330.87
2100498-10049897.69898.20
3101610-10161098.77999.33
4100529-10052997.72998.23
5101644-10164498.81399.32
699921-9992197.13897.65
45min199167-9916796.40597.401.0597.0698.071.05
2100462-10046297.66398.32
3101716-10171698.88399.60
4100416-10041697.61998.28
5100522-10052297.72298.40
698836-9883696.08396.76
60min198676-9867695.92797.251.2396.7598.081.23
2100453-10045397.65598.48
3101629-10162998.79899.68
4100370-10037097.57498.40
5100608-10060897.80598.64
698461-9846195.71896.56
极限199647-9964796.87197.620.9397.8598.620.94
2100689-10068997.88498.87
3101751-10175198.91799.96
4100224-10022497.43298.42
5101023-10102398.20999.21
699193-9919396.43097.43
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%
110.024881304879494882024880374881014880840.02
210.034942034948224945120.09
单位质量响应值RSD%判断
48710.9849303.290.86数据可信
中间条件6月-供试品溶液-2024120521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%
5min1213926-21392639.28844.6112.0539.2944.6112.05
2218359-21835940.10240.10
3292554-29255453.72953.73
4228538-22853841.97241.97
5252655-25265546.40146.40
6251507-25150746.19046.19
10min1416710-41671076.53078.324.3176.6078.404.32
2412935-41293575.83775.90
3458956-45895684.28984.38
4411153-41115375.51075.58
5422590-42259077.61077.69
6436481-43648180.16180.24
15min1521602-52160295.79494.711.4895.9994.911.49
2512643-51264394.14994.34
3527366-52736696.85397.08
4508378-50837893.36593.56
5508259-50825993.34493.55
6515865-51586594.74094.95
20min1522948-52294896.04196.360.5596.3996.720.56
2526095-52609596.61996.97
3528369-52836997.03797.43
4524009-52400996.23696.59
5526274-52627496.65297.01
6520287-52028795.55295.92
30min1523791-52379196.19696.610.7496.7197.130.74
2525561-52556196.52197.03
3527377-52737796.85597.41
4524704-52470496.36496.88
5532938-53293897.87698.40
6521768-52176895.82496.35
45min1519535-51953595.41496.130.7496.0996.810.74
2525083-52508396.43397.11
3527299-52729996.84097.55
4524100-52410096.25396.93
5526563-52656396.70597.39
6517870-51787095.10995.80
60min1520153-52015395.52895.970.7396.3696.810.73
2523611-52361196.16397.00
3526257-52625796.64997.52
4523480-52348096.13996.97
5525698-52569896.54697.39
6516179-51617994.79895.64
极限1524453-52445396.31895.910.6397.3196.910.63
2522502-52250295.95996.95
3525147-52514796.44597.48
4521078-52107895.69896.69
5523855-52385596.20897.22
6516217-51621794.80595.81
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%
19.668904988799890728904489161890250.16
29.658884788732887900.10
单位质量响应值RSD%判断
9215.849201.040.12数据可信
中间条件6月-供试品溶液-2024120621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%
5min153964-5396452.74341.8617.6252.7441.8617.61
234956-3495634.16534.16
339012-3901238.12938.13
438875-3887537.99538.00
550480-5048049.33749.34
639704-3970438.80538.81
10min189026-8902687.01178.478.5887.1078.548.59
271023-7102369.41569.47
379605-7960577.80377.87
475925-7592574.20674.27
587530-8753085.54985.63
678587-7858776.80876.87
15min198268-9826896.04495.073.4096.2895.273.41
292645-9264590.54890.72
399058-9905896.81697.01
493815-9381591.69291.88
5101135-10113598.84699.07
698680-9868096.44696.64
20min198431-9843196.20396.942.5496.6097.302.54
298559-9855996.32896.65
3101367-10136799.07399.43
494950-9495092.80193.14
5101931-10193199.624100.01
699861-9986197.60197.95
30min198291-9829196.06697.262.4196.6297.782.41
299225-9922596.97997.46
3101587-10158799.28899.81
495578-9557893.41593.91
5102073-10207399.763100.32
6100335-10033598.06498.58
45min198404-9840496.17797.442.8396.8998.132.83
299431-9943197.18097.83
3101154-10115498.86499.55
495102-9510292.94993.60
5103394-103394101.054101.78
6100726-10072698.44699.13
60min198169-9816995.94797.112.4396.8297.962.43
299520-9952097.26798.08
3101471-10147199.174100.02
495173-9517393.01993.82
5101555-10155599.256100.15
6100276-10027698.00698.85
极限198557-9855796.32697.572.4197.3698.582.41
2100132-10013297.86698.84
3101701-10170199.399100.41
495689-9568993.52394.48
5102219-10221999.905100.96
6100680-10068098.40199.41
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%
110.025045235058525059625071905076155062280.25
210.035081215071375076290.14
单位质量响应值RSD%判断
50521.7650611.070.13数据可信
中间条件6月-供试品溶液-2024120621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%
5min1327683-32768358.32248.0214.4958.3248.0214.49
2225851-22585140.19840.20
3248759-24875944.27544.28
4256477-25647745.64945.65
5307691-30769154.76454.76
6252407-25240744.92444.92
10min1501678-50167889.29181.947.0089.3982.027.00
2416142-41614274.06774.13
3456653-45665381.27781.35
4441346-44134678.55278.63
5493309-49330987.80187.89
6452971-45297180.62280.70
15min1542366-54236696.53295.882.5296.7896.102.52
2519351-51935192.43692.63
3548114-54811497.55597.76
4524943-52494393.43193.64
5553724-55372498.55498.79
6543719-54371996.77396.98
20min1543774-54377496.78397.161.6297.1997.541.62
2544600-54460096.93097.27
3553758-55375898.56098.93
4530553-53055394.43094.79
5554846-55484698.75499.16
6547791-54779197.49897.87
30min1542428-54242896.54397.201.6497.1197.741.65
2547335-54733597.41797.92
3554440-55444098.68199.22
4530571-53057194.43394.95
5554683-55468398.72599.29
6547401-54740197.42997.96
45min1540900-54090096.27197.402.4397.0098.112.42
2546164-54616497.20897.88
3553062-55306298.43699.14
4527731-52773193.92894.61
5567819-567819101.063101.79
6547926-54792697.52298.22
60min1540719-54071996.23996.801.7297.1397.671.72
2544629-54462996.93597.77
3552041-55204198.25499.12
4527104-52710493.81694.65
5552361-55236198.31199.21
6546469-54646997.26398.12
极限1539478-53947896.01896.751.7797.0797.771.76
2544820-54482096.96997.96
3551820-55182098.21599.24
4526595-52659593.72594.72
5552323-55232398.30599.37
6546373-54637397.24698.27
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%
19.668911989324895218912588892891960.27
29.658725487501873780.20
单位质量响应值RSD%判断
9233.549054.721.39数据可信
中间条件6月-供试品溶液-2024120621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%
5min141946-4194641.28947.4816.5241.2947.4816.52
249377-4937748.60348.60
343988-4398843.29943.30
461775-6177560.80760.81
540403-4040339.77039.77
651918-5191851.10551.10
10min179785-7978578.53584.348.4578.6084.428.46
285787-8578784.44384.52
379648-7964878.40078.47
498545-9854597.00197.10
581653-8165380.37480.44
688661-8866187.27287.36
15min198147-9814796.60996.631.7496.8196.851.75
295427-9542793.93294.15
397215-9721595.69295.89
4100317-10031798.74599.01
599353-9935397.79698.00
698550-9855097.00697.24
20min1100007-10000798.44097.881.7598.8098.261.75
295979-9597994.47594.85
3100461-10046198.88799.25
4100198-10019898.62899.06
5100537-10053798.96299.33
699431-9943197.87398.27
30min1100418-10041898.84597.741.8799.3798.291.86
295675-9567594.17694.71
3100315-10031598.74399.27
4100015-10001598.44899.04
5100330-10033098.75899.29
699038-9903897.48698.04
45min1100642-10064299.06598.042.0399.7598.752.02
295587-9558794.08994.78
3100467-10046798.89399.58
4100416-10041698.84399.60
5100939-10093999.358100.05
699582-9958298.02298.74
60min199997-9999798.43097.741.8399.2898.611.82
295792-9579294.29195.14
3100238-10023898.66899.52
4100228-10022898.65899.58
5100589-10058999.01399.87
698923-9892397.37398.25
极限1100343-10034398.77198.151.9199.7999.191.90
296066-9606694.56195.57
3100787-10078799.208100.23
4100536-10053698.961100.05
5101242-10124299.656100.68
699317-9931797.76198.80
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%
110.025086935101175084155092585089875090940.13
210.035072175079305075740.10
单位质量响应值RSD%判断
50807.7850605.580.29数据可信
中间条件6月-供试品溶液-2024120621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%
5min1263395-26339546.75152.9114.0446.7552.9114.04
2307905-30790554.65154.65
3274510-27451048.72348.72
4368301-36830165.37165.37
5257808-25780845.75945.76
6316673-31667356.20756.21
10min1457320-45732081.17186.526.7581.2586.616.76
2494690-49469087.80487.89
3458050-45805081.30081.38
4543358-54335896.44296.55
5470675-47067583.54183.62
6500771-50077188.88388.98
15min1542793-54279396.34196.620.9096.5596.850.90
2537938-53793895.48095.72
3540375-54037595.91296.13
4548703-54870397.39097.66
5550549-55054997.71897.93
6545720-54572096.86197.10
20min1548670-54867097.38597.150.9897.7697.540.97
2537992-53799295.48995.89
3551699-55169997.92298.30
4547407-54740797.16097.59
5552925-55292598.14098.52
6545297-54529796.78697.19
30min1548010-54801097.26796.951.0397.8097.501.01
2536689-53668995.25895.81
3550823-55082397.76798.31
4546738-54673897.04297.64
5551748-55174897.93198.47
6543197-54319796.41396.98
45min1546841-54684197.06096.951.0397.7697.671.02
2536620-53662095.24695.96
3550872-55087297.77598.48
4546130-54613096.93497.69
5552519-55251998.06898.77
6544396-54439696.62697.35
60min1545249-54524996.77796.741.0497.6497.621.03
2535766-53576695.09495.97
3549655-54965597.55998.43
4545287-54528796.78497.70
5551791-55179197.93998.81
6542376-54237696.26797.15
极限1544572-54457296.65796.561.0097.6897.600.99
2534534-53453494.87695.91
3548377-54837797.33398.36
4544977-54497796.72997.81
5549662-54966297.56198.59
6541916-54191696.18697.23
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