达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1250
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%
1 12.548302482917826248277482143826960.42
2 12.598385683624837400.20
单位质量响应值RSD%判断
6594.586651.310.61数据可信
供试品溶液-25042201批-达格列净-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min187592-8759285.06876.118.4685.0776.128.46
282765-8276580.38080.38
374739-7473972.58672.59
473653-7365371.53171.53
581485-8148579.13779.14
669998-6999867.98167.98
10min198672-9867295.82993.583.6895.9693.703.68
298482-9848295.64495.77
397581-9758194.76994.88
495417-9541792.66892.78
598409-9840995.57495.69
689566-8956686.98587.09
15min1100256-10025697.36794.923.2097.6495.173.20
299177-9917796.31996.58
398342-9834295.50895.76
497712-9771294.89795.14
599298-9929896.43796.70
691621-9162188.98189.21
20min1101643-10164398.71495.463.2899.1395.853.28
299426-9942696.56196.97
398597-9859795.75696.15
497833-9783395.01495.40
599951-9995197.07197.48
692276-9227689.61789.98
30min1101904-10190498.96896.002.9099.5396.542.91
299575-9957596.70697.26
398665-9866595.82296.36
499174-9917496.31796.85
5100311-10031197.42197.97
693471-9347190.77891.28
45min1102399-10239999.44996.012.86100.1696.692.86
299027-9902796.17496.87
398656-9865695.81396.50
499292-9929296.43197.11
599987-9998797.10697.80
693788-9378891.08691.72
60min1102690-10269099.73196.222.74100.5997.052.75
299626-9962696.75597.60
398648-9864895.80696.63
499522-9952296.65497.47
599676-9967696.80497.65
694308-9430891.59192.36
120min1102551-10255199.59696.172.63100.6197.142.64
298840-9884095.99296.98
398474-9847495.63796.61
499775-9977596.90097.87
599906-9990697.02798.02
694598-9459891.87292.78
180min1102213-10221399.26896.032.50100.4397.152.51
299105-9910596.25097.38
398219-9821995.38996.50
499667-9966796.79597.91
599430-9943096.56597.70
694641-9464191.91492.96
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1105347-105347102.31298.792.60103.62100.052.60
2101707-10170798.777100.05
3101335-10133598.41599.67
4102248-10224899.302100.56
5102506-10250699.553100.83
697184-9718494.38495.57
360min1104649-104649101.63498.262.53103.1099.672.54
2101268-10126898.35099.77
3100344-10034497.45398.86
4102082-10208299.141100.55
5101830-10183098.896100.33
696853-9685394.06295.39
480min1104317-104317101.31197.812.52102.9399.372.53
2100583-10058397.68599.26
3100423-10042397.53099.08
4101639-10163998.710100.26
5100872-10087297.96699.54
696448-9644893.66995.14
600min1103582-103582100.59897.062.47102.3798.762.48
299657-9965796.78698.50
398926-9892696.07697.77
4100826-10082697.92199.62
5100560-10056097.66399.39
696077-9607793.30994.92
720min1100689-10068997.78896.211.9799.7198.061.99
298959-9895996.10897.97
398807-9880795.96097.80
4100769-10076997.86699.71
599688-9968896.81698.69
695461-9546192.71094.46
极限1102397-10239799.44796.362.42101.5198.362.43
299238-9923896.37998.39
398494-9849495.65697.64
4100445-10044597.55199.55
599602-9960296.73298.75
695161-9516192.41994.31
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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%
19.981064110106376510625411065419106369510639060.10
210.081081638107709110793640.30
单位质量响应值RSD%判断
106603.81107079.760.32数据可信
供试品溶液-25042201批-二甲双胍-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min145322-453224.2423.807.614.243.807.58
241820-418203.9143.91
342054-420543.9363.94
436973-369733.4613.46
539069-390693.6573.66
638114-381143.5673.57
10min1109530-10953010.2529.856.6710.269.866.68
2114433-11443310.71110.72
3108941-10894110.19710.20
495683-956838.9568.96
5103891-1038919.7249.73
699217-992179.2869.29
15min1158775-15877514.86114.494.8714.8814.514.86
2162524-16252415.21215.23
3161388-16138815.10515.13
4144980-14498013.57013.59
5154635-15463514.47314.49
6146553-14655313.71713.74
20min1200555-20055518.77118.234.2718.8218.284.28
2195785-19578518.32518.37
3204585-20458519.14919.19
4184524-18452417.27117.31
5198447-19844718.57418.62
6184992-18499217.31517.35
30min1266505-26650524.94424.473.5525.0224.543.56
2260774-26077424.40824.48
3274522-27452225.69425.77
4252094-25209423.59523.66
5264613-26461324.76724.84
6249885-24988523.38823.45
45min1344145-34414532.21131.653.0032.3231.763.00
2333416-33341631.20731.32
3352005-35200532.94733.06
4328911-32891130.78530.89
5344177-34417732.21432.32
6326283-32628330.53930.64
60min1423953-42395339.68137.893.8439.8438.043.84
2396525-39652537.11337.27
3422000-42200039.49839.66
4391005-39100536.59736.74
5407087-40708738.10238.26
6388111-38811136.32636.47
120min1589219-58921955.14954.322.3355.3754.532.34
2569773-56977353.32953.54
3600708-60070856.22456.44
4570960-57096053.44053.64
5585087-58508754.76254.97
6566266-56626653.00153.20
180min1714948-71494866.91766.012.0067.2266.302.00
2694746-69474665.02665.32
3727086-72708668.05368.36
4694887-69488765.03965.32
5708298-70829866.29466.59
6691482-69148264.72165.00
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1832094-83209477.88176.781.9378.2877.171.93
2811302-81130275.93576.32
3845350-84535079.12279.53
4807141-80714175.54675.92
5820458-82045876.79277.19
6805374-80537475.38075.76
360min1960050-96005089.85888.851.6990.3789.361.69
2938491-93849187.84088.34
3976055-97605591.35691.88
4936979-93697987.69888.19
5948239-94823988.75289.26
6935990-93599087.60688.10
480min11042514-104251497.57696.481.5998.2397.121.60
21022286-102228695.68396.32
31058125-105812599.03799.70
41015708-101570895.06795.69
51027580-102758096.17896.82
61018926-101892695.36895.99
600min11086893-1086893101.730100.631.47102.53101.411.48
21064013-106401399.588100.37
31100745-1100745103.026103.84
41059008-105900899.12099.89
51072363-1072363100.370101.16
61067609-106760999.925100.69
720min11095504-1095504102.536102.231.38103.49103.171.39
21082712-1082712101.338102.27
31120920-1120920104.915105.88
41079430-1079430101.031101.95
51087163-1087163101.755102.69
61087762-1087762101.811102.73
极限11102364-1102364103.178102.431.35104.28103.521.36
21087711-1087711101.806102.89
31120178-1120178104.845105.97
41078863-1078863100.978102.04
51089876-1089876102.009103.10
61087554-1087554101.792102.86
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1250
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%
1 12.548428684007840948396484241841180.17
2 12.598464384837847400.17
单位质量响应值RSD%判断
6707.976730.740.24数据可信
供试品溶液-25042202批-达格列净-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min193659-9365989.65485.417.4189.6585.417.41
294914-9491490.85590.86
393254-9325489.26689.27
483076-8307679.52379.52
591569-9156987.65387.65
678897-7889775.52375.52
10min1101235-10123596.90694.282.6197.0494.412.62
299390-9939095.14095.28
3100090-10009095.81095.94
495675-9567591.58491.70
599668-9966895.40695.54
694913-9491390.85490.97
15min1101676-10167697.32895.162.0097.6195.432.01
2100406-10040696.11296.39
3100147-10014795.86496.14
497964-9796493.77594.03
5100103-10010395.82296.10
696172-9617292.05992.31
20min1102477-10247798.09595.492.1098.5295.902.11
2100438-10043896.14396.57
3100386-10038696.09396.51
498859-9885994.63295.03
5100162-10016295.87996.30
696192-9619292.07992.47
30min1103024-10302498.61896.502.9799.1997.052.97
2104654-104654100.179100.75
3101673-10167397.32597.89
499348-9934895.10095.64
599958-9995895.68496.25
696183-9618392.07092.60
45min1103443-10344399.01995.762.5799.7496.462.58
2100790-10079096.48097.20
3100694-10069496.38897.10
499946-9994695.67296.35
599847-9984795.57796.28
695523-9552391.43892.10
60min1102851-10285198.45396.032.1499.3296.872.14
2100901-10090196.58697.45
3100962-10096296.64597.50
4100757-10075796.44897.27
5100054-10005495.77596.62
696392-9639292.27093.07
120min1102909-10290998.50895.902.2199.5396.892.22
2100550-10055096.25097.26
3100647-10064796.34397.34
4100647-10064796.34397.31
5100218-10021895.93296.93
696124-9612492.01392.95
180min1103035-10303598.62996.112.7999.7997.242.78
2100239-10023995.95397.10
3100836-10083696.52497.67
4102845-10284598.44799.56
5100155-10015595.87297.01
695316-9531691.24092.32
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1106120-106120101.58298.472.47102.8999.742.47
2102843-10284398.44599.74
3103630-10363099.198100.49
4103318-10331898.900100.16
5102960-10296098.55799.84
698322-9832294.11795.33
360min1106047-106047101.51298.052.57102.9899.472.57
2102386-10238698.00899.45
3103109-10310998.700100.14
4102814-10281498.41799.83
5102349-10234997.97299.40
697866-9786693.68195.04
480min1105048-105048100.55697.682.62102.1799.252.61
2101550-10155097.20798.80
3102319-10231997.94499.53
4102413-10241398.03499.59
5103706-10370699.271100.85
697220-9722093.06394.56
600min1107320-107320102.73197.313.47104.5099.033.45
2101385-10138597.04998.79
3101890-10189097.53399.27
4101730-10173097.38099.09
5101421-10142197.08498.81
696194-9619492.08093.72
720min1102058-10205897.69496.302.0799.6298.162.07
2101482-10148297.14299.02
3100991-10099196.67298.55
4101703-10170397.35499.21
5100895-10089596.58098.45
696459-9645992.33494.11
极限1103428-10342899.00596.052.68101.0798.062.68
2100815-10081596.50498.53
3100428-10042896.13398.16
4101547-10154797.20599.20
5100498-10049896.20098.22
695352-9535291.27493.19
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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%
19.981087460108488510861091083612108703110858190.15
210.081088975108802510885000.07
单位质量响应值RSD%判断
108799.50107986.110.54数据可信
供试品溶液-25042202批-二甲双胍-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min145041-450414.1553.997.814.163.997.85
246195-461954.2624.26
337304-373043.4423.44
441880-418803.8643.86
542889-428893.9573.96
646019-460194.2464.25
10min1111673-11167310.3039.835.2310.319.845.24
2111650-11165010.30110.31
3100241-1002419.2489.25
4101280-1012809.3449.35
5111328-11132810.27110.28
6103094-1030949.5119.52
15min1163681-16368115.10114.444.0015.1214.464.00
2162110-16211014.95614.98
3148608-14860813.71013.73
4150242-15024213.86113.88
5159502-15950214.71514.74
6155117-15511714.31114.33
20min1218841-21884120.19018.465.3720.2318.505.37
2201156-20115618.55818.60
3189661-18966117.49817.54
4190257-19025717.55317.59
5203341-20334118.76018.80
6197180-19718018.19218.23
30min1273433-27343325.22624.735.3925.3024.805.39
2294596-29459627.17927.25
3256196-25619623.63623.70
4256727-25672723.68523.75
5265010-26501024.44924.52
6262400-26240024.20924.28
45min1353057-35305732.57231.322.4932.6831.432.50
2342471-34247131.59631.71
3328619-32861930.31830.42
4333488-33348830.76730.87
5341943-34194331.54731.66
6337440-33744031.13231.24
60min1415569-41556938.34037.152.0838.5037.312.09
2405099-40509937.37437.53
3390286-39028636.00736.15
4398167-39816736.73436.88
5404692-40469237.33637.49
6402541-40254137.13837.29
120min1594260-59426054.82553.561.5755.0453.771.58
2581879-58187953.68353.90
3565918-56591852.21152.41
4578468-57846853.36953.57
5582776-58277653.76653.98
6580258-58025853.53453.74
180min1721231-72123166.54065.241.4466.8465.531.44
2705765-70576565.11365.41
3692185-69218563.86064.14
4714903-71490365.95666.24
5707240-70724065.24965.54
6701523-70152364.72165.01
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1846992-84699278.14275.801.6878.5476.191.68
2818166-81816675.48375.88
3804979-80497974.26674.64
4818795-81879575.54175.92
5822331-82233175.86776.26
6818387-81838775.50375.89
360min1971303-97130389.61187.761.1690.1388.261.17
2948656-94865687.52188.03
3937547-93754786.49786.98
4950500-95050087.69288.19
5951148-95114887.75188.26
6947977-94797787.45987.96
480min11046057-104605796.50795.091.0897.1695.721.09
21025051-102505194.57095.21
31013086-101308693.46694.08
41032692-103269295.27495.90
51036520-103652095.62896.26
61030701-103070195.09195.72
600min11095235-1095235101.04598.951.28101.8499.721.28
21069239-106923998.64699.43
31054036-105403697.24498.00
41077909-107790999.446100.22
51071538-107153898.85899.64
61066970-106697098.43799.21
720min11099858-1099858101.471100.750.92102.42101.670.92
21093095-1093095100.847101.78
31072709-107270998.96699.87
41099586-1099586101.446102.37
51091900-1091900100.737101.66
61094810-1094810101.005101.93
极限11106646-1106646102.097100.511.28103.20101.581.28
21082571-108257199.876100.96
31067909-106790998.52499.57
41101320-1101320101.606102.68
51091666-1091666100.715101.79
61086442-1086442100.233101.31
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