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 12.037933179103789907914179132791390.16
2 12.077935479313793340.04
单位质量响应值RSD%判断
6578.476572.830.07数据可信
供试品溶液-25042203批-达格列净-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min185055-8505583.19782.787.8283.2082.787.82
292514-9251490.49390.49
381944-8194480.15480.15
487231-8723185.32585.33
573151-7315171.55371.55
687894-8789485.97485.97
10min199672-9967297.49596.363.2797.6296.483.27
2101511-10151199.29399.43
397252-9725295.12895.25
498943-9894396.78296.91
592722-9272290.69690.80
6100953-10095398.74898.88
15min1101624-10162499.40497.432.8799.6897.702.88
2102086-10208699.856100.14
396791-9679194.67794.94
499834-9983497.65397.93
595429-9542993.34493.59
6101867-10186799.64299.92
20min1102373-102373100.13797.792.88100.5698.202.89
2102078-10207899.848100.28
397111-9711194.99095.39
4100302-10030298.11198.53
595759-9575993.66794.05
6102226-10222699.993100.42
30min1103018-103018100.76898.013.00101.3498.573.00
2102476-102476100.237100.82
396209-9620994.10794.65
4100332-10033298.14098.71
596835-9683594.72095.24
6102330-102330100.095100.67
45min1103579-103579101.31698.373.64102.0499.073.64
2102865-102865100.618101.35
394805-9480592.73493.42
4101163-10116398.95399.67
597416-9741695.28895.95
6103549-103549101.287102.01
60min1103862-103862101.59397.993.68102.4798.843.68
2102436-102436100.198101.08
394085-9408592.03092.86
4100989-10098998.78399.65
597471-9747195.34296.15
6102213-10221399.980100.86
120min1107166-107166104.825100.324.71105.85101.334.69
2105908-105908103.594104.63
393800-9380091.75192.72
4103477-103477101.217102.23
5100748-10074898.54799.50
6104287-104287102.009103.04
180min1106675-106675104.34599.545.70105.53100.705.67
2105328-105328103.027104.22
390627-9062788.64789.75
4103622-103622101.358102.52
5100863-10086398.66099.76
6103464-103464101.204102.39
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1106770-106770104.43899.186.04105.78100.486.01
2104962-104962102.669104.01
389639-8963987.68188.92
4103573-103573101.310102.62
5100552-10055298.35599.60
6102897-102897100.649101.98
360min1105937-105937103.62398.415.84105.1299.865.80
2104116-104116101.842103.34
389396-8939687.44388.81
4102590-102590100.349101.82
599873-9987397.69199.09
6101752-10175299.529101.01
480min1103919-103919101.64997.316.32103.3098.916.28
2103364-103364101.106102.76
387107-8710785.20486.70
4102076-10207699.846101.46
599296-9929697.12798.67
6101165-10116598.955100.59
600min1104448-104448102.16697.516.92103.9799.266.87
2103074-103074100.822102.63
386200-8620084.31785.94
4101584-10158499.365101.13
598981-9898196.81998.51
6103864-103864101.595103.38
720min1102963-102963100.71496.226.64102.6798.116.59
2102377-102377100.141102.10
385474-8547483.60785.36
4101057-10105798.849100.77
598484-9848496.33398.17
699843-9984397.66299.60
极限1104431-104431102.15096.327.23104.2698.367.16
2102346-102346100.110102.22
384508-8450882.66284.54
4100708-10070898.508100.57
598914-9891496.75398.73
699933-9993397.75099.83
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%
1 10.131014868101562410147431016351101723310157640.11
2 10.161016494101659810165460.01
单位质量响应值RSD%判断
100272.85100053.740.16数据可信
供试品溶液-25042203批-二甲双胍-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min152227-522275.2144.2810.795.214.2810.72
241460-414604.1394.14
340541-405414.0474.05
440718-407184.0654.07
540337-403374.0274.03
641939-419394.1874.19
10min1106316-10631610.61410.284.0610.6210.284.07
2103834-10383410.36610.37
3106395-10639510.62210.63
4103521-10352110.33510.34
595012-950129.4869.49
6102649-10264910.24810.25
15min1151996-15199615.17514.811.9015.2014.831.91
2148206-14820614.79614.82
3148512-14851214.82714.85
4149753-14975314.95114.97
5143450-14345014.32214.34
6147997-14799714.77614.80
20min1190099-19009918.97918.522.0619.0318.562.07
2186176-18617618.58718.63
3186048-18604818.57418.62
4187119-18711918.68118.73
5178614-17861417.83217.87
6184835-18483518.45318.50
30min1250409-25040925.00024.581.5725.0824.651.58
2246477-24647724.60824.68
3246180-24618024.57824.65
4248882-24888224.84824.92
5239207-23920723.88223.95
6245835-24583524.54324.61
45min1323186-32318632.26631.821.2732.3831.931.27
2318367-31836731.78531.89
3318940-31894031.84231.95
4322556-32255632.20332.31
5312122-31212231.16131.27
6317067-31706731.65531.76
60min1382020-38202038.14037.641.2438.3037.801.24
2377249-37724937.66337.82
3376880-37688037.62737.78
4380693-38069338.00738.16
5368678-36867836.80836.96
6376633-37663337.60237.76
120min1574933-57493357.40056.181.2757.6256.401.27
2562193-56219356.12856.34
3562884-56288456.19756.41
4564280-56428056.33656.55
5553601-55360155.27055.48
6558513-55851355.76055.97
180min1684713-68471368.36068.080.6368.6668.380.63
2681925-68192568.08168.38
3681607-68160768.05068.35
4688040-68804068.69268.99
5675666-67566667.45767.75
6679515-67951567.84168.14
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1778539-77853977.72777.280.6778.1377.680.67
2776271-77627177.50177.90
3773942-77394277.26877.67
4779117-77911777.78578.19
5765399-76539976.41576.81
6771264-77126477.00177.40
360min1902204-90220490.07390.040.5690.6090.560.56
2900229-90022989.87690.39
3905649-90564990.41790.93
4908581-90858190.71091.23
5893966-89396689.25189.76
6900549-90054989.90890.42
480min1973337-97333797.17597.600.4297.8398.250.42
2975830-97583097.42498.07
3978291-97829197.67098.32
4983426-98342698.18298.84
5973772-97377297.21997.86
6980990-98099097.93998.59
600min11011080-1011080100.943101.750.94101.75102.550.93
21018951-1018951101.729102.53
31016242-1016242101.459102.26
41022597-1022597102.093102.90
51010147-1010147100.850101.63
61036003-1036003103.432104.23
720min11019806-1019806101.814102.930.74102.77103.880.74
21031797-1031797103.012103.96
31029293-1029293102.762103.71
41038410-1038410103.672104.63
51026438-1026438102.477103.41
61040243-1040243103.855104.80
极限11026171-1026171102.450102.940.53103.56104.040.53
21032081-1032081103.040104.14
31024872-1024872102.320103.42
41038196-1038196103.650104.76
51028629-1028629102.695103.79
61036390-1036390103.470104.58
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 12.037860578869788857880278804787930.15
2 12.077906878306786870.69
单位质量响应值RSD%判断
6549.716519.220.33数据可信
供试品溶液-25042203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%
5min167660-6766066.59979.0414.9466.6079.0414.94
268677-6867767.60067.60
378645-7864577.41277.41
494995-9499593.50693.51
577455-7745576.24176.24
694350-9435092.87192.87
10min191941-9194190.50095.474.5390.6095.594.55
291920-9192090.47990.58
3100007-10000798.43998.56
499963-9996398.39698.54
595974-9597494.47094.58
6102123-102123100.522100.66
15min195573-9557394.07597.643.1994.3197.913.21
296886-9688695.36795.60
3101399-10139999.810100.07
4101927-101927100.329100.62
596644-9664495.12995.39
6102770-102770101.159101.45
20min196615-9661595.10197.753.0595.4898.163.07
296026-9602694.52194.90
3101656-101656100.063100.48
4101056-10105699.47299.91
597268-9726895.74396.14
6103193-103193101.575102.02
30min197458-9745895.93098.232.7996.4598.792.81
297260-9726095.73596.26
3101933-101933100.335100.90
4101120-10112099.535100.12
597378-9737895.85296.39
6103627-103627102.003102.60
45min198349-9834996.80798.922.8497.4799.632.85
298221-9822196.68197.35
3102015-102015100.416101.13
4101940-101940100.342101.08
597686-9768696.15596.84
6104792-104792103.149103.90
60min198594-9859497.04999.112.4497.8699.962.46
298528-9852896.98497.79
3102223-102223100.621101.49
4101700-101700100.106100.99
598695-9869597.14897.98
6104397-104397102.761103.66
120min1102155-102155100.554102.102.18101.51103.102.20
2102457-102457100.851101.81
3105303-105303103.652104.67
4104865-104865103.221104.26
5100815-10081599.235100.21
6106750-106750105.077106.13
180min1101704-101704100.110101.772.22101.21102.932.23
2102395-102395100.790101.90
3104789-104789103.146104.32
4104810-104810103.167104.36
5100311-10031198.73999.86
6106363-106363104.696105.91
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1101491-10149199.900101.602.10101.16102.912.11
2102270-102270100.667101.93
3104528-104528102.889104.22
4104567-104567102.928104.27
5100406-10040698.832100.11
6106049-106049104.387105.76
360min1101688-101688100.094101.382.16101.50102.842.17
2102051-102051100.451101.86
3104072-104072102.441103.92
4104136-104136102.504104.01
599883-9988398.31799.74
6106136-106136104.472106.00
480min1100781-10078199.201100.782.07100.76102.402.09
2101495-10149599.904101.46
3103730-103730102.104103.74
4103615-103615101.991103.65
599548-9954897.98899.56
6105164-105164103.516105.20
600min1100861-10086199.280100.471.97100.98102.231.99
2101250-10125099.663101.37
3103173-103173101.556103.34
4103329-103329101.709103.52
599153-9915397.59999.31
6104638-104638102.998104.84
720min1100138-10013898.56899.912.06100.42101.822.08
2100495-10049598.920100.78
3102646-102646101.037102.98
4103165-103165101.548103.51
598567-9856797.02298.88
6103990-103990102.360104.35
极限199932-9993298.366100.022.19100.37102.082.21
2100635-10063599.058101.07
3102425-102425100.819102.91
4103361-103361101.741103.85
598729-9872997.18199.19
6104589-104589102.950105.10
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%
1 10.131010507101025910108181009854101062710104130.04
2 10.161011508101198510117460.04
单位质量响应值RSD%判断
99744.6299581.300.12数据可信
供试品溶液-25042203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%
5min133499-334993.3613.327.173.363.327.14
231496-314963.1603.16
331361-313613.1473.15
435774-357743.5903.59
530388-303883.0493.05
635888-358883.6013.60
10min184958-849588.5258.784.468.538.784.47
283490-834908.3778.38
386240-862408.6538.66
492897-928979.3219.33
585394-853948.5688.57
691767-917679.2089.21
15min1127572-12757212.80013.484.4512.8213.504.45
2138871-13887113.93413.95
3132110-13211013.25613.27
4142992-14299214.34814.37
5128889-12888912.93212.95
6135846-13584613.63113.65
20min1164250-16425016.48116.832.6516.5216.862.64
2163163-16316316.37116.41
3168201-16820116.87716.91
4174017-17401717.46117.50
5164727-16472716.52816.57
6171817-17181717.24017.28
30min1222381-22238122.31322.812.4722.3822.872.47
2222849-22284922.36022.42
3228704-22870422.94823.01
4234263-23426323.50623.57
5222318-22231822.30722.37
6233483-23348323.42723.49
45min1294279-29427929.52730.143.8429.6230.243.84
2293840-29384029.48329.58
3297345-29734529.83529.93
4322564-32256432.36632.47
5291516-29151629.25029.35
6302568-30256830.35930.46
60min1352245-35224535.34435.791.3935.4835.941.39
2353661-35366135.48635.63
3355565-35556535.67735.82
4362724-36272436.39536.55
5353067-35306735.42635.57
6363140-36314036.43736.58
120min1534871-53487153.66853.971.4253.8654.171.43
2536160-53616053.79753.99
3535473-53547353.72853.92
4548153-54815355.00155.21
5527338-52733852.91253.10
6545299-54529954.71454.92
180min1651191-65119165.33965.761.1165.6166.041.12
2659214-65921466.14466.42
3653029-65302965.52465.80
4666231-66623166.84867.14
5645179-64517964.73665.01
6657370-65737065.95966.24
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1741595-74159574.41074.770.8574.7875.150.85
2750564-75056475.31075.68
3744030-74403074.65575.03
4752251-75225175.48075.87
5735197-73519773.76874.14
6747458-74745874.99975.38
360min1869700-86970087.26487.500.9187.7587.990.92
2876293-87629387.92688.41
3869803-86980387.27587.76
4880001-88000188.29888.80
5858377-85837786.12886.61
6877969-87796988.09488.59
480min1945409-94540994.86195.250.7195.4795.860.72
2955066-95506695.83096.45
3947222-94722295.04395.66
4954540-95454095.77796.41
5938543-93854394.17294.78
6954720-95472095.79596.42
600min1990545-99054599.39099.640.62100.15100.410.62
2998504-998504100.188100.95
3992069-99206999.542100.30
4997215-997215100.059100.84
5982573-98257398.59099.34
6997622-997622100.100100.87
720min11008277-1008277101.169101.690.71102.07102.600.71
21020289-1020289102.374103.29
31012320-1012320101.574102.48
41019613-1019613102.306103.23
51002482-1002482100.587101.48
61017997-1017997102.144103.06
极限11012422-1012422101.585101.940.66102.64103.000.67
21018945-1018945102.239103.31
31012685-1012685101.611102.67
41022555-1022555102.601103.68
51006010-1006010100.941101.99
61022946-1022946102.641103.71
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