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%
110.17 9384294258942819419694600942350.29
210.219408794340942140.19
单位质量响应值RSD%判断
9265.989227.620.30数据可信
供试品溶液-F24706批-恩格列净-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%
5min152016-5201650.11738.9222.1550.1238.9222.15
238064-3806436.67436.67
333988-3398832.74732.75
431522-3152230.37130.37
535602-3560234.30234.30
651204-5120449.33449.33
10min193323-9332389.91575.9214.8490.0075.9914.84
275541-7554172.78372.84
369958-6995867.40367.46
470265-7026567.69967.75
569776-6977667.22867.29
693940-9394090.51090.59
15min1102484-10248498.74293.135.2798.9893.325.30
296966-9696693.42593.61
392431-9243189.05689.22
494633-9463391.17791.34
590642-9064287.33287.50
6102779-10277999.02699.26
20min1102932-10293299.17398.891.0499.5799.241.06
2103156-10315699.38999.73
3102681-10268198.93199.25
4102917-10291799.15999.47
5100558-10055896.88697.20
6103575-10357599.793100.19
30min1102387-10238798.64899.230.7599.2199.740.74
2103074-10307499.31099.81
3104340-104340100.530101.01
4102824-10282499.06999.55
5102141-10214198.41198.89
6103164-10316499.39799.96
45min1102235-10223598.50299.010.8799.2399.680.85
2103217-10321799.448100.12
3104313-104313100.504101.15
4102481-10248198.73999.38
5101824-10182498.10698.75
6102477-10247798.73599.46
60min1102185-10218598.45499.040.8799.3599.880.86
2103381-10338199.606100.44
3104219-104219100.413101.23
4102422-10242298.68299.49
5101776-10177698.05998.86
6102789-10278999.03699.93
极限1102235-10223598.50298.870.7799.5699.880.76
2102750-10275098.998100.00
3104068-104068100.268101.25
4102527-10252798.78399.76
5101746-10174698.03199.00
6102362-10236298.62499.68
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(%)99.9对照品水分(%)0对照品稀释倍数20
标示量(mg)500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%
19.854597374597764596914594654595304596400.03
29.944638744626414632580.19
单位质量响应值RSD%判断
46663.9646605.430.09数据可信
供试品溶液-F24706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%
5min1309389-30938959.64948.4918.4859.6548.4918.48
2238427-23842745.96845.97
3218799-21879942.18442.18
4205618-20561839.64239.64
5226458-22645843.66043.66
6310424-31042459.84959.85
10min1488356-48835694.15381.8512.2094.2581.9312.21
2411516-41151679.33979.42
3385425-38542574.30974.38
4386137-38613774.44674.51
5383960-38396074.02674.10
6491704-49170494.79994.90
15min1514595-51459599.21295.433.8699.4795.653.88
2498774-49877496.16296.37
3478600-47860092.27292.47
4489033-48903394.28494.47
5470823-47082390.77390.97
6518164-51816499.900100.16
20min1513945-51394599.08799.120.7699.5199.500.77
2516159-51615999.51499.88
3517523-51752399.777100.12
4513145-51314598.93399.28
5506999-50699997.74898.10
6517039-51703999.683100.11
30min1512540-51254098.81699.270.7199.4099.810.71
2515875-51587599.45999.99
3520875-520875100.423100.94
4513188-51318898.94199.45
5510563-51056398.43598.95
6516394-51639499.559100.15
45min1511057-51105798.53099.010.7399.2899.720.72
2513796-51379699.05899.76
3520461-520461100.343101.02
4511290-51129098.57599.25
5510363-51036398.39699.07
6514326-51432699.16099.92
60min1510067-51006798.33998.760.7499.2599.630.73
2511876-51187698.68899.55
3518586-51858699.982100.83
4510171-51017198.35999.20
5508248-50824897.98898.83
6514424-51442499.179100.10
极限1507739-50773997.89098.530.7798.9799.570.76
2511902-51190298.69399.72
3517465-51746599.765100.78
4509553-50955398.24099.25
5506911-50691197.73198.73
6512910-51291098.88799.97
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%
110.17 9437994386944659423794377943690.09
210.219421693852940340.28
单位质量响应值RSD%判断
9279.159209.990.53数据可信
供试品溶液-F24706批-恩格列净-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%
5min138137-3813736.75441.1015.5436.7541.1015.53
235390-3539034.10634.11
345115-4511543.47843.48
437362-3736236.00736.01
548149-4814946.40246.40
651705-5170549.82949.83
10min178646-7864675.79379.1010.9775.8579.1710.97
271354-7135468.76668.82
386207-8620783.08083.15
473214-7321470.55870.62
590067-9006786.80086.88
692972-9297289.59989.68
15min1100543-10054396.89696.504.8197.0896.704.83
292973-9297389.60089.77
3103149-10314999.40799.62
495565-9556592.09892.28
5104559-104559100.766100.99
6103991-103991100.219100.45
20min1103650-10365099.890100.020.81100.24100.380.83
2102388-10238898.67498.99
3103503-10350399.748100.13
4104288-104288100.505100.84
5104848-104848101.045101.43
6104021-104021100.248100.65
30min1103722-10372299.959100.350.92100.48100.880.93
2102531-10253198.81299.30
3104029-104029100.255100.80
4105298-105298101.478101.98
5104669-104669100.872101.43
6104487-104487100.697101.26
45min1103710-10371099.948100.270.73100.63100.960.75
2102849-10284999.11899.77
3103701-10370199.939100.65
4104789-104789100.988101.66
5104726-104726100.927101.65
6104482-104482100.692101.43
60min1103360-10336099.611100.120.66100.46100.990.67
2103008-10300899.271100.09
3103737-10373799.974100.85
4104522-104522100.730101.57
5104797-104797100.995101.89
6103923-103923100.153101.06
极限1103725-10372599.96299.990.64100.98101.020.66
2102666-10266698.94299.92
3103585-10358599.827100.87
4104369-104369100.583101.59
5104519-104519100.728101.79
6103629-10362999.870100.94
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(%)99.9对照品水分(%)0对照品稀释倍数20
标示量(mg)500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%
19.854576844578204583744598244593104586020.21
29.944618154618564618360.01
单位质量响应值RSD%判断
46558.5846462.370.15数据可信
供试品溶液-F24706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%
5min1230860-23086044.62848.3212.6744.6348.3212.67
2216288-21628841.81141.81
3261157-26115750.48550.48
4221611-22161142.84042.84
5276901-27690153.52853.53
6293038-29303856.64856.65
10min1399185-39918577.16780.238.9377.2480.318.93
2371734-37173471.86071.93
3432649-43264983.63683.72
4378501-37850173.16973.24
5449425-44942586.87986.97
6458615-45861588.65688.75
15min1482267-48226793.22892.963.3493.4393.173.36
2456020-45602088.15488.34
3492709-49270995.24695.47
4466902-46690290.25890.45
5495224-49522495.73295.97
6492108-49210895.13095.37
20min1490005-49000594.72495.060.5995.0895.430.60
2487345-48734594.20994.55
3491665-49166595.04495.43
4494568-49456895.60695.95
5494976-49497695.68596.08
6491865-49186595.08395.48
30min1489522-48952294.63094.960.5395.1595.490.54
2487065-48706594.15594.65
3491510-49151095.01595.56
4493861-49386195.46995.97
5493690-49369095.43695.99
6491702-49170295.05295.61
45min1489919-48991994.70794.910.4195.3895.590.43
2487935-48793594.32394.97
3490379-49037994.79695.49
4493080-49308095.31895.98
5493191-49319195.33996.05
6491169-49116994.94995.67
60min1488112-48811294.35894.780.6095.1995.630.60
2486606-48660694.06794.87
3491436-49143695.00095.86
4492868-49286895.27796.10
5493984-49398495.49396.36
6488856-48885694.50195.38
极限1487478-48747894.23594.600.5195.2295.600.52
2486063-48606393.96294.93
3488839-48883994.49895.51
4491909-49190995.09296.07
5492466-49246695.19996.23
6489459-48945994.61895.65
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%
110.17 9397194006940459408094124940450.07
210.219411193972940420.11
单位质量响应值RSD%判断
9247.309210.770.28数据可信
供试品溶液-F24706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%
5min146987-4698745.35840.2015.1945.3640.2015.19
246333-4633344.72744.73
344560-4456043.01543.02
430357-3035729.30529.30
543286-4328641.78641.79
638364-3836437.03437.03
10min187285-8728584.25977.978.7284.3478.048.73
286049-8604983.06683.14
382952-8295280.07780.15
468348-6834865.97966.03
582955-8295580.08080.15
677044-7704474.37374.44
15min1103463-10346399.87796.383.80100.0996.583.82
2101720-10172098.19498.41
3101727-10172798.20198.41
493383-9338390.14690.30
5101550-10155098.03098.23
697203-9720393.83494.02
20min1104547-104547100.92399.720.84101.31100.080.86
2102832-10283299.26899.64
3103568-10356899.978100.35
4102003-10200398.46798.78
5103696-103696100.102100.47
6103176-10317699.60099.94
30min1104233-104233100.62099.430.81101.1799.950.82
2102101-10210198.56299.10
3103123-10312399.549100.08
4102505-10250598.95299.43
5103681-103681100.087100.62
6102351-10235198.80399.31
45min1103602-103602100.01199.480.53100.73100.170.53
2102064-10206498.52699.23
3103288-10328899.708100.41
4102836-10283699.27199.91
5103217-10321799.639100.34
6103289-10328999.709100.38
60min1103398-10339899.81499.110.43100.7099.960.44
2102402-10240298.85399.72
3102805-10280599.242100.11
4102434-10243498.88399.69
5102776-10277699.214100.08
6102173-10217398.63199.47
极限1104137-104137100.52799.500.61101.58100.520.61
2102615-10261599.058100.09
3103396-10339699.812100.85
4103064-10306499.492100.46
5102769-10276999.207100.24
6102461-10246198.90999.91
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(%)99.9对照品水分(%)0对照品稀释倍数20
标示量(mg)500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%
19.854576884587454583464578354582744581780.10
29.944601074582964592020.28
单位质量响应值RSD%判断
46515.5346197.380.49数据可信
供试品溶液-F24706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%
5min1281924-28192454.68149.4812.3954.6849.4812.39
2277277-27727753.77953.78
3268479-26847952.07352.07
4197711-19771138.34738.35
5264663-26466351.33351.33
6240466-24046646.64046.64
10min1456314-45631488.50582.727.1188.6082.807.11
2448440-44844086.97887.07
3434504-43450484.27584.36
4373815-37381572.50472.57
5436197-43619784.60384.69
6409621-40962179.44879.53
15min1512367-51236799.37797.002.5699.6297.222.58
2503950-50395097.74497.98
3505337-50533798.01398.24
4478297-47829792.76892.95
5509011-50901198.72698.95
6491781-49178195.38495.59
20min1511558-51155899.22098.620.5899.6299.010.58
2503673-50367397.69098.09
3508129-50812998.55598.95
4506935-50693598.32398.66
5510794-51079499.07199.46
6509862-50986298.89199.26
30min1510215-51021598.95998.350.6599.5398.900.65
2502515-50251597.46698.03
3506776-50677698.29298.85
4508266-50826698.58199.08
5510525-51052599.01999.58
6504042-50404297.76298.30
45min1508184-50818498.56598.170.5799.3098.880.56
2500999-50099997.17297.89
3505880-50588098.11898.84
4507796-50779698.49099.16
5508617-50861798.64999.37
6505314-50531498.00998.71
60min1507536-50753698.44098.100.5999.3498.980.57
2501578-50157897.28498.17
3505760-50576098.09598.98
4509411-50941198.80399.63
5507391-50739198.41199.30
6503193-50319397.59798.46
极限1508905-50890598.70597.760.6899.7798.800.68
2500160-50016097.00998.06
3505338-50533898.01399.06
4504604-50460497.87198.87
5505152-50515297.97799.03
6499989-49998996.97698.00
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