二甲双胍,达格列净项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)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对照品水分(%)0对照品稀释倍数50
标示量(mg)1000供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.204226479420810542129304219091420722342147660.20
210.274215218421997742175980.08
单位质量响应值RSD%判断
413212.35410671.670.44数据可信
加速6月-供试品溶液-YA0011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%
5min1124148-1241483.0143.1413.663.013.1413.73
2164329-1643293.9893.99
3123314-1233142.9942.99
4116311-1163112.8242.82
5119162-1191622.8932.89
6128581-1285813.1213.12
10min1276342-2763426.7087.124.406.727.144.44
2306718-3067187.4467.47
3299722-2997227.2767.29
4284976-2849766.9186.93
5285401-2854016.9286.94
6307088-3070887.4557.47
15min1407041-4070419.88110.484.219.9310.534.18
2448490-44849010.88710.94
3435783-43578310.57910.63
4454078-45407811.02311.07
5416784-41678410.11810.17
6427688-42768810.38210.44
20min1517711-51771112.56813.022.8012.6713.122.79
2548862-54886213.32413.44
3558706-55870613.56313.67
4527017-52701712.79412.90
5532445-53244512.92513.03
6532648-53264812.93013.04
30min1713596-71359617.32317.691.5917.4817.861.61
2740767-74076717.98218.16
3743899-74389918.05918.23
4726174-72617417.62817.80
5721633-72163317.51817.68
6726217-72621717.62917.80
45min1971218-97121823.57723.681.1123.8223.941.13
2988576-98857623.99824.27
3981651-98165123.83024.09
4976720-97672023.71023.97
5956855-95685523.22823.48
6977936-97793623.74024.00
60min11159230-115923028.14128.381.1428.5128.761.15
21181974-118197428.69329.08
31187349-118734928.82329.20
41168298-116829828.36128.74
51152408-115240827.97528.34
61165964-116596428.30428.68
120min11781970-178197043.25843.831.0043.7644.341.00
21801273-180127343.72744.26
31820221-182022144.18744.71
41831576-183157644.46244.98
51793997-179399743.55044.06
61802915-180291543.76744.28
180min12255783-225578354.76055.360.5955.4856.090.60
22278921-227892155.32256.07
32294909-229490955.71056.46
42281416-228141655.38256.12
52282392-228239255.40656.13
62288768-228876855.56156.30
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12575147-257514762.51363.481.5963.5164.491.57
22628128-262812863.79964.83
32556546-255654662.06163.09
42662974-266297464.64565.66
52617650-261765063.54564.55
62648249-264824964.28865.30
360min13174451-317445177.06177.010.7178.3778.340.70
23143802-314380276.31777.66
33155353-315535376.59877.93
43204769-320476977.79779.14
53167210-316721076.88678.21
63189471-318947177.42678.76
480min13529264-352926485.67585.550.8287.3787.270.80
23483756-348375684.57086.30
33525017-352501785.57287.29
43572235-357223586.71888.45
53523822-352382285.54387.25
63511513-351151385.24486.97
600min13789471-378947191.99191.210.7894.1193.350.75
23728823-372882390.51992.67
33718536-371853690.26992.42
43779973-377997391.76193.92
53774443-377444391.62693.76
63751598-375159891.07293.22
720min13866283-386628393.85692.821.7696.4495.421.71
23763298-376329891.35693.96
33715301-371530190.19192.79
43866841-386684193.86996.49
53862765-386276593.77196.36
63868282-386828293.90496.51
极限13866045-386604593.85092.901.4496.9095.961.41
23832349-383234993.03296.09
33738149-373814990.74593.79
43896304-389630494.58597.67
53797551-379755192.18795.25
63830624-383062492.99096.06
二甲双胍,达格列净项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)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12500
标示量(mg)1000供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.611544115387153821552615402154280.39
212.741548815694155910.94
单位质量响应值RSD%判断
1223.471223.780.02数据可信
加速6月-供试品溶液-YA0011批-达格列净-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%
5min113504-135040.3550.375.670.350.375.81
214636-146360.3850.38
315041-150410.3950.40
412821-128210.3370.34
513903-139030.3650.37
614157-141570.3720.37
10min116363-163630.4300.464.270.430.464.35
217109-171090.4500.45
318101-181010.4760.48
416924-169240.4450.45
517638-176380.4640.47
618318-183180.4810.48
15min116862-168620.4430.473.190.450.473.01
217860-178600.4690.47
317977-179770.4720.48
417299-172990.4550.46
517791-177910.4680.47
618479-184790.4860.49
20min117162-171620.4510.462.530.460.471.91
217445-174450.4580.47
317802-178020.4680.47
417155-171550.4510.46
518045-180450.4740.48
618195-181950.4780.48
30min117382-173820.4570.472.290.470.482.43
217868-178680.4700.48
318217-182170.4790.49
417621-176210.4630.47
517959-179590.4720.48
618546-185460.4870.50
45min117611-176110.4630.472.550.470.483.12
217595-175950.4620.47
318213-182130.4790.49
417795-177950.4680.48
518000-180000.4730.48
618806-188060.4940.51
60min117694-176940.4650.470.800.480.481.13
217939-179390.4710.48
317996-179960.4730.49
417881-178810.4700.48
518092-180920.4760.49
617986-179860.4730.49
120min117410-174100.4580.472.790.470.492.81
217659-176590.4640.48
317706-177060.4650.48
418123-181230.4760.49
517854-178540.4690.49
618849-188490.4950.51
180min117406-174060.4570.472.850.480.492.81
217525-175250.4610.48
317946-179460.4720.49
417383-173830.4570.47
517869-178690.4700.49
618715-187150.4920.51
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min117073-170730.4490.473.440.470.493.60
217727-177270.4660.49
317535-175350.4610.48
417428-174280.4580.48
517664-176640.4640.48
618861-188610.4960.52
360min117715-177150.4660.472.010.490.492.00
217743-177430.4660.49
317909-179090.4710.49
417681-176810.4650.49
517567-175670.4620.48
618552-185520.4880.51
480min117303-173030.4550.462.410.480.492.40
217194-171940.4520.48
317837-178370.4690.49
417369-173690.4570.48
517602-176020.4630.49
618330-183300.4820.51
600min117314-173140.4550.461.590.480.491.54
217443-174430.4580.49
317987-179870.4730.50
417478-174780.4590.49
517699-176990.4650.49
617929-179290.4710.50
720min117463-174630.4590.462.380.490.492.00
217229-172290.4530.48
317344-173440.4560.49
417363-173630.4560.49
517548-175480.4610.49
618362-183620.4830.51
极限117256-172560.4540.462.420.480.492.49
217226-172260.4530.48
317186-171860.4520.48
417457-174570.4590.49
517150-171500.4510.48
618276-182760.4800.51
二甲双胍,达格列净项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)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对照品水分(%)0对照品稀释倍数50
标示量(mg)1000供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.204240660424724342468704246033424939842460410.08
210.274244787423323342390100.20
单位质量响应值RSD%判断
416278.53412756.570.61数据可信
加速6月-供试品溶液-YA0011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%
5min1115787-1157872.7933.087.652.793.087.65
2128213-1282133.0933.09
3121400-1214002.9292.93
4140608-1406083.3923.39
5137678-1376783.3213.32
6122375-1223752.9522.95
10min1246817-2468175.9546.927.715.976.947.67
2303770-3037707.3287.34
3276916-2769166.6816.70
4304888-3048887.3557.37
5291553-2915537.0347.05
6297175-2971757.1697.18
15min1376661-3766619.08710.238.839.1310.288.82
2415545-41554510.02510.08
3415852-41585210.03210.08
4491818-49181811.86511.92
5418691-41869110.10110.15
6426655-42665510.29310.34
20min1493400-49340011.90312.834.9111.9912.944.94
2521544-52154412.58212.68
3515442-51544212.43512.53
4559935-55993513.50813.62
5555295-55529513.39613.50
6546503-54650313.18413.29
30min1677704-67770416.35017.203.9216.5017.363.93
2704213-70421316.98917.15
3709230-70923017.11017.27
4758252-75825218.29318.47
5698109-69810916.84217.01
6730130-73013017.61417.78
45min1929630-92963022.42723.063.4622.6623.313.46
2933789-93378922.52822.78
3945057-94505722.79923.05
41014692-101469224.47924.75
5936879-93687922.60222.86
6974140-97414023.50123.76
60min11130167-113016727.26527.963.1327.6128.333.14
21114702-111470226.89227.25
31143357-114335727.58327.94
41200289-120028928.95729.35
51164970-116497028.10528.47
61201263-120126328.98029.35
120min11707108-170710841.18442.873.0741.6643.383.08
21737656-173765641.92142.42
31744004-174400442.07442.57
41844068-184406844.48845.03
51812622-181262243.72944.24
61816526-181652643.82344.34
180min12200087-220008753.07754.803.1953.7655.523.18
22230254-223025453.80554.51
32220371-222037153.56654.27
42350857-235085756.71457.48
52372039-237203957.22557.95
62254866-225486654.39855.14
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min12546651-254665161.43862.472.1262.3963.462.14
22530383-253038361.04562.02
32553301-255330161.59862.57
42671120-267112064.44065.49
52624911-262491163.32664.34
62609951-260995162.96563.97
360min13179009-317900976.69376.762.0577.9578.072.04
23053519-305351973.66674.95
33220203-322020377.68778.97
43229573-322957377.91379.28
53202100-320210077.25078.58
63206505-320650577.35778.68
480min13485179-348517984.07984.961.5185.7286.651.54
23453383-345338383.31284.96
33503928-350392884.53286.20
43605145-360514586.97488.73
53535501-353550185.29387.01
63547229-354722985.57687.29
600min13725413-372541389.87590.981.9891.9493.091.98
23697855-369785589.21091.28
33729117-372911789.96492.06
43876098-387609893.51095.70
53853169-385316992.95795.10
63744725-374472590.34192.48
720min13767884-376788490.90092.162.2793.4194.732.27
23705235-370523589.38891.90
33771472-377147290.98693.53
43942295-394229595.10797.77
53862687-386268793.18795.79
63870278-387027893.37095.96
极限13791282-379128291.46492.972.0594.4396.002.05
23756192-375619290.61893.58
33847871-384787192.82995.83
43983823-398382396.10999.24
53872584-387258493.42696.50
63869413-386941393.34996.41
二甲双胍,达格列净项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)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12500
标示量(mg)1000供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.611575115870158151593815979158710.58
212.741598915996159920.04
单位质量响应值RSD%判断
1258.601255.260.19数据可信
加速6月-供试品溶液-YA0011批-达格列净-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%
5min110306-103060.2640.3512.520.260.3412.99
214375-143750.3680.37
313811-138110.3530.35
415277-152770.3910.39
513761-137610.3520.35
613416-134160.3430.34
10min116285-162850.4170.443.570.420.443.81
217380-173800.4450.45
317269-172690.4420.44
417322-173220.4430.45
516453-164530.4210.42
617893-178930.4580.46
15min117621-176210.4510.452.160.450.451.81
217427-174270.4460.45
317940-179400.4590.46
417940-179400.4590.46
516997-169970.4350.44
617932-179320.4590.46
20min118278-182780.4680.461.950.470.461.95
217592-175920.4500.46
317466-174660.4470.45
417443-174430.4460.45
517849-178490.4570.46
618045-180450.4620.47
30min118359-183590.4700.453.050.480.462.95
217486-174860.4470.46
317839-178390.4560.46
417340-173400.4440.45
517070-170700.4370.45
618351-183510.4700.48
45min118900-189000.4840.463.220.490.473.15
217657-176570.4520.46
318027-180270.4610.47
417670-176700.4520.46
517339-173390.4440.45
618428-184280.4720.48
60min118735-187350.4790.453.730.490.473.30
217296-172960.4430.46
317475-174750.4470.46
417296-172960.4430.46
517331-173310.4430.46
618538-185380.4740.49
120min118613-186130.4760.462.540.490.472.48
217489-174890.4470.46
317658-176580.4520.47
417517-175170.4480.46
517676-176760.4520.47
618211-182110.4660.48
180min118761-187610.4800.463.110.500.483.08
217860-178600.4570.47
317446-174460.4460.46
417494-174940.4480.47
518628-186280.4770.49
618142-181420.4640.48
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min118683-186830.4780.453.300.500.473.57
217285-172850.4420.46
317383-173830.4450.46
417166-171660.4390.46
517242-172420.4410.46
617802-178020.4550.48
360min118645-186450.4770.463.210.500.482.78
216973-169730.4340.46
318087-180870.4630.48
417552-175520.4490.47
517721-177210.4530.48
618038-180380.4620.48
480min118223-182230.4660.452.270.490.482.06
217429-174290.4460.47
317382-173820.4450.47
417631-176310.4510.48
517431-174310.4460.47
618249-182490.4670.49
600min118251-182510.4670.451.740.490.481.58
217463-174630.4470.47
317396-173960.4450.47
417809-178090.4560.48
517856-178560.4570.48
617755-177550.4540.48
720min118617-186170.4760.453.750.510.484.03
217032-170320.4360.46
317273-172730.4420.47
417508-175080.4480.48
517096-170960.4370.47
618309-183090.4680.50
极限118356-183560.4700.452.410.500.482.14
217104-171040.4380.47
317478-174780.4470.48
417506-175060.4480.48
517459-174590.4470.48
617789-177890.4550.49
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