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%
112.608203081993821128179281774819400.19
212.618271883078828980.31
单位质量响应值RSD%判断
6503.176573.990.77数据可信
供试品溶液-WM0006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%
5min148106-4810647.32340.8912.9647.3240.8912.96
242631-4263141.93741.94
333003-3300332.46632.47
440240-4024039.58539.59
546125-4612545.37445.37
639267-3926738.62838.63
10min184365-8436582.99280.944.5883.0681.004.59
282149-8214980.81280.88
375005-7500573.78573.83
484347-8434782.97583.03
585328-8532883.94084.01
682501-8250181.15981.22
15min192676-9267691.16890.451.8791.3690.641.87
292735-9273591.22691.41
389328-8932887.87488.03
490557-9055789.08389.27
594079-9407992.54892.74
692320-9232090.81891.00
20min195551-9555193.99692.241.8794.3392.561.88
294291-9429192.75793.08
391696-9169690.20490.50
491573-9157390.08390.40
595412-9541293.85994.19
694087-9408792.55692.87
30min195581-9558194.02692.961.7794.5093.411.77
295233-9523393.68394.14
393002-9300291.48991.92
491837-9183790.34390.80
596012-9601294.45094.92
695293-9529393.74294.20
45min196622-9662295.05093.681.6495.6694.271.65
295747-9574794.18994.79
393893-9389392.36592.93
492739-9273991.23091.82
596476-9647694.90695.52
695888-9588894.32894.92
60min196898-9689895.32193.811.8396.0894.551.84
295695-9569594.13894.88
394246-9424692.71293.41
492421-9242190.91791.64
596886-9688695.31096.07
696044-9604494.48195.22
120min1102357-102357100.69199.091.93101.5999.971.93
2101028-10102899.384100.27
399454-9945497.83698.68
497421-9742195.83696.70
5102194-102194100.531101.43
6101928-101928100.269101.15
180min1102629-102629100.95998.802.06102.0199.832.06
2100522-10052298.88699.92
399155-9915597.54298.53
496992-9699295.41496.42
5101440-10144099.789100.84
6101872-101872100.214101.24
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1102083-102083100.42298.641.85101.6299.811.85
2100652-10065299.014100.19
399345-9934597.72898.86
497024-9702495.44596.59
5100946-10094699.303100.50
6101594-10159499.941101.12
360min1102078-102078100.41798.221.99101.7799.541.99
2100751-10075199.112100.44
398660-9866097.05598.34
496453-9645394.88496.17
5100516-10051698.880100.23
6100593-10059398.956100.29
480min1101371-10137199.72297.581.87101.2399.061.87
299132-9913297.51999.00
398291-9829196.69298.12
496103-9610394.53995.97
599795-9979598.17199.67
6100501-10050198.866100.34
600min1101132-10113299.48697.022.34101.1498.642.33
298530-9853096.92798.55
397894-9789496.30197.87
494552-9455293.01394.59
599612-9961297.99199.64
6100050-10005098.422100.05
720min1100796-10079699.15697.051.86100.9698.811.86
297989-9798996.39598.16
397180-9718095.59997.31
496401-9640194.83296.55
598762-9876297.15598.95
6100782-10078299.142100.92
960min199860-9986098.23595.842.46100.1997.742.44
299441-9944197.82399.74
395799-9579994.24096.10
493533-9353392.01193.87
597646-9764696.05798.00
698249-9824996.65098.57
1440min198830-9883097.22294.782.4699.3296.832.44
295933-9593394.37296.43
395201-9520193.65295.65
492594-9259491.08793.08
596755-9675595.18197.26
698801-9880197.19399.26
极限198619-9861997.01494.392.3999.2696.582.38
295724-9572494.16696.37
394751-9475193.20995.35
492281-9228190.77992.91
596394-9639494.82697.05
697940-9794096.34698.56
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 10.031161911115970411602301160116115924811602420.09
2 10.101174760117491211748360.01
单位质量响应值RSD%判断
115677.17116320.400.40数据可信
供试品溶液-WM0006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%
5min133791-337912.9132.867.412.912.877.34
232226-322262.7782.78
334299-342992.9572.96
436437-364373.1413.14
533584-335842.8952.90
629063-290632.5052.51
10min177939-779396.7196.784.466.726.784.41
279327-793276.8396.84
376682-766826.6116.62
485024-850247.3307.33
577994-779946.7246.73
674718-747186.4416.45
15min1123718-12371810.66610.634.5610.6810.654.55
2126413-12641310.89810.91
3116245-11624510.02110.04
4132132-13213211.39111.41
5122781-12278110.58510.60
6118840-11884010.24510.26
20min1166563-16656314.35913.904.2014.3913.934.20
2163448-16344814.09114.12
3153744-15374413.25413.28
4170074-17007414.66214.69
5160126-16012613.80413.83
6153502-15350213.23313.26
30min1220388-22038818.99919.112.9619.0519.162.97
2225037-22503719.40019.45
3215294-21529418.56018.61
4232711-23271120.06220.12
5221369-22136919.08419.13
6215449-21544918.57418.62
45min1294328-29432825.37425.572.4325.4525.642.43
2300660-30066025.91926.00
3290905-29090525.07825.16
4308481-30848126.59426.68
5296251-29625125.53925.62
6288699-28869924.88824.96
60min1355740-35574030.66830.891.8430.7931.011.85
2362354-36235431.23831.36
3353084-35308430.43930.55
4369481-36948131.85231.98
5357650-35765030.83230.95
6351901-35190130.33730.45
120min1564584-56458448.67249.211.6148.8449.371.61
2585371-58537150.46450.63
3563533-56353348.58148.74
4579069-57906949.92150.09
5567241-56724148.90149.07
6564981-56498148.70648.87
180min1705124-70512460.78860.860.7961.0361.100.79
2712348-71234861.41061.65
3700353-70035360.37660.61
4713316-71331661.49461.74
5701422-70142260.46960.71
6703503-70350360.64860.88
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1811821-81182169.98669.980.8270.3170.310.82
2818305-81830570.54570.88
3805290-80529069.42369.75
4820990-82099070.77671.12
5805720-80572069.46069.79
6808355-80835569.68770.01
360min1964490-96449083.14782.860.6983.5883.300.69
2968118-96811883.46083.90
3953333-95333382.18582.61
4967629-96762983.41883.86
5954024-95402482.24582.68
6959633-95963382.72883.16
480min11061665-106166591.52590.970.6692.0891.530.66
21060646-106064691.43792.00
31049463-104946390.47391.02
41060691-106069191.44192.01
51045047-104504790.09290.65
61053995-105399590.86391.42
600min11119981-111998196.55295.610.7097.2596.300.70
21112033-111203395.86796.57
31101400-110140094.95095.64
41111723-111172395.84096.55
51098858-109885894.73195.42
61110089-111008995.69996.39
720min11150307-115030799.16698.110.93100.0198.950.93
21136210-113621097.95198.80
31126764-112676497.13797.97
41147297-114729798.90799.76
51125042-112504296.98897.82
61142842-114284298.52399.35
960min11171069-1171069100.95699.320.97101.95100.300.97
21152549-115254999.359100.35
31143657-114365798.59399.57
41156062-115606299.662100.66
51139044-113904498.19599.17
61150036-115003699.143100.12
1440min11167394-1167394100.63999.360.84101.78100.500.84
21152165-115216599.326100.47
31143923-114392398.61699.74
41154509-115450999.528100.68
51140376-114037698.31099.44
61156906-115690699.735100.86
极限11167827-1167827100.67798.921.05101.97100.201.04
21149325-114932599.082100.37
31138306-113830698.13299.40
41151205-115120599.244100.54
51133846-113384697.74799.02
61144201-114420198.64099.92
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%
112.608292983082829918306183017830160.08
212.618347583278833760.17
单位质量响应值RSD%判断
6588.576611.900.25数据可信
供试品溶液-WM0006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%
5min141379-4137940.32436.2211.3940.3236.2211.39
230060-3006029.29429.29
335182-3518234.28534.29
440246-4024639.22039.22
536314-3631435.38935.39
639827-3982738.81238.81
10min187847-8784785.60879.528.1485.6779.578.14
276174-7617474.23374.28
373618-7361871.74271.79
489513-8951387.23287.29
584749-8474982.58982.64
677681-7768175.70175.76
15min198015-9801595.51790.215.8795.7190.385.88
292147-9214789.79989.95
387185-8718584.96385.12
497921-9792195.42595.62
594942-9494292.52292.70
685194-8519483.02383.19
20min195962-9596293.51692.285.4293.8592.585.42
294925-9492592.50692.80
390410-9041088.10688.39
4102558-10255899.944100.28
596405-9640593.94894.26
687873-8787385.63385.93
30min196491-9649194.03292.943.7494.5093.393.74
296262-9626293.80994.24
393178-9317890.80391.22
499785-9978597.24297.72
597011-9701194.53995.00
689513-8951387.23287.66
45min196640-9664094.17793.244.0194.7993.834.01
297037-9703794.56495.13
393437-9343791.05691.61
4100206-10020697.65298.28
597549-9754995.06395.66
689220-8922086.94687.50
60min196958-9695894.48793.613.7995.2494.333.79
297447-9744794.96395.67
393896-9389691.50392.19
4100395-10039597.83698.61
597680-9768095.19195.93
689958-8995887.66588.35
120min197211-9721194.73394.403.5595.6395.273.55
298437-9843795.92896.78
394751-9475192.33693.16
4101276-10127698.69599.62
598231-9823195.72796.61
691337-9133789.00989.83
180min1102416-10241699.80699.433.73100.84100.443.73
2103581-103581100.941101.94
399991-9999197.44398.41
4106970-106970104.244105.31
5103451-103451100.814101.84
695766-9576693.32594.28
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1103506-103506100.86899.273.80102.06100.433.80
2103357-103357100.723101.87
399615-9961597.07698.19
4106304-106304103.595104.82
5103147-103147100.518101.70
695280-9528092.85293.94
360min1101298-10129898.71698.473.62100.0699.783.63
2102827-102827100.206101.51
399265-9926596.73597.99
4105659-105659102.966104.35
5102307-10230799.700101.03
694915-9491592.49693.73
480min1100354-10035497.79697.773.9199.2899.223.91
2102071-10207199.470100.92
398651-9865196.13797.54
4105489-105489102.801104.34
5101579-10157998.990100.47
693798-9379891.40792.78
600min1100410-10041097.85197.593.7799.4999.193.77
2101490-10149098.903100.50
399377-9937796.84498.39
4104834-104834102.162103.85
5101345-10134598.762100.39
693417-9341791.03692.54
720min199264-9926496.73496.703.8398.5298.443.83
2100440-10044097.88099.63
397550-9755095.06496.76
4104462-104462101.800103.64
5100610-10061098.04699.82
693029-9302990.65892.30
960min198370-9837095.86396.134.3197.7998.024.30
2100994-10099498.420100.31
396609-9660994.14795.98
4104445-104445101.783103.78
599550-9955097.01398.94
691874-9187489.53391.31
1440min196844-9684494.37694.453.9196.4596.493.91
298596-9859696.08398.13
395342-9534292.91294.89
4102006-10200699.406101.56
598079-9807995.57997.65
690669-9066988.35890.27
极限196740-9674094.27494.403.8796.4996.583.87
298181-9818195.67997.87
395266-9526692.83894.95
4102176-10217699.572101.87
598015-9801595.51797.73
690846-9084688.53190.58
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 10.031176680117586511754661174812117523811756120.07
2 10.101162950116381111633800.06
单位质量响应值RSD%判断
117209.57115186.141.24数据可信
供试品溶液-WM0006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%
5min130709-307092.6433.0811.972.643.0812.00
232291-322912.7792.78
337562-375623.2333.23
433300-333002.8662.87
539462-394623.3963.40
641327-413273.5573.56
10min178526-785266.7587.1810.446.767.1810.42
277094-770946.6356.64
380881-808816.9616.97
479259-792596.8226.83
584040-840407.2337.24
6100466-1004668.6478.65
15min1132014-13201411.36210.863.9811.3810.883.98
2119061-11906110.24710.26
3122866-12286610.57510.59
4128969-12896911.10011.11
5130415-13041511.22411.24
6124084-12408410.67910.70
20min1165935-16593514.28114.295.2914.3114.325.28
2157557-15755713.56013.59
3159452-15945213.72313.75
4181822-18182215.64915.68
5169009-16900914.54614.58
6162714-16271414.00414.04
30min1230427-23042719.83219.621.7719.8819.681.78
2220436-22043618.97219.02
3228470-22847019.66419.72
4232097-23209719.97620.03
5229011-22901119.71019.76
6227516-22751619.58219.64
45min1307769-30776926.48926.011.8026.5726.101.80
2296944-29694425.55725.64
3297027-29702725.56425.65
4308905-30890526.58626.67
5304215-30421526.18326.27
6298555-29855525.69625.78
60min1371613-37161331.98331.411.5932.1131.531.59
2359832-35983230.97031.09
3359842-35984230.97031.09
4372533-37253332.06332.19
5364143-36414331.34131.46
6361410-36141031.10531.23
120min1559674-55967448.16947.591.2048.3447.761.20
2548260-54826047.18747.35
3545310-54531046.93347.10
4561024-56102448.28548.46
5548156-54815647.17847.35
6554991-55499147.76647.94
180min1729830-72983062.81462.121.2563.0662.361.25
2716694-71669461.68361.92
3711726-71172661.25661.49
4733024-73302463.08963.33
5713509-71350961.40961.65
6725556-72555662.44662.69
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1846100-84610072.82171.331.3573.1671.661.35
2823670-82367070.89171.22
3818260-81826070.42570.75
4838815-83881572.19472.53
5820666-82066670.63270.97
6824807-82480770.98871.32
360min1991134-99113485.30484.191.1085.7584.631.10
2972385-97238583.69084.12
3969370-96937083.43083.86
4992656-99265685.43585.88
5970307-97030783.51183.95
6973394-97339483.77784.22
480min11087515-108751593.59992.271.2394.1792.841.23
21066533-106653391.79392.35
31061744-106174491.38191.94
41090121-109012193.82394.40
51064724-106472491.63792.20
61061908-106190891.39591.96
600min11140240-114024098.13797.041.1198.8597.741.11
21118403-111840396.25796.95
31120661-112066196.45297.15
41146242-114624298.65399.37
51121541-112154196.52797.23
61117742-111774296.20096.90
720min11164253-1164253100.20399.191.42101.06100.041.42
21141417-114141798.23899.08
31138191-113819197.96098.80
41180167-1180167101.573102.44
51145791-114579198.61499.46
61144724-114472498.52399.37
960min11179682-1179682101.531100.471.41102.54101.471.41
21157474-115747499.620100.61
31152397-115239799.183100.17
41194678-1194678102.822103.84
51162817-1162817100.080101.07
61156969-115696999.576100.57
1440min11178441-1178441101.424100.171.39102.59101.321.39
21156685-115668599.552100.69
31148160-114816098.81899.95
41189240-1189240102.354103.53
51156349-115634999.523100.67
61154237-115423799.341100.49
极限11176277-1176277101.238100.011.34102.55101.311.34
21153349-115334999.265100.55
31148143-114814398.817100.10
41186550-1186550102.122103.45
51156270-115627099.516100.81
61151764-115176499.128100.42
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