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%
112.598141381731811588160681662815140.29
212.488200182264821320.23
单位质量响应值RSD%判断
6474.506581.091.16数据可信
供试品溶液-WM1800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%
5min143871-4387143.23047.1511.1443.2347.1511.14
251512-5151250.75950.76
353621-5362152.83852.84
439686-3968639.10639.11
547069-4706946.38146.38
651346-5134650.59650.60
10min180902-8090279.72086.317.4379.7886.387.44
292664-9266491.31091.39
390366-9036689.04689.13
477877-7787776.73976.80
593017-9301791.65891.73
690698-9069889.37389.45
15min191809-9180990.46896.274.8390.6596.474.83
2100747-10074799.27599.49
3100936-10093699.46199.67
491479-9147990.14390.32
599905-9990598.44598.65
6101314-10131499.834100.04
20min194217-9421792.84198.204.0793.1698.544.09
2101338-10133899.858100.22
3102846-102846101.343101.71
494810-9481093.42593.73
5101434-10143499.952100.31
6103265-103265101.756102.12
30min195223-9522393.83298.993.7194.2999.483.72
2101991-101991100.501101.01
3104265-104265102.742103.26
496610-9661095.19995.65
5101068-10106899.591100.10
6103584-103584102.071102.58
45min195806-9580694.40699.453.7995.01100.093.80
2101807-101807100.320100.98
3105821-105821104.275104.94
497128-9712895.70996.30
5101324-10132499.844100.50
6103668-103668102.153102.82
60min195946-9594694.54499.323.4495.29100.113.46
2101658-101658100.173100.99
3104793-104793103.262104.09
497419-9741995.99696.73
5101249-10124999.770100.57
6103664-103664102.150102.97
120min196428-9642895.01999.853.2395.90100.783.24
2102539-102539101.041102.00
3104673-104673103.144104.12
498337-9833796.90097.78
5101954-101954100.465101.42
6104037-104037102.517103.49
180min1100115-10011598.652103.423.3999.68104.513.40
2105330-105330103.791104.91
3108930-108930107.339108.47
4101631-101631100.146101.17
5105190-105190103.653104.76
6108507-108507106.922108.05
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1100225-10022598.761103.313.3099.93104.563.31
2105530-105530103.988105.26
3108716-108716107.128108.42
4101562-101562100.078101.25
5104717-104717103.187104.45
6108325-108325106.742108.03
360min199493-9949398.039102.773.0999.36104.173.10
2104983-104983103.449104.88
3107973-107973106.396107.85
4101819-101819100.331101.66
5104277-104277102.754104.17
6107232-107232105.665107.11
480min199422-9942297.969102.133.0499.44103.683.05
2103765-103765102.249103.83
3107731-107731106.157107.77
4100978-10097899.503100.98
5103529-103529102.016103.59
6106425-106425104.870106.47
600min198458-9845897.020101.553.0898.64103.263.09
2104235-104235102.712104.45
3106701-106701105.142106.92
4100340-10034098.874100.50
5102895-102895101.392103.11
6105705-105705104.161105.92
720min198377-9837796.940101.332.7398.70103.192.75
2102893-102893101.390103.28
3106353-106353104.799106.73
4101660-101660100.175101.95
5102526-102526101.028102.90
6105184-105184103.647105.57
960min199296-9929697.845100.222.5199.75102.232.54
2102122-102122100.630102.67
3104632-104632103.103105.19
498463-9846397.02598.95
5101328-10132899.848101.87
6104421-104421102.895104.97
1440min196338-9633894.93199.313.1496.98101.473.15
2101486-101486100.003102.20
3104629-104629103.100105.34
498154-9815496.72098.79
5100471-10047199.003101.18
6103595-103595102.082104.31
极限196558-9655895.14799.463.1997.34101.773.20
2101834-101834100.346102.69
3104694-104694103.164105.56
498017-9801796.58598.80
5100589-10058999.119101.44
6103932-103932102.414104.79
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 10.111114119111794111151651118289111958111170190.21
2 10.031109601110533011074660.28
单位质量响应值RSD%判断
110486.55110415.350.05数据可信
供试品溶液-WM1800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%
5min133133-331333.0003.285.973.003.286.00
236403-364033.2963.30
335451-354513.2103.21
438434-384343.4803.48
535001-350013.1693.17
638827-388273.5153.52
10min179701-797017.2167.954.917.227.964.90
289985-899858.1478.15
388876-888768.0478.05
487168-871687.8927.90
589069-890698.0648.07
692174-921748.3458.35
15min1123319-12331911.16512.174.8411.1812.184.84
2139312-13931212.61312.63
3137318-13731812.43212.45
4130075-13007511.77711.79
5136199-13619912.33112.35
6140224-14022412.69612.71
20min1162237-16223714.68915.844.6714.7215.884.67
2179849-17984916.28316.32
3174869-17486915.83215.87
4168534-16853415.25915.29
5182990-18299016.56816.60
6181410-18141016.42416.46
30min1223839-22383920.26621.483.3520.3221.543.36
2244527-24452722.13922.20
3239066-23906621.64521.70
4232641-23264121.06321.12
5239005-23900521.63921.70
6244688-24468822.15422.22
45min1297682-29768226.95228.835.2727.0428.925.26
2319868-31986828.96029.05
3347881-34788131.49631.59
4309040-30904027.98028.07
5315313-31531328.54828.64
6320781-32078129.04329.14
60min1360039-36003932.59733.922.2732.7234.062.28
2382519-38251934.63234.77
3376377-37637734.07634.22
4370547-37054733.54933.68
5376133-37613334.05434.19
6382497-38249734.63034.77
120min1541046-54104648.98550.391.5749.1650.581.57
2567206-56720651.35451.54
3558241-55824150.54250.73
4554586-55458650.21150.39
5557940-55794050.51550.70
6560547-56054750.75150.94
180min1694856-69485662.91164.171.1663.1664.431.17
2717080-71708064.92365.19
3712926-71292664.54764.81
4705872-70587263.90864.17
5706600-70660063.97464.24
6715356-71535664.76765.03
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1797181-79718172.17573.491.2572.5273.841.25
2821025-82102574.33474.70
3815979-81597973.87774.24
4806336-80633673.00473.36
5806225-80622572.99473.35
6823276-82327674.53874.90
360min1942393-94239385.32286.340.8485.7786.800.85
2966044-96604487.46487.94
3957114-95711486.65587.13
4951543-95154386.15186.61
5949252-94925285.94386.41
6955374-95537486.49886.97
480min11039150-103915094.08294.580.6894.6695.180.68
21055239-105523995.53996.15
31050492-105049295.10995.71
41038501-103850194.02494.62
51039160-103916094.08394.68
61045423-104542394.65095.26
600min11092837-109283798.94399.290.7399.66100.020.73
21111246-1111246100.610101.36
31099814-109981499.575100.32
41089639-108963998.65499.39
51092559-109255998.91899.66
61093623-109362399.01499.76
720min11123645-1123645101.732101.820.53102.60102.700.53
21134249-1134249102.693103.59
31128383-1128383102.161103.06
41117420-1117420101.169102.05
51121322-1121322101.522102.41
61122444-1122444101.624102.52
960min11160802-1160802105.097103.331.10106.12104.371.09
21152644-1152644104.358105.41
31135457-1135457102.802103.85
41128428-1128428102.166103.20
51134266-1134266102.694103.73
61136059-1136059102.856103.90
1440min11142219-1142219103.414103.480.61104.59104.680.61
21155930-1155930104.656105.87
31143182-1143182103.501104.70
41135215-1135215102.780103.97
51139729-1139729103.189104.38
61141497-1141497103.349104.55
极限11142693-1142693103.457103.440.73104.79104.790.73
21157816-1157816104.826106.19
31141925-1141925103.388104.75
41133272-1133272102.604103.94
51138342-1138342103.063104.41
61140788-1140788103.285104.64
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%
112.598291482424825228235282749825920.29
212.488306483470832670.35
单位质量响应值RSD%判断
6560.136672.041.20数据可信
供试品溶液-WM1800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%
5min143367-4336742.16351.2614.2042.1651.2614.20
244207-4420742.98042.98
361514-6151459.80759.81
453466-5346651.98251.98
554963-5496353.43853.44
658821-5882157.18857.19
10min185749-8574983.36983.343.7583.4383.423.76
280387-8038778.15678.22
389580-8958087.09487.18
485602-8560283.22683.30
588383-8838385.93086.01
684638-8463882.28982.37
15min196654-9665493.97190.892.9594.1691.092.94
289492-8949287.00887.19
391057-9105788.53088.75
494081-9408191.47091.67
595831-9583193.17193.38
693776-9377691.17391.38
20min198824-9882496.08192.733.0496.4193.073.03
292083-9208389.52789.84
391632-9163289.08989.44
495856-9585693.19693.54
597049-9704994.35694.70
696842-9684294.15494.50
30min199976-9997697.20193.983.0297.6794.463.00
294714-9471492.08592.53
391940-9194089.38889.88
496784-9678494.09894.58
598122-9812295.39995.89
698433-9843395.70196.19
45min1100422-10042297.63594.103.2898.2594.723.27
293592-9359290.99491.58
392244-9224489.68490.30
497626-9762694.91795.54
598216-9821695.49096.12
698621-9862195.88496.51
60min1104893-104893101.98298.343.42102.7599.103.40
297826-9782695.11195.83
395977-9597793.31394.07
4102617-10261799.769100.53
5102502-10250299.657100.43
6103071-103071100.210100.98
120min1104657-104657101.75298.233.42102.6799.133.41
298036-9803695.31596.18
395642-9564292.98893.88
4101870-10187099.04399.96
5103243-103243100.378101.30
6102734-10273499.883100.81
180min1104977-104977102.06398.003.28103.1399.063.27
298289-9828995.56196.57
395753-9575393.09594.13
4101048-10104898.24499.31
5101940-10194099.111100.19
6102774-10277499.922101.00
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1104358-104358101.46297.663.26102.6998.863.25
298268-9826895.54196.69
395162-9516292.52193.70
4101008-10100898.20599.41
5101368-10136898.55599.78
6102545-10254599.699100.92
360min1103942-103942101.05797.393.13102.4398.743.12
298169-9816995.44496.74
394993-9499392.35793.67
4100888-10088898.08899.44
5101434-10143498.61999.99
6101585-10158598.766100.14
480min1103386-103386100.51796.723.26102.0498.223.25
296936-9693694.24695.68
394418-9441891.79893.25
4100220-10022097.43998.94
5100854-10085498.05599.58
6101089-10108998.28399.81
600min1102720-10272099.86996.373.07101.5598.013.06
297629-9762994.91996.50
393903-9390391.29792.89
499742-9974296.97498.62
599953-9995397.17998.85
6100767-10076797.97099.64
720min1102008-10200899.17795.683.24101.0197.473.23
295598-9559892.94594.67
393560-9356090.96392.69
499386-9938696.62898.42
599512-9951296.75098.56
6100428-10042897.64199.46
960min1102335-10233599.49595.013.54101.4796.933.52
294844-9484492.21294.07
392613-9261390.04391.91
498402-9840295.67197.61
598986-9898696.23998.20
699130-9913096.37998.34
1440min1100670-10067097.87694.263.46100.0096.323.44
294234-9423491.61993.62
391697-9169789.15291.15
497444-9744494.74096.82
598845-9884596.10298.21
698783-9878396.04198.15
极限1100527-10052797.73793.923.38100.0196.133.36
293937-9393791.33093.47
391597-9159789.05591.19
497435-9743594.73196.96
597525-9752594.81897.07
698576-9857695.84098.09
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 10.111118763111275111178101115170111955711168100.26
2 10.031119151111850711188290.05
单位质量响应值RSD%判断
110465.88111548.260.69数据可信
供试品溶液-WM1800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%
5min143491-434913.9183.9013.313.923.9013.38
240329-403293.6333.63
345481-454814.0974.10
441618-416183.7493.75
553120-531204.7854.79
635993-359933.2423.24
10min187430-874307.8768.368.397.888.368.37
288008-880087.9287.93
3107654-1076549.6989.70
495054-950548.5638.57
588990-889908.0178.02
689585-895858.0708.08
15min1136437-13643712.29112.493.6112.3112.513.61
2134072-13407212.07812.10
3146948-14694813.23813.26
4142463-14246312.83412.85
5137266-13726612.36612.39
6134948-13494812.15712.17
20min1175931-17593115.84916.022.7215.8916.062.72
2172970-17297015.58215.62
3185305-18530516.69316.73
4181533-18153316.35416.39
5177759-17775916.01416.05
6173339-17333915.61615.65
30min1243198-24319821.90921.942.2421.9722.002.25
2249343-24934322.46222.52
3249199-24919922.44922.52
4243699-24369921.95422.02
5240689-24068921.68321.74
6234913-23491321.16221.22
45min1318270-31827028.67228.382.1928.7628.482.19
2305676-30567627.53727.63
3324167-32416729.20329.30
4318888-31888828.72828.82
5314749-31474928.35528.45
6308607-30860727.80127.89
60min1396444-39644435.71435.202.0035.8535.342.00
2379119-37911934.15434.29
3399556-39955635.99536.14
4394536-39453635.54235.68
5391063-39106335.22935.37
6384018-38401834.59534.73
120min1583380-58338052.55551.961.5852.7452.151.57
2562127-56212750.64050.83
3584850-58485052.68752.88
4582338-58233852.46152.65
5578403-57840352.10652.30
6569406-56940651.29651.48
180min1719975-71997564.86063.991.2665.1364.261.26
2695200-69520062.62862.89
3717088-71708864.60064.88
4713888-71388864.31264.58
5709165-70916563.88664.15
6706698-70669863.66463.92
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1820432-82043273.91073.071.0874.2873.431.08
2796610-79661071.76472.12
3815299-81529973.44773.82
4817599-81759973.65574.02
5810082-81008272.97773.34
6806309-80630972.63872.99
360min1966685-96668587.08586.160.8987.5686.630.90
2943963-94396385.03885.50
3958582-95858286.35586.84
4963543-96354386.80287.28
5956076-95607686.13086.60
6949639-94963985.55086.02
480min11058504-105850495.35794.460.9195.9695.060.91
21032972-103297293.05793.65
31047084-104708494.32894.94
41058562-105856295.36295.97
51048368-104836894.44495.05
61045993-104599394.23094.82
600min11110641-1110641100.05499.320.64100.80100.060.64
21092161-109216198.38999.12
31101363-110136399.21899.97
41110208-1110208100.015100.77
51100535-110053599.14399.89
61100014-110001499.09699.83
720min11136251-1136251102.361101.650.91103.26102.540.91
21109523-110952399.953100.83
31126383-1126383101.472102.37
41138338-1138338102.549103.45
51129659-1129659101.767102.66
61130244-1130244101.820102.70
960min11189266-1189266107.137103.721.78108.19104.771.76
21129049-1129049101.712102.74
31144728-1144728103.125104.18
41155313-1155313104.078105.13
51145653-1145653103.208104.25
61144281-1144281103.084104.12
1440min11153634-1153634103.927103.520.78105.14104.720.78
21132569-1132569102.029103.21
31146205-1146205103.258104.47
41157061-1157061104.236105.45
51154037-1154037103.963105.16
61150898-1150898103.680104.87
极限11153764-1153764103.939103.350.75105.31104.700.75
21131601-1131601101.942103.27
31144519-1144519103.106104.47
41155262-1155262104.074105.44
51148849-1148849103.496104.85
61149165-1149165103.524104.87
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