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%
112.471621701627861637711626161617741626230.47
212.531642841648861645850.26
单位质量响应值RSD%判断
13041.1413135.280.51数据可信
供试品溶液-25020502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%
5min1108072-10807253.11150.864.2653.1150.864.26
2106429-10642952.30452.30
3104108-10410851.16351.16
497489-9748947.91047.91
598632-9863248.47248.47
6106176-10617652.17952.18
10min1183550-18355090.20486.692.3090.2886.762.30
2178074-17807487.51387.59
3171762-17176284.41184.49
4175173-17517386.08786.16
5174323-17432385.66985.74
6175468-17546886.23286.31
15min1188491-18849192.63289.461.9892.8589.661.98
2183317-18331790.09090.30
3179265-17926588.09888.30
4180999-18099988.95089.15
5178541-17854187.74287.94
6181601-18160189.24689.45
20min1188658-18865892.71489.712.1593.0790.052.15
2185031-18503190.93291.28
3177689-17768987.32487.66
4181805-18180589.34689.68
5179567-17956788.24788.58
6182521-18252189.69890.04
30min1188799-18879992.78489.772.1193.2890.242.11
2181705-18170589.29789.78
3179766-17976688.34488.81
4182804-18280489.83790.31
5177966-17796687.46087.93
6184909-18490990.87291.35
45min1190187-19018793.46690.022.4594.1090.632.45
2181658-18165889.27489.89
3178893-17889387.91588.51
4186248-18624891.53092.13
5178611-17861187.77788.37
6183501-18350190.18090.79
60min1189304-18930493.03289.472.1393.8090.212.13
2182451-18245189.66490.41
3178484-17848487.71488.45
4179940-17994088.43089.17
5179850-17985088.38689.11
6182277-18227789.57890.33
120min1188103-18810392.44289.912.0793.3590.792.07
2186241-18624191.52692.41
3179174-17917488.05388.92
4182374-18237489.62690.50
5178540-17854087.74288.60
6183338-18333890.10090.98
180min1194458-19445895.56592.771.8096.6293.781.81
2189815-18981593.28394.30
3186056-18605691.43692.43
4189333-18933393.04694.05
5184752-18475290.79591.79
6188210-18821092.49493.51
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1193868-19386895.27592.411.8096.4793.571.80
2188847-18884792.80793.97
3185560-18556091.19292.32
4188279-18827992.52893.68
5184038-18403890.44491.57
6187690-18769092.23993.39
360min1192745-19274594.72391.871.7796.0693.161.77
2187927-18792792.35593.66
3184523-18452390.68291.95
4186889-18688991.84593.13
5183258-18325890.06191.32
6186346-18634691.57892.87
480min1192715-19271594.70891.492.0496.1992.922.04
2186956-18695691.87893.32
3182773-18277389.82291.23
4186650-18665091.72793.15
5182129-18212989.50690.90
6185768-18576891.29492.73
600min1190997-19099793.86491.142.1395.4892.702.12
2189000-18900092.88294.46
3181702-18170289.29690.84
4185416-18541691.12192.68
5181043-18104388.97290.51
6184525-18452590.68392.25
720min1189959-18995993.35490.371.9495.1292.081.94
2185042-18504290.93792.65
3180458-18045888.68490.36
4184414-18441490.62992.33
5180393-18039388.65390.32
6183058-18305889.96291.67
极限1190178-19017893.46189.972.2195.3691.812.21
2183941-18394190.39692.25
3179843-17984388.38290.19
4183366-18336690.11491.95
5178630-17863087.78689.59
6182517-18251789.69691.54
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 10.131089846109158510966561097890109239710936750.32
210.081106394111041111084020.26
单位质量响应值RSD%判断
107963.97109960.521.30数据可信
供试品溶液-25020502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%
5min152190-521904.7904.2914.764.794.2914.75
244912-449124.1224.12
342893-428933.9373.94
440184-401843.6883.69
542397-423973.8913.89
658073-580735.3305.33
10min199053-990539.0919.441.919.109.441.90
2104077-1040779.5529.56
3102904-1029049.4459.45
4104536-1045369.5959.60
5103424-1034249.4939.50
6102793-1027939.4359.44
15min1151310-15131013.88814.281.5213.9114.301.51
2156653-15665314.37814.40
3158431-15843114.54114.56
4155962-15596214.31514.33
5155352-15535214.25914.28
6155785-15578514.29814.32
20min1191810-19181017.60518.344.4817.6518.394.47
2217439-21743919.95720.00
3198722-19872218.23918.28
4196229-19622918.01018.05
5197836-19783618.15818.20
6197162-19716218.09618.14
30min1256467-25646723.53924.181.7523.6124.261.74
2261170-26117023.97124.04
3266806-26680624.48824.56
4269372-26937224.72424.79
5261901-26190124.03824.11
6265305-26530524.35024.42
45min1336383-33638330.87431.271.0930.9831.381.09
2337892-33789231.01331.12
3342244-34224431.41231.52
4346834-34683431.83331.94
5339604-33960431.17031.27
6341264-34126431.32231.43
60min1398411-39841136.56736.800.6336.7236.950.63
2401648-40164836.86437.02
3403126-40312637.00037.15
4397446-39744636.47936.63
5403730-40373037.05537.21
6401202-40120236.82336.98
120min1574530-57453052.73253.461.0552.9453.671.05
2592172-59217254.35154.56
3585788-58578853.76553.97
4578447-57844753.09153.30
5581192-58119253.34353.55
6582599-58259953.47253.68
180min1723800-72380066.43267.050.6266.7267.330.62
2731726-73172667.16067.45
3737191-73719167.66167.95
4729616-72961666.96667.25
5732333-73233367.21567.50
6728256-72825666.84167.13
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1823335-82333575.56875.920.5675.9576.310.56
2826468-82646875.85576.25
3835919-83591976.72377.11
4827633-82763375.96276.35
5826085-82608575.82076.21
6823778-82377875.60876.00
360min1958099-95809987.93788.180.6088.4388.680.60
2960630-96063088.16988.67
3971539-97153989.17089.68
4957261-95726187.86088.36
5961439-96143988.24388.75
6955551-95555187.70388.21
480min11043543-104354395.77995.670.2896.4196.310.28
21040748-104074895.52396.16
31046665-104666596.06696.71
41040559-104055995.50596.14
51044092-104409295.82996.46
61038751-103875195.33995.97
600min11085817-108581799.659100.010.54100.43100.790.54
21100306-1100306100.989101.77
31090826-1090826100.119100.90
41085737-108573799.652100.43
51090404-1090404100.080100.86
61084913-108491399.576100.35
720min11105767-1105767101.490101.610.30102.41102.540.30
21106338-1106338101.543102.48
31111361-1111361102.004102.94
41103977-1103977101.326102.25
51110870-1110870101.959102.89
61103974-1103974101.326102.25
极限11106591-1106591101.566101.370.24102.64102.460.24
21101547-1101547101.103102.19
31108379-1108379101.730102.82
41101898-1101898101.135102.21
51104045-1104045101.332102.41
61104563-1104563101.380102.46
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%
112.471644861638991647861649201637501643680.32
212.531656331643501649920.55
单位质量响应值RSD%判断
13181.0713167.760.08数据可信
供试品溶液-25020501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%
5min1132360-13236064.62161.779.8164.6261.779.81
2148617-14861772.55872.56
3114486-11448655.89455.89
4119436-11943658.31158.31
5119544-11954458.36458.36
6124692-12469260.87760.88
10min1181165-18116588.44890.871.5188.5590.961.51
2188207-18820791.88692.00
3185795-18579590.70990.79
4187017-18701791.30591.39
5189130-18913092.33792.42
6185415-18541590.52390.61
15min1182959-18295989.32493.062.1589.5593.292.15
2190527-19052793.01993.27
3192318-19231893.89394.11
4191706-19170693.59593.82
5195180-19518095.29195.52
6190989-19098993.24493.47
20min1185908-18590890.76493.511.8091.1393.881.79
2190508-19050893.01093.40
3191890-19189093.68494.05
4192197-19219793.83494.20
5196557-19655795.96396.33
6192106-19210693.79094.16
30min1186891-18689191.24493.591.5691.7494.101.56
2190923-19092393.21293.74
3191527-19152793.50794.01
4193166-19316694.30794.81
5196008-19600895.69596.21
6191644-19164493.56494.07
45min1187574-18757491.57793.441.4192.2194.091.41
2191045-19104593.27293.94
3190366-19036692.94093.58
4192726-19272694.09394.74
5195678-19567895.53496.19
6190930-19093093.21693.86
60min1187166-18716691.37893.872.4892.1594.662.46
2187683-18768391.63092.44
3191842-19184293.66194.44
4193908-19390894.67095.46
5200206-20020697.74498.54
6192790-19279094.12494.91
120min1191323-19132393.40893.541.2394.3294.471.23
2191184-19118493.34094.28
3189662-18966292.59793.52
4189738-18973892.63493.56
5196085-19608595.73296.68
6191541-19154193.51494.44
180min1196047-19604795.71496.491.0596.7797.561.05
2195434-19543495.41596.50
3197751-19775196.54697.61
4199191-19919197.24998.32
5200863-20086398.06599.16
6196502-19650295.93697.01
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1193737-19373794.58696.001.9795.7897.211.95
2190074-19007492.79894.02
3199100-19910097.20498.41
4198768-19876897.04298.26
5199708-19970897.50198.74
6198384-19838496.85598.07
360min1190312-19031292.91495.252.0894.2596.612.06
2189911-18991192.71894.08
3195507-19550795.45096.80
4197177-19717796.26697.63
5198749-19874997.03398.42
6198908-19890897.11198.47
480min1190237-19023792.87794.841.5294.3596.341.51
2192638-19263894.05095.55
3194531-19453194.97496.47
4196867-19686796.11497.62
5198249-19824996.78998.32
6193015-19301594.23495.74
600min1189733-18973392.63194.591.7294.2596.231.71
2189807-18980792.66794.31
3194445-19444594.93296.57
4194176-19417694.80096.45
5197356-19735696.35398.03
6196933-19693396.14697.79
720min1188423-18842391.99294.581.4493.7596.361.43
2195149-19514995.27597.06
3192892-19289294.17495.95
4194696-19469695.05496.85
5195669-19566995.52997.35
6195483-19548395.43997.23
极限1188253-18825391.90993.691.5793.8095.611.55
2190032-19003292.77794.70
3191492-19149293.49095.41
4193613-19361394.52696.46
5191087-19108793.29295.25
6196872-19687296.11798.05
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 10.131105878110335411075021106956109962911046640.30
210.081110651110373611071940.45
单位质量响应值RSD%判断
109048.77109840.670.52数据可信
供试品溶液-25020501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%
5min145379-453794.1463.955.204.153.955.24
243510-435103.9763.98
339519-395193.6113.61
442458-424583.8793.88
542610-426103.8933.89
645615-456154.1684.17
10min1108172-1081729.8849.593.239.899.603.24
2108244-1082449.8909.90
399446-994469.0879.09
4103229-1032299.4329.44
5104223-1042239.5239.53
6106433-1064339.7259.73
15min1155078-15507814.17014.171.4614.1914.191.46
2157381-15738114.38014.40
3152637-15263713.94713.97
4153313-15331314.00814.03
5158235-15823514.45814.48
6153938-15393814.06614.09
20min1196506-19650617.95517.983.1218.0018.023.10
2196686-19668617.97118.01
3192050-19205017.54817.59
4193671-19367117.69617.74
5208707-20870719.07019.11
6193160-19316017.64917.69
30min1260002-26000223.75723.561.2923.8323.631.29
2259279-25927923.69123.76
3253835-25383523.19323.26
4256815-25681523.46623.53
5262450-26245023.98024.05
6254771-25477123.27923.35
45min1334961-33496130.60630.261.3230.7130.361.32
2332464-33246430.37830.48
3327125-32712529.89029.99
4329766-32976630.13130.23
5336875-33687530.78130.89
6325867-32586729.77529.88
60min1394675-39467536.06236.173.2736.2136.313.27
2387909-38790935.44435.59
3390136-39013635.64735.79
4392463-39246335.86036.01
5421629-42162938.52538.68
6388006-38800635.45335.60
120min1576323-57632352.66051.631.8252.8651.841.81
2572634-57263452.32252.53
3556179-55617950.81951.02
4554880-55488050.70050.90
5574117-57411752.45852.67
6556430-55643050.84251.04
180min1722083-72208365.97864.641.5866.2664.921.58
2704632-70463264.38364.67
3703176-70317664.25064.53
4702056-70205664.14864.43
5719543-71954365.74666.03
6693109-69310963.33063.61
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1806847-80684773.72372.951.2174.1173.331.21
2781249-78124971.38471.76
3799848-79984873.08373.46
4797907-79790772.90673.28
5808042-80804273.83274.22
6796278-79627872.75773.13
360min1935386-93538685.46884.890.9585.9685.380.95
2915703-91570383.66984.15
3927349-92734984.73385.21
4923179-92317984.35284.84
5939756-93975685.86786.37
6932913-93291385.24285.72
480min11022367-102236793.41592.571.1094.0493.191.10
21013556-101355692.61093.22
31009880-100988092.27492.88
41011199-101119992.39593.00
51026858-102685893.82694.45
6995011-99501190.91691.53
600min11070208-107020897.78796.970.9898.5597.720.98
21052668-105266896.18496.93
31057839-105783996.65697.40
41047183-104718395.68396.43
51073159-107315998.05698.82
61066797-106679797.47598.22
720min11094001-109400199.96199.250.62100.87100.150.62
21086459-108645999.271100.17
31081052-108105298.77799.67
41076128-107612898.32799.22
51091509-109150999.733100.65
61088193-108819399.430100.32
极限11093341-109334199.90098.980.93100.96100.030.92
21081633-108163398.83099.87
31078849-107884998.57699.62
41075863-107586398.30399.34
51072534-107253497.99999.06
61097582-1097582100.288101.33
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