达格列净二甲双胍片项目信息
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%
112.431570101574221571361574031574011572740.13
212.551586661580641583650.27
单位质量响应值RSD%判断
12652.7812618.730.20数据可信
供试品溶液-24110601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%
5min1165363-16536384.17583.074.7284.1883.074.72
2173910-17391088.52688.53
3160640-16064081.77181.77
4157580-15758080.21380.21
5152865-15286577.81377.81
6168772-16877285.91085.91
10min1179741-17974191.49490.314.1091.6290.444.10
2188474-18847495.93996.07
3173288-17328888.20988.33
4174009-17400988.57688.70
5167785-16778585.40885.52
6181243-18124392.25992.39
15min1183130-18313093.21992.814.0193.4893.074.02
2193962-19396298.73399.01
3178021-17802190.61990.87
4178830-17883091.03091.28
5173326-17332688.22988.47
6186723-18672395.04895.32
20min1184303-18430393.81693.723.9694.2294.123.96
2196288-19628899.917100.34
3179415-17941591.32891.72
4180515-18051591.88892.28
5176003-17600389.59189.97
6188199-18819995.79996.21
30min1185532-18553294.44294.643.9194.9995.183.91
2198286-198286100.934101.51
3180937-18093792.10392.63
4182701-18270193.00193.53
5178207-17820790.71391.22
6189846-18984696.63897.19
45min1186186-18618694.77595.043.7695.4695.723.76
2198950-198950101.272102.00
3181816-18181692.55093.22
4183607-18360793.46294.13
5179599-17959991.42292.07
6190037-19003796.73597.43
60min1185598-18559894.47595.143.8295.3095.963.82
2198805-198805101.198102.08
3181852-18185292.56993.37
4183848-18384893.58594.39
5179635-17963591.44092.22
6191703-19170397.58398.43
120min1185386-18538694.36895.073.8695.3496.043.86
2198737-198737101.164102.19
3181630-18163092.45693.40
4183831-18383193.57694.52
5179366-17936691.30392.23
6191679-19167997.57198.56
180min1185080-18508094.21294.943.8595.3296.043.85
2198692-198692101.141102.32
3181383-18138392.33093.41
4184186-18418693.75794.84
5178937-17893791.08592.14
6190754-19075497.10098.24
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1191455-19145597.45798.143.7498.7199.393.74
2204811-204811104.256105.59
3187651-18765195.52196.74
4190188-19018896.81298.04
5185180-18518094.26395.46
6197478-197478100.523101.80
360min1190203-19020396.82097.543.7298.2298.943.72
2203896-203896103.790105.28
3186480-18648094.92496.29
4188682-18868296.04597.42
5184642-18464293.98995.33
6195767-19576799.652101.08
480min1189736-18973696.58297.163.6298.1398.713.62
2202547-202547103.103104.75
3186079-18607994.72096.23
4187935-18793595.66597.18
5183797-18379793.55995.04
6195148-19514899.337100.92
600min1188457-18845795.93196.613.6997.6298.303.70
2201670-201670102.657104.46
3184582-18458293.95895.61
4187177-18717795.27996.94
5182736-18273693.01994.64
6194086-19408698.796100.53
720min1187094-18709495.23796.103.7397.0797.943.73
2200942-200942102.286104.24
3183732-18373293.52695.32
4186191-18619194.77796.58
5181895-18189592.59194.35
6192903-19290398.194100.07
960min1185717-18571794.53695.193.5196.5197.173.52
2198393-198393100.989103.10
3182456-18245692.87694.81
4184297-18429793.81395.76
5180512-18051291.88793.78
6190597-19059797.02099.05
1200min1184465-18446593.89994.523.6696.0296.643.67
2197327-197327100.446102.70
3180691-18069191.97894.05
4183157-18315793.23395.32
5178847-17884791.03993.07
6189648-18964896.53798.71
极限1183864-18386493.59394.283.5195.8596.553.52
2196526-196526100.038102.45
3180464-18046491.86294.07
4182756-18275693.02995.26
5178899-17889991.06593.24
6188805-18880596.10898.42
达格列净二甲双胍片项目信息
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%
110.019878459871839891579903499903549889780.15
210.081004108100367610038920.04
单位质量响应值RSD%判断
98799.0099592.460.57数据可信
供试品溶液-24110601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%
5min147554-475544.7943.8514.114.793.8514.07
237907-379073.8213.82
339866-398664.0194.02
433426-334263.3703.37
532532-325323.2803.28
638045-380453.8353.84
10min193386-933869.4148.725.829.428.735.81
288895-888958.9628.97
389438-894389.0169.02
481794-817948.2468.25
580051-800518.0708.08
685474-854748.6178.62
15min1134710-13471013.58013.515.0813.6013.535.08
2131261-13126113.23313.25
3138725-13872513.98514.00
4122144-12214412.31412.33
5135521-13552113.66213.68
6141652-14165214.28014.30
20min1169937-16993717.13216.353.6517.1716.383.66
2166615-16661516.79716.84
3165262-16526216.66016.70
4155527-15552715.67915.71
5156640-15664015.79115.83
6158944-15894416.02416.06
30min1240012-24001224.19622.245.0324.2622.305.02
2223817-22381722.56422.63
3223250-22325022.50622.57
4209929-20992921.16321.22
5212961-21296121.46921.53
6213742-21374221.54821.61
45min1296053-29605329.84628.842.8729.9528.932.87
2292639-29263929.50229.60
3291087-29108729.34529.44
4276218-27621827.84627.94
5280127-28012728.24028.33
6280120-28012028.24028.34
60min1352719-35271935.55834.492.6935.7134.632.70
2349434-34943435.22735.37
3348548-34854835.13835.28
4330733-33073333.34233.47
5335208-33520833.79333.93
6335991-33599133.87234.01
120min1518116-51811652.23350.852.5752.4351.042.57
2515877-51587752.00752.20
3513996-51399651.81752.01
4489127-48912749.31049.49
5494413-49441349.84350.03
6494932-49493249.89550.08
180min1633160-63316063.83062.682.6464.1162.952.64
2644981-64498165.02265.30
3629721-62972163.48463.76
4605535-60553561.04561.30
5609554-60955461.45161.71
6607700-60770061.26461.53
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1744280-74428075.03373.511.9575.4173.871.95
2740856-74085674.68775.06
3741000-74100074.70275.07
4717112-71711272.29472.64
5716702-71670272.25272.61
6715167-71516772.09872.45
360min1862560-86256086.95785.911.7387.4586.381.73
2860510-86051086.75087.23
3871954-87195487.90488.38
4839643-83964384.64685.10
5841946-84194684.87985.34
6836386-83638684.31884.78
480min1940587-94058794.82393.461.7095.4494.061.70
2934134-93413494.17294.79
3947010-94701095.47096.08
4917181-91718192.46393.05
5914973-91497392.24192.83
6908274-90827491.56592.16
600min1983390-98339099.13898.021.7499.9098.761.74
2978605-97860598.65699.41
3996574-996574100.467101.22
4963415-96341597.12497.85
5960898-96089896.87097.60
6950729-95072995.84596.57
720min11003611-1003611101.176100.291.32102.09101.181.33
2998552-998552100.666101.57
31012001-1012001102.022102.93
4988394-98839499.642100.51
5992184-992184100.024100.90
6974233-97423398.21599.09
960min11017878-1017878102.615101.491.48103.68102.531.48
21010686-1010686101.890102.94
31026692-1026692103.503104.56
41001839-1001839100.998102.02
5998154-998154100.626101.65
6985219-98521999.322100.34
1200min11017914-1017914102.618101.591.40103.83102.781.40
21012465-1012465102.069103.27
31025236-1025236103.357104.57
41006106-1006106101.428102.60
5998919-998919100.703101.88
6985916-98591699.393100.56
极限11016820-1016820102.508101.461.35103.88102.811.35
21011457-1011457101.967103.33
31023026-1023026103.134104.50
41003492-1003492101.164102.49
5998358-998358100.647101.97
6985620-98562099.363100.68
达格列净二甲双胍片项目信息
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%
112.431586431585811588631587891588231587400.08
212.551598061596791597420.06
单位质量响应值RSD%判断
12770.7212728.450.24数据可信
供试品溶液-TL3535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%
5min1103043-10304351.98447.4819.8351.9847.4819.83
2104997-10499752.97052.97
399379-9937950.13650.14
456380-5638028.44328.44
5102748-10274851.83551.84
698142-9814249.51249.51
10min1168182-16818284.84681.3615.2984.9281.4315.30
2179479-17947990.54590.62
3166866-16686684.18284.26
4113020-11302057.01757.06
5178606-17860690.10590.18
6161486-16148681.46881.54
15min1186201-18620193.93691.409.3794.1491.599.39
2192985-19298597.35997.57
3183993-18399392.82293.02
4148526-14852674.93075.06
5195334-19533498.54498.76
6179989-17998990.80291.00
20min1191068-19106896.39293.219.2296.7493.549.24
2194449-19444998.09798.46
3190123-19012395.91596.26
4151077-15107776.21776.46
5197141-19714199.45599.82
6184733-18473393.19693.53
30min1194961-19496198.35695.886.8698.8596.356.89
2196933-19693399.35099.86
3195180-19518098.46698.95
4164585-16458583.03183.39
5200101-200101100.949101.46
6188503-18850395.09895.57
45min1197804-19780499.79097.784.70100.4398.394.74
2196923-19692399.345100.00
3197684-19768499.729100.36
4176485-17648589.03589.51
5202142-202142101.978102.64
6191870-19187096.79697.41
60min1199390-199390100.59098.853.38101.3899.613.43
2197293-19729399.532100.34
3198251-198251100.015100.80
4184307-18430792.98193.59
5203387-203387102.606103.42
6193001-19300197.36798.13
120min1201059-201059101.43299.911.96102.37100.812.00
2197219-19721999.495100.45
3198377-198377100.079101.01
4194107-19410797.92598.68
5203662-203662102.745103.71
6193776-19377697.75898.66
180min1201404-201404101.606100.091.89102.70101.151.91
2196625-19662599.195100.30
3198423-198423100.102101.18
4196678-19667899.222100.12
5203889-203889102.860103.98
6193400-19340097.56898.62
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1208592-208592105.232103.601.93106.48104.821.94
2203346-203346102.586103.84
3204772-204772103.305104.54
4205154-205154103.498104.55
5210799-210799106.346107.62
6199526-199526100.659101.86
360min1207785-207785104.825103.661.78106.23105.021.77
2202889-202889102.355103.76
3205694-205694103.770105.16
4206671-206671104.263105.47
5210015-210015105.950107.39
6199766-199766100.780102.13
480min1206273-206273104.062102.771.81105.62104.291.80
2201374-201374101.591103.15
3203221-203221102.523104.07
4205346-205346103.595104.95
5208118-208118104.993106.59
6197934-19793499.855101.36
600min1205072-205072103.456102.301.99105.17103.971.97
2200524-200524101.162102.88
3201952-201952101.882103.58
4205010-205010103.425104.94
5207703-207703104.784106.54
6196387-19638799.075100.73
720min1205021-205021103.431101.902.04105.30103.732.01
2199066-199066100.427102.29
3200802-200802101.302103.15
4204744-204744103.291104.96
5206448-206448104.151106.06
6195845-19584598.802100.60
960min1202760-202760102.290101.001.87104.32102.981.84
2197726-19772699.751101.77
3198650-198650100.217102.22
4202617-202617102.218104.04
5204628-204628103.232105.30
6194821-19482198.285100.23
1200min1201199-201199101.503100.301.84103.68102.431.81
2196258-19625899.010101.18
3197865-19786599.821101.97
4201169-201169101.487103.47
5203021-203021102.422104.64
6193332-19333297.53499.63
极限1201283-201283101.545100.171.88103.88102.451.85
2195844-19584498.801101.12
3197468-19746899.620101.92
4201165-201165101.485103.62
5202529-202529102.174104.55
6193030-19303097.38199.62
达格列净二甲双胍片项目信息
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%
110.011008280100941210092451008875100895110089530.05
210.081006448100600410062260.04
单位质量响应值RSD%判断
100794.5199824.010.69数据可信
供试品溶液-TL3535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%
5min138005-380053.7892.7621.593.792.7621.60
224697-246972.4622.46
323228-232282.3162.32
431785-317853.1693.17
524083-240832.4012.40
624084-240842.4012.40
10min164169-641696.3976.224.726.406.224.71
266188-661886.5996.60
362044-620446.1856.19
457457-574575.7285.73
563017-630176.2826.29
661535-615356.1356.14
15min1103583-10358310.32711.6629.3010.3411.6729.27
2104612-10461210.42910.44
398592-985929.8299.84
4186733-18673318.61618.63
5103779-10377910.34610.36
6104425-10442510.41110.42
20min1135249-13524913.48413.143.7813.5113.173.75
2136004-13600413.55913.59
3131561-13156113.11613.14
4123885-12388512.35112.39
5136035-13603513.56213.59
6128076-12807612.76812.80
30min1189305-18930518.87318.196.0118.9218.245.96
2189866-18986618.92918.98
3184868-18486818.43018.48
4161559-16155916.10616.17
5189292-18929218.87118.92
6179569-17956917.90217.95
45min1253797-25379725.30224.505.0925.3824.575.07
2253485-25348525.27125.35
3248943-24894324.81824.89
4221670-22167022.09922.18
5253435-25343525.26625.34
6242967-24296724.22224.30
60min1307680-30768030.67429.814.3630.7929.924.34
2306739-30673930.58030.70
3302313-30231330.13930.25
4274188-27418827.33527.45
5307540-30754030.66030.77
6295416-29541629.45129.56
120min1466081-46608146.46545.572.9446.6345.732.93
2463322-46332246.19046.35
3465891-46589146.44746.60
4433229-43322943.19043.35
5465356-46535646.39346.55
6448894-44889444.75244.91
180min1579408-57940857.76456.842.1158.0057.072.11
2575235-57523557.34757.58
3574635-57463557.28857.51
4550497-55049754.88155.10
5580661-58066157.88858.12
6560618-56061855.89056.11
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1688091-68809168.59967.761.5768.9268.071.57
2681897-68189767.98168.30
3684757-68475768.26668.58
4666483-66648366.44466.75
5690267-69026768.81569.13
6666416-66641666.43866.74
360min1816578-81657881.40880.841.2581.8381.251.25
2809652-80965280.71781.14
3821148-82114881.86482.28
4801168-80116879.87280.28
5819660-81966081.71582.14
6796789-79678979.43579.84
480min1898272-89827289.55289.380.8390.1089.920.83
2893818-89381889.10889.65
3905766-90576690.29990.84
4889572-88957288.68589.21
5903991-90399190.12390.67
6888113-88811388.54089.06
600min1950116-95011694.72194.491.0795.4095.161.07
2946357-94635794.34695.02
3959106-95910695.61796.29
4947651-94765194.47595.13
5954324-95432495.14095.82
6929540-92954092.67093.33
720min1976312-97631297.33297.180.9198.1598.000.91
2970575-97057596.76197.58
3984231-98423198.12298.94
4977633-97763397.46498.26
5980655-98065597.76598.59
6959494-95949495.65696.45
960min1994010-99401099.09798.970.61100.0699.930.61
2990222-99022298.71999.68
3998200-99820099.515100.48
4996236-99623699.319100.26
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