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%
112.701647801658971668091644461659791655820.59
212.781661691655841658760.25
单位质量响应值RSD%判断
13037.9512979.340.32数据可信
供试品溶液-25041503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%
5min1142956-14295670.68475.209.5770.6875.209.57
2128519-12851963.54563.55
3154834-15483476.55776.56
4154659-15465976.47076.47
5169567-16956783.84183.84
6162059-16205980.12980.13
10min1198803-19880398.29798.162.3398.4098.272.33
2191608-19160894.73994.83
3206001-206001101.856101.97
4197518-19751897.66197.78
5197681-19768197.74297.87
6199561-19956198.67298.79
15min1203980-203980100.856100.032.14101.11100.292.14
2197411-19741197.60897.85
3209777-209777103.723103.99
4200206-20020698.99099.25
5199840-19984098.80999.08
6202641-202641100.194100.46
20min1206363-206363102.035100.431.95102.44100.841.95
2199111-19911198.44998.83
3209114-209114103.395103.82
4200090-20009098.93399.34
5200620-20062099.19599.62
6203414-203414100.577101.00
30min1206784-206784102.243100.832.07102.80101.392.07
2199917-19991798.84899.38
3210840-210840104.248104.83
4200206-20020698.99099.55
5202312-202312100.032100.60
6203448-203448100.593101.16
45min1207137-207137102.417100.792.00103.13101.502.00
2200313-20031399.04399.72
3210389-210389104.025104.76
4200308-20030899.04199.75
5202145-20214599.949100.67
6202764-202764100.255100.98
60min1207814-207814102.752100.942.16103.62101.812.16
2201022-20102299.394100.22
3211157-211157104.405105.30
4200090-20009098.93399.79
5201468-20146899.614100.48
6203391-203391100.565101.44
120min1207462-207462102.578100.751.96103.60101.761.96
2200969-20096999.368100.35
3209875-209875103.771104.82
4199774-19977498.77799.78
5202136-20213699.945100.96
6202327-202327100.039101.06
180min1214879-214879106.245104.341.97107.42105.501.97
2208324-208324103.004104.13
3217418-217418107.501108.70
4207146-207146102.422103.57
5208396-208396103.040104.21
6209956-209956103.811104.98
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1213516-213516105.571103.842.03106.90105.172.03
2207436-207436102.565103.85
3216877-216877107.233108.60
4205681-205681101.697103.00
5208627-208627103.154104.48
6208002-208002102.845104.17
360min1212478-212478105.058103.322.02106.55104.802.01
2208983-208983103.330104.76
3215175-215175106.392107.92
4203724-203724100.730102.19
5206680-206680102.191103.67
6206754-206754102.228103.71
480min1210231-210231103.947102.451.85105.60104.081.85
2205314-205314101.516103.11
3213313-213313105.471107.16
4202906-202906100.325101.93
5205914-205914101.813103.44
6205526-205526101.621103.26
600min1208506-208506103.094101.531.97104.90103.311.97
2202740-202740100.243101.99
3211586-211586104.617106.46
4200574-20057499.172100.93
5204818-204818101.271103.05
6203781-203781100.758102.55
720min1207803-207803102.747101.051.73104.71102.991.73
2202142-20214299.948101.84
3209420-209420103.546105.55
4200119-20011998.947100.86
5203249-203249100.495102.43
6203526-203526100.632102.57
极限1207556-207556102.625100.641.89104.74102.741.89
2202125-20212599.939101.98
3208725-208725103.203105.36
4198539-19853998.166100.22
5201895-20189599.826101.91
6202473-202473100.111102.20
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%
19.991086572109329810989471086661109330010917560.48
29.961093725109091510923200.19
单位质量响应值RSD%判断
109284.88109670.680.25数据可信
供试品溶液-25041503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%
5min144616-446164.0754.199.094.084.199.07
239739-397393.6303.63
352249-522494.7734.77
446856-468564.2804.28
547587-475874.3474.35
644125-441254.0314.03
10min1104724-1047249.5669.664.069.579.674.06
299058-990589.0489.05
3105023-1050239.5939.60
4107181-1071819.7909.80
5112302-11230210.25810.26
6106461-1064619.7249.73
15min1153394-15339414.01114.083.1514.0314.103.14
2146766-14676613.40613.43
3152103-15210313.89413.92
4156224-15622414.27014.29
5161463-16146314.74914.77
6154847-15484714.14414.16
20min1190676-19067617.41717.822.8017.4617.872.80
2192788-19278817.61017.65
3189779-18977917.33517.38
4201947-20194718.44618.49
5201951-20195118.44718.49
6193598-19359817.68417.73
30min1254499-25449923.24723.532.5023.3123.602.51
2249837-24983722.82122.89
3255457-25545723.33423.40
4258140-25814023.57923.65
5269042-26904224.57524.65
6258551-25855123.61723.69
45min1329763-32976330.12230.392.4830.2230.492.49
2326819-32681929.85329.95
3324592-32459229.64929.75
4333105-33310530.42730.53
5347826-34782631.77131.88
6333964-33396430.50530.61
60min1391744-39174435.78336.182.2635.9336.332.26
2389080-38908035.54035.68
3390435-39043535.66435.81
4394720-39472036.05536.21
5413260-41326037.74837.90
6397339-39733936.29436.44
120min1567609-56760951.84752.653.3452.0552.863.33
2567539-56753951.84152.04
3559689-55968951.12451.33
4572943-57294352.33452.54
5613779-61377956.06456.28
6576949-57694952.70052.90
180min1713491-71349165.17266.062.7065.4566.342.69
2715162-71516265.32565.60
3705164-70516464.41264.69
4718236-71823665.60665.89
5760186-76018669.43869.73
6727181-72718166.42366.71
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1805107-80510773.54174.642.5373.9275.032.53
2809834-80983473.97374.35
3799586-79958673.03773.41
4811153-81115374.09374.48
5856825-85682578.26578.67
6820658-82065874.96175.34
360min1935894-93589485.48787.102.2485.9787.602.25
2958153-95815387.52188.01
3934890-93489085.39685.88
4944829-94482986.30486.80
5992530-99253090.66191.18
6954985-95498587.23187.73
480min11014809-101480992.69694.182.1393.3194.802.13
21023545-102354593.49494.11
31013556-101355692.58193.19
41023827-102382793.51994.14
51071758-107175897.89898.55
61038621-103862194.87195.50
600min11059693-105969396.79698.082.0997.5598.852.09
21060505-106050596.87097.63
31058042-105804296.64597.40
41065383-106538397.31598.08
51115174-1115174101.863102.66
61083826-108382699.00099.77
720min11077986-107798698.46699.871.9699.37100.791.97
21084097-108409799.02599.93
31072887-107288798.00198.90
41087808-108780899.364100.27
51129534-1129534103.175104.13
61108003-1108003101.208102.13
极限11077287-107728798.40399.831.9399.45100.891.93
21085464-108546499.150100.20
31074837-107483798.17999.22
41085225-108522599.128100.19
51130274-1130274103.243104.35
61104415-1104415100.881101.95
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