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%
112.431587321588181588201590761587991588490.09
212.551601291604471602880.15
单位质量响应值RSD%判断
12779.4912771.950.05数据可信
供试品溶液-24112601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%
5min1112389-11238956.58346.4718.8856.5846.4718.88
271459-7145935.97635.98
3102548-10254851.62851.63
473023-7302336.76436.76
5106007-10600753.37053.37
688364-8836444.48744.49
10min1182202-18220291.73188.844.9791.8288.914.98
2160526-16052680.81880.87
3181174-18117491.21391.29
4171744-17174486.46586.52
5181187-18118791.22091.30
6181971-18197191.61491.68
15min1192825-19282597.07995.791.9997.3095.992.00
2183798-18379892.53492.71
3191352-19135296.33796.55
4187812-18781294.55594.74
5191920-19192096.62396.84
6193896-19389697.61897.82
20min1197396-19739699.38098.151.7699.7598.501.78
2189037-18903795.17295.49
3195503-19550398.42798.79
4193059-19305997.19797.52
5196273-19627398.81599.18
6198438-19843899.905100.26
30min1203256-203256102.330100.721.77102.85101.211.78
2194136-19413697.73998.20
3201838-201838101.616102.12
4197376-19737699.37099.84
5201758-201758101.576102.09
6201935-201935101.665102.17
45min1205025-205025103.221101.811.72103.89102.451.74
2195929-19592998.64199.24
3204737-204737103.076103.73
4200843-200843101.115101.74
5202417-202417101.908102.57
6204371-204371102.892103.54
60min1205519-205519103.470101.911.75104.30102.711.77
2196315-19631598.83699.59
3204772-204772103.094103.91
4200977-200977101.183101.96
5201706-201706101.550102.37
6205190-205190103.304104.11
120min1204222-204222102.817102.021.52103.80102.971.54
2196563-19656398.96199.86
3203536-203536102.471103.44
4202748-202748102.075103.00
5203646-203646102.527103.49
6205120-205120103.269104.23
180min1205104-205104103.261101.731.74104.40102.841.75
2195645-19564598.49899.55
3203479-203479102.443103.56
4200846-200846101.117102.20
5202667-202667102.034103.16
6204690-204690103.052104.17
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1217003-217003109.251107.661.64110.54108.911.65
2207286-207286104.359105.55
3214348-214348107.915109.19
4213103-213103107.288108.52
5214920-214920108.203109.48
6216336-216336108.915110.19
360min1214290-214290107.885106.891.27109.34108.311.29
2207626-207626104.530105.88
3212402-212402106.935108.37
4211334-211334106.397107.79
5212921-212921107.196108.63
6215306-215306108.397109.83
480min1213600-213600107.538105.931.75109.15107.511.75
2204044-204044102.727104.24
3210686-210686106.071107.67
4208636-208636105.039106.59
5211712-211712106.587108.19
6213795-213795107.636109.23
600min1211414-211414106.437105.071.70108.21106.801.71
2201946-201946101.671103.33
3208707-208707105.075106.83
4209009-209009105.227106.93
5209453-209453105.450107.21
6211642-211642106.552108.31
720min1210815-210815106.136103.971.86108.07105.861.87
2200151-200151100.767102.58
3205863-205863103.643105.56
4204784-204784103.100104.97
5207916-207916104.676106.59
6209517-209517105.482107.40
960min1205032-205032103.224101.611.68105.32103.661.69
2196052-19605298.703100.67
3201624-201624101.509103.58
4200446-200446100.916102.94
5202707-202707102.054104.13
6205133-205133103.275105.35
1200min1201075-201075101.23299.841.66103.48102.041.68
2192503-19250396.91799.03
3198513-19851399.942102.16
4197016-19701699.189101.36
5199233-199233100.305102.53
6201508-201508101.450103.68
极限1201529-201529101.46199.851.78103.86102.201.78
2191854-19185496.59098.85
3197938-19793899.653102.02
4198177-19817799.773102.09
5199225-199225100.301102.68
6201242-201242101.316103.70
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%
110.019526619527769519749517369522169522730.05
210.089624599632039628310.06
单位质量响应值RSD%判断
95132.1795518.950.29数据可信
供试品溶液-24112601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%
5min137099-370993.8923.496.343.893.496.27
231514-315143.3063.31
333930-339303.5593.56
433324-333243.4963.50
531517-315173.3063.31
632293-322933.3883.39
10min187863-878639.2178.267.069.228.277.06
272868-728687.6447.65
382269-822698.6308.64
474027-740277.7667.77
577969-779698.1798.18
677524-775248.1338.14
15min1124610-12461013.07212.523.1113.0912.543.13
2115214-11521412.08612.10
3123035-12303512.90712.93
4116355-11635512.20612.22
5118552-11855212.43712.45
6118435-11843512.42412.44
20min1157585-15758516.53116.152.4116.5716.192.42
2149516-14951615.68515.72
3156641-15664116.43216.47
4150426-15042615.78015.82
5152021-15202115.94815.98
6157479-15747916.52016.56
30min1214075-21407522.45722.012.5322.5222.072.51
2208390-20839021.86121.92
3214382-21438222.49022.55
4205217-20521721.52821.59
5214465-21446522.49822.56
6202325-20232521.22521.29
45min1280565-28056529.43228.562.3929.5328.662.39
2269516-26951628.27328.36
3280054-28005429.37929.47
4270673-27067328.39528.49
5267999-26799928.11428.21
6264940-26494027.79327.89
60min1325770-32577034.17533.861.1734.3234.001.18
2322580-32258033.84033.97
3328237-32823734.43334.57
4321726-32172633.75033.88
5321063-32106333.68133.82
6317438-31743833.30133.43
120min1478070-47807050.15150.301.9450.3450.491.93
2476655-47665550.00350.19
3483053-48305350.67450.87
4496095-49609552.04252.23
5473163-47316349.63749.82
6469972-46997249.30249.49
180min1586374-58637461.51361.400.8661.7861.660.86
2586748-58674861.55261.81
3593753-59375362.28762.55
4583899-58389961.25361.52
5580731-58073160.92161.18
6580015-58001560.84661.10
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
240min1706135-70613574.07673.890.7474.4474.240.74
2706514-70651474.11674.47
3712156-71215674.70875.07
4703240-70324073.77374.13
5700312-70031273.46673.82
6697575-69757573.17873.53
360min1819959-81995986.01786.290.6486.4986.760.64
2829527-82952787.02187.48
3829023-82902386.96887.44
4819231-81923185.94186.41
5818323-81832385.84586.31
6819320-81932085.95086.41
480min1896132-89613294.00893.700.6194.6194.300.61
2896534-89653494.05094.64
3900656-90065694.48395.09
4886598-88659893.00893.60
5888492-88849293.20693.80
6890695-89069593.43894.03
600min1932215-93221597.79397.520.3798.5398.250.37
2930224-93022497.58498.32
3934459-93445998.02998.77
4927609-92760997.31098.04
5925329-92532997.07197.80
6927830-92783097.33398.06
720min1954153-954153100.09599.040.69100.9899.920.69
2946780-94678099.321100.20
3947284-94728499.374100.27
4937289-93728998.32599.20
5939340-93934098.54199.42
6939682-93968298.57699.45
960min1949543-94954399.61199.140.53100.65100.170.53
2947892-94789299.438100.47
3950417-95041799.703100.74
4939024-93902498.50799.53
5939748-93974898.58399.61
6943695-94369598.997100.02
1200min1943481-94348198.97598.570.51100.1699.740.52
2941749-94174998.79399.97
3945933-94593399.232100.42
4934281-93428198.01099.18
5935123-93512398.09899.27
6937083-93708398.30499.47
极限1945333-94533399.16998.600.47100.5199.930.48
2940770-94077098.691100.02
3944486-94448699.080100.42
4938193-93819398.42099.74
5934614-93461498.04599.36
6935981-93598198.18899.51
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