达格列净片项目信息
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1000
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%
112.269918899047989449884599359990770.21
212.339948999412994500.06
单位质量响应值RSD%判断
8081.328065.690.14数据可信
供试品溶液-25032603批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min182371-8237182.02982.321.8682.0382.321.86
282381-8238182.03982.04
385662-8566285.30785.31
481573-8157381.23581.23
581519-8151981.18181.18
682458-8245882.11682.12
10min194645-9464594.25293.922.2294.3894.052.22
292879-9287992.49492.62
397706-9770697.30197.43
495151-9515194.75694.88
593902-9390293.51293.63
691613-9161391.23391.36
15min197007-9700796.60496.121.0796.8796.381.07
295576-9557695.17995.44
397413-9741397.00997.28
497317-9731796.91397.18
596882-9688296.48096.74
694910-9491094.51694.78
20min198612-9861298.20397.912.3498.6198.322.34
298117-9811797.71098.11
3101803-101803101.381101.80
498406-9840697.99898.41
598423-9842398.01598.42
694560-9456094.16894.57
30min1102179-102179101.75598.702.12102.3199.252.11
297655-9765597.25097.80
399511-9951199.09899.67
499311-9931198.89999.46
599954-9995499.539100.09
696029-9602995.63196.17
45min1101886-101886101.46399.801.54102.17100.511.54
299220-9922098.80899.51
3100685-100685100.267100.99
4100358-10035899.942100.65
5101463-101463101.042101.75
697707-9770797.30297.99
60min1102566-102566102.140100.961.75103.00101.821.74
2100393-10039399.976100.82
3101350-101350100.929101.80
4100873-100873100.454101.31
5104106-104106103.674104.53
699022-9902298.61199.44
极限1102783-102783102.357102.351.30103.37103.351.29
2104615-104615104.181105.18
3101971-101971101.548102.57
4101208-101208100.788101.79
5104103-104103103.671104.68
6101968-101968101.545102.53
达格列净片项目信息
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1000
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%
112.261993991992451987441990031986081990000.17
212.331983411985121984260.07
单位质量响应值RSD%判断
16231.6516092.940.61数据可信
供试品溶液-25032601批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1162041-16204180.60977.443.6580.6177.443.66
2151276-15127675.25475.25
3157377-15737778.28978.29
4148218-14821873.73373.73
5153282-15328276.25276.25
6161776-16177680.47880.48
10min1178702-17870288.89886.792.2389.0286.902.24
2171569-17156985.34985.46
3175669-17566987.38987.51
4168115-16811583.63183.74
5176040-17604087.57387.69
6176683-17668387.89388.01
15min1183000-18300091.03689.451.9791.2989.701.97
2180847-18084789.96590.21
3179875-17987589.48189.73
4172911-17291186.01786.25
5181050-18105090.06690.31
6181229-18122990.15590.41
20min1184741-18474191.90290.162.0892.2990.542.08
2177585-17758588.34288.72
3182952-18295291.01291.39
4175485-17548587.29787.66
5183711-18371191.38991.77
6182921-18292190.99691.38
30min1187715-18771593.38191.722.2993.9192.232.29
2179683-17968389.38689.89
3187715-18771593.38193.90
4178324-17832488.71089.21
5186549-18654992.80193.32
6186209-18620992.63293.16
45min1192010-19201095.51893.901.5396.1994.561.53
2183628-18362891.34891.99
3189786-18978694.41295.07
4187672-18767293.36093.99
5189986-18998694.51195.17
6189499-18949994.26994.93
60min1194810-19481096.91194.742.3597.7295.532.35
2185442-18544292.25193.03
3193149-19314996.08596.89
4184147-18414791.60692.38
5192596-19259695.80996.61
6192496-19249695.76096.56
极限1208435-208435103.689103.530.68104.65104.460.68
2209061-209061104.000104.92
3210201-210201104.567105.51
4206502-206502102.727103.63
5206787-206787102.869103.81
6207669-207669103.308104.26
达格列净片项目信息
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1000
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%
112.261999491997121999731997101997971998280.07
212.332004872002602003740.09
单位质量响应值RSD%判断
16299.1816250.930.21数据可信
供试品溶液-25032602批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1157480-15748077.79679.984.2877.8079.984.27
2165328-16532881.67381.67
3156811-15681177.46677.47
4173073-17307385.50085.50
5154667-15466776.40776.41
6164053-16405381.04481.04
10min1173974-17397485.94587.482.8086.0687.602.81
2183293-18329390.54890.67
3175761-17576186.82786.94
4182683-18268390.24790.38
5170716-17071684.33584.45
6176077-17607786.98487.11
15min1178006-17800687.93689.372.4988.1889.622.49
2187543-18754392.64892.91
3179893-17989388.86989.12
4184834-18483491.31091.57
5175332-17533286.61686.86
6179804-17980488.82589.08
20min1180143-18014388.99290.512.1189.3790.902.11
2187051-18705192.40592.80
3181892-18189289.85690.24
4188851-18885193.29493.69
5179351-17935188.60188.97
6182006-18200689.91390.30
30min1182589-18258990.20191.742.0290.7192.262.03
2190245-19024593.98394.52
3186199-18619991.98492.50
4189525-18952593.62794.17
5180783-18078389.30889.81
6184903-18490391.34491.86
45min1186118-18611891.94493.742.2592.5994.402.25
2193750-19375095.71496.39
3190657-19065794.18694.84
4195241-19524196.45197.13
5184401-18440191.09691.73
6188382-18838293.06293.72
60min1188165-18816592.95595.172.0493.7495.972.04
2198294-19829497.95998.78
3194244-19424495.95896.75
4194629-19462996.14896.97
5188397-18839793.07093.84
6192172-19217294.93595.73
极限1212991-212991105.219103.501.01106.14104.441.00
2208964-208964103.230104.20
3210552-210552104.014104.95
4209356-209356103.424104.39
5206766-206766102.144103.06
6208455-208455102.979103.92
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