普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数100
标示量(mg)150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%
117.141082331082941083261083751083861083230.06
217.191079671079621079640.01
单位质量响应值RSD%判断
6319.896280.630.45数据可信
供试品溶液-24090201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%
2min187233-8723382.57883.224.5482.5883.224.54
283942-8394279.46379.46
390099-9009985.29185.29
492220-9222087.29987.30
591344-9134486.47086.47
682606-8260678.19878.20
5min1105225-10522599.61099.280.8299.6199.280.81
2103467-10346797.94697.95
3104280-10428098.71598.72
4105364-10536499.74199.74
5105811-105811100.165100.16
6105082-10508299.47499.47
10min1105631-10563199.99499.700.7899.9999.700.78
2103895-10389598.35198.35
3104802-10480299.20999.21
4105838-105838100.190100.19
5106077-106077100.416100.42
6105673-105673100.034100.03
15min1105684-105684100.04499.760.80100.0499.760.80
2103928-10392898.38298.38
3104879-10487999.28299.28
4105829-105829100.182100.18
5106158-106158100.493100.49
6105845-105845100.197100.20
30min1105575-10557599.94199.710.7799.9499.710.77
2103988-10398898.43998.44
3104748-10474899.15899.16
4105896-105896100.245100.25
5106101-106101100.439100.44
6105681-105681100.041100.04
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数100
标示量(mg)150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%
117.141080311080621080471079821080391080320.03
217.191078611077821078220.06
单位质量响应值RSD%判断
6302.926272.370.35数据可信
供试品溶液-24090201批-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%
2min183663-8366379.35783.334.1579.3683.334.15
294089-9408989.24789.25
386182-8618281.74681.75
489267-8926784.67384.67
588234-8823483.69383.69
685643-8564381.23581.24
5min1104869-10486999.47299.190.9099.4799.180.90
2105323-10532399.90299.90
3105072-10507299.66499.66
4102814-10281497.52297.52
5105094-10509499.68599.69
6104230-10423098.86698.87
10min1105538-105538100.10699.750.94100.1199.750.94
2105440-105440100.013100.01
3106182-106182100.717100.72
4103295-10329597.97997.98
5105403-10540399.97899.98
6105087-10508799.67899.68
15min1105671-105671100.23299.850.94100.2399.850.94
2105763-105763100.320100.32
3106163-106163100.699100.70
4103359-10335998.03998.04
5105455-105455100.028100.03
6105189-10518999.77599.78
30min1105585-105585100.15199.801.04100.1599.801.04
2105827-105827100.380100.38
3106315-106315100.843100.84
4103210-10321097.89897.90
5105448-105448100.021100.02
6104882-10488299.48499.48
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数100
标示量(mg)150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%
117.141080211079411079651078961079491079540.05
217.191075901075181075540.05
单位质量响应值RSD%判断
6298.376256.780.47数据可信
供试品溶液-24090201批-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%
2min185932-8593281.64082.552.3781.6482.552.37
287885-8788583.49683.50
383427-8342779.26179.26
489520-8952085.04985.05
587204-8720482.84982.85
687380-8738083.01683.02
5min1102129-10212997.02997.081.6297.0397.081.62
2103491-10349198.32398.32
3100614-10061495.58995.59
4103369-10336998.20798.21
599790-9979094.80694.81
6103711-10371198.53298.53
10min1103666-10366698.48998.271.5298.4998.271.52
2104661-10466199.43499.43
3102403-10240397.28997.29
4104351-10435199.14099.14
5100775-10077595.74295.74
6104759-10475999.52799.53
15min1103987-10398798.79498.531.5098.7998.531.50
2104930-10493099.69099.69
3102432-10243297.31697.32
4104743-10474399.51299.51
5101215-10121596.16096.16
6104935-10493599.69499.69
30min1104287-10428799.07998.891.4299.0898.901.42
2105348-105348100.087100.09
3102875-10287597.73797.74
4105052-10505299.80699.81
5101751-10175196.66996.67
6105232-10523299.97799.98
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