替普瑞酮颗粒项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50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%
1107.65480885487605481625473325456705476020.22
2107.25526255513895520070.16
单位质量响应值RSD%判断
5089.245149.320.83数据可信
供试品溶液-25071401批-pH6.8(内含2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1424078-42407873.36571.661.7073.3771.661.70
2410740-41074071.05871.06
3414472-41447271.70371.70
4404145-40414569.91769.92
5419827-41982772.63072.63
6412071-41207171.28871.29
10min1450283-45028377.89977.042.4378.0277.162.42
2445518-44551877.07477.19
3441909-44190976.45076.57
4426835-42683573.84273.96
5459292-45929279.45779.58
6448191-44819177.53777.66
15min1462447-46244780.00379.322.4680.2679.562.46
2459156-45915679.43479.68
3449983-44998377.84778.09
4441322-44132276.34876.59
5472746-47274681.78582.04
6465200-46520080.47980.73
20min1471770-47177081.61680.792.2982.0081.172.29
2466598-46659880.72181.10
3459897-45989779.56279.94
4450291-45029177.90078.27
5480568-48056883.13883.53
6472703-47270381.77782.16
30min1475992-47599282.34681.982.6282.8782.492.61
2471990-47199081.65482.17
3465315-46531580.49981.01
4456067-45606778.89979.40
5490785-49078584.90585.43
6483041-48304183.56684.08
45min1481809-48180983.35383.582.3284.0184.232.32
2482837-48283783.53084.18
3474241-47424182.04382.69
4468513-46851381.05281.68
5498485-49848586.23786.91
6492877-49287785.26785.93
60min1487501-48750184.33784.412.3285.1385.202.32
2489482-48948284.68085.47
3477744-47774482.64983.43
4473023-47302381.83382.60
5503166-50316687.04787.86
6496698-49669885.92886.73
极限1503368-50336887.08286.611.9588.0287.541.95
2501206-50120686.70887.64
3493968-49396885.45686.37
4485133-48513383.92884.83
5511533-51153388.49589.45
6508616-50861687.99088.93
替普瑞酮颗粒项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50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%
1107.65669395650855659715659245656565659150.12
2107.25702445704435703440.03
单位质量响应值RSD%判断
5259.435320.370.82数据可信
供试品溶液-25071501批-pH6.8(内含2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1464574-46457477.77877.531.5177.7877.531.51
2461826-46182677.31877.32
3460744-46074477.13777.14
4458078-45807876.69176.69
5476252-47625279.73479.73
6457050-45705076.51976.52
10min1482406-48240680.76480.710.8280.8980.840.82
2483459-48345980.94081.07
3479492-47949280.27680.40
4477213-47721379.89480.02
5488762-48876281.82881.96
6481271-48127180.57480.70
15min1491926-49192682.35882.170.8382.6282.430.83
2490194-49019482.06882.33
3488721-48872181.82182.08
4486174-48617481.39581.66
5498119-49811983.39483.66
6489715-48971581.98882.25
20min1491196-49119682.23582.701.1882.6483.101.17
2491509-49150982.28882.69
3493415-49341582.60783.01
4488016-48801681.70382.10
5504803-50480384.51484.92
6494866-49486682.85083.25
30min1499589-49958983.64183.461.2184.1884.001.21
2494896-49489682.85583.39
3497159-49715983.23483.77
4491542-49154282.29382.83
5509324-50932485.27085.82
6498472-49847283.45483.99
45min1503238-50323884.25284.441.2184.9385.121.20
2501015-50101583.87984.56
3502075-50207584.05784.73
4498671-49867183.48784.16
5515913-51591386.37487.06
6505369-50536984.60885.28
60min1507375-50737584.94484.960.9485.7685.780.94
2505613-50561384.64985.46
3503597-50359784.31285.13
4503308-50330884.26385.07
5516059-51605986.39887.23
6509005-50900585.21786.03
极限1513769-51376986.01585.811.1486.9786.771.14
2512579-51257985.81586.77
3508584-50858485.14786.10
4504994-50499484.54685.50
5522361-52236187.45388.43
6513000-51300085.88686.84
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