普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
116.631043731042131041541041681043371042490.10
216.661039171038411038790.06
单位质量响应值RSD%判断
6268.736235.230.38数据可信
加速6月-供试品溶液-2024120821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%
2min194881-9488190.51190.862.8390.5190.862.83
293688-9368889.37389.37
3100511-10051195.88295.88
493120-9312088.83188.83
595241-9524190.85590.85
694028-9402889.69789.70
5min1104945-104945100.112100.230.86101.12101.240.87
2105184-105184100.340101.33
3106719-106719101.804102.87
4105027-105027100.190101.18
5104205-10420599.406100.42
6104362-10436299.556100.55
10min1105051-105051100.213100.460.93102.33102.580.94
2105524-105524100.664102.77
3107075-107075102.144104.34
4105266-105266100.418102.52
5104235-10423599.434101.55
6104707-10470799.885101.99
15min1105076-105076100.237100.510.84103.47103.740.86
2105569-105569100.707103.93
3106959-106959102.033105.36
4105392-105392100.538103.75
5104537-10453799.722102.94
6104616-10461699.798103.01
30min1104946-104946100.113100.450.91104.46104.800.92
2105702-105702100.834105.18
3106994-106994102.066106.53
4105134-105134100.292104.63
5104358-10435899.552103.88
6104635-10463599.816104.14
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
116.631040141040871039791039051039581039890.07
216.661041221040741040980.04
单位质量响应值RSD%判断
6253.106248.380.06数据可信
长期6月-供试品溶液-2024120821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%
2min190740-9074086.57889.073.8186.5889.063.82
299762-9976295.18695.19
394289-9428989.96489.96
489929-8992985.80485.80
593638-9363889.34389.34
691728-9172887.52087.52
5min1104264-10426499.48199.890.72100.44100.880.72
2104252-10425299.470100.53
3106161-106161101.291102.29
4104389-10438999.600100.55
5104830-104830100.021101.01
6104284-10428499.500100.47
10min1104213-10421399.432100.070.80101.50102.170.80
2104843-104843100.034102.20
3106519-106519101.633103.76
4104527-10452799.732101.79
5104662-10466299.861101.96
6104506-10450699.712101.79
15min1104182-10418299.403100.110.79102.58103.320.80
2105019-105019100.202103.48
3106489-106489101.604104.86
4104713-10471399.910103.08
5104764-10476499.958103.17
6104350-10435099.563102.75
30min1104165-10416599.387100.100.71103.66104.430.72
2104860-104860100.050104.44
3106304-106304101.428105.81
4104796-10479699.989104.27
5104950-104950100.136104.46
6104419-10441999.629103.92
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
116.631036401035091038121036411036311036470.11
216.661037631037461037540.02
单位质量响应值RSD%判断
6232.536227.730.06数据可信
中间条件6月-供试品溶液-2024120821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%
2min186964-8696483.24985.354.0783.2585.354.07
287275-8727583.54783.55
394946-9494690.89090.89
485334-8533481.68981.69
592095-9209588.16188.16
688320-8832084.54784.55
5min1103564-10356499.14099.330.68100.07100.280.69
2103582-10358299.157100.09
3105026-105026100.540101.55
4104000-10400099.557100.47
5102989-10298998.59099.57
6103405-10340598.98899.93
10min1103858-10385899.42299.520.77101.45101.570.78
2103987-10398799.545101.58
3105385-105385100.883103.01
4104064-10406499.619101.63
5103083-10308398.680100.75
6103372-10337298.956101.00
15min1103941-10394199.50199.560.86102.63102.720.87
2103974-10397499.533102.67
3105528-105528101.020104.27
4104292-10429299.837102.96
5102951-10295198.553101.72
6103314-10331498.901102.04
30min1103486-10348699.06599.360.81103.30103.630.81
2103633-10363399.206103.45
3105288-105288100.790105.16
4103632-10363299.205103.44
5102766-10276698.376102.64
6103981-10398199.539103.78
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
116.631656116565165151647116594165410.30
216.661675916803167810.19
单位质量响应值RSD%判断
994.651007.260.90数据可信
加速6月-供试品溶液-2024121521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%
2min115740-1574093.78796.213.7693.7996.213.76
216134-1613496.13596.14
316365-1636597.51297.51
416118-1611896.04096.04
517155-17155102.219102.22
615366-1536691.55991.56
5min116867-16867100.503103.012.27101.54104.082.29
217187-17187102.409103.48
317487-17487104.197105.28
417323-17323103.220104.29
517932-17932106.849107.98
616934-16934100.902101.92
10min116953-16953101.015103.102.22103.17105.312.23
217022-17022101.426103.63
317293-17293103.041105.28
417357-17357103.422105.64
518021-18021107.379109.70
617171-17171102.314104.45
15min116920-16920100.819102.702.63104.10106.062.62
217253-17253102.803106.14
317353-17353103.399106.78
416959-16959101.051104.41
518067-18067107.653111.17
616863-16863100.479103.75
30min116951-16951101.003102.962.74105.40107.462.73
217101-17101101.897106.37
317328-17328103.250107.78
417245-17245102.755107.24
518178-18178108.314113.03
616874-16874100.544104.94
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
116.631668516715168001665916726167170.32
216.661661616676166460.26
单位质量响应值RSD%判断
1005.23999.160.43数据可信
长期6月-供试品溶液-2024121521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%
2min115617-1561792.93792.181.2892.9492.181.28
215390-1539091.58691.59
315346-1534691.32491.32
415823-1582394.16294.16
515465-1546592.03292.03
615302-1530291.06291.06
5min117690-17690105.273105.561.57106.31106.591.56
217718-17718105.440106.46
317868-17868106.332107.35
417779-17779105.803106.85
518114-18114107.796108.82
617265-17265102.744103.76
10min117762-17762105.701105.501.46107.90107.701.45
217707-17707105.374107.56
317867-17867106.326108.52
417737-17737105.553107.77
518037-18037107.338109.56
617264-17264102.738104.89
15min118007-18007107.159105.901.54110.54109.271.53
217794-17794105.892109.25
317713-17713105.410108.79
417886-17886106.439109.83
518066-18066107.511110.92
617304-17304102.976106.27
30min117944-17944106.785105.911.89111.35110.451.86
218026-18026107.273111.81
317869-17869106.338110.89
417761-17761105.696110.27
518034-18034107.320111.93
617144-17144102.024106.46
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