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%
116.771073911075211075041076441076391075400.10
216.781075261074921075090.03
单位质量响应值RSD%判断
6412.646406.970.07数据可信
供试品溶液-24090901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%
2min192592-9259286.15283.124.3886.1583.124.38
284884-8488478.98078.98
391576-9157685.20785.21
494150-9415087.60287.60
586848-8684880.80880.81
685919-8591979.94379.94
5min1109811-109811102.174102.250.48102.17102.250.48
2109366-109366101.760101.76
3110885-110885103.173103.17
4109612-109612101.988101.99
5109956-109956102.308102.31
6109711-109711102.081102.08
10min1110426-110426102.746102.840.37102.75102.840.37
2110167-110167102.505102.50
3111262-111262103.524103.52
4110359-110359102.683102.68
5110689-110689102.991102.99
6110281-110281102.611102.61
15min1110449-110449102.767102.860.39102.77102.860.38
2110201-110201102.536102.54
3111338-111338103.594103.59
4110363-110363102.687102.69
5110698-110698102.999103.00
6110272-110272102.603102.60
30min1110461-110461102.778102.840.45102.78102.840.45
2110200-110200102.536102.54
3111434-111434103.684103.68
4110220-110220102.554102.55
5110724-110724103.023103.02
6110126-110126102.467102.47
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%
116.771075761075671075551075581075021075520.03
216.781067451067001067220.03
单位质量响应值RSD%判断
6413.366360.070.60数据可信
供试品溶液-24090901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%
2min181075-8107575.71080.946.8175.7180.946.81
277822-7782272.67272.67
392295-9229586.18886.19
490169-9016984.20284.20
591067-9106785.04185.04
687650-8765081.85081.85
5min1108283-108283101.118101.370.94101.12101.370.94
2107589-107589100.470100.47
3109152-109152101.929101.93
4107712-107712100.585100.58
5108293-108293101.127101.13
6110287-110287102.989102.99
10min1109505-109505102.259102.430.90102.26102.430.90
2109381-109381102.143102.14
3109939-109939102.664102.66
4108898-108898101.692101.69
5108898-108898101.692101.69
6111534-111534104.154104.15
15min1109457-109457102.214102.320.92102.21102.320.92
2109298-109298102.066102.07
3109562-109562102.312102.31
4108735-108735101.540101.54
5108894-108894101.688101.69
6111504-111504104.126104.13
30min1109466-109466102.223102.370.81102.22102.370.81
2109533-109533102.285102.29
3109747-109747102.485102.49
4108765-108765101.568101.57
5108960-108960101.750101.75
6111253-111253103.891103.89
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%
116.771075611075341075101074851074381075060.05
216.781070381071181070780.06
单位质量响应值RSD%判断
6410.616381.290.33数据可信
供试品溶液-24090901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%
2min176527-7652771.35974.264.3371.3674.264.34
276139-7613970.99771.00
384287-8428778.59578.60
477374-7737472.14972.15
582726-8272677.14077.14
680753-8075375.30075.30
5min1101828-10182894.95295.830.9294.9595.830.92
2102622-10262295.69295.69
3104210-10421097.17397.17
4101825-10182594.94994.95
5103482-10348296.49496.49
6102647-10264795.71595.72
10min1105162-10516298.06098.330.6198.0698.330.61
2105031-10503197.93897.94
3106730-10673099.52399.52
4105277-10527798.16898.17
5105367-10536798.25298.25
6105124-10512498.02598.02
15min1105764-10576498.62298.840.6498.6298.840.64
2105600-10560098.46998.47
3107360-107360100.110100.11
4105701-10570198.56398.56
5105858-10585898.70998.71
6105706-10570698.56898.57
30min1106715-10671599.50999.560.6599.5199.560.65
2106620-10662099.42099.42
3108110-108110100.809100.81
4106278-10627899.10199.10
5106710-10671099.50499.50
6106205-10620599.03399.03
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