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%
117.651101181100531101761102111102001101520.06
217.611096401096161096280.02
单位质量响应值RSD%判断
6240.916225.330.18数据可信
供试品溶液-2024121021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%
2min197855-9785593.63091.301.4893.6391.301.48
294637-9463790.55190.55
396242-9624292.08792.09
494205-9420590.13890.14
595284-9528491.17091.17
694304-9430490.23390.23
5min1105687-105687101.124100.660.64101.12100.660.64
2105718-105718101.154101.15
3105809-105809101.241101.24
4104549-104549100.035100.04
5105180-105180100.639100.64
6104240-10424099.74099.74
10min1105794-105794101.226100.790.64101.23100.790.64
2105921-105921101.348101.35
3105895-105895101.323101.32
4104755-104755100.232100.23
5105319-105319100.772100.77
6104324-10432499.82099.82
15min1104310-10431099.807100.990.7199.81100.990.70
2106249-106249101.662101.66
3105040-105040100.505100.51
4106012-106012101.435101.44
5106030-106030101.452101.45
6105640-105640101.079101.08
30min1104384-10438499.877100.860.6299.88100.860.62
2105469-105469100.916100.92
3104882-104882100.354100.35
4106020-106020101.443101.44
5105970-105970101.395101.39
6105743-105743101.178101.18
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%
117.651095421096311097691096211095901096310.08
217.611094541096041095290.10
单位质量响应值RSD%判断
6211.396219.700.10数据可信
供试品溶液-2024121021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%
2min193906-9390690.10690.821.4590.1190.821.45
296419-9641992.51792.52
396329-9632992.43192.43
493202-9320289.43089.43
594033-9403390.22790.23
694030-9403090.22590.22
5min1104350-104350100.127100.610.59100.13100.610.59
2104494-104494100.265100.27
3104255-104255100.036100.04
4105899-105899101.613101.61
5104997-104997100.748100.75
6105097-105097100.844100.84
10min1104369-104369100.145100.720.60100.15100.720.60
2104575-104575100.343100.34
3104401-104401100.176100.18
4105797-105797101.515101.52
5105065-105065100.813100.81
6105593-105593101.320101.32
15min1104155-10415599.940100.610.6499.94100.620.64
2104538-104538100.307100.31
3104345-104345100.122100.12
4105925-105925101.638101.64
5104882-104882100.637100.64
6105307-105307101.045101.05
30min1104307-104307100.086100.680.66100.09100.680.66
2104707-104707100.469100.47
3104215-10421599.997100.00
4105862-105862101.578101.58
5104822-104822100.580100.58
6105662-105662101.386101.39
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%
117.651097911098161097611095671096701097210.10
217.611094551093491094020.07
单位质量响应值RSD%判断
6216.496212.490.05数据可信
供试品溶液-2024121021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%
2min1105603-105603101.34699.221.16101.3599.221.16
2102805-10280598.66198.66
3103746-10374699.56499.56
4102672-10267298.53498.53
5102274-10227498.15298.15
6103213-10321399.05399.05
5min1105099-105099100.86399.691.19100.8699.681.19
2102098-10209897.98397.98
3105125-105125100.888100.89
4103553-10355399.37999.38
5102912-10291298.76498.76
6104449-104449100.239100.24
10min1103780-10378099.59799.471.1199.6099.471.11
2104546-104546100.332100.33
3105229-105229100.988100.99
4103404-10340499.23699.24
5102085-10208597.97097.97
6102826-10282698.68198.68
15min1103097-10309798.94197.521.9798.9497.521.97
298251-9825194.29194.29
3104022-10402299.82999.83
4102042-10204297.92997.93
5101034-10103496.96296.96
6101229-10122997.14997.15
30min1101932-10193297.82397.401.2397.8297.401.22
299278-9927895.27695.28
3101953-10195397.84497.84
4102890-10289098.74398.74
5101911-10191197.80397.80
6101005-10100596.93496.93
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%
117.651096121096141096961096171095371096150.06
217.611095001096941095970.13
单位质量响应值RSD%判断
6210.486223.570.15数据可信
供试品溶液-2024121021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%
2min1101060-10106096.94797.610.9996.9597.610.99
2101216-10121697.09797.10
3102831-10283198.64698.65
4100865-10086596.76096.76
5101331-10133197.20797.21
6103215-10321599.01499.01
5min1103120-10312098.923100.651.4198.92100.651.41
2104411-104411100.162100.16
3107406-107406103.035103.03
4104721-104721100.459100.46
5104155-10415599.91699.92
6105710-105710101.408101.41
10min1103173-10317398.974100.601.1398.97100.601.13
2104504-104504100.251100.25
3106490-106490102.156102.16
4104844-104844100.577100.58
5104330-104330100.084100.08
6105890-105890101.581101.58
15min1103171-10317198.972100.591.2098.97100.591.20
2104429-104429100.179100.18
3106674-106674102.333102.33
4104801-104801100.536100.54
5104188-10418899.94899.95
6105866-105866101.558101.56
30min1103094-10309498.898100.551.1498.90100.551.14
2104432-104432100.182100.18
3106450-106450102.118102.12
4104874-104874100.606100.61
5104222-10422299.98099.98
6105797-105797101.491101.49
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