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%
117.031059151057261060191060341059541059300.12
217.101059551058151058850.10
单位质量响应值RSD%判断
6220.206192.110.33数据可信
中间条件36月-供试品溶液-2022101211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%
2min192617-9261789.00488.302.0589.0088.302.05
291890-9189088.30588.31
390765-9076587.22487.22
489701-8970186.20186.20
595140-9514091.42891.43
691174-9117487.61787.62
5min199791-9979195.89894.071.8895.9094.071.88
297875-9787594.05794.06
395943-9594392.20092.20
496545-9654592.77892.78
5100428-10042896.51096.51
696768-9676892.99392.99
10min1100820-10082096.88795.231.7896.8995.231.78
298941-9894195.08195.08
397447-9744793.64593.65
498238-9823894.40594.41
5101635-10163597.67097.67
697488-9748893.68593.68
15min1101248-10124897.29895.561.8397.3095.561.83
299474-9947495.59395.59
397339-9733993.54193.54
498504-9850494.66194.66
5101948-10194897.97197.97
698138-9813894.30994.31
30min1101560-10156097.59895.801.7297.6095.801.72
299266-9926695.39395.39
397569-9756993.76393.76
499162-9916295.29395.29
5101937-10193797.96097.96
698639-9863994.79194.79
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%
117.031060161056821060301058081062141059500.20
217.101057481059121058300.11
单位质量响应值RSD%判断
6221.376188.890.38数据可信
中间条件36月-供试品溶液-2022101411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%
2min196616-9661692.86289.793.6492.8689.803.64
296174-9617492.43792.44
396263-9626392.52392.52
488549-8854985.10985.11
591043-9104387.50687.51
691902-9190288.33188.33
5min1103733-10373399.70395.773.3499.7095.773.34
2102565-10256598.58098.58
3101368-10136897.43097.43
496032-9603292.30192.30
597632-9763293.83993.84
696522-9652292.77292.77
10min1104458-104458100.39996.773.00100.4096.773.00
2103313-10331399.29999.30
3102267-10226798.29498.29
497562-9756293.77193.77
598651-9865194.81894.82
697851-9785194.04994.05
15min1103868-10386899.83296.752.5699.8396.752.56
2102970-10297098.96998.97
3101893-10189397.93497.93
498401-9840194.57894.58
599075-9907595.22695.23
697775-9777593.97693.98
30min1103812-10381299.77997.042.1499.7897.042.14
2102600-10260098.61498.61
3102102-10210298.13598.13
498610-9861094.77994.78
599608-9960895.73895.74
699015-9901595.16895.17
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%
117.031058871060081058951059681061141059740.09
217.101058681057641058160.07
单位质量响应值RSD%判断
6222.786188.070.40数据可信
中间条件36月-供试品溶液-2022101511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%
2min196280-9628092.53593.332.3592.5393.332.35
297993-9799394.18194.18
3101357-10135797.41497.41
495512-9551291.79791.80
595526-9552691.81091.81
695962-9596292.22992.23
5min1101908-10190897.94498.772.0997.9498.772.09
2103670-10367099.63799.64
3106660-106660102.511102.51
4101611-10161197.65997.66
5100662-10066296.74696.75
6102113-10211398.14198.14
10min1102180-10218098.20599.652.2098.2199.652.19
2105106-105106101.018101.02
3107371-107371103.194103.19
4102243-10224398.26698.27
5101279-10127997.33997.34
6103912-10391299.87099.87
15min1101958-10195897.99299.802.2797.9999.802.27
2105467-105467101.365101.36
3107596-107596103.411103.41
4103021-10302199.01499.01
5101237-10123797.29997.30
6103747-10374799.71199.71
30min1102085-10208598.11499.662.2998.1199.662.29
2104993-104993100.909100.91
3107633-107633103.446103.45
4102607-10260798.61698.62
5101055-10105597.12497.12
6103819-10381999.78199.78
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%
117.031061351058161061281062921061141060970.17
217.101069371069871069620.04
单位质量响应值RSD%判断
6230.016255.090.29数据可信
中间条件36月-供试品溶液-EP4189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%
2min162516-6251659.72755.555.1359.7355.555.13
259996-5999657.31957.32
357464-5746454.90054.90
458883-5888356.25656.26
554295-5429551.87351.87
655681-5568153.19753.20
5min1100764-10076496.26892.352.6196.2792.352.61
297612-9761293.25793.26
394479-9447990.26490.26
497733-9773393.37293.37
595113-9511390.86990.87
694289-9428990.08290.08
10min1107741-107741102.934101.381.49102.93101.381.49
2106980-106980102.207102.21
3106125-106125101.390101.39
4107180-107180102.398102.40
5105190-105190100.497100.50
6103452-10345298.83698.84
15min1108303-108303103.471102.381.53103.47102.381.53
2107763-107763102.955102.95
3107723-107723102.917102.92
4108745-108745103.893103.89
5106013-106013101.283101.28
6104404-10440499.74699.75
30min1108465-108465103.626102.231.61103.63102.231.61
2107286-107286102.499102.50
3106533-106533101.780101.78
4109312-109312104.435104.43
5105730-105730101.013101.01
6104701-104701100.030100.03
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