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200
标示量(mg)75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%
116.991726017242172201726617251172480.11
217.081729617197172460.41
单位质量响应值RSD%判断
1015.191009.720.39数据可信
供试品溶液-LW0489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%
2min113948-1394882.16376.614.3282.1676.614.32
213414-1341479.01879.02
312646-1264674.49474.49
412876-1287675.84975.85
512558-1255873.97573.98
612587-1258774.14674.15
5min118805-18805110.774105.513.08110.77105.513.08
218370-18370108.212108.21
317448-17448102.781102.78
417737-17737104.483104.48
517613-17613103.753103.75
617493-17493103.046103.05
10min119120-19120112.630109.421.79112.63109.421.79
218746-18746110.427110.43
318187-18187107.134107.13
418345-18345108.065108.06
518435-18435108.595108.59
618618-18618109.673109.67
15min118999-18999111.917109.451.67111.92109.451.67
218868-18868111.146111.15
318184-18184107.116107.12
418594-18594109.532109.53
518343-18343108.053108.05
618490-18490108.919108.92
30min119150-19150112.807109.571.63112.81109.571.63
218643-18643109.820109.82
318353-18353108.112108.11
418461-18461108.748108.75
518660-18660109.920109.92
618338-18338108.024108.02
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200
标示量(mg)75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%
116.991732117200173661735517307173100.39
217.081748117303173920.73
单位质量响应值RSD%判断
1018.831018.270.04数据可信
供试品溶液-LW0489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%
2min113693-1369380.17876.752.9280.1876.752.92
213002-1300276.13276.13
312743-1274374.61574.62
413278-1327877.74877.75
513258-1325877.63177.63
612669-1266974.18274.18
5min117947-17947105.086105.722.16105.09105.722.16
218117-18117106.082106.08
317516-17516102.563102.56
418722-18722109.624109.62
517970-17970105.221105.22
618064-18064105.772105.77
10min118314-18314107.235109.282.03107.24109.282.02
219012-19012111.322111.32
318326-18326107.306107.31
419218-19218112.529112.53
518448-18448108.020108.02
618661-18661109.267109.27
15min118292-18292107.107109.231.89107.11109.241.89
218925-18925110.813110.81
318397-18397107.721107.72
419214-19214112.505112.51
518477-18477108.190108.19
618627-18627109.068109.07
30min118383-18383107.639108.771.62107.64108.761.62
218863-18863110.450110.45
318286-18286107.071107.07
419032-19032111.440111.44
518482-18482108.219108.22
618406-18406107.774107.77
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200
标示量(mg)75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%
116.995570555772558815573755618557430.18
217.085532755281553040.06
单位质量响应值RSD%判断
3280.933237.940.94数据可信
供试品溶液-LR6707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%
2min139580-3958072.42566.2410.2272.4366.2410.22
238232-3823269.95969.96
339094-3909471.53671.54
430255-3025555.36255.36
536801-3680167.34067.34
633246-3324660.83560.84
5min154447-5444799.63097.561.2899.6397.561.28
252974-5297496.93496.93
353838-5383898.51598.52
453018-5301897.01597.01
552724-5272496.47796.48
652878-5287896.75996.76
10min155010-55010100.660101.020.33100.66101.020.33
255248-55248101.095101.10
355267-55267101.130101.13
455297-55297101.185101.18
554981-54981100.607100.61
655449-55449101.463101.46
15min155498-55498101.553101.700.86101.55101.700.86
256397-56397103.198103.20
355337-55337101.258101.26
455870-55870102.233102.23
555115-55115100.852100.85
655263-55263101.123101.12
30min154902-54902100.462101.270.65100.46101.260.65
255629-55629101.792101.79
355410-55410101.392101.39
455821-55821102.144102.14
554991-54991100.625100.62
655295-55295101.181101.18
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200
标示量(mg)75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%
116.995582255881556065586955953558260.24
217.085551555713556140.26
单位质量响应值RSD%判断
3285.823256.090.65数据可信
供试品溶液-LR6707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%
2min136599-3659966.73362.336.8866.7362.326.88
232796-3279659.79959.80
335146-3514664.08464.08
435538-3553864.79964.80
534899-3489963.63363.63
630113-3011354.90754.91
5min155895-55895101.91796.864.50101.9296.864.50
253525-5352597.59597.60
354649-5464999.64599.64
453069-5306996.76496.76
552723-5272396.13396.13
648854-4885489.07889.08
10min156448-56448102.925100.921.71102.93100.921.71
255897-55897101.920101.92
356214-56214102.498102.50
454767-5476799.86099.86
554353-5435399.10599.11
654417-5441799.22299.22
15min156548-56548103.107101.162.40103.11101.162.40
256445-56445102.920102.92
356456-56456102.940102.94
455015-55015100.312100.31
555289-55289100.812100.81
653126-5312696.86896.87
30min156632-56632103.261100.802.45103.26100.802.45
256106-56106102.301102.30
356362-56362102.768102.77
454577-5457799.51499.51
554937-54937100.170100.17
653076-5307696.77796.78
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