比拉斯汀口腔崩解片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.903821083813593822153818583817743818630.09
210.983814113819193816650.10
单位质量响应值RSD%判断
35033.3034760.020.56数据可信
供试品溶液-4A84A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%
5min1269363-26936369.19364.747.3669.1964.747.36
2266181-26618168.37668.38
3228046-22804658.58058.58
4237807-23780761.08761.09
5240955-24095561.89661.90
6269831-26983169.31369.31
10min1344958-34495888.61286.662.6188.7386.762.61
2340458-34045887.45687.57
3324038-32403883.23883.34
4331690-33169085.20385.31
5335278-33527886.12586.23
6347627-34762789.29789.41
15min1365402-36540293.86393.331.2994.1393.581.29
2361866-36186692.95593.21
3355792-35579291.39591.63
4361605-36160592.88893.13
5366114-36611494.04694.29
6369191-36919194.83795.10
20min1374788-37478896.27496.160.7896.6996.560.78
2374927-37492796.31096.72
3368601-36860194.68595.07
4375267-37526796.39796.80
5376744-37674496.77797.18
6375638-37563896.49396.92
30min1381133-38113397.90497.830.9198.4898.400.91
2384155-38415598.68099.26
3375085-37508596.35196.90
4381919-38191998.10698.67
5383905-38390598.61699.18
6378819-37881997.31097.89
极限1384265-38426598.70998.180.9999.4598.910.98
2384126-38412698.67399.41
3376173-37617396.63097.34
4384940-38494098.88299.60
5384948-38494898.88499.61
6378864-37886497.32198.07
比拉斯汀口腔崩解片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.903810373813653800693797763790383802570.25
210.983813543817183815360.07
单位质量响应值RSD%判断
34885.9634748.270.28数据可信
供试品溶液-4A84A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%
5min1248000-24800063.85065.794.1263.8565.794.12
2266476-26647668.60768.61
3269412-26941269.36369.36
4243534-24353462.70062.70
5256440-25644066.02366.02
6249347-24934764.19764.20
10min1336817-33681786.71788.091.6786.8288.201.67
2346728-34672889.26989.38
3350706-35070690.29390.41
4339001-33900187.27987.38
5342854-34285488.27188.38
6336777-33677786.70786.81
15min1361736-36173693.13394.741.3193.3894.991.32
2371109-37110995.54695.81
3375289-37528996.62296.89
4367264-36726494.55694.81
5368043-36804394.75795.01
6364371-36437193.81194.06
20min1371161-37116195.55997.141.2295.9797.561.22
2381106-38110698.12098.54
3383086-38308698.63099.06
4378682-37868297.49697.90
5376596-37659696.95997.37
6373262-37326296.10096.51
30min1376900-37690097.03798.461.0897.6099.031.08
2384599-38459999.01999.60
3388153-38815399.934100.53
4382904-38290498.58399.15
5383373-38337398.70399.28
6378567-37856797.46698.03
极限1377961-37796197.31098.781.0998.0499.521.09
2386039-38603999.390100.14
3389361-389361100.245101.00
4384577-38457799.01399.75
5384280-38428098.93799.68
6379907-37990797.81198.54
比拉斯汀口腔崩解片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.903806003808663808333813353809903809250.08
210.983812593817543815060.10
单位质量响应值RSD%判断
34947.2534745.540.41数据可信
供试品溶液-3L77C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%
5min1264743-26474368.10464.175.5468.1064.175.54
2256521-25652165.98965.99
3254064-25406465.35765.36
4235241-23524160.51560.51
5256539-25653965.99365.99
6229554-22955459.05259.05
10min1337201-33720186.74383.432.0886.8683.542.09
2323665-32366583.26183.37
3322077-32207782.85382.96
4320496-32049682.44682.55
5324602-32460283.50283.61
6317919-31791981.78381.88
15min1360402-36040292.71290.391.4892.9790.641.48
2350147-35014790.07490.32
3344817-34481788.70388.95
4349022-34902289.78490.02
5351116-35111690.32390.57
6352767-35276790.74890.98
20min1374457-37445796.32794.091.4696.7494.491.46
2366102-36610294.17894.58
3357725-35772592.02392.42
4365916-36591694.13094.52
5365156-36515693.93594.33
6365291-36529193.96994.36
30min1380488-38048897.87996.401.3698.4596.961.36
2374125-37412596.24296.80
3365526-36552694.03094.58
4377725-37772597.16897.71
5376132-37613296.75897.31
6374549-37454996.35196.89
极限1383056-38305698.53997.021.5699.2897.731.56
2376045-37604596.73697.45
3366597-36659794.30595.01
4382158-38215898.30899.02
5377215-37721597.03797.75
6377775-37777597.18197.88
比拉斯汀口腔崩解片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D1BSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.903807503815663803243799403801083805380.18
210.983814423803073808740.22
单位质量响应值RSD%判断
34911.7434687.980.46数据可信
供试品溶液-3L77C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%
5min1268137-26813769.06967.516.4569.0767.516.46
2277614-27761471.51171.51
3234689-23468960.45460.45
4272550-27255070.20670.21
5247914-24791463.86063.86
6271512-27151269.93969.94
10min1335661-33566186.46386.442.5786.5886.562.57
2345510-34551089.00089.12
3322442-32244283.05883.16
4341433-34143387.95088.07
5328704-32870484.67184.78
6339686-33968687.50087.62
15min1361412-36141293.09692.801.5793.3693.061.58
2365818-36581894.23194.50
3350490-35049090.28390.52
4363568-36356893.65193.92
5357011-35701191.96292.21
6363382-36338293.60493.87
20min1370487-37048795.43495.751.2895.8596.161.28
2376569-37656997.00097.42
3363600-36360093.66094.05
4374543-37454396.47896.90
5370063-37006395.32495.73
6374942-37494296.58197.00
30min1376533-37653396.99196.981.3797.5697.551.38
2381581-38158198.29198.88
3366712-36671294.46195.01
4378755-37875597.56398.14
5376380-37638096.95297.51
6378912-37891297.60498.18
极限1378142-37814297.40697.520.8398.1498.250.84
2382930-38293098.63999.39
3373275-37327596.15296.86
4379765-37976597.82498.57
5378219-37821997.42598.15
6379116-37911697.65698.40
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