比拉斯汀片项目信息
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%
1 11.083825843823913832693823383824703826100.10
2 11.063826383825623826000.02
单位质量响应值RSD%判断
34531.5934593.130.13数据可信
供试品溶液-2024122121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%
5min1199282-19928251.68552.641.9951.6952.641.98
2199016-19901651.61651.62
3202410-20241052.49752.50
4204216-20421652.96552.96
5210016-21001654.46954.47
6202741-20274152.58252.58
10min1266724-26672469.17770.712.6969.2670.802.69
2267682-26768269.42569.51
3263996-26399668.46968.56
4279921-27992172.60072.69
5280492-28049272.74872.84
6277043-27704371.85371.94
15min1298357-29835777.38178.933.1277.5879.133.12
2300419-30041977.91678.12
3290141-29014175.25075.45
4313462-31346281.29981.51
5313100-31310081.20581.42
6310438-31043880.51480.72
20min1314227-31422781.49783.383.4981.8383.713.49
2315860-31586081.92182.25
3305391-30539179.20579.53
4332500-33250086.23686.58
5331660-33166086.01986.37
6329190-32919085.37885.72
30min1328964-32896485.31987.694.1085.7988.164.09
2332119-33211986.13886.61
3317723-31772382.40482.86
4349580-34958090.66691.15
5349157-34915790.55691.05
6351064-35106491.05191.53
45min1338226-33822687.72190.524.2388.3391.144.22
2343444-34344489.07589.69
3327505-32750584.94185.54
4360897-36089793.60194.24
5362084-36208493.90994.55
6361935-36193593.87194.51
60min1344497-34449789.34892.194.1790.1092.964.16
2349593-34959390.67091.43
3334134-33413486.66087.40
4368508-36850895.57596.37
5368519-36851995.57896.38
6367523-36752395.32096.11
极限1392437-392437101.781101.050.59102.69101.980.58
2387209-387209100.426101.34
3388483-388483100.756101.64
4388638-388638100.796101.75
5388474-388474100.754101.71
6392514-392514101.801102.75
比拉斯汀片项目信息
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%
1 11.083825263818863824303822783822643822770.07
2 11.063833213831953832580.03
单位质量响应值RSD%判断
34501.5334652.620.31数据可信
供试品溶液-2024122221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%
5min1208447-20844754.03954.043.4954.0454.043.49
2203274-20327452.69852.70
3209242-20924254.24654.25
4198624-19862451.49351.49
5219937-21993757.01857.02
6211169-21116954.74554.75
10min1278741-27874172.26371.982.7072.3572.062.70
2269314-26931469.81969.91
3278057-27805772.08672.18
4269308-26930869.81869.90
5288826-28882674.87874.97
6281528-28152872.98673.08
15min1307921-30792179.82880.362.5280.0480.572.52
2299075-29907577.53577.74
3314522-31452281.53981.75
4303501-30350178.68278.88
5319522-31952282.83583.06
6315217-31521781.71981.93
20min1324677-32467784.17284.732.5784.5285.072.57
2314190-31419081.45381.79
3333285-33328586.40486.75
4320546-32054683.10183.43
5333683-33368386.50786.86
6334500-33450086.71887.07
30min1344922-34492289.42088.972.7089.9089.462.70
2327255-32725584.84085.31
3348121-34812190.25090.74
4337415-33741587.47487.95
5350392-35039290.83891.34
6351109-35110991.02491.52
45min1363863-36386394.33192.232.9694.9692.862.95
2336800-33680087.31587.93
3360246-36024693.39394.03
4350075-35007590.75691.37
5362441-36244193.96294.62
6361136-36113693.62494.27
60min1371895-37189596.41394.173.2397.2094.963.22
2343336-34333689.00989.77
3366955-36695595.13295.93
4354860-35486091.99792.77
5370556-37055696.06696.88
6371954-37195496.42897.23
极限1389458-389458100.966100.660.68101.92101.610.68
2388508-388508100.720101.62
3391235-391235101.427102.38
4383474-38347499.415100.34
5389114-389114100.877101.85
6387970-387970100.580101.54
比拉斯汀片项目信息
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%
1 11.083821963825063826823825873830323826010.08
2 11.063831993834233833110.05
单位质量响应值RSD%判断
34530.7834657.410.26数据可信
供试品溶液-2024122321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%
5min1204763-20476353.05851.932.5953.0651.932.59
2201198-20119852.13452.13
3202864-20286452.56652.57
4204745-20474553.05453.05
5191376-19137649.58949.59
6197517-19751751.18151.18
10min1270193-27019370.01269.840.9670.1069.930.96
2274327-27432771.08471.17
3268063-26806369.46169.55
4268123-26812369.47669.56
5267128-26712869.21869.30
6269343-26934369.79269.88
15min1296876-29687676.92776.992.6177.1377.202.61
2306054-30605479.30579.51
3300371-30037177.83278.04
4299828-29982877.69277.90
5282941-28294173.31673.51
6296736-29673676.89077.09
20min1312684-31268481.02380.792.5881.3681.122.58
2321110-32111083.20683.54
3316898-31689882.11582.45
4311386-31138680.68681.02
5297364-29736477.05377.37
6311374-31137480.68381.01
30min1328617-32861785.15184.662.7485.6285.132.73
2337385-33738587.42387.90
3332992-33299286.28586.75
4327652-32765284.90185.37
5311974-31197480.83981.29
6321766-32176683.37683.84
45min1339950-33995088.08887.423.1788.7088.033.16
2351971-35197191.20391.82
3343843-34384389.09789.71
4336854-33685487.28687.90
5321336-32133683.26583.85
6330312-33031285.59186.19
60min1345832-34583289.61288.813.4990.3789.573.48
2359360-35936093.11793.89
3348413-34841390.28191.04
4344132-34413289.17289.93
5324981-32498184.20984.93
6333806-33380686.49687.24
极限1391271-391271101.386100.251.04102.29101.161.05
2391791-391791101.521102.45
3386716-386716100.206101.12
4386355-386355100.112101.02
5382539-38253999.12499.99
6382727-38272799.172100.06
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