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%
111.383890633887963888953889893893643890210.06
211.343877503875613876560.04
单位质量响应值RSD%判断
34184.6234184.830.01数据可信
供试品溶液-2024122321批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1372771-37277197.74999.771.1097.7599.761.10
2384820-384820100.908100.91
3381952-381952100.156100.16
4382840-382840100.389100.39
5379428-37942899.49599.49
6380952-38095299.89499.89
10min1377794-37779499.066100.921.0299.23101.091.02
2388646-388646101.912102.08
3386307-386307101.298101.47
4387678-387678101.658101.83
5383391-383391100.534100.70
6385408-385408101.063101.23
15min1381542-381542100.049100.910.65100.38101.240.65
2388208-388208101.797102.13
3384509-384509100.827101.16
4387089-387089101.503101.84
5383002-383002100.432100.77
6384509-384509100.827101.16
20min1377412-37741298.966100.701.0299.46101.201.02
2388861-388861101.968102.48
3385433-385433101.069101.57
4385940-385940101.202101.71
5382297-382297100.247100.75
6384200-384200100.746101.25
30min1376400-37640098.700100.541.0999.36101.211.09
2387774-387774101.683102.36
3384300-384300100.772101.44
4387006-387006101.482102.16
5381394-381394100.010100.68
6383582-383582100.584101.25
极限1375940-37594098.580100.280.9399.40101.110.94
2385901-385901101.192102.04
3383050-383050100.444101.28
4385215-385215101.012101.86
5381585-381585100.060100.89
6382742-382742100.364101.20
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%
111.383890403891293887813892703896083891660.08
211.343880943886533883740.11
单位质量响应值RSD%判断
34197.3634248.150.11数据可信
供试品溶液-2024122321批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1383839-383839100.539100.251.54100.54100.251.54
2389251-389251101.957101.96
3382814-382814100.271100.27
4381974-381974100.051100.05
5372040-37204097.44997.45
6386549-386549101.249101.25
10min1388802-388802101.839101.211.55102.01101.381.55
2394117-394117103.232103.40
3386526-386526101.243101.41
4386682-386682101.284101.45
5375821-37582198.43998.60
6386544-386544101.248101.42
15min1385380-385380100.943100.732.51101.28101.062.50
2401414-401414105.143105.48
3381409-38140999.903100.24
4383254-383254100.386100.72
5371638-37163897.34497.67
6384262-384262100.650100.99
20min1383586-383586100.473100.111.64100.98100.621.64
2388287-388287101.704102.22
3382161-382161100.100100.60
4386455-386455101.225101.73
5370440-37044097.03097.52
6382303-382303100.137100.64
30min1382109-382109100.08699.871.08100.76100.541.08
2387623-387623101.531102.22
3380003-38000399.535100.20
4381925-381925100.038100.71
5374888-37488898.19598.85
6381073-38107399.815100.49
极限1382126-382126100.09199.401.40100.93100.241.40
2385615-385615101.005101.86
3379592-37959299.427100.26
4380369-38036999.630100.47
5369724-36972496.84297.66
6379460-37946099.392100.23
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%
111.383884343882663883483879413877143881410.08
211.343882983878883880930.08
单位质量响应值RSD%判断
34107.2934223.370.25数据可信
供试品溶液-2024122321批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1381690-381690100.14599.011.47100.1499.011.46
2385221-385221101.071101.07
3373314-37331497.94797.95
4376786-37678698.85898.86
5377161-37716198.95698.96
6369978-36997897.07297.07
10min1385007-385007101.01599.711.63101.1899.881.63
2389353-389353102.155102.32
3373953-37395398.11598.28
4379584-37958499.59299.76
5378773-37877399.37999.54
6373608-37360898.02498.19
15min1380236-38023699.76398.691.45100.1099.021.45
2383858-383858100.714101.05
3370784-37078497.28397.61
4376500-37650098.78399.11
5375794-37579498.59898.93
6369599-36959996.97297.30
20min1376008-37600898.65497.731.4499.1698.221.44
2378903-37890399.41499.92
3367483-36748396.41796.91
4376211-37621198.70799.20
5370688-37068897.25897.75
6365596-36559695.92296.41
30min1372009-37200997.60596.451.4398.2797.111.43
2374992-37499298.38799.06
3362381-36238195.07995.73
4367010-36701096.29396.95
5367771-36777196.49397.15
6361584-36158494.87095.52
极限1367653-36765396.46295.351.4797.2996.161.47
2370993-37099397.33898.17
3358632-35863294.09594.90
4363168-36316895.28596.11
5363122-36312295.27396.09
6356817-35681793.61994.42
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%
111.383880893887153892003885373886453886370.11
211.343862693881163871920.34
单位质量响应值RSD%判断
34150.8834143.920.02数据可信
供试品溶液-2024122321批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1385557-385557101.212101.440.80101.21101.440.80
2392104-392104102.931102.93
3386532-386532101.468101.47
4386708-386708101.514101.51
5384708-384708100.989100.99
6383041-383041100.552100.55
10min1386582-386582101.481101.790.93101.65101.960.93
2393858-393858103.391103.56
3384951-384951101.053101.22
4390224-390224102.437102.61
5386269-386269101.399101.57
6384714-384714100.991101.16
15min1387186-387186101.640101.540.92101.98101.880.92
2392891-392891103.137103.48
3384962-384962101.056101.39
4388285-388285101.928102.27
5384338-384338100.892101.23
6383176-383176100.587100.92
20min1385441-385441101.182101.371.08101.69101.881.08
2393958-393958103.418103.93
3384083-384083100.825101.33
4387309-387309101.672102.18
5383441-383441100.657101.16
6382755-382755100.477100.98
30min1381728-381728100.207100.910.97100.88101.580.97
2391033-391033102.650103.34
3383209-383209100.596101.27
4386514-386514101.463102.14
5381925-381925100.259100.93
6381932-381932100.261100.93
极限1382480-382480100.404100.971.88101.25101.821.87
2398800-398800104.689105.55
3379376-37937699.590100.43
4385051-385051101.079101.93
5381574-381574100.167101.01
6380555-38055599.899100.74
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