比拉斯汀口崩片项目信息
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DIBSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.65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%
110.963848303866543867403870293869393864380.24
211.063860803858503859650.05
单位质量响应值RSD%判断
35258.9434897.380.73数据可信
供试品溶液-24061803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%
5min1370949-37094994.84494.371.0394.8494.371.03
2366135-36613593.61393.61
3374482-37448295.74795.75
4365002-36500293.32393.32
5371641-37164195.02195.02
6366445-36644593.69293.69
10min1374789-37478995.82695.320.9595.9895.480.94
2370666-37066694.77194.93
3378260-37826096.71396.87
4368498-36849894.21794.37
5373762-37376295.56395.72
6370862-37086294.82294.98
15min1373667-37366795.53995.230.9295.8695.550.92
2371860-37186095.07795.39
3377668-37766896.56296.88
4367914-36791494.06894.38
5373763-37376395.56395.88
6369935-36993594.58494.90
20min1373926-37392695.60595.091.0196.0895.571.01
2369668-36966894.51694.99
3377450-37745096.50696.99
4367387-36738793.93394.40
5373695-37369595.54696.02
6369461-36946194.46394.94
30min1373089-37308995.39194.930.9296.0395.560.93
2370618-37061894.75995.39
3376115-37611596.16596.81
4366504-36650493.70794.33
5372683-37268395.28795.92
6368756-36875694.28394.91
45min1371832-37183295.07094.481.0495.8695.271.04
2365359-36535993.41594.20
3375341-37534195.96796.77
4365827-36582793.53494.32
5370726-37072694.78795.58
6368125-36812594.12294.91
极限1371341-37134194.94494.550.9395.9095.500.93
2368954-36895494.33495.28
3374916-37491695.85896.82
4365266-36526693.39194.33
5371117-37111794.88795.84
6367184-36718493.88194.82
比拉斯汀口崩片项目信息
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DIBSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.65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%
110.963908163906383903213902753900163904130.09
211.063858903861653860280.06
单位质量响应值RSD%判断
35621.6234903.071.45数据可信
供试品溶液-24061803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%
5min1307295-30729578.16479.021.7478.1679.021.74
2313489-31348979.74079.74
3306008-30600877.83777.84
4305376-30537677.67677.68
5312627-31262779.52179.52
6319177-31917781.18781.19
10min1360517-36051791.70291.970.9291.8392.100.92
2362552-36255292.22092.35
3358298-35829891.13891.27
4359760-35976091.51091.64
5360506-36050691.69991.83
6367733-36773393.53893.67
15min1370839-37083994.32893.661.0694.6193.941.06
2368437-36843793.71794.00
3362919-36291992.31392.59
4365709-36570993.02393.30
5367404-36740493.45493.74
6373953-37395395.12095.41
20min1371679-37167994.54193.750.9994.9894.190.99
2369371-36937193.95494.40
3363460-36346092.45192.89
4367134-36713493.38593.82
5366447-36644793.21093.65
6373350-37335094.96695.42
30min1369309-36930993.93893.621.0794.5494.221.07
2367773-36777393.54894.15
3363313-36331392.41393.00
4366845-36684593.31293.90
5366117-36611793.12793.72
6374937-37493795.37095.98
45min1369982-36998294.11093.671.0394.8694.421.03
2368049-36804993.61894.37
3363128-36312892.36693.11
4366942-36694293.33694.08
5366988-36698893.34894.10
6374455-37445595.24796.01
极限1370817-37081794.32293.481.1595.2394.381.15
2365915-36591593.07593.99
3363107-36310792.36193.26
4364896-36489692.81693.72
5365870-36587093.06493.97
6374336-37433695.21796.14
比拉斯汀口崩片项目信息
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DIBSF0200923对照品来源自制对照品使用方法直接使用
对照品含量(%)99.65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%
110.963864113862763857613865213862893862520.08
211.063860173860073860120.01
单位质量响应值RSD%判断
35241.9734901.630.69数据可信
供试品溶液-24061803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%
5min1294851-29485175.40176.620.9675.4076.620.96
2302395-30239577.33077.33
3299664-29966476.63176.63
4300860-30086076.93776.94
5297893-29789376.17876.18
6302087-30208777.25177.25
10min1344686-34468688.14589.010.7388.2789.130.73
2350486-35048689.62889.76
3350354-35035489.59489.72
4348664-34866489.16289.29
5345175-34517588.27088.40
6348946-34894689.23489.36
15min1361025-36102592.32393.300.6992.6093.580.69
2366938-36693893.83594.11
3367484-36748493.97594.25
4365266-36526693.40793.68
5362680-36268092.74693.02
6365744-36574493.53093.81
20min1367396-36739693.95294.980.6994.3895.420.69
2373535-37353595.52295.96
3373952-37395295.62996.06
4372277-37227795.20095.63
5369427-36942794.47194.90
6371976-37197695.12395.56
30min1373419-37341995.49296.270.6196.0896.860.61
2378301-37830196.74197.33
3379397-37939797.02197.61
4377437-37743796.52097.11
5374603-37460395.79596.38
6375691-37569196.07396.67
45min1375261-37526195.96396.680.7196.7197.430.71
2380227-38022797.23397.99
3381529-38152997.56698.32
4379082-37908296.94097.69
5375088-37508895.91996.66
6377253-37725396.47397.22
极限1374565-37456595.78596.450.5896.6997.370.58
2379210-37921096.97397.89
3379669-37966997.09198.01
4378426-37842696.77397.69
5375285-37528595.96996.88
6375945-37594596.13897.05
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