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%
111.131903201900151899471899371896151899670.14
211.031884721897111890920.47
单位质量响应值RSD%判断
17068.0117143.430.32数据可信
供试品溶液-3208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%
5min1187493-18749398.25398.392.3398.2598.392.33
2190616-19061699.89099.89
3186573-18657397.77197.77
4183082-18308295.94295.94
5184001-18400196.42396.42
6194781-194781102.073102.07
10min1193729-193729101.521101.343.20101.69101.513.20
2193383-193383101.340101.51
3198587-198587104.067104.23
4186741-18674197.85998.02
5186240-18624097.59797.76
6201657-201657105.676105.85
15min1190823-19082399.998100.112.47100.33100.442.47
2192496-192496100.875101.21
3194375-194375101.860102.20
4187216-18721698.10898.43
5184201-18420196.52896.85
6197075-197075103.275103.62
20min1188783-18878398.92999.302.4699.4399.802.46
2191277-191277100.236100.74
3192099-192099100.667101.17
4184758-18475896.82097.31
5183890-18389096.36596.85
6196114-196114102.771103.29
30min1188674-18867498.87298.852.5199.5499.522.52
2191180-191180100.186100.86
3191923-191923100.575101.25
4183519-18351996.17196.82
5182410-18241095.59096.23
6194085-194085101.708102.40
极限1188448-18844898.75498.872.5199.5899.702.51
2190640-19064099.903100.74
3191268-191268100.232101.07
4183724-18372496.27897.09
5182803-18280395.79696.60
6195172-195172102.277103.14
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%
111.131911761906921912541902901906681908160.21
211.031907511901181904340.24
单位质量响应值RSD%判断
17144.2917265.100.50数据可信
供试品溶液-3208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%
5min1197384-197384102.84297.483.86102.8497.483.85
2177856-17785692.66892.67
3192589-192589100.344100.34
4184071-18407195.90695.91
5181962-18196294.80794.81
6188695-18869598.31598.32
10min1199057-199057103.71498.803.78103.8998.963.78
2180573-18057394.08394.24
3197295-197295102.796102.96
4185628-18562896.71796.88
5186677-18667797.26497.42
6188474-18847498.20098.36
15min1199587-199587103.99097.954.19104.3398.284.19
2177380-17738092.42092.73
3193502-193502100.820101.16
4184079-18407995.91096.23
5184066-18406695.90396.22
6189383-18938398.67499.00
20min1196973-196973102.62897.344.02103.1597.834.03
2176553-17655391.98992.45
3193690-193690100.918101.42
4182961-18296195.32895.81
5183470-18347095.59396.07
6187301-18730197.58998.08
30min1197319-197319102.80996.773.86103.5097.423.86
2176152-17615291.78092.40
3189004-18900498.47699.15
4182828-18282895.25895.90
5182488-18248895.08195.72
6186564-18656497.20597.86
极限1196126-196126102.18796.343.82103.0597.163.82
2175752-17575291.57292.34
3187989-18798997.94798.79
4181388-18138894.50895.31
5181240-18124094.43195.23
6186935-18693597.39898.21
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%
111.131904661902401903491913791905611905990.24
211.031906051907871906960.07
单位质量响应值RSD%判断
17124.8017288.850.68数据可信
供试品溶液-3208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%
5min177769-7776940.51538.912.7240.5238.912.72
272695-7269537.87237.87
372509-7250937.77537.77
475213-7521339.18439.18
575925-7592539.55439.55
673992-7399238.54738.55
10min1144620-14462075.34271.852.8975.4171.922.89
2133716-13371669.66269.72
3136213-13621370.96371.03
4140140-14014073.00873.07
5137830-13783071.80571.87
6134997-13499770.32970.39
15min1166678-16667886.83485.142.3587.0385.332.35
2161140-16114083.94984.13
3162087-16208784.44284.62
4165477-16547786.20886.40
5167632-16763287.33187.52
6157587-15758782.09882.28
20min1173264-17326490.26589.871.9290.6090.201.92
2172108-17210889.66389.98
3171616-17161689.40689.73
4177387-17738792.41392.74
5173457-17345790.36690.70
6167185-16718587.09887.42
30min1177272-17727292.35392.671.7992.8493.151.79
2177699-17769992.57593.04
3178367-17836792.92393.39
4180948-18094894.26894.75
5180801-18080194.19294.67
6172230-17223089.72690.19
极限1181114-18111494.35595.312.0195.0095.942.00
2182215-18221594.92895.55
3181058-18105894.32594.95
4188597-18859798.25398.89
5186007-18600796.90497.54
6178640-17864093.06693.68
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%
111.131896731903931890961896911902461898200.28
211.031895581903491899540.30
单位质量响应值RSD%判断
17054.8117221.580.69数据可信
供试品溶液-3208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%
5min174563-7456339.00138.672.5539.0038.672.54
270330-7033036.78636.79
374723-7472339.08439.08
475541-7554139.51239.51
573533-7353338.46238.46
674913-7491339.18439.18
10min1139757-13975773.10172.052.9173.1772.122.91
2134452-13445270.32670.39
3136318-13631871.30271.37
4137845-13784572.10072.17
5144507-14450775.58575.65
6133584-13358469.87269.94
15min1167846-16784687.79385.122.6887.9885.302.68
2158388-15838882.84683.02
3164838-16483886.21986.40
4162669-16266985.08585.27
5165887-16588786.76886.96
6156789-15678982.00982.19
20min1178549-17854993.39191.032.8593.7291.352.85
2172777-17277790.37290.69
3173111-17311190.54790.87
4179838-17983894.06594.39
5174018-17401891.02191.36
6165890-16589086.77087.09
30min1185998-18599897.28794.022.7297.7894.502.71
2178092-17809293.15293.62
3179057-17905793.65794.14
4181835-18183595.11095.59
5181977-18197795.18495.67
6171557-17155789.73490.20
极限1195457-195457102.23596.493.52102.8997.133.51
2185235-18523596.88897.51
3183429-18342995.94396.58
4178478-17847893.35494.00
5186689-18668997.64998.29
6177598-17759892.89393.51
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