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%
111.221924011923811929301921601926361925020.16
211.211959261957431958340.07
单位质量响应值RSD%判断
17157.0417469.581.28数据可信
供试品溶液-25070901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%
5min1138806-13880671.87371.013.6371.8771.013.63
2135125-13512569.96769.97
3128367-12836766.46866.47
4143061-14306174.07674.08
5138836-13883671.88871.89
6138616-13861671.77571.77
10min1178606-17860692.48190.992.3292.6091.112.32
2175034-17503490.63290.75
3168307-16830787.14887.26
4175198-17519890.71690.84
5177675-17767591.99992.12
6179542-17954292.96693.09
15min1190703-19070398.74596.602.2999.0296.882.29
2186561-18656196.60096.87
3178373-17837392.36092.62
4187010-18701096.83397.11
5188156-18815697.42697.70
6188603-18860397.65897.93
20min1195750-195750101.35898.512.54101.8098.942.55
2190358-19035898.56698.99
3181449-18144993.95394.36
4189367-18936798.05398.49
5192161-19216199.50099.94
6192374-19237499.610100.05
30min1198538-198538102.80298.962.81103.4199.562.81
2190855-19085598.82499.42
3182185-18218594.33494.90
4189536-18953698.14198.74
5193340-193340100.110100.71
6192263-19226399.553100.16
极限1193871-193871100.38598.772.25101.1699.532.25
2190023-19002398.39399.15
3182414-18241494.45395.18
4192200-19220099.520100.28
5193307-193307100.093100.86
6192669-19266999.763100.53
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%
111.221922991922341927741920131927701924180.18
211.211921351917121919240.16
单位质量响应值RSD%判断
17149.5517120.790.12数据可信
供试品溶液-25071501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%
5min1142123-14212374.35072.601.9574.3572.611.95
2140725-14072573.61873.62
3139326-13932672.88672.89
4139249-13924972.84672.85
5134813-13481370.52570.53
6136487-13648771.40171.40
10min1177264-17726492.73390.931.2992.8691.051.29
2174502-17450291.28891.41
3172514-17251490.24890.37
4171821-17182189.88690.01
5171594-17159489.76789.88
6175188-17518891.64791.77
15min1186571-18657197.60296.340.8297.8896.610.82
2184131-18413196.32596.60
3182472-18247295.45795.73
4184024-18402496.26996.54
5182752-18275295.60495.87
6184967-18496796.76397.03
20min1190194-19019499.49798.011.1799.9498.441.17
2188047-18804798.37498.81
3185287-18528796.93097.36
4187767-18776798.22798.66
5184278-18427896.40296.83
6188553-18855398.63999.07
30min1191610-191610100.23898.800.98100.8499.400.98
2189096-18909698.92399.52
3187165-18716597.91398.51
4189094-18909498.92299.52
5186464-18646497.54698.13
6189718-18971899.24899.85
极限1190809-19080999.81998.351.09100.5999.121.09
2188292-18829298.50299.27
3186933-18693397.79198.55
4186164-18616497.38998.15
5185856-18585697.22897.98
6189975-18997599.383100.15
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%
111.221917451915301919181915731916581916850.09
211.211915991916771916380.03
单位质量响应值RSD%判断
17084.2217095.270.05数据可信
供试品溶液-25071502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%
5min1142664-14266474.83172.463.7974.8372.463.78
2140703-14070373.80273.80
3134180-13418070.38170.38
4142229-14222974.60374.60
5129484-12948467.91867.92
6139602-13960273.22573.22
10min1177771-17777193.24590.962.8293.3791.082.82
2176200-17620092.42192.54
3171069-17106989.73089.85
4177410-17741093.05693.18
5165022-16502286.55886.67
6172971-17297190.72890.85
15min1186903-18690398.03595.832.6898.3296.112.68
2184807-18480796.93697.21
3178769-17876993.76994.04
4188564-18856498.90799.19
5175947-17594792.28992.55
6181217-18121795.05395.33
20min1195789-195789102.69698.722.65103.1499.152.65
2187041-18704198.10898.55
3181970-18197095.44895.87
4190769-190769100.063100.51
5189671-18967199.48799.90
6183979-18397996.50296.93
30min1190657-190657100.00497.822.33100.6298.412.33
2188923-18892399.09599.70
3183087-18308796.03496.62
4190916-190916100.140100.75
5180406-18040694.62795.20
6184933-18493397.00297.59
极限1189075-18907599.17597.422.4699.9698.182.47
2187754-18775498.48299.25
3182590-18259095.77396.52
4191165-191165100.271101.05
5178710-17871093.73894.47
6185117-18511797.09997.85
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%
111.221928171923681920991929791920251924580.23
211.211919421919471919440.01
单位质量响应值RSD%判断
17153.1217122.570.13数据可信
供试品溶液-25070901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%
5min1188931-18893198.82198.341.3998.8298.341.39
2185237-18523796.88996.89
3192537-192537100.707100.71
4185897-18589797.23497.23
5187646-18764698.14998.15
6187781-18778198.21998.22
10min1195025-195025102.008101.651.77102.17101.811.77
2190078-19007899.42199.58
3197392-197392103.247103.41
4190950-19095099.877100.04
5198688-198688103.924104.09
6193852-193852101.395101.56
15min1198191-198191103.664101.692.50104.00102.022.49
2189077-18907798.89799.22
3202010-202010105.662106.00
4190664-19066499.727100.06
5192930-192930100.913101.25
6193645-193645101.287101.62
20min1193785-193785101.360100.992.14101.87101.502.14
2188501-18850198.59699.09
3200621-200621104.935105.45
4190653-19065399.722100.22
5192118-192118100.488100.99
6192840-192840100.866101.37
30min1193413-193413101.165101.061.78101.84101.731.77
2188270-18827098.47599.13
3194924-194924101.956102.65
4198556-198556103.855104.52
5191955-191955100.403101.08
6192118-192118100.488101.16
极限1193080-193080100.991100.532.35101.84101.372.34
2187851-18785198.25699.08
3200694-200694104.974105.83
4189582-18958299.162100.00
5190936-19093699.870100.71
6190999-19099999.903100.74
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%
111.221922371920851912781921391914781918430.23
211.211919771919621919700.01
单位质量响应值RSD%判断
17098.3117124.890.11数据可信
供试品溶液-25071501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%
5min1196426-196426102.89999.551.97102.9099.551.97
2189415-18941599.22699.23
3191101-191101100.109100.11
4186797-18679797.85597.85
5190540-19054099.81599.82
6185955-18595597.41497.41
10min1197019-197019103.209100.052.50103.38100.222.49
2191164-191164100.142100.31
3193282-193282101.252101.42
4189049-18904999.03499.20
5192545-192545100.866101.03
6182905-18290595.81695.98
15min1196744-196744103.06599.302.58103.4199.632.58
2189755-18975599.40499.74
3191549-191549100.344100.68
4187412-18741298.17798.50
5189984-18998499.52499.86
6181878-18187895.27895.60
20min1194996-194996102.15099.072.52102.6799.572.52
2188056-18805698.51499.01
3191366-191366100.248100.75
4187139-18713998.03498.53
5191826-191826100.489100.99
6181282-18128294.96695.45
30min1194724-194724102.00798.802.47102.6999.472.47
2188302-18830298.64399.31
3190845-19084599.975100.65
4186610-18661097.75798.41
5190223-19022399.649100.32
6180934-18093494.78395.42
极限1192864-192864101.03398.631.91101.8999.451.91
2187688-18768898.32199.15
3188463-18846398.72799.56
4186471-18647197.68498.50
5191330-191330100.229101.06
6182796-18279695.75996.56
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%
111.221915691919901912621918121915781916420.15
211.211920111917291918700.11
单位质量响应值RSD%判断
17080.3917115.970.15数据可信
供试品溶液-25071502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%
5min1190966-190966100.11797.921.44100.1297.921.44
2188643-18864398.89998.90
3184603-18460396.78196.78
4187337-18733798.21598.21
5184785-18478596.87796.88
6184365-18436596.65696.66
10min1198147-198147103.88299.282.43104.0599.442.43
2190196-19019699.71399.88
3187972-18797298.54798.71
4187921-18792198.52198.68
5186597-18659797.82797.99
6185342-18534297.16997.33
15min1192694-192694101.02398.741.45101.3699.061.45
2190288-19028899.762100.09
3186657-18665797.85898.18
4187938-18793898.53098.86
5187243-18724398.16598.49
6185157-18515797.07297.39
20min1192788-192788101.07298.731.50101.5899.221.50
2189649-18964999.42799.92
3186894-18689497.98298.47
4188624-18862498.88999.38
5187455-18745598.27698.76
6184461-18446196.70797.19
30min1191974-191974100.64699.201.70101.3299.851.69
2190029-19002999.626100.29
3187688-18768898.39999.05
4187038-18703898.05898.71
5193513-193513101.452102.10
6185035-18503597.00897.65
极限1190067-19006799.64698.771.92100.4999.591.91
2189064-18906499.12099.95
3185605-18560597.30798.12
4187226-18722698.15698.98
5194266-194266101.847102.67
6184124-18412496.53097.34
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%
111.221914901903391911341909481908451909510.23
211.211917531911681914600.22
单位质量响应值RSD%判断
17018.8117079.390.26数据可信
供试品溶液-25070901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%
5min1118845-11884562.48662.261.4162.4962.261.41
2119642-11964262.90562.91
3115595-11559560.77760.78
4120378-12037863.29263.29
5117914-11791461.99662.00
6118077-11807762.08262.08
10min1155085-15508581.54082.491.4281.6482.591.42
2157856-15785682.99783.10
3157075-15707582.58682.69
4160759-16075984.52384.63
5154978-15497881.48481.59
6155579-15557981.80081.90
15min1172491-17249190.69291.841.4890.9392.081.48
2176152-17615292.61792.86
3175517-17551792.28392.52
4178680-17868093.94694.19
5171984-17198490.42590.66
6173174-17317491.05191.29
20min1184680-18468097.10196.241.7697.4996.631.75
2183708-18370896.58996.99
3182907-18290796.16896.56
4187887-18788798.78799.19
5179694-17969494.47994.87
6179342-17934294.29494.69
30min1184987-18498797.26298.571.8597.8199.121.84
2188755-18875599.24399.80
3188262-18826298.98499.54
4193330-193330101.649102.22
5183762-18376296.61897.17
6185728-18572897.65298.20
极限1186686-18668698.15599.952.3498.87100.672.33
2191630-191630100.755101.48
3189760-18976099.771100.49
4198257-198257104.239104.98
5187393-18739398.52799.24
6186843-18684398.23898.95
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%
111.221905911906211913391908761905021907860.18
211.211916331918341917340.08
单位质量响应值RSD%判断
17004.1017103.840.42数据可信
供试品溶液-25071501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%
5min1117770-11777061.90361.431.0161.9061.431.01
2118281-11828162.17262.17
3115730-11573060.83160.83
4116551-11655161.26361.26
5115347-11534760.63060.63
6117521-11752161.77361.77
10min1154616-15461681.27181.361.4081.3781.461.40
2156433-15643382.22682.33
3153505-15350580.68780.79
4158022-15802283.06183.16
5151906-15190679.84679.95
6154260-15426081.08481.19
15min1181853-18185395.58791.052.8695.8391.292.85
2173291-17329191.08791.33
3170052-17005289.38489.62
4175432-17543292.21292.45
5168250-16825088.43788.67
6170421-17042189.57889.82
20min1179916-17991694.56994.281.1694.9794.671.16
2180617-18061794.93895.33
3177968-17796893.54593.93
4182523-18252395.94096.33
5176813-17681392.93893.32
6178343-17834393.74294.13
30min1184681-18468197.07497.021.2597.6397.571.24
2185183-18518397.33897.89
3186531-18653198.04698.59
4187294-18729498.44799.00
5181592-18159295.45095.99
6182166-18216695.75296.30
极限1187796-18779698.71197.741.5399.4398.441.53
2186460-18646098.00998.72
3184688-18468897.07897.78
4190355-190355100.056100.77
5182774-18277496.07196.77
6183573-18357396.49197.19
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%
111.221916691916281914751922541918491917750.16
211.211914601917571916080.11
单位质量响应值RSD%判断
17092.2517092.600.01数据可信
供试品溶液-25071502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%
5min1120431-12043163.15962.232.1863.1662.232.18
2120518-12051863.20563.20
3114023-11402359.79959.80
4118150-11815061.96361.96
5118036-11803661.90361.90
6120770-12077063.33763.34
10min1156948-15694882.31080.832.1382.4280.932.14
2155224-15522481.40681.51
3149173-14917378.23378.33
4153709-15370980.61280.71
5151781-15178179.60079.70
6157926-15792682.82382.93
15min1173059-17305990.76089.822.3691.0090.052.36
2173496-17349690.98991.23
3164908-16490886.48586.71
4170363-17036389.34689.58
5169201-16920188.73688.97
6176529-17652992.57992.82
20min1181996-18199695.44793.852.2495.8494.242.24
2180828-18082894.83495.23
3172577-17257790.50790.88
4177710-17771093.19993.59
5177066-17706692.86193.24
6183586-18358696.28096.68
30min1187431-18743198.29796.512.1998.8597.062.19
2184864-18486496.95197.50
3177286-17728692.97693.50
4182687-18268795.80996.35
5183297-18329796.12996.67
6188613-18861398.91799.48
极限1187823-18782398.50297.082.1899.2297.782.18
2186574-18657497.84798.56
3178339-17833993.52994.21
4183893-18389396.44197.14
5184048-18404896.52397.22
6189942-18994299.614100.34
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