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%
111.161918211920081916681925991923361920860.20
211.171921471925361923420.15
单位质量响应值RSD%判断
17212.0117219.520.04数据可信
供试品溶液-2025073121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%
5min1194998-194998101.53398.981.65101.5398.981.65
2186700-18670097.21297.21
3189327-18932798.58098.58
4187491-18749197.62497.62
5192508-192508100.236100.24
6189533-18953398.68798.69
10min1197516-197516102.844101.141.95103.01101.301.95
2190349-19034999.11299.27
3192663-192663100.317100.48
4190517-19051799.19999.36
5194872-194872101.467101.63
6199568-199568103.912104.08
15min1197849-197849103.017100.461.50103.36100.791.50
2189537-18953798.68999.02
3193218-193218100.606100.94
4191189-19118999.54999.88
5194067-194067101.048101.38
6191745-19174599.839100.18
20min1197370-197370102.768100.221.59103.28100.721.59
2189138-18913898.48198.97
3192153-192153100.051100.55
4190056-19005698.95999.45
5194630-194630101.341101.85
6191490-19149099.706100.21
30min1197412-197412102.790100.101.54103.47100.771.54
2189208-18920898.51899.17
3192045-19204599.995100.66
4190197-19019799.03399.69
5193655-193655100.833101.51
6190975-19097599.438100.11
极限1196611-196611102.37399.921.50103.23100.761.50
2188946-18894698.38199.20
3191436-19143699.678100.51
4189582-18958298.71399.54
5193834-193834100.927101.77
6190982-19098299.442100.28
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%
111.161920151917481920891919101919761919480.07
211.171929411928401928900.04
单位质量响应值RSD%判断
17199.6417268.580.29数据可信
供试品溶液-2025073121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%
5min1187820-18782097.69199.011.4897.6999.011.48
2186742-18674297.13197.13
3192827-192827100.296100.30
4189960-18996098.80598.80
5194045-194045100.929100.93
6190769-19076999.22599.23
10min1191997-19199799.864100.491.29100.03100.661.29
2189703-18970398.67198.83
3195339-195339101.602101.77
4192545-192545100.149100.31
5196678-196678102.299102.47
6192969-192969100.370100.53
15min1191925-19192599.827100.431.24100.16100.761.24
2189756-18975698.69899.02
3195186-195186101.523101.86
4191885-19188599.806100.14
5196240-196240102.071102.41
6193480-193480100.635100.97
20min1191040-19104099.366100.691.6299.86101.191.62
2189134-18913498.37598.87
3194794-194794101.319101.82
4196880-196880102.404102.90
5196754-196754102.338102.85
6192946-192946100.358100.86
30min1191340-19134099.522100.161.51100.18100.831.51
2188748-18874898.17498.83
3195973-195973101.932102.61
4191437-19143799.573100.24
5196089-196089101.992102.67
6191857-19185799.791100.46
极限1190407-19040799.03799.911.5299.86100.741.52
2188150-18815097.86398.68
3194437-194437101.133101.98
4190478-19047899.07499.91
5195995-195995101.944102.79
6192994-192994100.383101.22
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%
111.161925871921201921921917691920661921470.16
211.171924871924841924860.01
单位质量响应值RSD%判断
17217.4717232.410.07数据可信
供试品溶液-2025080121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%
5min1185918-18591896.75397.612.2896.7597.612.27
2187100-18710097.36897.37
3190105-19010598.93298.93
4180217-18021793.78693.79
5192289-192289100.069100.07
6189797-18979798.77298.77
10min1188734-18873498.21998.712.1498.3898.872.14
2189711-18971198.72798.89
3191772-19177299.80099.96
4182230-18223094.83494.99
5193609-193609100.756100.92
6192042-19204299.940100.10
15min1187678-18767897.66998.782.1197.9999.112.11
2189513-18951398.62498.95
3192031-19203199.935100.27
4183147-18314795.31195.63
5194311-194311101.121101.46
6192209-192209100.027100.36
20min1187655-18765597.65798.902.7198.1499.392.71
2188682-18868298.19298.68
3196544-196544102.283102.78
4181945-18194594.68695.16
5193948-193948100.932101.44
6191442-19144299.628100.13
30min1187593-18759397.62598.222.2898.2898.872.28
2188432-18843298.06298.72
3191285-19128599.546100.21
4180997-18099794.19294.82
5193233-193233100.560101.23
6190823-19082399.30699.97
极限1187166-18716697.40398.162.4098.2298.982.40
2188541-18854198.11898.94
3190898-19089899.345100.18
4180560-18056093.96594.75
5193533-193533100.716101.56
6190971-19097199.383100.21
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%
111.161919921921121917481913941914541917400.17
211.171924571924621924600.01
单位质量响应值RSD%判断
17181.0017230.080.21数据可信
供试品溶液-2025080121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%
5min1193615-193615100.87398.092.02100.8798.092.02
2186476-18647697.15397.15
3182173-18217394.91194.91
4188324-18832498.11698.12
5189261-18926198.60498.60
6189801-18980198.88698.89
10min1194667-194667101.42199.501.99101.5999.671.99
2189319-18931998.63498.80
3184865-18486596.31496.47
4189752-18975298.86099.02
5194781-194781101.480101.64
6192544-192544100.315100.48
15min1194858-194858101.52099.502.54101.8699.832.54
2188169-18816998.03598.36
3183577-18357795.64395.96
4190105-19010599.04499.37
5197100-197100102.688103.02
6192043-192043100.054100.39
20min1194381-194381101.27298.781.97101.7899.281.97
2188003-18800397.94998.44
3183387-18338795.54496.02
4189400-18940098.67799.17
5191099-19109999.562100.07
6191374-19137499.705100.20
30min1193849-193849100.99598.662.00101.6799.322.00
2187785-18778597.83598.49
3182924-18292495.30395.94
4189507-18950798.73299.39
5190278-19027899.13499.80
6191892-19189299.975100.64
极限1192700-192700100.39698.421.80101.2499.241.80
2186947-18694797.39998.21
3183151-18315195.42196.22
4189369-18936998.66099.48
5190474-19047499.236100.07
6190806-19080699.409100.24
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%
111.161921261925101924221924151922981923540.08
211.171924801926721925760.08
单位质量响应值RSD%判断
17236.0217240.470.02数据可信
供试品溶液-2025080122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%
5min1187139-18713997.31499.161.7197.3199.161.71
2192036-19203699.86099.86
3192352-192352100.024100.02
4195733-195733101.782101.78
5188677-18867798.11398.11
6188219-18821997.87597.88
10min1189250-18925098.411100.111.6898.57100.281.68
2194368-194368101.073101.24
3194581-194581101.183101.35
4196972-196972102.427102.60
5190668-19066899.14999.31
6189277-18927798.42598.59
15min1189351-18935198.464100.701.8198.79101.031.81
2194023-194023100.893101.23
3194704-194704101.247101.58
4196960-196960102.420102.76
5197327-197327102.611102.94
6189550-18955098.56798.89
20min1189153-18915398.36199.961.5798.85100.461.57
2193544-193544100.644101.15
3193868-193868100.813101.32
4196811-196811102.343102.85
5190244-19024498.92899.43
6189731-18973198.66199.15
30min1188478-18847898.01099.841.5998.66100.501.59
2193568-193568100.657101.33
3194245-194245101.009101.68
4196036-196036101.940102.62
5190307-19030798.96199.63
6189298-18929898.43699.09
极限1188143-18814397.83699.601.6998.65100.441.69
2193345-193345100.541101.38
3193322-193322100.529101.37
4196139-196139101.994102.85
5190059-19005998.83299.66
6188254-18825497.89398.71
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%
111.161923631920841927021923261921661923280.13
211.171925791922171923980.14
单位质量响应值RSD%判断
17233.6917224.530.04数据可信
供试品溶液-2025080122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%
5min1189629-18962998.66199.681.7498.6699.681.74
2194750-194750101.325101.32
3189816-18981698.75898.76
4188766-18876698.21298.21
5196772-196772102.377102.38
6189756-18975698.72798.73
10min1191300-19130099.530100.751.6899.69100.911.67
2196345-196345102.155102.32
3191908-19190899.846100.01
4191416-19141699.59099.75
5198977-198977103.524103.69
6191886-19188699.835100.00
15min1190654-19065499.194100.471.8799.52100.811.87
2196315-196315102.139102.48
3191061-19106199.40699.74
4190200-19020098.95899.29
5198916-198916103.492103.84
6191541-19154199.65599.99
20min1190306-19030699.013100.291.8299.51100.801.82
2195660-195660101.798102.31
3190236-19023698.97699.47
4190770-19077099.25499.75
5198553-198553103.304103.82
6191082-19108299.41799.91
30min1190681-19068199.208100.281.5899.87100.941.58
2195197-195197101.558102.24
3190508-19050899.11899.78
4190774-19077499.25699.92
5197779-197779102.901103.59
6191457-19145799.612100.27
极限1190586-19058699.159100.021.6899.98100.861.68
2194905-194905101.406102.25
3190318-19031899.01999.85
4189877-18987798.79099.62
5197578-197578102.796103.66
6190191-19019198.95399.78
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