比拉斯汀口腔崩解片项目信息
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%
111.063837393832703837393830543826873832980.12
211.073833393828113830750.10
单位质量响应值RSD%判断
34656.2434604.790.11数据可信
供试品溶液-2L96B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%
5min1393665-393665101.89998.362.31101.9098.362.31
2377089-37708997.60897.61
3380990-38099098.61898.62
4367742-36774295.18995.19
5384591-38459199.55099.55
6375883-37588397.29697.30
10min1400203-400203103.591101.111.50103.76101.271.50
2395353-395353102.336102.50
3386769-386769100.114100.28
4385760-38576099.853100.01
5388534-388534100.571100.74
6386996-386996100.173100.33
15min1399893-399893103.511101.051.50103.85101.381.50
2394158-394158102.027102.36
3390864-390864101.174101.51
4385602-38560299.812100.14
5386820-386820100.127100.46
6384943-38494399.64199.97
20min1397996-397996103.020100.971.55103.54101.471.55
2396974-396974102.756103.26
3389463-389463100.811101.31
4385184-38518499.704100.20
5386810-386810100.125100.63
6384048-38404899.41099.90
30min1397992-397992103.019101.081.27103.71101.751.27
2393663-393663101.898102.57
3388493-388493100.560101.23
4386633-386633100.079100.74
5391751-391751101.404102.07
6384538-38453899.537100.20
极限1397386-397386102.862100.821.36103.72101.661.36
2394111-394111102.014102.86
3387714-387714100.359101.19
4386742-386742100.107100.93
5388233-388233100.493101.33
6382908-38290899.11599.94
比拉斯汀口腔崩解片项目信息
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%
111.063844413830543825793824803815873828280.28
211.073884313874423879360.19
单位质量响应值RSD%判断
34613.7435043.900.88数据可信
供试品溶液-2L96B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%
5min1384240-38424098.89795.424.3798.9095.424.37
2359715-35971592.58492.58
3345569-34556988.94488.94
4381867-38186798.28698.29
5366942-36694294.44594.44
6385958-38595899.33999.34
10min1390413-390413100.486100.340.85100.65100.500.85
2393342-393342101.239101.39
3384198-38419898.88699.03
4388803-388803100.071100.24
5389661-389661100.292100.45
6392722-392722101.080101.25
15min1389824-389824100.33499.910.80100.67100.240.80
2391593-391593100.789101.11
3383377-38337798.67598.99
4385922-38592299.33099.66
5387983-38798399.860100.18
6390374-390374100.476100.81
20min1388707-388707100.04799.680.64100.55100.180.64
2389546-389546100.262100.75
3383332-38333298.66399.14
4385358-38535899.18599.68
5387677-38767799.781100.27
6389128-389128100.155100.66
30min1389273-389273100.19299.870.79100.86100.530.79
2390012-390012100.382101.04
3382008-38200898.32298.96
4389451-389451100.238100.90
5387929-38792999.846100.50
6389496-389496100.250100.92
极限1387110-38711099.63599.470.72100.47100.300.73
2388651-388651100.032100.86
3381664-38166498.23499.04
4385059-38505999.10899.94
5387067-38706799.624100.45
6389310-389310100.202101.04
比拉斯汀口腔崩解片项目信息
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%
111.063827943824553822683816513818113821960.13
211.073835133830233832680.10
单位质量响应值RSD%判断
34556.6034622.220.14数据可信
供试品溶液-2024121821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%
5min1395926-395926102.606100.891.40102.61100.891.40
2384900-38490099.74999.75
3389243-389243100.874100.87
4386399-386399100.137100.14
5395800-395800102.573102.57
6383594-38359499.41099.41
10min1403195-403195104.490102.821.28104.66102.991.28
2391764-391764101.527101.69
3395316-395316102.448102.62
4396566-396566102.772102.94
5402239-402239104.242104.41
6391410-391410101.436101.60
15min1400116-400116103.692102.141.14104.04102.481.14
2390229-390229101.130101.47
3392467-392467101.710102.05
4392006-392006101.590101.93
5399425-399425103.513103.86
6390509-390509101.202101.54
20min1399907-399907103.638101.831.28104.16102.341.28
2389900-389900101.044101.55
3392010-392010101.591102.10
4390239-390239101.132101.64
5398233-398233103.204103.72
6387358-387358100.386100.89
30min1400092-400092103.686101.941.22104.38102.621.22
2388855-388855100.774101.45
3393553-393553101.991102.67
4391738-391738101.521102.20
5397762-397762103.082103.77
6388157-388157100.593101.26
极限1399273-399273103.473101.591.23104.34102.441.23
2388540-388540100.692101.53
3391029-391029101.337102.18
4389651-389651100.980101.83
5396429-396429102.736103.60
6387110-387110100.321101.16
比拉斯汀口腔崩解片项目信息
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%
111.063888293892263899753893803893203893460.11
211.073914783921533918160.13
单位质量响应值RSD%判断
35203.0735394.400.39数据可信
供试品溶液-2024121821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%
5min1388701-38870198.71098.850.9698.7198.850.96
2382890-38289097.23497.23
3389817-38981798.99398.99
4388458-38845898.64898.65
5391851-39185199.51099.51
6393790-393790100.002100.00
10min1397197-397197100.868100.820.76101.03100.990.76
2393181-39318199.848100.01
3396362-396362100.656100.82
4394474-394474100.176100.34
5400527-400527101.713101.88
6400390-400390101.678101.85
15min1395244-395244100.372100.300.83100.70100.630.83
2390102-39010299.06699.39
3395777-395777100.507100.84
4393142-39314299.838100.17
5395536-395536100.446100.78
6399927-399927101.561101.90
20min1394194-394194100.10599.970.94100.60100.470.94
2387890-38789098.50499.00
3392929-39292999.784100.28
4392275-39227599.618100.12
5395894-395894100.537101.04
6398812-398812101.278101.78
30min1392997-39299799.80199.830.89100.47100.500.89
2387510-38751098.40899.07
3393694-39369499.978100.64
4391362-39136299.386100.05
5395696-395696100.486101.16
6397417-397417100.924101.60
极限1392016-39201699.55299.651.15100.39100.491.15
2385412-38541297.87598.70
3393618-39361899.959100.79
4389937-38993799.02499.85
5394917-394917100.289101.13
6398589-398589101.221102.06
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