比拉斯汀口崩片片项目信息
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%
110.963881233877853879873880793878843879720.04
211.063892003892943892470.02
单位质量响应值RSD%判断
35398.9135194.120.42数据可信
供试品溶液-24061801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%
5min1363419-36341992.34294.861.7492.3494.861.74
2381741-38174196.99797.00
3371828-37182894.47994.48
4369614-36961493.91693.92
5377948-37794896.03496.03
6375422-37542295.39295.39
10min1367690-36769093.42795.721.6093.5895.881.60
2384808-38480897.77797.94
3374931-37493195.26795.42
4373789-37378994.97795.13
5381137-38113796.84497.00
6377893-37789396.02096.18
15min1366765-36676593.19295.591.6693.5095.901.67
2384395-38439597.67298.00
3375798-37579895.48795.80
4372043-37204394.53394.85
5380632-38063296.71697.04
6377494-37749495.91896.24
20min1365967-36596792.98995.401.6293.4595.881.62
2383074-38307497.33697.82
3375424-37542495.39295.87
4371781-37178194.46794.94
5379968-37996896.54797.03
6376523-37652395.67296.15
30min1364788-36478892.69095.211.6593.3195.841.65
2382406-38240697.16697.82
3374759-37475995.22395.86
4371233-37123394.32794.96
5378975-37897596.29596.94
6376003-37600395.53996.18
45min1364562-36456292.63294.701.6393.4195.501.63
2381989-38198997.06097.87
3373490-37349094.90195.69
4369748-36974893.95094.74
5369948-36994894.00194.81
6376437-37643795.65096.45
极限1363309-36330992.31494.751.7193.2495.701.71
2380977-38097796.80397.78
3372615-37261594.67995.63
4368336-36833693.59194.53
5377236-37723695.85396.81
6374927-37492795.26696.22
比拉斯汀口崩片片项目信息
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%
110.963848353849183849883849003847223848730.03
211.063863423861353862380.04
单位质量响应值RSD%判断
35116.1534922.060.40数据可信
供试品溶液-24061801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%
5min1329715-32971584.44284.622.4484.4484.622.44
2323270-32327082.79182.79
3325337-32533783.32083.32
4323738-32373882.91182.91
5337873-33787386.53186.53
6342473-34247387.70987.71
10min1368324-36832494.33095.570.7594.4795.710.75
2372833-37283395.48495.62
3374666-37466695.95496.09
4373625-37362595.68795.83
5372898-37289895.50195.65
6376703-37670396.47696.62
15min1371761-37176195.21096.730.9395.5197.030.93
2379029-37902997.07197.37
3381917-38191797.81198.11
4379411-37941197.16997.47
5375970-37597096.28896.59
6378122-37812296.83997.15
20min1373201-37320195.57996.890.9196.0497.360.90
2376160-37616096.33696.80
3382370-38237097.92798.39
4381091-38109197.59998.06
5377344-37734496.64097.10
6379809-37980997.27197.74
30min1373216-37321695.58296.970.9196.2097.600.90
2378478-37847896.93097.55
3383072-38307298.10798.73
4380406-38040697.42498.05
5376661-37666196.46597.09
6380063-38006397.33697.97
45min1372103-37210395.29796.900.9096.0797.680.90
2378390-37839096.90897.69
3381337-38133797.66298.45
4380587-38058797.47098.25
5377506-37750696.68197.47
6380271-38027197.38998.18
极限1370485-37048594.88396.581.0295.8297.531.02
2378319-37831996.88997.83
3380562-38056297.46498.42
4380651-38065197.48798.43
5375211-37521196.09397.04
6377467-37746796.67197.63
比拉斯汀口崩片片项目信息
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%
110.963855143855043856263856063856893855880.03
211.063837263837883837570.02
单位质量响应值RSD%判断
35181.3934697.740.98数据可信
供试品溶液-24061801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%
5min1298648-29864876.66275.581.8576.6675.581.85
2297645-29764576.40576.40
3297801-29780176.44576.45
4297551-29755176.38176.38
5287966-28796673.92073.92
6286915-28691573.65173.65
10min1349117-34911789.61888.671.6889.7588.801.68
2347084-34708489.09689.22
3348889-34888989.55989.69
4351144-35114490.13890.27
5338566-33856686.90987.03
6337765-33776586.70486.83
15min1365808-36580893.90293.381.4994.1893.651.49
2365318-36531893.77794.05
3366109-36610993.98094.26
4370701-37070195.15895.44
5358469-35846992.01892.29
6356151-35615191.42391.69
20min1371989-37198995.48995.071.4195.9295.501.41
2371854-37185495.45495.89
3372970-37297095.74196.17
4377001-37700196.77697.21
5365421-36542193.80394.22
6362875-36287593.14993.57
30min1373554-37355495.89196.081.4696.4896.671.47
2376220-37622096.57597.17
3377382-37738296.87397.47
4381840-38184098.01898.62
5370459-37045995.09695.67
6366343-36634394.04094.61
45min1375936-37593696.50296.301.4097.2597.051.40
2375354-37535496.35397.10
3378224-37822497.08997.84
4382288-38228898.13398.89
5372313-37231395.57296.31
6366868-36686894.17494.91
极限1374959-37495996.25196.161.3897.1697.061.38
2376791-37679196.72297.63
3377075-37707596.79597.71
4380517-38051797.67898.60
5372794-37279495.69696.59
6365427-36542793.80594.69
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