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%
110.793844753845123844863842933834083842350.13
210.773854533853573854050.02
单位质量响应值RSD%判断
35610.2935785.050.35数据可信
供试品溶液-2L96B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%
5min1224832-22483256.48656.411.4356.4956.411.43
2222724-22272455.95655.96
3229498-22949857.65857.66
4222863-22286355.99155.99
5220579-22057955.41755.42
6226640-22664056.94056.94
10min1298027-29802774.87575.300.5374.9775.400.53
2301636-30163675.78275.88
3300625-30062575.52875.62
4301068-30106875.63975.73
5298084-29808474.89074.98
6298924-29892475.10175.20
15min1334648-33464884.07684.560.6684.2984.780.66
2339276-33927685.23885.46
3336394-33639484.51484.74
4339335-33933585.25385.47
5334550-33455084.05184.27
6335365-33536584.25684.48
20min1353974-35397488.93189.370.7689.2989.730.75
2358647-35864790.10590.47
3353430-35343088.79489.16
4359352-35935290.28290.64
5355474-35547489.30889.67
6353350-35335088.77489.13
30min1369474-36947492.82593.630.9993.3394.140.98
2376583-37658394.61195.12
3369671-36967192.87593.39
4376965-37696594.70795.22
5374088-37408893.98594.49
6369201-36920192.75793.27
45min1375412-37541294.31795.071.0194.9895.741.01
2381979-38197995.96796.64
3375251-37525194.27794.94
4383464-38346496.34097.01
5379768-37976895.41296.07
6374674-37467494.13294.79
极限1376187-37618794.51295.391.0495.3396.221.04
2382863-38286396.18997.02
3376566-37656694.60795.43
4383926-38392696.45697.29
5383009-38300996.22697.05
6375579-37557994.35995.18
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%
110.793835373836063831633837093835383835110.06
210.773846983844143845560.06
单位质量响应值RSD%判断
35543.1935706.220.33数据可信
供试品溶液-2L96B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%
5min1229690-22969057.82556.642.7257.8256.642.72
2228509-22850957.52757.53
3226207-22620756.94856.95
4212934-21293453.60653.61
5227345-22734557.23457.23
6225321-22532156.72556.72
10min1305570-30557076.92775.741.1677.0275.841.15
2301825-30182575.98576.08
3295492-29549274.39074.49
4298629-29862975.18075.27
5301054-30105475.79175.89
6302597-30259776.17976.27
15min1342628-34262886.25784.941.0786.4885.161.06
2337470-33747084.95885.18
3331749-33174983.51883.74
4337993-33799385.09085.30
5335770-33577084.53084.75
6338747-33874785.28085.50
20min1361957-36195791.12389.820.9791.4990.180.97
2356195-35619589.67290.04
3352400-35240088.71789.08
4358628-35862890.28590.64
5353762-35376289.06089.42
6357723-35772390.05790.42
30min1378486-37848695.28493.881.1295.8094.391.12
2371267-37126793.46793.98
3368968-36896892.88893.39
4375416-37541694.51195.02
5367904-36790492.62093.13
6375299-37529994.48295.00
45min1383359-38335996.51195.341.0097.1996.000.99
2376885-37688594.88195.55
3374923-37492394.38795.05
4380694-38069495.84096.50
5374506-37450694.28294.95
6381816-38181696.12296.79
极限1384055-38405596.68695.430.9897.5396.260.98
2376282-37628294.72995.56
3376297-37629794.73395.55
4381050-38105095.93096.75
5375017-37501794.41195.23
6381799-38179996.11896.95
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