比拉斯汀片项目信息
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%
110.993783203783093784473779003776843781320.09
211.073782923781823782370.03
单位质量响应值RSD%判断
34406.9234167.750.50数据可信
供试品溶液-24052201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%
5min1374803-37480397.98997.223.7297.9997.213.72
2356800-35680093.28293.28
3383926-383926100.374100.37
10min1385017-385017100.659100.360.67100.82100.520.67
2385697-385697100.837100.99
3380949-38094999.59699.76
15min1381528-38152899.74798.903.71100.0899.233.71
2362917-36291794.88195.20
3390386-390386102.063102.40
20min1391848-391848102.445102.160.74102.94102.650.72
2392901-392901102.720103.20
3387491-387491101.306101.81
30min1381076-38107699.62998.853.54100.3099.513.53
2363479-36347995.02895.68
3389715-389715101.887102.56
45min1390850-390850102.184101.920.79103.02102.750.77
2392275-392275102.557103.37
3386437-386437101.030101.87
60min1380364-38036499.44398.563.56100.4599.563.54
2362203-36220394.69595.68
3388364-388364101.534102.54
极限1389107-389107101.728101.680.74102.90102.840.71
2391661-391661102.396103.54
3385970-385970100.908102.09
比拉斯汀片项目信息
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%
110.993774063774583774363772703775293774200.03
211.073779743778503779120.03
单位质量响应值RSD%判断
34342.1334138.390.43数据可信
供试品溶液-24052201批
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1310521-31052181.29484.817.9281.2984.817.92
2307849-30784980.59580.59
3353520-35352092.55192.55
10min1383501-383501100.40099.961.25100.54100.101.24
2385506-385506100.925101.06
3376466-37646698.55998.71
15min1377923-37792398.94096.346.0599.2496.656.03
2342538-34253889.67689.98
3383538-383538100.410100.73
20min1389169-389169101.884101.620.90102.35102.090.88
2391023-391023102.370102.82
3384299-384299100.609101.10
30min1381235-38123599.80796.605.96100.4497.235.93
2343620-34362089.96090.58
3382069-382069100.025100.68
45min1388763-388763101.778101.460.93102.58102.260.90
2390382-390382102.202102.97
3383511-383511100.403101.22
60min1381786-38178699.95196.686.05100.9297.656.01
2343540-34354089.93990.88
3382556-382556100.153101.14
极限1387010-387010101.319101.070.97102.46102.200.94
2389220-389220101.898102.99
3381930-38193099.989101.14
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