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%
111.033829653830223826443829443829743829100.04
211.093845013846853845930.04
单位质量响应值RSD%判断
34715.3234679.260.08数据可信
供试品溶液-3176A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%
5min1174772-17477245.15244.574.4645.1544.574.46
2177571-17757145.87545.88
3179753-17975346.43946.44
4158941-15894141.06241.06
5175732-17573245.40045.40
6168294-16829443.47943.48
10min1264328-26432868.28965.733.8468.3665.803.84
2259793-25979367.11767.19
3264142-26414268.24168.32
4246280-24628063.62663.69
5250712-25071264.77164.85
6241222-24122262.31962.39
15min1308607-30860779.72875.874.1579.9276.054.15
2298785-29878577.19177.38
3303504-30350478.41078.60
4289029-28902974.67074.84
5286237-28623773.94974.13
6275843-27584371.26471.44
20min1334096-33409686.31381.494.3986.6481.804.39
2321147-32114782.96883.28
3323177-32317783.49283.81
4312841-31284180.82281.12
5306625-30662579.21679.52
6294660-29466076.12576.42
30min1360460-36046093.12487.185.0593.5987.635.04
2344466-34446688.99289.45
3347221-34722189.70490.17
4334505-33450586.41986.85
5325744-32574484.15684.59
6312411-31241180.71181.13
45min1375251-37525196.94690.805.1497.5791.405.13
2360398-36039893.10893.71
3361358-36135893.35693.97
4348142-34814289.94290.52
5339018-33901887.58588.16
6324672-32467283.87984.44
60min1382233-38223398.74992.685.0999.5393.425.09
2368382-36838295.17195.93
3369042-36904295.34296.11
4355089-35508991.73792.46
5346308-34630889.46890.19
6331446-33144685.62986.32
极限1386248-38624899.78797.471.72100.7398.371.74
2382140-38214098.72599.64
3379496-37949698.04298.97
4371868-37186896.07296.95
5374776-37477696.82397.70
6369181-36918195.37796.22
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%
111.033831203827533828973827863829063828920.04
211.093854783854883854830.01
单位质量响应值RSD%判断
34713.6934759.510.10数据可信
供试品溶液-3176A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%
5min1186257-18625748.06544.903.7548.0644.903.75
2174612-17461245.06045.06
3167037-16703743.10543.10
4171758-17175844.32344.32
5171487-17148744.25344.25
6172794-17279444.59144.59
10min1270946-27094669.91967.742.6670.0067.822.66
2267997-26799769.15869.23
3265297-26529768.46268.53
4258391-25839166.67966.75
5260542-26054267.23567.31
6251858-25185864.99465.07
15min1309546-30954679.88079.342.6980.0879.542.69
2314957-31495781.27781.47
3316446-31644681.66181.85
4303442-30344278.30578.49
5306494-30649479.09379.28
6293939-29393975.85376.04
20min1329435-32943585.01385.422.9185.3485.742.91
2339416-33941687.58887.91
3343390-34339088.61488.94
4325324-32532483.95284.27
5331722-33172285.60385.92
6316721-31672181.73282.04
30min1347260-34726089.61390.943.0490.0891.413.03
2360947-36094793.14593.62
3367712-36771294.89095.36
4347211-34721189.60090.06
5353433-35343391.20691.67
6337916-33791687.20187.65
45min1359783-35978392.84494.262.5893.4794.882.57
2372991-37299196.25396.88
3378103-37810397.57298.20
4363079-36307993.69594.30
5365860-36586094.41395.02
6351805-35180590.78691.38
60min1366842-36684294.66695.672.1095.4496.452.10
2375978-37597897.02497.81
3382150-38215098.61699.41
4368463-36846395.08495.85
5371404-37140495.84396.61
6359665-35966592.81493.56
极限1378229-37822997.60498.471.1798.5499.401.16
2379239-37923997.86598.81
3384877-38487799.320100.27
4376037-37603797.03997.96
5387697-387697100.048100.98
6383343-38334398.92499.82
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