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%
110.903751713745683751913753013747113749880.09
210.983743933750793747360.13
单位质量响应值RSD%判断
34402.5734128.960.57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%
5min1229807-22980760.11958.192.2960.1258.192.29
2223836-22383658.55758.56
3225595-22559559.01759.02
4215545-21554556.38856.39
5221039-22103957.82557.83
6218787-21878757.23657.24
10min1313050-31305081.89680.161.3182.0080.261.32
2304191-30419179.57879.68
3307108-30710880.34180.44
4301260-30126078.81278.91
5307902-30790280.54980.65
6304909-30490979.76679.86
15min1343012-34301289.73490.051.0389.9790.281.03
2350021-35002191.56891.80
3344711-34471190.17990.41
4338987-33898788.68188.91
5344079-34407990.01390.24
6344408-34440890.09990.33
20min1361230-36123094.50094.500.6094.8994.880.60
2359370-35937094.01394.40
3361628-36162894.60494.99
4358211-35821193.71094.08
5363517-36351795.09895.48
6363477-36347795.08895.47
30min1373955-37395597.82998.210.8698.3798.750.86
2372315-37231597.40097.94
3375854-37585498.32698.87
4372545-37254597.46097.99
5377156-37715698.66699.21
6380739-38073999.604100.14
极限1379161-37916199.191100.131.2499.90100.831.23
2375996-37599698.36399.06
3381643-38164399.840100.54
4388161-388161101.545102.24
5384169-384169100.501101.20
6387309-387309101.323102.03
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%
110.903744483748743743823744913743613745110.06
210.983750723756483753600.11
单位质量响应值RSD%判断
34358.8134185.790.36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%
5min1237353-23735362.08159.123.8862.0859.123.88
2214032-21403255.98155.98
3220503-22050357.67357.67
4221428-22142857.91557.92
5231022-23102260.42560.42
6231936-23193660.66460.66
10min1313474-31347481.99079.271.8982.0979.371.89
2295931-29593177.40277.50
3302695-30269579.17179.27
4301896-30189678.96279.06
5303198-30319879.30379.40
6301261-30126178.79678.90
15min1341142-34114289.22789.070.4989.4789.300.49
2338953-33895388.65588.88
3341283-34128389.26489.49
4342826-34282689.66889.90
5340669-34066989.10389.34
6338264-33826488.47488.71
20min1359367-35936793.99493.970.2394.3894.350.23
2359944-35994494.14594.51
3360486-36048694.28794.66
4358774-35877493.83994.22
5358279-35827993.70994.09
6358904-35890493.87394.25
30min1371671-37167197.21297.990.5897.7698.530.57
2378328-37832898.95399.48
3374945-37494598.06898.60
4374499-37449997.95298.49
5374371-37437197.91898.46
6374170-37417097.86698.40
极限1377045-37704598.61899.230.5799.3399.930.56
2383120-383120100.207100.90
3379036-37903699.13899.84
4380260-38026099.459100.16
5378004-37800498.86899.57
6378771-37877199.06999.77
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%
110.903749123742103749683743783747333746400.09
210.983743173748433745800.10
单位质量响应值RSD%判断
34370.6434114.750.53数据可信
供试品溶液-2024122021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%
5min1249017-24901765.18865.141.4365.1965.141.44
2248207-24820764.97664.98
3243236-24323663.67563.67
4248212-24821264.97764.98
5250169-25016965.49065.49
6254245-25424566.55766.56
10min1323687-32368784.73584.191.4784.8484.301.47
2321177-32117784.07884.19
3313965-31396582.19082.30
4319101-31910183.53583.64
5324190-32419084.86784.98
6327539-32753985.74485.85
15min1359880-35988094.21093.171.7094.4693.421.70
2362229-36222994.82595.07
3346339-34633990.66590.91
4351817-35181792.09992.35
5355185-35518592.98193.23
6360081-36008194.26394.52
20min1370230-37023096.92096.331.3097.3396.741.31
2365450-36545095.66896.07
3360619-36061994.40494.80
4366491-36649195.94196.34
5371109-37110997.15097.56
6374037-37403797.91698.33
30min1387316-387316101.39299.601.56101.96100.161.56
2376183-37618398.47899.04
3372545-37254597.52698.08
4378237-37823799.01699.58
5381546-38154699.882100.45
6386949-386949101.296101.87
极限1389240-389240101.896100.381.61102.63101.111.61
2378212-37821299.00999.74
3375199-37519998.22098.93
4382326-382326100.086100.81
5384601-384601100.682101.42
6391036-391036102.366103.11
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%
110.903763623752033756383757093757543757330.12
210.983748933750903749920.04
单位质量响应值RSD%判断
34470.9234152.280.66数据可信
供试品溶液-2024122021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%
5min1246870-24687064.49764.791.3764.5064.791.37
2246970-24697064.52364.52
3251407-25140765.68265.68
4252914-25291466.07666.08
5244538-24453863.88863.89
6245261-24526164.07664.08
10min1323029-32302984.39484.620.9184.5084.730.91
2324620-32462084.81084.92
3325652-32565285.07985.19
4326040-32604085.18185.29
5318364-31836483.17583.28
6325743-32574385.10385.21
15min1356822-35682293.22393.190.8393.4793.440.84
2357282-35728293.34393.59
3357656-35765693.44193.69
4358903-35890393.76694.02
5350872-35087291.66891.91
6358618-35861893.69293.94
20min1379967-37996799.27097.641.2499.6798.051.24
2374514-37451497.84598.25
3374316-37431697.79398.20
4372965-37296597.44097.85
5365696-36569695.54195.94
6374994-37499497.97098.38
30min1382576-38257699.951100.501.06100.52101.061.05
2384053-384053100.337100.90
3391179-391179102.199102.77
4384211-384211100.378100.95
5379202-37920299.07099.63
6386783-386783101.050101.62
极限1391379-391379102.251101.650.91102.99102.390.91
2391717-391717102.339103.07
3388138-388138101.404102.14
4387964-387964101.359102.10
5382998-382998100.061100.78
6392358-392358102.507103.24
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