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%
110.793802243806033805053801313798023802530.09
210.773803113802733802920.01
单位质量响应值RSD%判断
35241.2435310.310.14数据可信
供试品溶液-2L96B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%
5min1363585-36358592.43894.691.4192.4494.691.41
2375157-37515795.38095.38
3376621-37662195.75295.75
4369713-36971393.99694.00
5377532-37753295.98495.98
6372061-37206194.59394.59
10min1388896-38889698.87396.761.2399.0396.921.23
2380519-38051996.74396.90
3380498-38049896.73896.90
4375515-37551595.47195.63
5381216-38121696.92097.08
6376863-37686395.81495.97
15min1388670-38867098.81596.661.3799.1396.981.37
2378789-37878996.30396.62
3383191-38319197.42297.74
4374906-37490695.31695.63
5380385-38038596.70997.03
6375261-37526195.40695.72
20min1387623-38762398.54996.471.2299.0396.951.22
2378666-37866696.27296.75
3379579-37957996.50496.99
4374807-37480795.29195.77
5380572-38057296.75797.24
6375357-37535795.43195.91
30min1387174-38717498.43596.281.2799.0896.931.26
2377932-37793296.08596.73
3379229-37922996.41597.06
4373877-37387795.05495.69
5379587-37958796.50697.15
6374492-37449295.21195.85
45min1386384-38638498.23496.041.2699.0596.851.26
2377188-37718895.89696.70
3378082-37808296.12496.93
4373366-37336694.92595.72
5378156-37815696.14296.95
6373408-37340894.93595.73
极限1384993-38499397.88195.811.2398.8696.771.23
2376624-37662495.75396.71
3377098-37709895.87396.84
4372216-37221694.63295.58
5377554-37755495.98996.95
6372567-37256794.72195.67
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%
110.793809283803403809303804033813993808000.12
210.773802563805193803880.05
单位质量响应值RSD%判断
35291.9435319.220.06数据可信
供试品溶液-2L96B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%
5min1375352-37535295.34995.940.7695.3595.940.76
2381532-38153296.91996.92
3381041-38104196.79496.79
4376397-37639795.61495.61
5376787-37678795.71395.71
6375028-37502895.26795.27
10min1380814-38081496.73697.440.7196.9097.600.71
2386764-38676498.24898.41
3386982-38698298.30398.46
4381348-38134896.87297.03
5382024-38202497.04497.20
6383682-38368297.46597.62
15min1380315-38031596.61097.140.6196.9397.460.61
2384741-38474197.73498.06
3385620-38562097.95798.28
4380641-38064196.69297.01
5380624-38062496.68897.01
6382477-38247797.15997.48
20min1378559-37855996.16396.970.7996.6497.450.78
2385012-38501297.80398.29
3385290-38529097.87398.36
4379660-37966096.44396.93
5379281-37928196.34796.83
6382510-38251097.16797.65
30min1379362-37936296.36796.860.6397.0197.510.63
2384010-38401097.54898.20
3384553-38455397.68698.34
4379228-37922896.33396.98
5379764-37976496.47097.11
6380942-38094296.76997.41
45min1378233-37823396.08196.690.6896.8897.500.68
2383510-38351097.42198.23
3384062-38406297.56198.38
4378728-37872896.20697.01
5378844-37884496.23697.04
6380425-38042596.63797.44
极限1377539-37753995.90496.410.6596.8797.380.65
2381991-38199197.03598.01
3382890-38289097.26498.24
4377551-37755195.90796.87
5377430-37743095.87796.84
6379686-37968696.45097.42
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%
110.793802733799113803703803583803103802440.06
210.773827563833313830440.11
单位质量响应值RSD%判断
35240.4135565.830.65数据可信
供试品溶液-2L96B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%
5min1290542-29054273.60370.855.7973.6070.855.79
2282989-28298971.69071.69
3248928-24892863.06163.06
4294100-29410074.50474.50
5284259-28425972.01172.01
6277306-27730670.25070.25
10min1351062-35106288.93589.111.1289.0689.231.12
2347606-34760688.05988.18
3349986-34998688.66288.77
4358998-35899890.94591.07
5352744-35274489.36189.48
6350118-35011888.69688.81
15min1366907-36690792.94993.641.0893.2293.901.07
2364250-36425092.27692.54
3375501-37550195.12695.38
4372363-37236394.33194.61
5368948-36894893.46693.73
6369802-36980293.68293.95
20min1371495-37149594.11194.621.0394.5495.051.02
2367903-36790393.20193.62
3379104-37910496.03996.45
4375493-37549395.12495.56
5372443-37244394.35194.78
6374685-37468594.91995.34
30min1368582-36858293.37394.741.2293.9695.321.21
2369731-36973193.66494.24
3380861-38086196.48497.06
4375976-37597695.24695.84
5375781-37578195.19795.78
6372889-37288994.46495.04
45min1371140-37114094.02194.810.9494.7695.550.93
2371884-37188494.21094.94
3380579-38057996.41297.14
4375886-37588695.22395.97
5372451-37245194.35395.09
6373580-37358094.63995.38
极限1369724-36972493.66294.421.1094.5695.321.09
2368092-36809293.24994.14
3379556-37955696.15397.05
4374632-37463294.90695.81
5371213-37121394.04094.94
6373040-37304094.50295.40
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%
110.793800813797393795223798933793803797230.08
210.773800743803483802110.06
单位质量响应值RSD%判断
35192.1235302.790.23数据可信
供试品溶液-2L96B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%
5min1299480-29948076.20168.767.9976.2068.767.98
2263203-26320366.97166.97
3251797-25179764.06864.07
4292449-29244974.41274.41
5268399-26839968.29368.29
6246053-24605362.60762.61
10min1362631-36263192.26989.752.0392.4089.872.04
2347688-34768888.46788.58
3343842-34384287.48987.60
4357804-35780491.04191.17
5355902-35590290.55790.67
6348566-34856688.69188.80
15min1377035-37703595.93494.511.7396.2294.771.73
2365061-36506192.88893.15
3363452-36345292.47892.73
4372930-37293094.89095.17
5379600-37960096.58796.85
6370486-37048694.26894.52
20min1380260-38026096.75595.681.3297.2096.101.33
2370007-37000794.14694.56
3369881-36988194.11494.52
4377362-37736296.01896.45
5381190-38119096.99297.42
6377461-37746196.04396.45
30min1380621-38062196.84796.001.4697.4596.581.46
2370950-37095094.38694.96
3370198-37019894.19594.76
4377509-37750996.05596.65
5382760-38276097.39197.98
6381681-38168197.11797.69
45min1380279-38027996.76095.961.5597.5296.701.55
2370596-37059694.29695.02
3369647-36964794.05594.78
4377079-37707995.94696.70
5383655-38365597.61998.37
6381496-38149697.07097.80
极限1381077-38107796.96396.031.4897.8996.931.48
2370462-37046294.26295.15
3371144-37114494.43695.31
4376916-37691695.90496.82
5383794-38379497.65498.57
6381074-38107496.96297.86
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