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%
110.963881323881263876653878273881673879830.06
211.063884873882833883850.04
单位质量响应值RSD%判断
35399.9135116.180.57数据可信
供试品溶液-24061802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%
5min1377462-37746296.01695.160.7596.0295.160.75
2371458-37145894.48894.49
3373854-37385495.09895.10
4372568-37256894.77194.77
5371597-37159794.52494.52
6377615-37761596.05596.05
10min1381299-38129996.99296.020.8497.1596.180.83
2375127-37512795.42295.58
3377829-37782996.10996.27
4375651-37565195.55595.71
5373913-37391395.11395.27
6381068-38106896.93397.09
15min1380252-38025296.72595.840.6997.0596.160.69
2375655-37565595.55695.87
3377004-37700495.89996.22
4375173-37517395.43395.75
5373339-37333994.96795.28
6379163-37916396.44896.77
20min1378994-37899496.40595.650.6796.8996.130.67
2373762-37376295.07495.55
3376401-37640195.74696.22
4374671-37467195.30695.78
5373366-37336694.97495.45
6378934-37893496.39096.87
30min1378035-37803596.16195.440.7196.8096.080.70
2373381-37338194.97895.61
3375661-37566195.55796.20
4373840-37384095.09495.73
5371909-37190994.60395.24
6378428-37842896.26196.90
45min1377125-37712595.93095.230.7796.7396.030.77
2372730-37273094.81295.60
3374551-37455195.27596.07
4373350-37335094.97095.76
5370455-37045594.23395.02
6378086-37808696.17496.98
极限1376351-37635195.73395.050.6696.7096.000.66
2371783-37178394.57195.52
3374557-37455795.27796.23
4372076-37207694.64695.60
5370751-37075194.30995.26
6376391-37639195.74396.71
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%
110.963859823861943862073860543859853860840.03
211.063860873859153860010.04
单位质量响应值RSD%判断
35226.6434900.630.66数据可信
供试品溶液-24061802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%
5min1339470-33947086.83186.081.6086.8386.081.60
2329877-32987784.37784.38
3336016-33601685.94785.95
4332755-33275585.11385.11
5335872-33587285.91085.91
6345263-34526388.31388.31
10min1371288-37128894.96995.170.9195.1195.320.91
2373809-37380995.61495.75
3373808-37380895.61495.76
4369356-36935694.47594.62
5367537-36753794.01094.15
6376721-37672196.35996.51
15min1374539-37453995.80196.111.0296.1096.421.01
2377670-37767096.60296.90
3379155-37915596.98297.28
4372188-37218895.19995.50
5370884-37088494.86695.17
6380143-38014397.23497.54
20min1375505-37550596.04896.051.0396.5196.511.03
2377223-37722396.48796.95
3379647-37964797.10797.57
4371871-37187195.11895.58
5369981-36998194.63595.09
6378783-37878396.88697.36
30min1376102-37610296.20196.071.3896.8296.701.38
2378477-37847796.80897.43
3379347-37934797.03197.66
4372896-37289695.38196.00
5366537-36653793.75494.37
6380257-38025797.26397.89
45min1374629-37462995.82495.850.9896.6196.640.98
2377916-37791696.66597.45
3375820-37582096.12896.92
4371784-37178495.09695.87
5369392-36939294.48495.26
6378949-37894996.92997.72
极限1374766-37476695.85995.751.2296.8096.691.22
2376990-37699096.42897.37
3379040-37904096.95297.90
4369952-36995294.62895.56
5367653-36765394.04094.97
6377604-37760496.58597.54
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%
110.963853793855763856723858373854843855900.05
211.063847343844663846000.05
单位质量响应值RSD%判断
35181.5734773.960.83数据可信
供试品溶液-24061802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%
5min1307929-30792978.95776.372.0378.9676.372.03
2302357-30235777.52977.53
3294595-29459575.53875.54
4295724-29572475.82875.83
5293978-29397875.38075.38
6292465-29246574.99274.99
10min1355399-35539991.12989.571.1491.2689.701.14
2351843-35184390.21890.35
3346943-34694388.96189.09
4350372-35037289.84089.97
5346805-34680588.92689.05
6344624-34462488.36788.49
15min1372915-37291595.62194.081.0495.9094.361.04
2368755-36875594.55494.83
3363972-36397293.32893.60
4368535-36853594.49894.77
5364243-36424393.39793.67
6363127-36312793.11193.38
20min1379333-37933397.26695.760.9097.7196.190.90
2374144-37414495.93696.37
3371503-37150395.25995.69
4374314-37431495.98096.41
5371420-37142095.23795.67
6370051-37005194.88695.31
30min1383081-38308198.22896.740.8998.8397.330.89
2378137-37813796.96097.56
3375379-37537996.25396.84
4377975-37797596.91897.51
5375564-37556496.30096.89
6373491-37349195.76896.35
45min1384143-38414398.50096.920.8999.2797.680.89
2378113-37811396.95497.71
3375584-37558496.30597.05
4378330-37833097.00997.76
5377148-37714896.70697.45
6374640-37464096.06396.81
极限1383480-38348098.33096.770.8899.2697.690.88
2378059-37805996.94097.86
3375681-37568196.33097.24
4377545-37754596.80897.72
5375575-37557596.30397.21
6374133-37413395.93396.84
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