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%
111.273818353834143831073825723836193829090.19
211.253828103812333820220.30
单位质量响应值RSD%判断
33975.9533957.510.04数据可信
加速6月-供试品溶液-2024121821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%
5min1373718-37371898.62699.952.4598.6399.962.45
2381089-381089100.571100.57
3370571-37057197.79697.80
4378420-37842099.86799.87
5395950-395950104.493104.49
6372744-37274498.36998.37
10min1377196-37719699.544101.142.0599.71101.312.04
2395093-395093104.267104.43
3375453-37545399.08499.25
4381223-381223100.607100.77
5390575-390575103.075103.25
6380026-380026100.291100.45
15min1376112-37611299.258100.371.6599.59100.711.65
2385625-385625101.768102.11
3374658-37465898.87499.20
4379299-379299100.099100.43
5390284-390284102.998103.34
6376062-37606299.24599.58
20min1374265-37426598.771100.281.5299.27100.781.52
2384150-384150101.379101.89
3375333-37533399.05299.55
4379928-379928100.265100.77
5389213-389213102.715103.23
6376944-37694499.47899.97
30min1373827-37382798.655100.121.6799.32100.791.67
2383027-383027101.083101.76
3373864-37386498.66599.32
4379441-379441100.136100.80
5390060-390060102.939103.63
6376028-37602899.23699.90
极限1371137-37113797.94599.621.6098.77100.461.60
2382249-382249100.878101.73
3370807-37080797.85898.68
4378815-37881599.971100.81
5385814-385814101.818102.68
6376111-37611199.258100.09
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%
111.273817363821823812723819173807053815620.16
211.253824923819293822100.11
单位质量响应值RSD%判断
33856.4333974.220.25数据可信
中间条件6月-供试品溶液-2024121821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%
5min1381249-381249100.766100.590.83100.77100.590.83
2385687-385687101.939101.94
3379986-379986100.433100.43
4378976-378976100.166100.17
5381401-381401100.807100.81
6376200-37620099.43299.43
10min1385999-385999102.022101.730.77102.19101.900.77
2390144-390144103.117103.29
3384145-384145101.532101.70
4383316-383316101.313101.48
5384127-384127101.527101.70
6381550-381550100.846101.01
15min1385299-385299101.837101.760.83102.17102.090.83
2389862-389862103.043103.38
3383280-383280101.303101.64
4385036-385036101.767102.10
5386160-386160102.064102.40
6380312-380312100.519100.85
20min1384466-384466101.617101.650.62102.12102.150.62
2386518-386518102.159102.67
3387759-387759102.487102.99
4383167-383167101.273101.78
5384481-384481101.621102.13
6381100-381100100.727101.23
30min1384075-384075101.513101.440.61102.19102.110.61
2387072-387072102.305102.99
3383092-383092101.254101.93
4384272-384272101.565102.24
5384319-384319101.578102.25
6379909-379909100.412101.08
极限1382557-382557101.112101.180.67101.96102.030.67
2385827-385827101.976102.83
3380722-380722100.627101.47
4385176-385176101.804102.65
5383379-383379101.329102.18
6379259-379259100.240101.08
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%
111.273836583833393833583819643826693829980.18
211.253833713832263832980.03
单位质量响应值RSD%判断
33983.8534070.930.19数据可信
加速6月-供试品溶液-2024121921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%
5min1370833-37083397.69097.901.1597.6997.901.15
2372812-37281298.21298.21
3379087-37908799.86599.86
4370963-37096397.72597.72
5369820-36982097.42497.42
6366183-36618396.46696.47
10min1375679-37567998.96799.111.4099.1399.271.40
2378244-37824499.64399.81
3384978-384978101.417101.58
4373098-37309898.28798.45
5375944-37594499.03799.20
6369373-36937397.30697.47
15min1374811-37481198.73899.031.3999.0799.361.40
2377017-37701799.32099.65
3385600-385600101.581101.92
4372714-37271498.18698.51
5374816-37481698.74099.07
6370573-37057397.62297.94
20min1373781-37378198.46798.881.3598.9699.381.34
2378304-37830499.659100.15
3384066-384066101.177101.68
4372574-37257498.14998.64
5373325-37332598.34798.84
6370098-37009897.49797.98
30min1373957-37395798.51398.941.4299.1799.601.42
2376473-37647399.17699.84
3385678-385678101.601102.27
4372211-37221198.05398.71
5374551-37455198.67099.33
6370661-37066197.64598.29
极限1371612-37161297.89698.271.4998.7299.101.49
2373926-37392698.50599.33
3383220-383220100.954101.80
4371082-37108297.75698.57
5371972-37197297.99198.81
6366494-36649496.54797.36
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%
111.273825053834073831923826573821433827810.14
211.253845753840863843300.09
单位质量响应值RSD%判断
33964.6034162.670.42数据可信
中间条件6月-供试品溶液-2024121921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%
5min1381566-381566100.41299.011.25100.4199.011.24
2382323-382323100.611100.61
3370945-37094597.61797.62
4374245-37424598.48598.49
5372916-37291698.13598.14
6375480-37548098.81098.81
10min1385044-385044101.327100.351.45101.49100.521.45
2388525-388525102.243102.41
3374035-37403598.43098.59
4382062-382062100.542100.71
5375839-37583998.90599.07
6382576-382576100.677100.84
15min1384453-384453101.171100.361.05101.51100.691.05
2385930-385930101.560101.90
3376799-37679999.15799.48
4381751-381751100.460100.79
5376323-37632399.03299.36
6382871-382871100.755101.09
20min1384501-384501101.184100.261.17101.69100.761.17
2386241-386241101.642102.15
3374158-37415898.46298.95
4381651-381651100.434100.93
5377760-37776099.41099.90
6381632-381632100.429100.93
30min1384937-384937101.299100.111.22101.97100.781.22
2385283-385283101.390102.07
3375567-37556798.83399.49
4382668-382668100.702101.37
5374684-37468498.60199.26
6379419-37941999.847100.51
极限1382510-382510100.66099.451.28101.50100.281.27
2384240-384240101.115101.96
3372489-37248998.02398.84
4375908-37590898.92399.76
5373457-37345798.27899.10
6378859-37885999.699100.53
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