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%
111.153874683869983873653872843866963871620.09
211.153857313864463860880.14
单位质量响应值RSD%判断
34723.0534626.730.20数据可信
加速6月-供试品溶液-2024122121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%
5min1261062-26106267.48968.781.9967.4968.781.99
2265145-26514568.54468.54
3272736-27273670.50770.51
4271920-27192070.29670.30
5265101-26510168.53368.53
6260257-26025767.28167.28
10min1341834-34183488.37089.621.2488.4889.741.24
2344876-34487689.15689.27
3352218-35221891.05491.17
4350893-35089390.71190.83
5347501-34750189.83589.95
6342702-34270288.59488.71
15min1372019-37201996.17396.771.7396.4397.031.73
2370429-37042995.76296.02
3383063-38306399.02899.30
4381984-38198498.74999.02
5369310-36931095.47395.74
6369136-36913695.42895.69
20min1382684-38268498.93099.601.4699.35100.031.46
2383205-38320599.06599.49
3391825-391825101.293101.73
4392739-392739101.529101.96
5382328-38232898.83899.26
6378970-37897097.97098.39
30min1389750-389750100.757101.291.49101.34101.881.49
2389339-389339100.650101.24
3398875-398875103.116103.72
4399390-399390103.249103.85
5387701-387701100.227100.81
6385857-38585799.750100.33
45min1392056-392056101.353101.811.48102.11102.581.48
2390506-390506100.952101.71
3401319-401319103.747104.52
4400717-400717103.592104.37
5391244-391244101.143101.90
6387215-387215100.101100.85
60min1393633-393633101.760101.731.38102.68102.661.38
2390927-390927101.061101.98
3399744-399744103.340104.29
4400219-400219103.463104.41
5387962-387962100.294101.22
6388601-388601100.460101.37
极限1392622-392622101.499101.581.12102.59102.681.12
2391035-391035101.089102.18
3399142-399142103.185104.30
4397325-397325102.715103.83
5388312-388312100.385101.48
6389222-389222100.620101.70
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%
111.153872673869413868283862273866093867740.11
211.153860513860673860590.01
单位质量响应值RSD%判断
34688.2534624.130.14数据可信
加速6月-供试品溶液-2024122221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%
5min1263367-26336768.12169.451.9368.1269.441.93
2276840-27684071.60671.61
3268235-26823569.38069.38
4264097-26409768.31068.31
5266227-26622768.86168.86
6272150-27215070.39370.39
10min1348930-34893090.25390.941.1390.3791.061.13
2354169-35416991.60891.73
3352421-35242191.15691.27
4347374-34737489.85089.96
5348807-34880790.22190.34
6357768-35776892.53992.66
15min1370877-37087795.92997.331.5796.1997.601.57
2377669-37766997.68697.96
3378234-37823497.83298.10
4369476-36947695.56795.83
5375574-37557497.14497.41
6385909-38590999.817100.09
20min1380680-38068098.46599.741.4898.89100.171.48
2387628-387628100.262100.70
3386663-386663100.012100.44
4378121-37812197.80398.23
5386183-38618399.888100.32
6394311-394311101.991102.43
30min1384363-38436399.418100.721.35100.01101.321.35
2390811-390811101.085101.69
3391080-391080101.155101.75
4383196-38319699.11699.70
5389190-389190100.666101.26
6397704-397704102.868103.48
45min1384432-38443299.435100.591.54100.19101.351.54
2390352-390352100.967101.74
3389888-389888100.847101.61
4381444-38144498.66399.41
5388404-388404100.463101.22
6398876-398876103.171103.95
60min1381294-38129498.624100.251.4699.54101.181.46
2389759-389759100.813101.75
3388471-388471100.480101.41
4381903-38190398.78199.70
5387312-387312100.180101.11
6396665-396665102.600103.55
极限1382364-38236498.90099.991.5699.98101.081.56
2388675-388675100.533101.64
3385731-38573199.771100.87
4379279-37927998.10399.18
5386593-38659399.994101.09
6396758-396758102.624103.75
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%
111.153861463872793863083864653856423863680.16
211.153862753863623863180.02
单位质量响应值RSD%判断
34651.8434647.350.01数据可信
加速6月-供试品溶液-2024122321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%
5min1273658-27365870.79768.892.0070.8068.892.00
2265207-26520768.61068.61
3264389-26438968.39968.40
4271487-27148770.23570.23
5263439-26343968.15368.15
6259473-25947367.12767.13
10min1349270-34927090.35888.551.3190.4888.661.32
2341107-34110788.24688.36
3339918-33991887.93888.05
4343757-34375788.93189.05
5343659-34365988.90689.02
6335917-33591786.90387.02
15min1373128-37312896.53095.410.8096.8095.670.81
2367144-36714494.98295.24
3367553-36755395.08895.35
4370759-37075995.91796.18
5369399-36939995.56595.83
6364792-36479294.37394.63
20min1381756-38175698.76297.960.7299.1998.380.73
2379932-37993298.29098.71
3377127-37712797.56497.98
4379329-37932998.13498.56
5379863-37986398.27298.69
6374011-37401196.75897.17
30min1385643-38564399.76899.540.41100.36100.130.41
2386012-38601299.863100.45
3382363-38236398.91999.50
4385882-38588299.829100.42
5385502-38550299.731100.32
6383243-38324399.14799.72
45min1385949-38594999.84799.890.29100.61100.640.29
2386862-386862100.083100.83
3384088-38408899.365100.11
4386259-38625999.927100.68
5386308-38630899.940100.69
6387306-387306100.198100.94
60min1385113-38511399.63099.750.41100.56100.670.41
2386900-386900100.093101.01
3383287-38328799.158100.07
4387323-387323100.202101.12
5384421-38442199.451100.37
6386433-38643399.972100.88
极限1386598-386598100.01599.530.53101.11100.610.53
2383904-38390499.318100.40
3381096-38109698.59199.67
4386110-38611099.888100.98
5384749-38474999.536100.62
6385887-38588799.831100.90
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%
111.153869193879523868233881993878463875480.17
211.153860293858063859180.05
单位质量响应值RSD%判断
34757.6734611.480.30数据可信
加速6月-供试品溶液-3176A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%
5min1224982-22498258.14558.131.5058.1558.131.50
2221537-22153757.25557.26
3227019-22701958.67258.67
4223617-22361757.79357.79
5230401-23040159.54659.55
6221950-22195057.36257.36
10min1300918-30091877.77178.631.7977.8778.721.79
2295725-29572576.42976.52
3309202-30920279.91280.01
4305641-30564178.99179.09
5310343-31034380.20680.31
6303531-30353178.44678.54
15min1330919-33091985.52486.531.9985.7586.761.99
2325073-32507384.01384.24
3343039-34303988.65788.89
4336403-33640386.94287.17
5340844-34084488.08988.32
6332655-33265585.97386.20
20min1345782-34578289.36590.342.2789.7390.722.27
2337039-33703987.10687.47
3360068-36006893.05893.44
4349292-34929290.27390.65
5355238-35523891.80992.19
6349964-34996490.44690.82
30min1360016-36001693.04493.952.1393.5694.472.13
2351115-35111590.74491.25
3373424-37342496.50997.04
4366954-36695494.83795.36
5367900-36790095.08295.61
6361691-36169193.47794.00
45min1368107-36810795.13596.062.3995.8196.742.38
2357357-35735792.35793.02
3384542-38454299.383100.08
4372788-37278896.34597.03
5374196-37419696.70997.40
6373018-37301896.40497.08
60min1371737-37173796.07397.302.2396.9198.142.22
2363967-36396794.06594.88
3388957-388957100.524101.38
4376520-37652097.31098.15
5380322-38032298.29299.14
6377410-37741097.54098.38
极限1383559-38355999.12999.251.69100.12100.251.69
2375566-37556697.06398.03
3395619-395619102.246103.27
4382137-38213798.76199.77
5383263-38326399.052100.07
6384022-38402299.248100.25
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