比拉斯汀口崩片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
111.203786243777593781343781783785733782540.10
211.253783413782833783120.02
单位质量响应值RSD%判断
33772.6833627.730.31数据可信
中间条件3月-供试品溶液-2024122021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%
5min1367677-36767797.80098.710.9897.8098.710.98
2375138-37513899.78499.78
3370278-37027898.49298.49
4368687-36868798.06898.07
5368668-36866898.06398.06
6376104-376104100.041100.04
10min1373575-37357599.369100.862.08100.46101.962.06
2387391-387391103.044104.15
3373939-37393999.465100.56
4377951-377951100.533101.62
5371780-37178098.89199.98
6390427-390427103.851104.96
15min1372424-37242499.06299.721.20101.25101.941.20
2381050-381050101.357103.61
3372684-37268499.132101.33
4371801-37180198.897101.10
5371253-37125398.751100.94
6380200-380200101.131103.40
20min1376186-376186100.06399.761.05103.35103.081.05
2380406-380406101.186104.57
3372660-37266099.125102.43
4371910-37191098.926102.23
5370614-37061498.581101.87
6378425-378425100.659104.05
30min1370846-37084698.64399.361.14103.05103.791.14
2378993-378993100.810105.31
3372058-37205898.965103.37
4370511-37051198.554102.96
5369898-36989898.391102.77
6378865-378865100.776105.28
极限1370875-37087598.65098.711.09104.15104.251.06
2378677-378677100.726106.35
3371539-37153998.827104.33
4369864-36986498.381103.88
5367716-36771697.810103.28
6367904-36790497.860103.49
比拉斯汀口崩片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
111.203811713810503813733805973809613810300.08
211.253777613773123775360.09
单位质量响应值RSD%判断
34020.5433558.760.97数据可信
中间条件3月-供试品溶液-2024122021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%
5min1390784-390784103.675103.061.48103.68103.061.48
2385893-385893102.378102.38
3385197-385197102.193102.19
4398551-398551105.736105.74
5382154-382154101.386101.39
6388094-388094102.962102.96
10min1392547-392547104.143102.301.12105.29103.451.12
2383694-383694101.794102.93
3381460-381460101.202102.34
4388549-388549103.082104.26
5381786-381786101.288102.41
6385637-385637102.310103.45
15min1392406-392406104.106102.021.81106.41104.301.79
2389165-389165103.246105.51
3373184-37318499.006101.27
4387174-387174102.718105.04
5379829-379829100.769103.02
6385431-385431102.255104.54
20min1384300-384300101.955102.520.95105.42105.930.89
2383870-383870101.841105.26
3393515-393515104.400107.76
4386197-386197102.458105.92
5386470-386470102.531105.90
6384125-384125101.909105.33
30min1384012-384012101.879101.360.89106.48105.920.88
2383907-383907101.851106.40
3377755-377755100.219104.74
4385945-385945102.392106.99
5378103-378103100.311104.82
6382641-382641101.515106.06
极限1384190-384190101.92699.425.72107.66105.105.44
2382811-382811101.560107.24
3331250-33125087.88193.51
4386832-386832102.627108.36
5379894-379894100.786106.41
6383603-383603101.770107.45
比拉斯汀口崩片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
111.203789243790333784473783703782973786140.09
211.253777813779183778500.03
单位质量响应值RSD%判断
33804.8233586.670.46数据可信
中间条件3月-供试品溶液-2024122021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%
5min1369043-36904398.17799.201.9398.1899.201.93
2371899-37189998.93698.94
3365293-36529397.17997.18
4385228-385228102.482102.48
5368895-36889598.13798.14
6376990-376990100.291100.29
10min1367626-36762697.80099.231.7098.89100.331.71
2373351-37335199.323100.42
3368827-36882798.11999.20
4383744-383744102.088103.23
5367895-36789597.87198.96
6376504-376504100.162101.28
15min1365051-36505197.11598.751.6699.29100.951.66
2369353-36935398.259100.46
3365353-36535397.19599.37
4381318-381318101.442103.72
5371639-37163998.867101.05
6374387-37438799.598101.83
20min1360290-36029095.84897.852.3599.10101.152.32
2372608-37260899.125102.42
3361577-36157796.19099.44
4381625-381625101.524104.92
5360377-36037795.87199.15
6370420-37042098.543101.88
30min1356533-35653394.84996.481.8899.17100.871.79
2365098-36509897.127101.52
3357809-35780995.18899.51
4356975-35697594.96699.49
5373726-37372699.422103.76
6365830-36583097.322101.75
极限1352507-35250793.77895.081.7599.15100.541.73
2357739-35773995.169100.64
3352844-35284493.86799.24
4368232-36823297.961103.54
5352641-35264193.81399.26
6360499-36049995.904101.41
比拉斯汀口崩片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
111.203778933793123787893789043780473785890.16
211.253777033785153781090.16
单位质量响应值RSD%判断
33802.5933609.690.41数据可信
中间条件3月-供试品溶液-2024122021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%
5min1373927-37392799.445100.190.8399.45100.190.83
2376172-376172100.042100.04
3382046-382046101.604101.60
4374167-37416799.50999.51
5375398-37539899.83699.84
6378602-378602100.688100.69
10min1376332-376332100.085100.700.70101.19101.810.70
2378172-378172100.574101.69
3383354-383354101.952103.08
4376416-376416100.107101.21
5377810-377810100.478101.59
6379739-379739100.991102.11
15min1376045-376045100.008100.470.71102.23102.700.71
2377774-377774100.468102.70
3382701-382701101.778104.04
4375416-37541699.841102.06
5376401-376401100.103102.33
6378346-378346100.620102.86
20min1375519-37551999.868100.480.68103.20103.830.67
2376873-376873100.229103.57
3381539-381539101.469104.86
4375075-37507599.750103.08
5380004-380004101.061104.40
6377848-377848100.488103.85
30min1379490-379490100.925100.310.66105.36104.770.65
2375653-37565399.904104.36
3380544-380544101.205105.72
4373943-37394399.449103.88
5376011-37601199.999104.46
6377411-377411100.372104.85
极限1375809-37580999.94699.860.63105.50105.440.63
2374138-37413899.501105.07
3379688-379688100.977106.62
4372839-37283999.156104.70
5374636-37463699.634105.21
6375740-37574099.927105.52
比拉斯汀口崩片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
111.203778563789033776413778843778783780320.14
211.253765143782933774040.34
单位质量响应值RSD%判断
33752.8633547.020.44数据可信
中间条件3月-供试品溶液批-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%
5min1241212-24121264.25760.305.1464.2660.305.15
2232142-23214261.84161.84
3236349-23634962.96262.96
4213651-21365156.91556.91
5218144-21814458.11258.11
6216675-21667557.72157.72
10min1311635-31163583.01779.043.0183.7379.723.03
2299537-29953779.79480.48
3299859-29985979.88080.58
4287824-28782476.67477.31
5292650-29265077.96078.61
6288808-28880876.93677.58
15min1338207-33820790.09688.151.5491.7389.691.57
2331938-33193888.42690.00
3334348-33434889.06890.65
4325034-32503486.58788.07
5330102-33010287.93789.45
6325717-32571786.76888.26
20min1355794-35579494.78193.011.2197.4295.541.26
2350189-35018993.28895.84
3351425-35142593.61796.19
4347097-34709792.46494.91
5346554-34655492.31994.81
6343887-34388791.60994.07
30min1368273-36827398.10596.831.02101.80100.401.05
2362527-36252796.574100.17
3365211-36521197.289100.91
4363485-36348596.830100.30
5364343-36434397.058100.57
6357167-35716795.14798.62
极限1375886-375886100.13398.661.24104.91103.301.23
2366011-36601197.503102.17
3370525-37052598.705103.40
4373803-37380399.578104.13
5371950-37195099.085103.68
6363972-36397296.959101.49
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