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%
1 11.083822953824063828153825973827083825640.06
2 11.063820393813743817060.13
单位质量响应值RSD%判断
34527.4434512.300.04数据可信
供试品溶液-3001A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%
5min1157146-15714640.80741.792.2440.8141.782.24
2163332-16333242.41342.41
3155779-15577940.45240.45
4163313-16331342.40942.41
5161541-16154141.94841.95
6164369-16436942.68342.68
10min1217159-21715956.39159.543.1656.4659.613.16
2226639-22663958.85358.92
3234322-23432260.84860.92
4232098-23209860.27060.34
5227751-22775159.14259.21
6237779-23777961.74661.82
15min1249309-24930964.74068.163.0064.9068.333.00
2260857-26085767.73867.91
3264384-26438468.65468.82
4267337-26733769.42169.59
5260428-26042867.62767.80
6272589-27258970.78570.96
20min1268599-26859969.74973.473.0570.0273.763.04
2280600-28060072.86573.15
3284061-28406173.76474.05
4288994-28899475.04575.33
5281521-28152173.10473.39
6293864-29386476.31076.60
30min1290461-29046175.42679.553.1375.8179.963.13
2302407-30240778.52878.93
3311785-31178580.96381.37
4313460-31346081.39881.81
5303556-30355678.82679.23
6316438-31643882.17282.59
45min1306811-30681179.67283.612.7880.1884.142.78
2319926-31992683.07783.61
3322677-32267783.79284.33
4329936-32993685.67786.22
5320487-32048783.22383.76
6331947-33194786.19986.76
60min1315184-31518481.84685.592.7182.4986.272.71
2325919-32591984.63485.31
3330374-33037485.79086.47
4339109-33910988.05988.75
5328343-32834385.26385.94
6338720-33872087.95888.66
极限1371913-37191396.57798.411.3397.3699.241.33
2378022-37802298.16398.98
3375789-37578997.58498.41
4386604-386604100.392101.23
5381015-38101598.94199.76
6380581-38058198.82899.67
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%
1 11.083823023824253820163822843824433822940.05
2 11.063830003831813830900.04
单位质量响应值RSD%判断
34503.0734637.430.28数据可信
供试品溶液-3001A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%
5min1152746-15274639.60741.062.3339.6141.062.33
2163428-16342842.37742.38
3158128-15812841.00241.00
4156067-15606740.46840.47
5160352-16035241.57941.58
6159391-15939141.33041.33
10min1217429-21742956.37956.731.3456.4556.801.34
2220336-22033657.13357.20
3214688-21468855.66855.74
4217097-21709756.29356.36
5222896-22289657.79757.87
6220205-22020557.09957.17
15min1251884-25188465.31364.822.0565.4764.982.05
2252079-25207965.36465.53
3240959-24095962.48062.64
4247884-24788464.27664.44
5255991-25599166.37866.54
6251144-25114465.12165.29
20min1272158-27215870.57070.112.6470.8470.382.63
2271431-27143170.38270.66
3258928-25892867.14067.41
4267041-26704169.24369.51
5280518-28051872.73873.01
6272294-27229470.60670.88
30min1294789-29478976.43976.022.6276.8276.402.61
2294309-29430976.31476.71
3278787-27878772.28972.67
4293867-29386776.19976.58
5295236-29523676.55476.95
6301956-30195678.29778.69
45min1314792-31479281.62579.712.3482.1480.222.33
2310934-31093480.62581.14
3294437-29443776.34776.84
4304457-30445778.94579.46
5310084-31008480.40480.93
6309761-30976180.32180.84
60min1327552-32755284.93482.342.7085.5882.982.69
2320283-32028383.04983.70
3301606-30160678.20678.83
4318699-31869982.63883.28
5318739-31873982.64983.31
6318323-31832382.54183.20
极限1385089-38508999.85398.921.54100.6499.701.54
2387409-387409100.455101.25
3372281-37228196.53297.29
4378549-37854998.15798.94
5379082-37908298.29699.09
6386499-386499100.219101.01
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%
1 11.083817083811723814293814083803923812220.14
2 11.063836693834973835830.04
单位质量响应值RSD%判断
34406.3234682.010.57数据可信
供试品溶液-2927A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%
5min1191028-19102849.57147.473.2549.5747.473.25
2177029-17702945.93945.94
3178383-17838346.29046.29
4178143-17814346.22846.23
5188311-18831148.86648.87
6184734-18473447.93847.94
10min1252882-25288265.62264.383.5265.7164.463.52
2237878-23787861.72961.81
3237600-23760061.65761.73
4248577-24857764.50564.58
5259234-25923467.27167.35
6252332-25233265.48065.56
15min1292762-29276275.97173.564.2076.1673.744.20
2266162-26616269.06969.25
3272940-27294070.82771.01
4282362-28236273.27273.46
5296203-29620376.86477.06
6290278-29027875.32775.52
20min1315277-31527781.81478.315.2582.1378.625.24
2282348-28234873.26973.56
3282962-28296273.42873.73
4302229-30222978.42878.73
5318602-31860282.67783.00
6309161-30916180.22780.54
30min1345048-34504889.53984.306.0889.9984.746.07
2300873-30087378.07678.49
3301582-30158278.26078.68
4326719-32671984.78385.22
5344651-34465189.43689.90
6330265-33026585.70386.15
45min1364643-36464394.62488.706.7495.2389.286.73
2312971-31297181.21581.76
3314093-31409381.50782.06
4345301-34530189.60590.18
5362449-36244994.05594.66
6351538-35153891.22391.81
60min1372214-37221496.58991.096.9797.3591.826.95
2320326-32032683.12483.81
3321160-32116083.34084.03
4354912-35491292.09992.83
5374166-37416697.09597.86
6363402-36340294.30295.05
极限1382259-38225999.19598.291.23100.1299.171.27
2372919-37291996.77297.59
3375983-37598397.56798.39
4374956-37495697.30098.18
5383372-38337299.484100.41
6383085-38308599.410100.31
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%
1 11.083829533828793831913826933829193829270.05
2 11.063850693847153848920.07
单位质量响应值RSD%判断
34560.2034800.360.49数据可信
供试品溶液-2927A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%
5min1188668-18866848.76746.214.6948.7746.214.70
2179423-17942346.37746.38
3182114-18211447.07347.07
4166134-16613442.94242.94
5171791-17179144.40444.40
6184551-18455147.70247.70
10min1242220-24222062.60964.073.6062.6964.153.60
2249293-24929364.43764.51
3261146-26114667.50167.58
4238413-23841361.62561.70
5241110-24111062.32262.40
6255113-25511365.94166.02
15min1273287-27328770.63973.393.6970.8273.573.69
2286211-28621173.97974.16
3301253-30125377.86778.06
4275814-27581471.29271.47
5277850-27785071.81872.00
6289116-28911674.73074.92
20min1291299-29129975.29579.184.0875.6079.484.07
2311139-31113980.42380.73
3327076-32707684.54284.86
4297662-29766276.93977.23
5301968-30196878.05278.35
6308753-30875379.80680.12
30min1315630-31563081.58485.974.2182.0186.414.21
2344430-34443089.02889.47
3352877-35287791.21191.67
4321360-32136083.06583.49
5328730-32873084.97085.40
6332543-33254385.95586.40
45min1326046-32604684.27690.564.6484.8491.144.63
2366969-36696994.85495.44
3368368-36836895.21595.83
4340385-34038587.98288.54
5346577-34657789.58390.15
6353806-35380691.45192.04
60min1334158-33415886.37392.584.2887.0893.324.27
2373981-37398196.66697.41
3373763-37376396.61097.38
4349391-34939190.31091.02
5355433-35543391.87292.59
6362386-36238693.66994.41
极限1378810-37881097.91497.651.4298.7698.531.40
2380182-38018298.26999.18
3376714-37671497.37298.31
4382771-38277198.93899.80
5367682-36768295.03895.91
6380475-38047598.34599.24
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