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%
111.083828163832103830903832163828163830300.06
211.063833523826603830060.13
单位质量响应值RSD%判断
34569.4934629.840.13数据可信
供试品溶液-3001A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%
5min1233689-23368960.54459.282.6260.5459.282.62
2234404-23440460.72960.73
3228581-22858159.22059.22
4232668-23266860.27960.28
5223821-22382157.98757.99
6219675-21967556.91356.91
10min1308007-30800779.79878.802.0879.9078.902.09
2306988-30698879.53479.64
3305809-30580979.22879.33
4308849-30884980.01680.12
5303394-30339478.60378.70
6291831-29183175.60775.70
15min1342624-34262488.76687.681.6089.0087.911.60
2342182-34218288.65288.89
3341925-34192588.58588.82
4340276-34027688.15888.39
5333814-33381486.48486.71
6329690-32969085.41585.64
20min1352688-35268891.37491.112.1891.7691.492.18
2358807-35880792.95993.34
3356637-35663792.39792.78
4356068-35606892.24992.63
5347498-34749890.02990.40
6338300-33830087.64688.01
30min1368263-36826395.40995.292.1295.9495.822.11
2380602-38060298.60699.14
3365351-36535194.65495.19
4371761-37176196.31596.85
5358521-35852192.88593.41
6362381-36238193.88594.39
极限1375514-37551497.287100.583.0497.98101.273.02
2399111-399111103.401104.10
3389354-389354100.873101.56
4404893-404893104.899105.59
5378279-37827998.00498.68
6382291-38229199.04399.71
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%
111.083831053833563833233829753823973830310.11
211.063836183839283837730.06
单位质量响应值RSD%判断
34569.5834699.190.27数据可信
供试品溶液-2927A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%
5min1263607-26360768.22666.452.6068.2366.452.60
2262069-26206967.82867.83
3245610-24561063.56863.57
4253903-25390365.71565.71
5255104-25510466.02666.03
6260173-26017367.33867.34
10min1332139-33213985.96484.402.2586.0884.512.25
2330022-33002285.41685.53
3318322-31832282.38882.49
4328432-32843285.00485.11
5315476-31547681.65181.76
6332122-33212285.95986.07
15min1356917-35691792.37790.702.1392.6390.952.13
2351325-35132590.93091.18
3343483-34348388.90089.14
4355117-35511791.91192.16
5339214-33921487.79588.04
6356681-35668192.31692.57
20min1366238-36623894.78992.952.4095.2093.352.40
2360348-36034893.26593.67
3353642-35364291.52991.92
4365892-36589294.70095.10
5344445-34444589.14989.54
6364265-36426594.27994.69
30min1372144-37214496.31895.002.7896.8995.562.77
2365843-36584394.68795.25
3362990-36299093.94994.49
4381430-38143098.72199.28
5350811-35081190.79691.34
6369089-36908995.52796.09
极限1382962-38296299.11898.241.2499.8598.951.24
2376767-37676797.51498.23
3378342-37834297.92298.62
4387367-387367100.258100.98
5374826-37482697.01297.70
6377124-37712497.60798.33
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%
111.083831583830813831473835653830723832050.06
211.063844173843583843880.02
单位质量响应值RSD%判断
34585.2934754.790.35数据可信
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%
5min1288592-28859274.61674.451.2274.6274.451.22
2286818-28681874.15874.16
3286906-28690674.18074.18
4287892-28789274.43574.44
5294055-29405576.02976.03
6283380-28338073.26973.27
10min1362235-36223593.65793.421.1493.7893.541.14
2360435-36043593.19293.32
3360266-36026693.14893.27
4358366-35836692.65792.78
5369002-36900295.40795.53
6357585-35758592.45592.58
15min1385380-38538099.64199.171.2299.9299.451.22
2381675-38167598.68398.96
3381673-38167398.68398.96
4381842-38184298.72799.00
5392051-392051101.366101.65
6378707-37870797.91698.19
20min1392116-392116101.383100.891.11101.83101.341.11
2388660-388660100.489100.93
3387948-387948100.305100.75
4389695-389695100.757101.20
5397684-397684102.823103.28
6385191-38519199.592100.03
30min1396888-396888102.617101.510.83103.23102.120.83
2390054-390054100.850101.46
3390165-390165100.878101.49
4391425-391425101.204101.82
5396622-396622102.548103.17
6390527-390527100.972101.58
极限1396959-396959102.635101.631.26103.42102.421.25
2392534-392534101.491102.27
3392896-392896101.585102.36
4391121-391121101.126101.91
5399600-399600103.318104.11
6385399-38539999.646100.42
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%
111.083830653828893821623823573824123825770.10
211.063850323845943848130.09
单位质量响应值RSD%判断
34528.6134793.220.54数据可信
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%
5min1293177-29317775.82275.131.2375.8275.131.22
2286708-28670874.14974.15
3293102-29310275.80375.80
4293900-29390076.00976.01
5285697-28569773.88873.89
6290504-29050475.13175.13
10min1355211-35521191.86693.581.2791.9993.701.27
2360464-36046493.22493.35
3363154-36315493.92094.05
4365783-36578394.60094.73
5367573-36757395.06395.19
6358816-35881692.79892.92
15min1373410-37341096.57397.412.7696.8597.692.75
2378849-37884997.97998.26
3382302-38230298.87299.16
4387489-387489100.214100.50
5357650-35765092.49792.78
6380136-38013698.31298.59
20min1377512-37751297.63499.401.3098.0799.841.30
2384680-38468099.48799.93
3385522-38552299.705100.15
4392633-392633101.544102.00
5381688-38168898.71499.15
6384052-38405299.32599.77
30min1376628-37662897.40599.901.5998.01100.511.59
2385268-38526899.639100.25
3390897-390897101.095101.71
4394108-394108101.926102.55
5383204-38320499.10699.71
6387590-387590100.240100.85
极限1379744-37974498.211100.771.6098.98101.551.60
2387372-387372100.184100.96
3395721-395721102.343103.13
4396011-396011102.418103.21
5386951-386951100.075100.84
6392105-392105101.408102.18
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%
111.083828983828723827963826683827023827870.03
211.063824213829293826750.10
单位质量响应值RSD%判断
34547.5634599.910.11数据可信
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%
5min1282106-28210673.14273.470.8973.1473.470.89
2280609-28060972.75472.75
3283507-28350773.50573.51
4283542-28354273.51573.51
5288015-28801574.67474.67
6282406-28240673.22073.22
10min1358009-35800992.82293.401.0392.9493.521.03
2354710-35471091.96692.09
3359330-35933093.16493.29
4362061-36206193.87293.99
5365257-36525794.70194.83
6361989-36198993.85493.98
15min1381436-38143698.89698.991.0699.1799.271.06
2374486-37448697.09497.37
3380715-38071598.70998.99
4385136-38513699.855100.13
5383968-38396899.55299.83
6385087-38508799.842100.12
20min1387004-387004100.339100.811.22100.78101.251.21
2380330-38033098.60999.05
3393544-393544102.035102.48
4391272-391272101.446101.89
5389206-389206100.910101.36
6391501-391501101.505101.95
30min1388069-388069100.615100.951.13101.22101.561.13
2381091-38109198.80699.41
3391922-391922101.614102.23
4391520-391520101.510102.12
5390447-390447101.232101.85
6393100-393100101.920102.53
极限1388325-388325100.682101.020.64101.46101.800.64
2385438-38543899.933100.70
3390259-390259101.183101.96
4390261-390261101.184101.97
5390859-390859101.339102.12
6392584-392584101.786102.57
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