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%
111.083781533781203783503784293782123782530.04
211.063777273776403776840.02
单位质量响应值RSD%判断
34138.3634148.640.03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%
5min1221963-22196358.27457.011.4358.2757.001.43
2213909-21390956.15956.16
3216145-21614556.74656.75
4217576-21757657.12257.12
5219082-21908257.51857.52
6214116-21411656.21456.21
10min1304923-30492380.05476.062.8280.1576.162.82
2290979-29097976.39376.49
3289228-28922875.93476.03
4284623-28462374.72574.82
5281607-28160773.93374.03
6286932-28693275.33175.42
15min1333683-33368387.60584.722.1787.8484.942.17
2323957-32395785.05185.27
3324535-32453585.20385.42
4322491-32249184.66684.89
5312508-31250882.04682.26
6319002-31900283.75083.97
20min1343939-34393990.29788.361.8690.6788.721.86
2337110-33711088.50588.87
3338633-33863388.90489.27
4341059-34105989.54189.90
5326897-32689785.82386.18
6331769-33176987.10287.46
30min1353899-35389992.91291.511.9593.4492.021.95
2346729-34672991.03091.54
3350055-35005591.90392.41
4357892-35789293.96194.47
5339538-33953889.14289.64
6343253-34325390.11790.62
极限1378133-37813399.27599.272.7699.9699.932.75
2373249-37324997.99298.65
3380519-38051999.901100.57
4396149-396149104.005104.67
5364538-36453895.70596.35
6376012-37601298.71899.37
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%
111.083783513779913766113779193773513776450.19
211.063790393790183790280.01
单位质量响应值RSD%判断
34083.4834270.160.39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%
5min1251558-25155865.98065.782.1165.9865.782.11
2257987-25798767.66667.67
3243483-24348363.86263.86
4247362-24736264.87964.88
5255120-25512066.91466.91
6249175-24917565.35565.35
10min1328712-32871286.21684.631.9186.3384.741.91
2325622-32562285.40685.52
3315325-31532582.70582.81
4318425-31842583.51883.63
5329782-32978286.49786.61
6318117-31811783.43783.55
15min1350555-35055591.94591.301.8592.2091.551.85
2348697-34869791.45891.71
3341460-34146089.56089.80
4344773-34477390.42990.68
5359316-35931694.24394.50
6343676-34367690.14190.39
20min1359224-35922494.21993.781.8394.6394.181.83
2358407-35840794.00594.41
3350194-35019491.85192.24
4354884-35488493.08193.48
5368984-36898496.77997.19
6353518-35351892.72293.12
30min1366444-36644496.11395.662.0496.6896.222.04
2362894-36289495.18295.75
3357171-35717193.68194.23
4362808-36280895.15995.71
5378550-37855099.28899.86
6360474-36047494.54795.10
极限1380329-38032999.75598.141.85100.4898.861.84
2373522-37352297.96998.69
3365952-36595295.98496.69
4373907-37390798.07098.78
5383641-383641100.623101.36
6367702-36770296.44397.15
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%
111.083787213787543788523789913786783787990.04
211.063801973798573800270.07
单位质量响应值RSD%判断
34187.6434360.490.36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%
5min1280039-28003973.24273.810.6173.2473.810.60
2283834-28383474.23474.23
3281620-28162073.65573.66
4281020-28102073.49873.50
5284516-28451674.41274.41
6282263-28226373.82373.82
10min1350091-35009191.56392.431.1391.6992.561.13
2357541-35754193.51193.64
3350005-35000591.54191.66
4349848-34984891.49991.62
5358421-35842193.74293.87
6354580-35458092.73792.86
15min1370877-37087796.99998.251.1197.2798.531.11
2381112-38111299.67699.96
3373295-37329597.63297.91
4374242-37424297.87998.15
5380511-38051199.51999.80
6374022-37402297.82298.10
20min1376295-37629598.416100.401.5598.85100.841.55
2390739-390739102.194102.64
3378282-37828298.93699.37
4384091-384091100.455100.89
5390200-390200102.053102.50
6383784-383784100.375100.82
30min1378676-37867699.039100.501.1599.64101.111.15
2390817-390817102.214102.83
3381842-38184299.867100.47
4382093-38209399.933100.54
5387739-387739101.409102.03
6384511-384511100.565101.17
极限1380208-38020899.440101.011.45100.21101.781.45
2393837-393837103.004103.79
3383131-383131100.204100.97
4381966-38196699.900100.67
5392067-392067102.541103.33
6386002-386002100.955101.73
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%
111.083787423788313789613787503787523788070.03
211.063794753796683795720.04
单位质量响应值RSD%判断
34188.3634319.350.28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%
5min1280446-28044673.39173.911.6473.3973.911.64
2283064-28306474.07674.08
3285757-28575774.78174.78
4286195-28619574.89674.90
5285019-28501974.58874.59
6274022-27402271.71071.71
10min1349368-34936891.42892.551.2791.5592.681.27
2352655-35265592.28892.41
3361302-36130294.55194.68
4353681-35368192.55692.68
5355568-35556893.05093.17
6349399-34939991.43691.56
15min1368816-36881696.51797.580.7596.7997.860.75
2373468-37346897.73498.01
3371669-37166997.26497.55
4372694-37269497.53297.81
5373343-37334397.70297.98
6377339-37733998.74799.02
20min1372827-37282797.56799.081.5098.0099.521.50
2379459-37945999.30299.74
3374367-37436797.97098.41
4388673-388673101.713102.16
5379961-37996199.43499.88
6376267-37626798.46798.90
30min1377250-37725098.72499.110.6099.3299.720.60
2380609-38060999.603100.21
3376899-37689998.63299.24
4381166-38116699.749100.36
5380457-38045799.563100.17
6376069-37606998.41599.02
极限1381229-38122999.765100.070.43100.53100.840.43
2384066-384066100.508101.28
3381024-38102499.712100.48
4383418-383418100.338101.12
5384070-384070100.509101.28
6380556-38055699.589100.35
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%
111.083790853790443789603777193773863784390.22
211.063809883803993806940.11
单位质量响应值RSD%判断
34155.1434420.800.55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%
5min1277846-27784672.63972.581.2972.6472.581.29
2278033-27803372.68872.69
3275156-27515671.93671.94
4275237-27523771.95771.96
5284357-28435774.34174.34
6275043-27504371.90671.91
10min1351402-35140291.86992.071.4491.9992.191.44
2351378-35137891.86391.98
3354093-35409392.57392.69
4346956-34695690.70790.83
5361103-36110394.40694.53
6348126-34812691.01391.13
15min1373080-37308097.53797.381.3697.8197.661.36
2373684-37368497.69597.97
3374972-37497298.03198.31
4365779-36577995.62895.90
5379711-37971199.27099.55
6367741-36774196.14196.41
20min1381273-38127399.67999.372.16100.1299.802.15
2377784-37778498.76799.20
3381266-38126699.677100.11
4371672-37167297.16997.60
5394741-394741103.200103.65
6373705-37370597.70098.13
30min1381863-38186399.83399.641.79100.44100.241.79
2377961-37796198.81399.41
3388423-388423101.548102.15
4373048-37304897.52898.12
5389683-389683101.877102.50
6375657-37565798.21198.81
极限1377381-37738198.66199.991.2899.43100.761.28
2380017-38001799.350100.12
3383511-383511100.264101.04
4379154-37915499.12599.88
5391008-391008102.224103.01
6383756-383756100.328101.09
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