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 10.883760993754903751913761853760873758100.12
2 10.823759813754833757320.10
单位质量响应值RSD%判断
34541.3634725.690.38数据可信
加速6月-供试品溶液-2024122121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%
5min1197993-19799351.24651.792.2051.2551.792.20
2200413-20041351.87251.87
3197185-19718551.03751.04
4195441-19544150.58550.59
5207794-20779453.78353.78
6201783-20178352.22752.23
10min1276303-27630371.51471.901.7771.6071.981.77
2280914-28091472.70872.79
3273283-27328370.73370.82
4272365-27236570.49570.58
5285417-28541773.87373.96
6278459-27845972.07272.16
15min1316153-31615381.82981.701.4582.0381.901.45
2317520-31752082.18282.39
3310838-31083880.45380.66
4310319-31031980.31980.52
5322632-32263283.50683.72
6316402-31640281.89382.10
20min1333323-33332386.27386.291.5886.6186.631.58
2335541-33554186.84787.19
3327281-32728184.70985.05
4328343-32834384.98485.32
5341807-34180788.46988.82
6333937-33393786.43286.78
30min1348235-34823590.13289.941.5590.6290.431.55
2350865-35086590.81391.30
3340976-34097688.25488.73
4343302-34330288.85689.33
5355793-35579392.08992.59
6345800-34580089.50289.99
45min1357476-35747692.52491.801.7093.1692.431.70
2357193-35719392.45193.09
3345737-34573789.48690.11
4350602-35060290.74591.37
5362984-36298493.95094.60
6354028-35402891.63292.27
60min1361175-36117593.48292.941.7694.2793.721.76
2361284-36128493.51094.30
3349305-34930590.40991.18
4356821-35682192.35593.13
5368304-36830495.32796.14
6357507-35750792.53293.32
极限1395742-395742102.428101.061.61103.37102.011.61
2396146-396146102.533103.48
3381060-38106098.62899.55
4386827-386827100.121101.05
5395582-395582102.387103.36
6387476-387476100.289101.23
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 10.883760263764203766313754753767693762640.14
2 10.823767313755453761380.23
单位质量响应值RSD%判断
34583.0934763.220.37数据可信
加速6月-供试品溶液-2024122221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%
5min1220048-22004856.88955.971.7456.8955.971.74
2217894-21789456.33256.33
3218094-21809456.38456.38
4218198-21819856.41156.41
5215272-21527255.65455.65
6209476-20947654.15654.16
10min1293579-29357975.89975.501.3075.9975.591.30
2291859-29185975.45475.55
3292705-29270575.67375.77
4297716-29771676.96977.06
5289922-28992274.95475.05
6286351-28635174.03074.12
15min1327315-32731584.62184.811.6584.8485.031.65
2327180-32718084.58684.81
3329781-32978185.25885.48
4337575-33757587.27387.50
5324372-32437283.86084.08
6322022-32202283.25283.47
20min1342714-34271488.60289.181.8988.9689.541.89
2343328-34332888.76189.12
3345170-34517089.23789.60
4357675-35767592.47092.84
5340087-34008787.92388.28
6340770-34077088.09988.45
30min1355268-35526891.84892.702.2692.3693.212.25
2355973-35597392.03092.54
3355238-35523891.84092.35
4375046-37504696.96197.48
5355591-35559191.93192.44
6354354-35435491.61192.11
45min1361855-36185593.55094.502.2994.2195.162.29
2363439-36343993.96094.62
3362030-36203093.59694.26
4382538-38253898.89899.58
5361898-36189893.56294.22
6361370-36137093.42594.08
60min1367104-36710494.90895.722.2795.7396.542.27
2368427-36842795.25096.07
3365793-36579394.56995.39
4387304-387304100.130100.98
5366559-36655994.76795.58
6366324-36632494.70695.51
极限1393604-393604101.759101.721.18102.74102.711.18
2398907-398907103.130104.11
3386986-386986100.048101.03
4398123-398123102.927103.94
5389720-389720100.754101.73
6393498-393498101.731102.70
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%
1 10.883754833758013754673757923760383757160.07
2 10.823763973760433762200.07
单位质量响应值RSD%判断
34532.7234770.790.49数据可信
加速6月-供试品溶液-2024122321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%
5min1206553-20655353.43354.381.3953.4354.381.39
2207644-20764453.71653.72
3214546-21454655.50155.50
4212067-21206754.86054.86
5210285-21028554.39954.40
6210170-21017054.36954.37
10min1280646-28064672.60173.420.8772.6973.510.87
2282802-28280273.15873.25
3288070-28807074.52174.61
4284273-28427373.53973.63
5284172-28417273.51373.60
6282888-28288873.18173.27
15min1319581-31958182.67383.190.7382.8883.400.73
2323636-32363683.72283.93
3323922-32392283.79684.01
4321368-32136883.13583.35
5322835-32283583.51583.73
6318155-31815582.30482.52
20min1341346-34134688.30388.360.9988.6588.710.98
2346116-34611689.53789.89
3341764-34176488.41188.77
4340160-34016087.99688.35
5343791-34379188.93689.29
6336233-33623386.98187.33
30min1359186-35918692.91892.981.3893.4193.471.37
2365550-36555094.56595.06
3355784-35578492.03892.54
4357666-35766692.52593.02
5364957-36495794.41194.91
6353295-35329591.39491.89
45min1367970-36797095.19195.601.6095.8496.261.60
2376620-37662097.42898.09
3364562-36456294.30994.97
4369762-36976295.65496.31
5376194-37619497.31897.98
6362288-36228893.72194.37
60min1374241-37424196.81396.801.5797.6297.621.56
2380553-38055398.44699.27
3368785-36878595.40196.22
4373821-37382196.70497.52
5381012-38101298.56499.38
6366821-36682194.89395.70
极限1387756-387756100.309100.530.42101.28101.500.42
2388755-388755100.568101.55
3387693-387693100.293101.27
4388538-388538100.511101.49
5391666-391666101.321102.30
6387137-387137100.149101.11
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 10.883767343769723772413771093765853769280.08
2 10.823768723770163769440.03
单位质量响应值RSD%判断
34644.1234837.710.40数据可信
加速6月-供试品溶液-3176A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%
5min1170552-17055244.00744.823.9044.0144.823.90
2168757-16875743.54443.54
3170858-17085844.08644.09
4180108-18010846.47346.47
5167818-16781843.30143.30
6184211-18421147.53147.53
10min1258183-25818366.61867.222.5766.6967.302.57
2257650-25765066.48066.55
3257443-25744366.42766.50
4265532-26553268.51468.59
5253002-25300265.28165.35
6271402-27140270.02970.11
15min1302112-30211277.95378.772.7478.1478.952.74
2300787-30078777.61177.79
3303196-30319678.23378.42
4306221-30622179.01379.20
5297883-29788376.86277.04
6321360-32136082.91983.12
20min1328991-32899184.88885.682.6585.2086.002.66
2326219-32621984.17384.49
3333397-33339786.02586.34
4332463-33246385.78486.11
5323124-32312483.37483.68
6348241-34824189.85590.19
30min1357034-35703492.12491.671.8492.5892.131.85
2353095-35309591.10891.56
3352817-35281791.03691.49
4353397-35339791.18691.65
5348025-34802589.80090.25
6367216-36721694.75195.24
45min1371666-37166695.90095.441.8896.5196.051.88
2366855-36685594.65895.26
3368399-36839995.05795.67
4365296-36529694.25694.87
5364075-36407593.94194.54
6382994-38299498.82399.46
60min1382961-38296198.81497.422.1699.5898.202.15
2373423-37342396.35397.12
3376899-37689997.25098.02
4370434-37043495.58296.36
5370563-37056395.61596.37
6391100-391100100.914101.72
极限1400416-400416103.318100.202.58104.25101.142.56
2382489-38248998.69299.62
3397454-397454102.554103.48
4374429-37442996.61397.55
5383081-38308198.84599.76
6392122-392122101.178102.15
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