比拉斯汀口崩片项目信息
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%
110.601803971798921799801797451796641799360.16
210.671793641798201795920.18
单位质量响应值RSD%判断
16975.0916831.490.61数据可信
加速6月-供试品溶液-2025073121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%
5min1117216-11721662.16263.111.9362.1663.111.93
2116886-11688661.98761.99
3119665-11966563.46163.46
4119704-11970463.48163.48
5122952-12295265.20465.20
6117568-11756862.34962.35
10min1166905-16690588.51389.221.0788.6289.331.07
2166803-16680388.45988.56
3169144-16914489.70189.81
4167070-16707088.60188.71
5171384-17138490.88891.00
6168115-16811589.15589.26
15min1183923-18392397.53897.511.0097.7997.760.99
2180730-18073095.84596.10
3184522-18452297.85698.11
4183382-18338297.25197.50
5184401-18440197.79298.05
6186283-18628398.79099.04
20min1189171-189171100.321100.141.18100.73100.561.18
2185356-18535698.29898.71
3189927-189927100.722101.14
4187507-18750799.43999.85
5189136-189136100.303100.73
6191917-191917101.778102.19
30min1191192-191192101.393100.971.28101.97101.551.27
2187688-18768899.535100.11
3191846-191846101.740102.33
4188778-188778100.113100.69
5188718-188718100.081100.67
6194124-194124102.948103.53
极限1191306-191306101.453100.911.19102.20101.661.19
2186170-18617098.73099.47
3190745-190745101.156101.91
4189559-189559100.527101.28
5191119-191119101.354102.11
6192746-192746102.217102.98
比拉斯汀口崩片项目信息
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%
110.601794631796331794801794301803521796720.22
210.671798851801281800060.10
单位质量响应值RSD%判断
16950.1916870.290.34数据可信
加速6月-供试品溶液-2025080121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%
5min1130735-13073569.30264.455.2769.3064.455.27
2127900-12790067.79967.80
3115390-11539061.16861.17
4121466-12146664.38964.39
5117349-11734962.20662.21
6116602-11660261.81061.81
10min1172923-17292391.66689.722.5091.7889.832.50
2174873-17487392.69992.81
3164648-16464887.27987.38
4170927-17092790.60890.72
5166274-16627488.14188.24
6165904-16590487.94588.05
15min1184750-18475097.93597.401.5498.2097.651.54
2187390-18739099.33599.60
3180188-18018895.51795.76
4185901-18590198.54598.80
5183243-18324397.13697.39
6180949-18094995.92096.17
20min1186878-18687899.06399.281.3399.4999.701.34
2190229-190229100.840101.27
3184280-18428097.68698.09
4189915-189915100.673101.10
5187575-18757599.43399.85
6184843-18484397.98598.39
30min1188199-18819999.76499.941.13100.36100.521.13
2191612-191612101.573102.17
3187020-18702099.13999.71
4190218-190218100.834101.42
5188344-18834499.840100.42
6185744-18574498.46299.03
极限1187489-18748999.38799.381.19100.15100.131.19
2191057-191057101.279102.05
3185694-18569498.43699.17
4188934-188934100.153100.91
5185128-18512898.13698.88
6186561-18656198.89599.63
比拉斯汀口崩片项目信息
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%
110.601799021800441795501797031793791797160.15
210.671796421800531798480.17
单位质量响应值RSD%判断
16954.3416855.480.42数据可信
加速6月-供试品溶液-2025080122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%
5min1113064-11306459.95460.455.8359.9560.455.83
2119461-11946163.34663.35
3108795-10879557.69057.69
4124606-12460666.07466.07
5109885-10988558.26858.27
6108203-10820357.37657.38
10min1165841-16584187.94087.993.9688.0488.093.96
2169441-16944189.84989.95
3160382-16038285.04585.14
4177275-17727594.00394.11
5162163-16216385.98986.09
6160552-16055285.13585.23
15min1185332-18533298.27597.662.9998.5297.912.99
2184434-18443497.79998.05
3178700-17870094.75895.00
4194249-194249103.003103.27
5181425-18142596.20396.44
6180922-18092295.93796.17
20min1190138-190138100.82399.302.62101.2399.712.62
2187685-18768599.52399.94
3182904-18290496.98897.38
4195428-195428103.629104.07
5183253-18325397.17397.57
6184205-18420597.67798.07
30min1189367-189367100.41599.822.76100.99100.402.76
2186935-18693599.12599.71
3182074-18207496.54797.10
4197381-197381104.664105.28
5185124-18512498.16598.73
6188621-188621100.019100.58
极限1191126-191126101.347100.162.45102.09100.902.45
2188421-18842199.913100.66
3185353-18535398.28699.00
4196727-196727104.317105.10
5183751-18375197.43798.16
6187924-18792499.649100.38
比拉斯汀口崩片项目信息
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%
110.601797491797791797501797461794681796980.08
210.671795541797991796760.10
单位质量响应值RSD%判断
16952.6416839.360.48数据可信
中间条件6月-供试品溶液-2025073121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%
5min1130653-13065369.31769.003.6869.3269.003.68
2121610-12161064.52064.52
3128744-12874468.30568.30
4134800-13480071.51871.52
5130247-13024769.10269.10
6134313-13431371.25971.26
10min1178033-17803394.45592.631.6094.5792.741.61
2171040-17104090.74590.85
3171994-17199491.25191.36
4177367-17736794.10194.22
5174377-17437792.51592.63
6174700-17470092.68692.81
15min1190737-190737101.19598.562.11101.4798.832.11
2181399-18139996.24096.50
3182736-18273696.95097.22
4190397-190397101.014101.29
5184689-18468997.98698.26
6184688-18468897.98598.26
20min1194883-194883103.394100.142.26103.84100.582.26
2184897-18489798.09698.52
3185367-18536798.34698.77
4193162-193162102.481102.93
5188023-18802399.755100.19
6186199-18619998.78799.22
30min1194637-194637103.264100.761.99103.88101.361.99
2186357-18635798.87199.45
3186576-18657698.98799.58
4194320-194320103.096103.71
5190094-190094100.854101.45
6187500-18750099.477100.08
极限1193978-193978102.914100.111.84103.70100.881.84
2184532-18453297.90398.65
3186545-18654598.97199.73
4191534-191534101.618102.40
5187247-18724799.343100.11
6188311-18831199.908100.67
比拉斯汀口崩片项目信息
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%
110.601799481802921805411803541802161802700.13
210.671794961804051799500.36
单位质量响应值RSD%判断
17006.6016865.040.60数据可信
中间条件6月-供试品溶液-2025080121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%
5min1119914-11991463.47160.517.3663.4760.517.36
2123175-12317565.19765.20
3120007-12000763.52063.52
4101075-10107553.49953.50
5113346-11334659.99459.99
6108378-10837857.36557.36
10min1169544-16954489.74085.704.2689.8585.804.27
2170114-17011490.04290.15
3160197-16019784.79384.90
4151921-15192180.41280.50
5160528-16052884.96885.07
6159151-15915184.23984.33
15min1182565-18256596.63295.292.3996.8995.532.40
2184653-18465397.73798.00
3177004-17700493.68893.94
4173076-17307691.60991.83
5180157-18015795.35795.60
6182706-18270696.70796.94
20min1187646-18764699.32197.642.2899.7498.052.27
2185860-18586098.37698.80
3178483-17848394.47194.87
4180994-18099495.80096.18
5184142-18414297.46797.87
6189735-189735100.427100.82
30min1188430-18843099.73698.701.94100.3299.271.94
2187490-18749099.23999.82
3182547-18254796.62297.18
4182812-18281296.76397.30
5185577-18557798.22698.79
6192003-192003101.627102.19
极限1186143-18614398.52698.581.6999.2799.301.69
2187342-18734299.16099.91
3182689-18268996.69897.42
4183215-18321596.97697.67
5186704-18670498.82399.55
6191340-191340101.277102.01
比拉斯汀口崩片项目信息
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%
110.601791041796941789371799101792911793870.23
210.671799981799001799490.04
单位质量响应值RSD%判断
16923.3016864.950.25数据可信
中间条件6月-供试品溶液-2025080122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%
5min1130221-13022169.09564.384.8669.1064.384.87
2116536-11653661.83461.83
3124359-12435965.98565.98
4121541-12154164.49064.49
5121932-12193264.69764.70
6113443-11344360.19360.19
10min1173456-17345692.03688.183.2292.1588.293.22
2161954-16195485.93386.04
3168456-16845689.38389.49
4169150-16915089.75189.86
5165543-16554387.83787.94
6158598-15859884.15284.25
15min1185091-18509198.20995.611.7198.4895.861.72
2179933-17993395.47295.72
3181858-18185896.49496.75
4176958-17695893.89494.15
5180282-18028295.65895.91
6177010-17701093.92294.16
20min1186651-18665199.03798.290.8799.4798.700.88
2185582-18558298.47098.88
3184388-18438897.83698.26
4187355-18735599.41199.82
5184451-18445197.87098.28
6183002-18300297.10197.50
30min1188704-188704100.12698.801.11100.7299.381.11
2187274-18727499.36899.94
3186257-18625798.82899.41
4186524-18652498.97099.55
5185904-18590498.64199.22
6182540-18254096.85697.41
极限1188936-188936100.24998.331.27101.0199.071.27
2184402-18440297.84498.58
3184653-18465397.97798.72
4187346-18734699.406100.15
5183915-18391597.58598.33
6182654-18265496.91697.64
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