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%
110.601799551799941794921795491801521798280.17
210.671797431794291795860.13
单位质量响应值RSD%判断
16964.9116830.930.57数据可信
加速6月-供试品溶液-2025073121批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1185071-18507198.17899.531.2198.1899.531.21
2189376-189376100.462100.46
3188077-18807799.77399.77
4184699-18469997.98197.98
5188327-18832799.90599.91
6190186-190186100.891100.89
10min1189049-189049100.288101.041.21100.45101.201.21
2193234-193234102.508102.68
3191327-191327101.497101.66
4186669-18666999.02699.19
5190760-190760101.196101.36
6191719-191719101.705101.87
15min1189146-189146100.340100.870.92100.67101.200.93
2192383-192383102.057102.40
3190121-190121100.857101.19
4187326-18732699.37499.70
5190830-190830101.233101.57
6191072-191072101.361101.70
20min1188433-18843399.961100.871.08100.46101.371.08
2192613-192613102.179102.69
3190345-190345100.976101.48
4187142-18714299.27799.77
5190629-190629101.126101.63
6191690-191690101.689102.20
30min1188128-18812899.800100.550.95100.46101.220.95
2191996-191996101.852102.53
3189455-189455100.504101.18
4186998-18699899.20099.86
5190023-190023100.805101.48
6190683-190683101.155101.83
极限1188121-18812199.796100.451.24100.63101.291.23
2193220-193220102.501103.35
3189349-189349100.447101.29
4186284-18628498.82199.65
5188819-188819100.166101.01
6190344-190344100.975101.82
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%
110.601800641800991802031805641799711801800.13
210.671807481810181808830.11
单位质量响应值RSD%判断
16998.1116952.480.20数据可信
加速6月-供试品溶液-2025080121批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1185693-18569398.05798.770.5998.0698.770.59
2188174-18817499.36899.37
3187781-18778199.16099.16
4186407-18640798.43598.43
5188073-18807399.31499.31
6186143-18614398.29598.30
10min1188802-18880299.69999.640.6899.8699.800.68
2189782-189782100.217100.38
3189321-18932199.973100.14
4187353-18735398.93499.10
5189932-189932100.296100.46
6186898-18689898.69498.86
15min1190298-190298100.48999.590.79100.8299.920.79
2189243-18924399.932100.26
3188983-18898399.795100.13
4187413-18741398.96699.29
5189371-189371100.000100.33
6186242-18624298.34798.68
20min1187827-18782799.18499.280.6299.6899.780.62
2189231-18923199.926100.42
3188182-18818299.37299.87
4187190-18719098.84899.34
5189305-18930599.965100.46
6186314-18631498.38598.88
30min1186808-18680898.64699.090.6999.3199.750.69
2188785-18878599.690100.36
3188261-18826199.414100.08
4186608-18660898.54199.20
5189253-18925399.937100.60
6186140-18614098.29498.95
极限1187360-18736098.93898.910.5699.7699.730.56
2187427-18742798.97399.81
3188089-18808999.323100.15
4186801-18680198.64399.47
5188534-18853499.558100.39
6185590-18559098.00398.82
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%
110.601794231795851795481793641793071794450.07
210.671807211810691808950.14
单位质量响应值RSD%判断
16928.7716953.610.11数据可信
加速6月-供试品溶液-2025080122批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1196403-196403103.922100.422.12103.92100.422.12
2185638-18563898.22698.23
3189164-189164100.091100.09
4190753-190753100.932100.93
5191061-191061101.095101.10
6185694-18569498.25598.26
10min1198553-198553105.059101.372.07105.23101.532.07
2186792-18679298.83699.00
3190668-190668100.887101.05
4191019-191019101.073101.24
5192829-192829102.031102.20
6189582-189582100.313100.48
15min1198776-198776105.177101.392.20105.53101.732.21
2186205-18620598.52698.85
3190921-190921101.021101.36
4190431-190431100.762101.10
5193472-193472102.371102.71
6189905-189905100.483100.81
20min1198438-198438104.998101.112.19105.52101.612.19
2185735-18573598.27798.77
3190803-190803100.959101.46
4190215-190215100.647101.15
5191920-191920101.550102.06
6189403-189403100.218100.72
30min1198034-198034104.785101.012.21105.48101.682.21
2185857-18585798.34299.00
3190121-190121100.598101.27
4189468-189468100.252100.92
5193175-193175102.214102.89
6188732-18873299.863100.53
极限1197876-197876104.701100.612.28105.57101.462.28
2185697-18569798.25799.08
3189439-189439100.237101.08
4188012-18801299.482100.32
5192053-192053101.620102.47
6187814-18781499.377100.21
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%
110.601805921805671803471804041800371803890.13
210.671798851798841798840.01
单位质量响应值RSD%判断
17017.8316858.860.67数据可信
中间条件6月-供试品溶液-2025073121批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1185793-18579398.32699.160.8898.3399.160.88
2186502-18650298.70298.70
3188660-18866099.84499.84
4188977-188977100.011100.01
5185407-18540798.12298.12
6188845-18884599.94299.94
10min1186942-18694298.934100.200.9599.10100.370.95
2188076-18807699.53599.70
3190791-190791100.971101.14
4189924-189924100.513100.68
5188602-18860299.81399.98
6191700-191700101.452101.62
15min1187983-18798399.485100.471.1899.81100.801.18
2188635-18863599.830100.16
3193797-193797102.562102.90
4188910-18891099.976100.31
5188564-18856499.793100.12
6191199-191199101.187101.52
20min1186783-18678398.850100.040.8899.34100.540.88
2188520-18852099.770100.27
3189918-189918100.509101.02
4189765-189765100.428100.93
5187815-18781599.39699.89
6191382-191382101.284101.79
30min1186503-18650398.70299.710.8099.36100.380.80
2187024-18702498.97899.64
3189208-189208100.134100.81
4189488-189488100.282100.95
5187882-18788299.432100.09
6190326-190326100.725101.40
极限1186088-18608898.48299.760.8799.31100.590.87
2187769-18776999.372100.20
3189766-189766100.429101.27
4188970-188970100.008100.84
5187783-18778399.379100.21
6190626-190626100.884101.73
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%
110.601799171799361801701803101802221801110.10
210.671795531800811798170.21
单位质量响应值RSD%判断
16991.6016852.580.59数据可信
中间条件6月-供试品溶液-2025080121批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1185627-18562798.332100.751.6298.33100.751.62
2191615-191615101.504101.50
3189560-189560100.416100.42
4194840-194840103.213103.21
5188776-188776100.000100.00
6190714-190714101.027101.03
10min1187498-18749899.323101.691.5499.49101.861.54
2193074-193074102.277102.45
3191505-191505101.446101.61
4196413-196413104.046104.22
5190581-190581100.957101.12
6192687-192687102.072102.24
15min1187471-18747199.309101.481.4899.64101.821.48
2193037-193037102.258102.60
3191470-191470101.428101.76
4195893-195893103.771104.12
5190090-190090100.697101.03
6191453-191453101.419101.76
20min1187119-18711999.123101.371.4599.62101.871.45
2192203-192203101.816102.33
3191537-191537101.463101.97
4195618-195618103.625104.14
5190222-190222100.766101.27
6191427-191427101.405101.91
30min1186468-18646898.778101.081.5499.44101.751.54
2192061-192061101.741102.42
3190459-190459100.892101.57
4195326-195326103.470104.16
5189435-189435100.350101.02
6191087-191087101.225101.90
极限1186727-18672798.915100.921.4299.74101.761.42
2191694-191694101.546102.40
3190510-190510100.919101.76
4194845-194845103.215104.08
5189284-189284100.270101.11
6189960-189960100.628101.47
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%
110.601807491800341803811807561803171804470.18
210.671797781799521798650.07
单位质量响应值RSD%判断
17023.3016857.080.70数据可信
中间条件6月-供试品溶液-2025080122批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1188330-18833099.658101.263.8299.66101.263.82
2184097-18409797.41897.42
3189784-189784100.428100.43
4188352-18835299.67099.67
5192400-192400101.812101.81
6205226-205226108.599108.60
10min1188097-18809799.535100.311.4399.70100.481.43
2185108-18510897.95398.12
3191928-191928101.562101.73
4189852-189852100.464100.63
5192490-192490101.860102.03
6189926-189926100.503100.68
15min1189295-189295100.169100.822.05100.50101.162.04
2185582-18558298.20498.53
3197060-197060104.278104.61
4189388-189388100.218100.55
5192565-192565101.899102.24
6189313-189313100.178100.53
20min1188257-18825799.62099.891.40100.12100.391.40
2184479-18447997.62098.11
3190608-190608100.864101.37
4188907-18890799.964100.46
5192225-192225101.719102.23
6188084-18808499.528100.04
30min1188317-18831799.65199.801.25100.32100.471.25
2184447-18444797.60498.26
3190590-190590100.854101.53
4188565-18856599.783100.45
5191117-191117101.133101.81
6188584-18858499.793100.47
极限1193156-193156102.212100.071.59103.04100.911.58
2184341-18434197.54798.36
3190001-190001100.543101.39
4187771-18777199.363100.20
5190820-190820100.976101.82
6188586-18858699.794100.64
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