富马酸伏诺拉生片项目信息
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17570对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.78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0.7485
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.052462092454252452822469242453302458340.30
215.162462512465402463960.09
单位质量响应值RSD%判断
16334.4916253.030.36数据可信
长期12月-供试品溶液-12297369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%
5min1206246-20624685.08379.499.7685.0879.499.76
2210427-21042786.80886.81
3180880-18088074.61974.62
4194937-19493780.41880.42
5202832-20283283.67583.67
6160768-16076866.32266.32
10min1237230-23723097.86594.214.2298.0194.344.23
2234795-23479596.86197.01
3224422-22442292.58292.71
4225778-22577893.14193.28
5235884-23588497.31097.45
6212095-21209587.49687.61
15min1242229-24222999.92897.251.80100.2397.541.81
2236044-23604497.37697.68
3232891-23289196.07596.35
4234022-23402296.54296.83
5238760-23876098.49698.80
6230507-23050795.09295.35
20min1241509-24150999.63198.630.57100.1099.080.58
2237683-23768398.05298.52
3238683-23868398.46598.90
4238237-23823798.28198.73
5239648-23964898.86399.33
6238747-23874798.49198.91
30min1244054-244054100.68099.580.74101.32100.200.75
2241607-24160799.671100.30
3242234-24223499.930100.53
4240664-24066499.28299.90
5241121-24112199.470100.10
6238665-23866598.45799.04
45min1243845-243845100.59499.920.98101.40100.700.98
2240602-24060299.256100.05
3245050-245050101.091101.86
4243084-243084100.280101.06
5242150-24215099.895100.69
6238501-23850198.39099.13
60min1243146-243146100.30699.750.78101.28100.700.78
2240158-24015899.073100.04
3244406-244406100.826101.76
4242330-24233099.969100.92
5241383-24138399.579100.54
6239396-23939698.75999.67
极限1246839-246839101.829100.320.95102.97101.440.95
2241391-24139199.582100.71
3244513-244513100.870101.98
4243671-243671100.522101.64
5242056-24205699.856100.99
6240651-24065199.277100.35
富马酸伏诺拉生片项目信息
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17570对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.78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0.7485
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.052468772453712453732453262471862460270.38
215.162451462462192456820.31
单位质量响应值RSD%判断
16347.3116205.940.62数据可信
中间条件12月-供试品溶液-12297369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%
5min1160584-16058466.31770.6218.5366.3270.6218.53
2163154-16315467.37867.38
3186859-18685977.16877.17
4184781-18478176.31076.31
5211901-21190187.50987.51
6118721-11872149.02949.03
10min1222956-22295692.07595.274.3292.1995.394.33
2227958-22795894.14194.25
3234912-23491297.01297.14
4226990-22699093.74193.87
5248835-248835102.762102.91
6222487-22248791.88191.96
15min1234997-23499797.04799.192.2597.3199.462.26
2239641-23964198.96599.23
3239751-23975199.01199.30
4235994-23599497.45997.74
5250188-250188103.321103.64
6240484-24048499.31399.55
20min1236720-23672097.75999.821.8998.18100.261.90
2239162-23916298.76799.20
3241951-24195199.919100.37
4239022-23902298.71099.16
5249494-249494103.034103.52
6243869-243869100.711101.11
30min1238144-23814498.347100.801.6598.94101.411.66
2244046-244046100.784101.38
3242827-242827100.281100.90
4243232-243232100.448101.06
5250423-250423103.418104.08
6245875-245875101.540102.11
45min1239643-23964398.966101.241.3099.72102.021.31
2245739-245739101.484102.25
3244490-244490100.968101.76
4245896-245896101.548102.33
5249483-249483103.030103.86
6245677-245677101.458102.20
60min1238376-23837698.443100.851.3199.36101.801.33
2245714-245714101.473102.41
3245086-245086101.214102.17
4243755-243755100.664101.61
5247934-247934102.390103.40
6244377-244377100.921101.83
极限1238362-23836298.437100.891.3099.52102.001.31
2244943-244943101.155102.26
3244245-244245100.867101.99
4244828-244828101.107102.22
5247795-247795102.333103.51
6245596-245596101.425102.50
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