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1000
标示量(mg)10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%
114.811235581229941235891232871231601233180.21
214.851229801230381230090.04
单位质量响应值RSD%判断
8326.678283.430.37数据可信
长期12月-供试品溶液-2023031211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%
5min1102220-10222082.73283.842.2582.7383.842.25
2105955-10595585.75585.76
3105274-10527485.20485.20
499675-9967580.67280.67
5104804-10480484.82484.82
6103593-10359383.84383.84
10min1120535-12053597.55597.021.1497.6997.161.14
2118671-11867196.04796.19
3121685-12168598.48698.63
4119579-11957996.78296.92
5120727-12072797.71197.85
6118060-11806095.55295.69
15min1122427-12242799.08798.290.8699.3998.600.86
2120358-12035897.41297.72
3122525-12252599.16699.47
4121695-12169598.49498.79
5121645-12164598.45498.76
6120021-12002197.13997.44
20min1121938-12193898.69198.350.8899.1698.820.88
2120531-12053197.55298.02
3122685-12268599.29699.77
4122175-12217598.88399.34
5121874-12187498.63999.11
6119904-11990497.04597.51
30min1122605-12260599.23198.780.7199.8699.400.70
2121120-12112098.02998.66
3122790-12279099.381100.02
4122984-12298499.538100.16
5121671-12167198.47599.11
6121080-12108097.99798.62
45min1123028-12302899.57399.020.73100.3799.810.72
2121344-12134498.21099.00
3123063-12306399.601100.40
4123238-12323899.743100.53
5122082-12208298.80899.60
6121324-12132498.19498.98
60min1122739-12273999.33999.040.79100.30100.000.78
2121215-12121598.10699.06
3123404-12340499.877100.85
4123457-12345799.920100.88
5121714-12171498.51099.47
6121724-12172498.51899.47
极限1122106-12210698.82798.970.7199.95100.100.70
2121507-12150798.34299.46
3123187-12318799.702100.84
4123472-12347299.933101.06
5121410-12141098.26499.39
6122041-12204198.77499.89
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1000
标示量(mg)10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%
114.811231611227601225681222451223971226260.29
214.851223281221741222510.09
单位质量响应值RSD%判断
8279.958232.390.41数据可信
长期12月-供试品溶液-2023031212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%
5min192083-9208374.96982.667.6674.9782.667.66
2103675-10367584.40784.41
393955-9395576.49376.49
4101571-10157182.69482.69
5104464-10446485.04985.05
6113454-11345492.36892.37
10min1117798-11779895.90597.272.2396.0397.412.23
2120666-12066698.24098.38
3116989-11698995.24695.37
4117376-11737695.56195.70
5120071-12007197.75597.90
6123957-123957100.919101.07
15min1121651-12165199.04298.941.4299.3399.241.43
2121921-12192199.26299.57
3119878-11987897.59897.88
4119592-11959297.36597.66
5121754-12175499.12699.43
6124388-124388101.270101.59
20min1122952-122952100.10199.461.27100.5599.921.27
2122627-12262799.836100.31
3120661-12066198.23698.68
4119984-11998497.68598.14
5122620-12262099.831100.30
6124118-124118101.050101.54
30min1123757-123757100.75699.781.05101.37100.411.06
2122349-12234999.610100.25
3121061-12106198.56199.17
4121233-12123398.70199.32
5122723-12272399.915100.55
6124199-124199101.116101.78
45min1124597-124597101.440100.051.05102.22100.851.05
2122600-12260099.814100.62
3121101-12110198.59499.37
4122073-12207399.385100.17
5122895-122895100.055100.86
6124066-124066101.008101.84
60min1124203-124203101.12099.941.00102.07100.901.01
2122396-12239699.648100.62
3121181-12118198.65999.60
4121712-12171299.091100.04
5122962-122962100.109101.08
6124056-124056101.000102.00
极限1123988-123988100.944100.040.98102.07101.170.98
2122231-12223199.514100.65
3120884-12088498.41799.52
4122726-12272699.917101.03
5123614-123614100.640101.78
6123839-123839100.823101.99
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1000
标示量(mg)10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%
114.811225441226201225861224991226441225790.05
214.851223711222501223100.07
单位质量响应值RSD%判断
8276.778236.360.35数据可信
长期12月-供试品溶液-2023031311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%
5min1109255-10925588.94587.383.0588.9587.383.05
2106279-10627986.52286.52
3103453-10345384.22284.22
4106944-10694487.06487.06
5105307-10530785.73185.73
6112748-11274891.78991.79
10min1119477-11947797.26797.791.4397.4297.941.43
2122256-12225699.52999.67
3121533-12153398.94199.08
4119694-11969497.44497.59
5117383-11738395.56295.71
6120369-12036997.99398.15
15min1120449-12044998.05899.081.1198.3799.391.10
2123102-123102100.218100.53
3123676-123676100.685100.99
4120679-12067998.24598.55
5121196-12119698.66698.97
6121156-12115698.63498.95
20min1121409-12140998.84099.441.0699.3199.911.05
2123357-123357100.426100.90
3124175-124175101.092101.56
4121545-12154598.95099.42
5121214-12121498.68199.15
6121191-12119198.66299.14
30min1122106-12210699.407100.010.98100.05100.640.97
2123854-123854100.830101.47
3124649-124649101.477102.12
4122846-122846100.010100.65
5122023-12202399.34099.97
6121566-12156698.96899.61
45min1123509-123509100.549100.220.95101.35101.030.95
2123548-123548100.581101.39
3124924-124924101.701102.51
4122921-122921100.071100.87
5122085-12208599.390100.19
6121673-12167399.05599.86
60min1123967-123967100.922100.330.84101.89101.300.83
2123702-123702100.707101.69
3124530-124530101.381102.36
4123118-123118100.231101.20
5122043-12204399.356100.32
6122052-12205299.363100.34
极限1124390-124390101.267100.380.89102.41101.520.89
2123438-123438100.492101.64
3124114-124114101.042102.19
4122748-12274899.930101.07
5123709-123709100.712101.84
6121388-12138898.82399.96
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