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%
114.941245971252671253451239711254561249270.51
214.981240871243791242330.17
单位质量响应值RSD%判断
8361.918293.260.59数据可信
中间条件24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%
5min1106629-10662986.06883.514.6286.0783.514.63
2110890-11089089.50789.51
397927-9792779.04479.04
4100747-10074781.32081.32
5100263-10026380.92980.93
6104330-10433084.21284.21
10min1121005-12100597.67297.752.3797.8297.882.37
2120264-12026497.07497.22
3119464-11946496.42896.56
4123004-12300499.28599.42
5117308-11730894.68894.82
6125535-125535101.328101.47
15min1121842-12184298.34799.122.0298.6599.432.02
2122288-12228898.70799.02
3122959-12295999.24999.54
4124094-124094100.165100.47
5119096-11909696.13196.42
6126554-126554102.151102.46
20min1121442-12144298.02599.591.7298.49100.051.72
2123376-12337699.586100.06
3123112-12311299.37399.83
4125378-125378101.202101.67
5120791-12079197.49997.95
6126165-126165101.837102.32
30min1124004-124004100.093100.661.53100.73101.291.53
2124423-124423100.431101.07
3124219-124219100.266100.89
4126497-126497102.105102.74
5121889-12188998.38599.00
6127174-127174102.651103.30
45min1123683-12368399.833100.861.21100.63101.661.21
2124609-124609100.581101.39
3125377-125377101.201101.99
4126520-126520102.123102.93
5122905-12290599.20599.98
6126624-126624102.207103.03
60min1124170-124170100.227100.981.30101.19101.951.30
2124185-124185100.239101.22
3125515-125515101.312102.27
4127024-127024102.530103.51
5122941-12294199.235100.18
6126803-126803102.352103.34
极限1125007-125007100.902101.220.88102.04102.360.88
2124174-124174100.230101.37
3125241-125241101.091102.22
4126827-126827102.371103.52
5124538-124538100.524101.63
6126637-126637102.218103.38
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%
114.941246171235311240901255781249921245620.64
214.981250821248801249810.12
单位质量响应值RSD%判断
8337.488343.190.05数据可信
中间条件24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%
5min1108987-10898787.83586.701.0787.8486.711.07
2108540-10854087.47587.48
3107181-10718186.38086.38
4108037-10803787.07087.07
5105952-10595285.38985.39
6106803-10680386.07586.08
10min1121733-12173398.10898.150.8598.2598.290.85
2123408-12340899.45899.60
3121492-12149297.91398.06
4122513-12251398.73698.88
5120641-12064197.22897.37
6120919-12091997.45297.60
15min1122120-12212098.41999.201.2298.7399.501.21
2125573-125573101.202101.51
3123470-12347099.50799.81
4123779-12377999.757100.07
5121725-12172598.10198.41
6121845-12184598.19898.50
20min1121821-12182198.17999.521.0398.65100.001.03
2124922-124922100.678101.16
3124124-124124100.035100.51
4123525-12352599.552100.03
5124439-124439100.288100.76
6122108-12210898.41098.88
30min1123607-12360799.618100.080.55100.26100.720.55
2124838-124838100.610101.26
3124941-124941100.693101.33
4123929-12392999.877100.52
5124458-124458100.304100.94
6123275-12327599.35099.98
45min1123028-12302899.151100.200.9299.95101.010.92
2125667-125667101.278102.09
3125259-125259100.949101.76
4123643-12364399.647100.46
5125098-125098100.820101.62
6123286-12328699.359100.16
60min1122943-12294399.083100.221.02100.05101.191.02
2126295-126295101.784102.77
3124944-124944100.695101.67
4123413-12341399.462100.44
5124952-124952100.702101.67
6123548-12354899.570100.54
极限1122335-12233598.593100.201.0899.73101.341.07
2126106-126106101.632102.79
3124678-124678100.481101.62
4124235-124235100.124101.26
5125217-125217100.915102.05
6123434-12343499.478100.61
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%
114.941243491254121248621249871241281247480.42
214.981241121245431243280.25
单位质量响应值RSD%判断
8349.938299.600.43数据可信
中间条件24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%
5min1110056-11005688.86483.825.2288.8683.825.22
2103695-10369583.72783.73
3110140-11014088.93188.93
4102060-10206082.40782.41
596552-9655277.96077.96
6100386-10038681.05681.06
10min1124466-124466100.49997.932.60100.6598.072.61
2121991-12199198.50098.64
3124891-124891100.842100.99
4120828-12082897.56197.70
5117006-11700694.47594.61
6118534-11853495.70995.84
15min1125251-125251101.13399.042.15101.4599.342.15
2123765-12376599.933100.24
3125810-125810101.584101.90
4120826-12082697.56097.86
5119585-11958596.55896.84
6120691-12069197.45197.75
20min1125071-125071100.98799.391.51101.4799.861.52
2124321-124321100.382100.85
3124758-124758100.734101.22
4121687-12168798.25598.72
5120628-12062897.40097.85
6122113-12211398.59999.06
30min1124979-124979100.91399.761.04101.57100.401.05
2124418-124418100.460101.10
3124716-124716100.701101.35
4122566-12256698.96599.59
5122449-12244998.87099.48
6122195-12219598.66599.29
45min1124275-124275100.344100.071.01101.17100.881.02
2125652-125652101.456102.26
3125034-125034100.957101.78
4122688-12268899.06399.85
5123319-12331999.573100.35
6122673-12267399.05199.84
60min1124392-124392100.43999.761.21101.43100.721.21
2125518-125518101.348102.32
3124396-124396100.442101.43
4121499-12149998.10399.06
5123063-12306399.366100.31
6122418-12241898.84599.80
极限1123672-12367299.85899.761.38101.01100.891.38
2125025-125025100.950102.09
3125904-125904101.660102.82
4121396-12139698.02099.14
5123119-12311999.411100.52
6122161-12216198.63899.75
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%
114.942494802495172492872487742486982491510.16
214.982465892479182472540.39
单位质量响应值RSD%判断
16676.7716505.610.73数据可信
中间条件24月-供试品溶液-2023030911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%
5min1187163-18716375.82879.166.8875.8379.166.88
2194510-19451078.80578.80
3211860-21186085.83485.83
4211549-21154985.70885.71
5186988-18698875.75775.76
6180200-18020073.00773.01
10min1231162-23116293.65495.412.5393.7895.542.53
2236950-23695095.99996.13
3243332-24333298.58598.73
4241244-24124497.73997.88
5231612-23161293.83793.96
6228694-22869492.65592.78
15min1242267-24226798.15498.681.4298.4498.971.43
2244292-24429298.97499.27
3247227-247227100.163100.47
4247671-247671100.343100.65
5240669-24066997.50697.79
6239246-23924696.93097.21
20min1243054-24305498.47299.331.3898.9299.791.38
2245143-24514399.31999.78
3247638-247638100.330100.80
4250530-250530101.501101.97
5243288-24328898.56799.01
6241442-24144297.81998.26
30min1247190-247190100.14899.581.00100.76100.201.01
2245914-24591499.631100.25
3246909-246909100.034100.68
4248727-248727100.771101.41
5244136-24413698.91199.52
6241896-24189698.00398.60
45min1250429-250429101.460100.271.43102.24101.051.43
2245828-24582899.596100.38
3249136-249136100.937101.74
4251929-251929102.068102.88
5244298-24429898.97699.75
6243274-24327498.56299.33
60min1249524-249524101.094100.001.18102.04100.961.18
2246261-24626199.772100.73
3247896-247896100.434101.41
4250174-250174101.357102.34
5243113-24311398.49699.44
6243963-24396398.84199.77
极限1249060-249060100.906100.441.65102.02101.561.65
2246201-24620199.747100.87
3248709-248709100.764101.91
4254980-254980103.304104.45
5244904-24490499.222100.33
6243571-24357198.68299.77
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