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430030-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.0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%
115.322537352537272538192536812539232537770.04
215.382532182535272533720.09
单位质量响应值RSD%判断
16565.0816474.120.39数据可信
长期9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%
5min1207555-20755583.79386.227.2383.7986.227.24
2237770-23777095.99195.99
3220112-22011288.86288.86
4204450-20445082.53982.54
5218448-21844888.19088.19
6193064-19306477.94377.94
10min1235327-23532795.00597.182.8095.1497.322.80
2248159-248159100.185100.35
3242187-24218797.77497.92
4239074-23907496.51796.65
5247973-247973100.110100.26
6231563-23156393.48593.62
15min1241666-24166697.56499.161.2697.8699.471.27
2248600-248600100.363100.69
3245223-24522399.00099.31
4244810-24481098.83399.13
5249861-249861100.872101.19
6243580-24358098.33798.62
20min1242323-24232397.82999.390.9898.2999.860.98
2246253-24625399.41699.91
3245568-24556899.13999.62
4246190-24619099.39099.85
5249764-249764100.833101.32
6247038-24703899.733100.18
30min1242508-24250897.90499.871.2198.53100.501.21
2248331-248331100.255100.91
3245950-24595099.29399.93
4246846-24684699.655100.28
5249781-249781100.840101.49
6250839-250839101.267101.88
45min1243757-24375798.408100.131.1999.19100.931.18
2248484-248484100.316101.14
3246281-24628199.427100.23
4247349-24734999.858100.65
5250101-250101100.969101.79
6252114-252114101.782102.57
60min1243813-24381398.431100.031.1799.38101.001.16
2247626-24762699.970100.96
3246271-24627199.423100.40
4246988-24698899.712100.67
5249993-249993100.926101.91
6252018-252018101.743102.70
极限1244931-24493198.882100.281.23100.00101.411.22
2247601-24760199.960101.12
3245701-24570199.193100.33
4248344-248344100.260101.39
5250732-250732101.224102.38
6252986-252986102.134103.26
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430030-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.0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%
115.322523262530552536192532632534102531350.20
215.382530502531902531200.04
单位质量响应值RSD%判断
16523.1716457.740.29数据可信
长期9月-供试品溶液-2023031011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%
5min1221792-22179289.69887.576.3789.7087.576.37
2211873-21187385.68785.69
3223873-22387390.54090.54
4236863-23686395.79395.79
5206413-20641383.47983.48
6198331-19833180.21080.21
10min1245692-24569299.36497.783.5099.5197.923.50
2241475-24147597.65997.80
3239475-23947596.85097.00
4255585-255585103.365103.52
5238115-23811596.30096.44
6230292-23029293.13693.27
15min1246649-24664999.75199.332.67100.0799.642.68
2245160-24516099.14999.45
3242503-24250398.07498.39
4257267-257267104.045104.38
5244654-24465498.94499.24
6237424-23742496.02096.31
20min1247376-247376100.04599.932.26100.53100.402.27
2246562-24656299.716100.19
3243640-24364098.53499.01
4257462-257462104.124104.63
5246343-24634399.627100.09
6241139-24113997.52397.97
30min1246729-24672999.784100.172.02100.43100.812.03
2246593-24659399.729100.37
3245168-24516899.15299.79
4257382-257382104.092104.77
5247309-247309100.018100.65
6242946-24294698.25498.87
45min1247090-24709099.930100.491.83100.74101.301.84
2247502-247502100.096100.90
3245838-24583899.423100.23
4257439-257439104.115104.97
5248046-248046100.316101.11
6244968-24496899.07199.85
60min1246832-24683299.825100.411.66100.81101.391.67
2247676-247676100.167101.14
3246408-24640899.654100.62
4256311-256311103.659104.68
5247960-247960100.281101.25
6244534-24453498.89699.84
极限1246782-24678299.805100.551.81100.95101.691.82
2246959-24695999.877101.01
3247240-24724099.990101.13
4257244-257244104.036105.23
5249164-249164100.768101.90
6244338-24433898.81799.92
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430030-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.0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%
115.322536642540592535872536682538302537620.08
215.382535092535802535440.02
单位质量响应值RSD%判断
16564.1016485.310.34数据可信
长期9月-供试品溶液-2023031111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%
5min1182206-18220673.53681.469.6073.5481.469.60
2214467-21446786.55686.56
3222431-22243189.77189.77
4205165-20516582.80282.80
5212784-21278485.87785.88
6173959-17395970.20870.21
10min1229402-22940292.58495.824.5092.7195.954.51
2246742-24674299.58299.73
3250789-250789101.215101.37
4239526-23952696.67096.81
5235807-23580795.16995.31
6222195-22219589.67589.79
15min1243933-24393398.44898.582.5298.7398.882.52
2249058-249058100.517100.83
3253112-253112102.153102.47
4242698-24269897.95098.25
5241206-24120697.34897.65
6235614-23561495.09195.36
20min1249067-249067100.52099.472.12100.9699.932.12
2250110-250110100.941101.42
3253564-253564102.335102.82
4243797-24379798.39498.86
5241745-24174597.56598.03
6240495-24049597.06197.49
30min1253236-253236102.203100.062.13102.81100.682.13
2250665-250665101.165101.81
3253799-253799102.430103.09
4244806-24480698.80199.43
5242733-24273397.96498.59
6242254-24225497.77198.36
45min1256823-256823103.651100.452.41104.43101.242.40
2251005-251005101.303102.12
3254281-254281102.625103.45
4244956-24495698.86199.65
5242873-24287398.02198.81
6243359-24335998.21798.97
60min1257903-257903104.087100.542.44105.04101.502.44
2250621-250621101.148102.13
3254146-254146102.570103.57
4245021-24502198.88899.84
5243185-24318598.14799.10
6243822-24382298.40499.32
极限1259158-259158104.593100.722.55105.72101.852.54
2250280-250280101.010102.16
3254707-254707102.797103.97
4245336-24533699.015100.14
5243221-24322198.16199.28
6244636-24463698.73299.81
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430030-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.0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%
115.322533202537282534792532402536102534750.08
215.382530982530322530650.02
单位质量响应值RSD%判断
16545.3716454.160.40数据可信
长期9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%
5min1204926-20492682.83174.2614.8082.8374.2614.80
2197484-19748479.82379.82
3154206-15420662.33062.33
4194914-19491478.78478.78
5206397-20639783.42583.43
6144421-14442158.37558.37
10min1240480-24048097.20295.092.8997.3495.212.90
2243842-24384298.56198.69
3224575-22457590.77390.88
4236432-23643295.56695.70
5234669-23466994.85394.99
6231524-23152493.58293.68
15min1243966-24396698.61198.041.2098.9198.321.21
2247292-24729299.955100.25
3240666-24066697.27797.53
4241998-24199897.81598.11
5238819-23881996.53096.83
6242516-24251698.02598.28
20min1244261-24426198.73098.751.0499.1999.191.03
2248187-248187100.317100.78
3243412-24341298.38798.80
4243533-24353398.43698.89
5240664-24066497.27697.73
6245763-24576399.33799.75
30min1244932-24493299.00199.111.0399.6399.721.03
2249788-249788100.964101.60
3244621-24462198.87699.46
4243688-24368898.49899.12
5242422-24242297.98798.61
6245694-24569499.30999.89
45min1244200-24420098.70599.421.1899.50100.201.17
2251104-251104101.496102.30
3247064-24706499.863100.61
4243817-24381798.55199.33
5243424-24342498.39299.18
6246199-24619999.513100.26
60min1243436-24343698.39799.281.0999.36100.221.08
2250483-250483101.245102.21
3246302-24630299.555100.47
4243877-24387798.57599.52
5243694-24369498.50199.45
6245871-24587199.381100.29
极限1242586-24258698.05399.091.2099.18100.191.19
2250323-250323101.180102.32
3246219-24621999.521100.60
4242547-24254798.03799.15
5243922-24392298.59399.70
6245264-24526499.135100.21
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