富马酸比索洛尔片项目信息
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100711-202203对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
110.171683471680131682931680511677351680880.15
210.091683351679391681370.17
单位质量响应值RSD%判断
16527.8316663.730.58数据可信
供试品溶液-25022401批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1136608-13660873.93678.093.9973.9478.103.99
2151389-15138981.93681.94
3146405-14640579.23979.24
4140473-14047376.02876.03
5141301-14130176.47676.48
6149542-14954280.93780.94
10min1159535-15953586.34589.802.3686.4789.932.36
2168028-16802890.94291.08
3163507-16350788.49588.63
4166702-16670290.22490.35
5166892-16689290.32790.45
6170813-17081392.44992.58
15min1167706-16770690.76893.301.6291.0393.581.62
2173608-17360893.96294.25
3170218-17021892.12792.41
4174173-17417394.26894.54
5174347-17434794.36294.64
6174237-17423794.30294.59
20min1172736-17273693.49094.640.8693.9195.080.86
2175162-17516294.80395.25
3173423-17342393.86294.30
4175744-17574495.11895.55
5176692-17669295.63196.07
6175412-17541294.93895.38
30min1178642-17864296.68795.780.7697.2696.370.75
2176139-17613995.33295.93
3175753-17575395.12395.71
4176957-17695795.77596.37
5178544-17854496.63497.23
6175730-17573095.11195.71
45min1179201-17920196.98996.020.8597.7296.770.84
2176657-17665795.61296.37
3176697-17669795.63496.38
4176983-17698395.78996.54
5179315-17931597.05197.81
6175626-17562695.05495.82
极限1182309-18230998.67196.281.4399.5797.191.41
2176496-17649695.52596.45
3177268-17726895.94396.85
4176558-17655895.55996.47
5179381-17938197.08798.00
6175343-17534394.90195.82
富马酸比索洛尔片项目信息
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100711-202203对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
110.171674611675451676921675831674611675480.06
210.091678781673421676100.23
单位质量响应值RSD%判断
16474.7316611.500.59数据可信
供试品溶液-25022402批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1172873-17287393.86294.302.0093.8694.302.00
2179137-17913797.26397.26
3176544-17654495.85595.86
4171150-17115092.92792.93
5170068-17006892.33992.34
6172286-17228693.54393.54
10min1180002-18000297.73397.780.7797.8997.940.77
2180931-18093198.23798.40
3182328-18232898.99699.16
4178404-17840496.86597.02
5179612-17961297.52197.67
6179287-17928797.34597.50
15min1185585-185585100.76498.751.27101.0899.071.27
2181560-18156098.57998.90
3183498-18349899.63199.96
4179174-17917497.28397.60
5181041-18104198.29798.61
6180437-18043797.96998.29
20min1182109-18210998.87798.560.7999.3699.050.79
2181487-18148798.53999.03
3183421-18342199.589100.08
4179691-17969197.56498.04
5182416-18241699.04499.52
6180067-18006797.76898.25
30min1183418-18341899.58898.680.95100.2499.330.95
2181461-18146198.52599.18
3183324-18332499.537100.19
4179614-17961497.52298.16
5182838-18283899.27399.92
6179852-17985297.65198.30
45min1182033-18203398.83698.370.8799.6599.180.87
2180945-18094598.24599.06
3183043-18304399.384100.21
4179393-17939397.40298.21
5182303-18230398.98299.79
6179292-17929297.34798.15
极限1182064-18206498.85298.190.8299.8499.170.81
2180430-18043097.96598.95
3182282-18228298.97199.96
4179296-17929697.35098.32
5181984-18198498.80999.78
6179017-17901797.19898.17
富马酸比索洛尔片项目信息
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100711-202203对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
110.171682421679651680801681541681861681250.07
210.091676641676451676540.01
单位质量响应值RSD%判断
16531.4716615.860.37数据可信
供试品溶液-25022403批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1185923-185923100.76197.075.62100.7697.065.63
2169895-16989592.07492.07
3190011-190011102.976102.98
4183169-18316999.26899.27
5163852-16385288.79988.80
6181775-18177598.51398.51
10min1191225-191225103.634101.493.71103.80101.653.71
2180805-18080597.98798.14
3194526-194526105.423105.59
4191787-191787103.939104.10
5176844-17684495.84095.99
6188419-188419102.113102.28
15min1192682-192682104.424102.782.77104.76103.112.77
2185201-185201100.369100.69
3196901-196901106.710107.06
4191623-191623103.850104.19
5182474-18247498.89199.20
6188969-188969102.411102.75
20min1192880-192880104.531103.322.28105.05103.832.29
2186685-186685101.174101.66
3197644-197644107.113107.64
4191678-191678103.879104.39
5186084-186084100.848101.32
6188958-188958102.405102.91
30min1193176-193176104.691103.682.02105.38104.352.03
2187044-187044101.368102.02
3197812-197812107.204107.91
4191673-191673103.877104.56
5189230-189230102.553103.19
6188909-188909102.379103.05
45min1192913-192913104.549103.611.88105.41104.461.88
2186914-186914101.298102.12
3197009-197009106.769107.65
4191198-191198103.619104.48
5190855-190855103.433104.24
6188230-188230102.011102.86
极限1192057-192057104.085103.431.73105.12104.451.73
2187390-187390101.556102.55
3196558-196558106.524107.58
4190420-190420103.198104.23
5190650-190650103.322104.31
6188020-188020101.897102.91
富马酸比索洛尔片项目信息
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100711-202203对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)5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%
110.171702251702591702381702021700911702030.04
210.091679661678341679000.06
单位质量响应值RSD%判断
16735.7916640.240.41数据可信
供试品溶液-25022404批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1133248-13324871.71964.4211.2371.7264.4211.23
2128465-12846569.14469.14
3102400-10240055.11555.12
4103462-10346255.68755.69
5122267-12226765.80865.81
6128258-12825869.03369.03
10min1151357-15135781.46676.796.8581.5976.906.86
2148858-14885880.12180.24
3130701-13070170.34870.44
4131040-13104070.53070.62
5142204-14220476.53976.65
6151882-15188281.74881.86
15min1159970-15997086.10184.044.0386.3684.284.04
2163454-16345487.97788.23
3150101-15010180.79081.00
4148592-14859279.97780.19
5153307-15330782.51582.75
6161437-16143786.89187.14
20min1165807-16580789.24387.762.8189.6488.142.82
2168853-16885390.88391.28
3158170-15817085.13385.48
4159374-15937485.78186.12
5159466-15946685.83086.20
6166649-16664989.69690.09
30min1173144-17314493.19292.171.9593.7492.691.97
2175653-17565394.54395.09
3167204-16720489.99590.48
4169548-16954891.25791.74
5168404-16840490.64191.16
6173487-17348793.37793.92
45min1177109-17710995.32694.431.5596.0395.101.57
2178295-17829595.96596.67
3172057-17205792.60793.24
4173834-17383493.56494.20
5173256-17325693.25293.92
6178068-17806895.84296.54
极限1179330-17933096.52295.741.5897.3896.571.60
2179934-17993496.84797.71
3174716-17471694.03894.83
4175243-17524394.32295.12
5176466-17646694.98095.80
6181596-18159697.74198.60
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