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%
110.101687451694321695521696571696711694110.23
210.121696741690881693810.25
单位质量响应值RSD%判断
16773.3716737.250.16数据可信
供试品溶液-25042201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%
5min1185071-18507199.21197.981.0499.2197.981.04
2182512-18251297.83997.84
3182793-18279397.99097.99
4179409-17940996.17696.18
5183871-18387198.56898.57
6183010-18301098.10698.11
10min1191029-191029102.40599.432.07102.5799.602.07
2188871-188871101.248101.41
3185057-18505799.20399.37
4180519-18051996.77196.93
5183704-18370498.47898.64
6183723-18372398.48898.65
15min1189503-189503101.58799.701.86101.92100.031.86
2190660-190660102.207102.54
3185614-18561499.50299.83
4181604-18160497.35297.67
5183981-18398198.62798.96
6184529-18452998.92099.25
20min1188229-188229100.90499.541.78101.41100.041.77
2190555-190555102.151102.65
3185660-18566099.527100.02
4181341-18134197.21197.70
5183669-18366998.45998.95
6184712-18471299.01899.51
30min1187639-187639100.58899.601.79101.26100.261.79
2191103-191103102.444103.12
3185955-18595599.685100.35
4181781-18178197.44798.09
5183205-18320598.21198.87
6185053-18505399.20199.86
45min1187335-187335100.42599.491.82101.27100.311.82
2191114-191114102.450103.29
3185751-18575199.575100.40
4181718-18171897.41398.22
5182853-18285398.02298.84
6184746-18474699.03799.86
极限1186754-186754100.11399.341.89101.12100.331.89
2191256-191256102.527103.54
3185365-18536599.369100.36
4181484-18148497.28898.26
5182410-18241097.78498.77
6184616-18461698.96799.95
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%
110.101682191684531684031684991684851684120.07
210.121693531689571691550.17
单位质量响应值RSD%判断
16674.4616714.920.18数据可信
供试品溶液-25042202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%
5min1180251-18025196.97897.772.9096.9897.772.90
2190467-190467102.474102.47
3178029-17802995.78295.78
4178739-17873996.16496.16
5177111-17711195.28995.29
6185765-18576599.94599.94
10min1189618-189618102.018100.532.35102.18100.692.35
2193469-193469104.089104.26
3182206-18220698.03098.19
4183802-18380298.88899.05
5183494-18349498.72398.88
6188485-188485101.408101.57
15min1191528-191528103.045101.222.25103.38101.552.25
2194368-194368104.573104.92
3183981-18398198.98599.31
4184978-18497899.52199.85
5184835-18483599.44499.77
6189114-189114101.746102.08
20min1192139-192139103.374101.422.11103.88101.922.11
2194169-194169104.466104.98
3185269-18526999.678100.17
4184950-18495099.506100.00
5185320-18532099.705100.19
6189142-189142101.761102.27
30min1192270-192270103.444101.482.13104.12102.142.13
2194256-194256104.513105.21
3185367-18536799.730100.38
4185112-18511299.593100.25
5185205-18520599.643100.30
6189458-189458101.931102.61
45min1192538-192538103.589101.412.14104.44102.252.14
2193918-193918104.331105.20
3185431-18543199.765100.59
4184547-18454799.289100.11
5185415-18541599.756100.58
6189116-189116101.747102.59
极限1192833-192833103.747101.292.16104.77102.292.16
2193339-193339104.020105.06
3185285-18528599.686100.67
4184370-18437099.194100.18
5184884-18488499.471100.46
6188851-188851101.605102.62
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