贝派度酸片项目信息
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BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180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%
110.053022713025473025913026173026723025400.06
210.123026773028473027620.04
单位质量响应值RSD%判断
30103.4829917.190.44数据可信
供试品溶液-2010685批-pH6.6
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min184716-8471628.15025.579.7628.1525.589.76
275655-7565525.13925.14
383784-8378427.84027.84
466995-6699522.26222.26
581185-8118526.97726.98
669445-6944523.07623.08
10min1226530-22653075.27372.532.5175.3272.582.51
2218627-21862772.64772.69
3217406-21740672.24272.29
4209676-20967669.67369.71
5217009-21700972.11072.15
6220477-22047773.26273.30
15min1273038-27303890.72789.820.8590.9089.980.86
2272381-27238190.50990.67
3268261-26826189.14089.31
4267100-26710088.75488.91
5270360-27036089.83890.00
6270650-27065089.93490.09
20min1287782-28778295.62794.840.8295.9595.160.82
2288236-28823695.77896.09
3283272-28327294.12894.44
4282518-28251893.87894.18
5285838-28583894.98195.30
6284874-28487494.66094.97
30min1293932-29393297.67097.400.6898.1597.870.68
2295974-29597498.34998.82
3290558-29055896.54997.02
4291478-29147896.85597.31
5294200-29420097.75998.23
6292624-29262497.23697.70
45min1295308-29530898.12897.850.7398.7798.480.73
2297374-29737498.81499.45
3291390-29139096.82697.46
4292913-29291397.33297.95
5295729-29572998.26798.90
6294103-29410397.72798.36
60min1295302-29530298.12697.820.8398.9398.620.83
2297866-29786698.97899.78
3291192-29119296.76097.55
4292521-29252197.20197.98
5295828-29582898.30099.10
6293676-29367697.58598.38
极限1296270-29627098.44798.110.9299.4299.070.92
2298602-29860299.222100.19
3291530-29153096.87297.83
4293203-29320397.42898.37
5297584-29758498.88499.85
6294339-29433997.80698.76
贝派度酸片项目信息
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BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180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%
110.053029433027743030203027143027743028450.05
210.123032713033743033220.03
单位质量响应值RSD%判断
30133.8329972.530.38数据可信
供试品溶液-2010685批-pH6.6
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min172441-7244124.03724.1112.5224.0424.1112.52
287012-8701228.87228.87
372285-7228523.98523.99
468027-6802722.57222.57
559616-5961619.78119.78
676602-7660225.41825.42
10min1207871-20787168.97569.333.9169.0169.373.91
2221921-22192173.63773.68
3214316-21431671.11371.15
4202916-20291667.33067.37
5199153-19915366.08266.11
6207473-20747368.84268.88
15min1269994-26999489.58887.842.8489.7487.992.84
2270031-27003189.60089.77
3263471-26347187.42387.58
4268736-26873689.17089.32
5265714-26571488.16888.31
6250342-25034283.06783.22
20min1287224-28722495.30594.711.6295.6195.011.61
2284178-28417894.29494.61
3277507-27750792.08192.38
4287965-28796595.55195.85
5284742-28474294.48194.77
6291015-29101596.56396.86
30min1295204-29520497.95397.481.9498.4297.941.93
2291030-29103096.56897.05
3284382-28438294.36294.82
4297390-29739098.67899.14
5293793-29379397.48597.93
6300881-30088199.837100.29
45min1296378-29637898.34297.971.9998.9798.591.98
2292379-29237997.01697.65
3285570-28557094.75695.37
4299578-29957899.404100.03
5295359-29535998.00498.61
6302299-302299100.307100.93
60min1296469-29646998.37397.941.9699.1698.731.95
2292315-29231596.99497.79
3285561-28556194.75395.53
4299165-29916599.267100.06
5295409-29540998.02198.79
6302128-302128100.250101.04
极限1296445-29644598.36597.891.9499.3298.841.93
2292106-29210696.92597.89
3285477-28547794.72595.66
4299629-29962999.421100.37
5295061-29506197.90598.84
6301354-30135499.994100.95
贝派度酸片项目信息
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BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180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%
110.053026733023593025013027613025553025700.06
210.123032483030273031380.06
单位质量响应值RSD%判断
30106.4729954.350.36数据可信
供试品溶液-2010685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%
5min196040-9604031.89232.009.7131.8932.009.70
2102901-10290134.17034.17
3107938-10793835.84235.84
485891-8589128.52128.52
5100532-10053233.38333.38
684834-8483428.17028.17
10min1234852-23485277.98682.103.5278.0482.153.52
2248284-24828482.44782.50
3259725-25972586.24686.31
4241001-24100180.02880.08
5252555-25255583.86583.92
6247015-24701582.02582.07
15min1289346-28934696.08296.891.0796.2697.081.08
2287276-28727695.39495.59
3295519-29551998.13298.34
4292465-29246597.11897.30
5294577-29457797.81998.01
6291429-29142996.77496.96
20min1296386-29638698.42098.661.0198.7699.011.00
2291798-29179896.89697.25
3299564-29956499.47599.84
4298629-29862999.16499.51
5299718-29971899.52699.88
6296509-29650998.46098.81
30min1297409-29740998.75998.970.9799.2799.490.96
2292782-29278297.22397.74
3300048-30004899.636100.17
4299426-29942699.42999.94
5300678-30067899.845100.37
6297941-29794198.93699.44
45min1297145-29714598.67298.890.9799.3499.570.97
2292428-29242897.10597.78
3299934-29993499.598100.30
4299192-29919299.351100.03
5300160-30016099.673100.36
6297891-29789198.91999.59
60min1297206-29720698.69298.801.0099.5399.640.99
2291895-29189596.92897.77
3299447-29944799.436100.30
4298793-29879399.219100.06
5300023-30002399.627100.48
6297755-29775598.87499.71
极限1297916-29791698.92898.780.9099.9399.790.90
2292415-29241597.10198.10
3299921-29992199.593100.62
4297772-29777298.88099.88
5299314-29931499.392100.41
6297563-29756398.81099.81
贝派度酸片项目信息
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BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180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%
110.053032193031743031143030663030433031230.03
210.123022033025163023600.08
单位质量响应值RSD%判断
30161.4929877.470.67数据可信
供试品溶液-2010685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%
5min182765-8276527.49429.9810.9727.4929.9810.97
2103072-10307234.24034.24
396674-9667432.11432.11
476278-7627825.33925.34
595245-9524531.64031.64
687478-8747829.05929.06
10min1246967-24696782.04082.882.3282.0982.932.32
2254344-25434484.49184.55
3258547-25854785.88785.94
4244253-24425381.13981.18
5248520-24852082.55682.61
6244345-24434581.16981.22
15min1287263-28726395.42695.971.0095.6196.161.00
2288913-28891395.97596.17
3292768-29276897.25597.45
4286987-28698795.33595.51
5285580-28558094.86795.06
6291878-29187896.95997.14
20min1291367-29136796.79097.300.8297.1397.650.83
2293403-29340397.46697.82
3295944-29594498.31098.67
4291334-29133496.77997.12
5290016-29001696.34196.69
6295394-29539498.12798.47
30min1291767-29176796.92397.631.0797.4398.141.07
2293508-29350897.50198.02
3296508-29650898.49899.02
4292049-29204997.01697.51
5290724-29072496.57697.09
6298794-29879499.25799.77
45min1291539-29153996.84797.531.1197.5198.201.11
2293445-29344597.48098.16
3296165-29616598.38499.07
4291714-29171496.90597.56
5290084-29008496.36497.03
6298672-29867299.21699.89
60min1291063-29106396.68997.401.0697.5198.241.06
2293100-29310097.36598.21
3295358-29535898.11598.97
4291350-29135096.78497.60
5290089-29008996.36597.20
6298287-29828799.08899.93
极限1290662-29066296.55697.211.0397.5498.211.03
2292988-29298897.32898.34
3295035-29503598.00899.02
4290427-29042796.47797.46
5289551-28955196.18697.18
6297158-29715898.71399.72
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