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%
110.26 3067003063723068213067223066353066500.06
210.253069643063843066740.14
单位质量响应值RSD%判断
29887.9129919.410.08数据可信
供试品溶液-2024090421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%
5min1102025-10202534.02243.6212.5234.0243.6212.53
2148832-14883249.63149.63
3132221-13222144.09244.09
4136538-13653845.53145.53
5124085-12408541.37941.38
6141187-14118747.08247.08
10min1208265-20826569.45079.376.2669.5179.446.26
2243241-24324181.11481.20
3244635-24463581.57981.65
4249080-24908083.06183.14
5243208-24320881.10381.17
6239663-23966379.92180.00
15min1245638-24563881.91389.844.4782.0990.044.48
2271585-27158590.56690.78
3274295-27429591.46991.68
4279932-27993293.34993.56
5273381-27338191.16591.37
6271605-27160590.57290.78
20min1265627-26562788.57994.263.1888.8994.623.20
2282765-28276594.29494.66
3286169-28616995.42995.79
4292368-29236897.49697.87
5284325-28432594.81495.17
6284792-28479294.97095.33
30min1283899-28389994.67297.621.9495.1398.131.95
2290726-29072696.94997.47
3293695-29369597.93998.46
4301288-301288100.471101.00
5292196-29219697.43997.95
6294663-29466398.26298.78
45min1294883-29488398.33599.281.3398.9599.951.34
2294010-29401098.04498.73
3297671-29767199.26599.95
4304760-304760101.629102.33
5295667-29566798.59699.27
6299266-29926699.797100.48
60min1298715-29871599.613100.021.26100.39100.861.26
2295776-29577698.63399.48
3299724-29972499.949100.80
4306698-306698102.275103.14
5297761-29776199.295100.14
6301027-301027100.384101.23
极限1301856-301856100.660101.010.71101.60102.020.72
2301092-301092100.405101.42
3302413-302413100.846101.86
4307098-307098102.408103.45
5302653-302653100.926101.93
6302358-302358100.828101.85
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%
110.26 3063803066313068383065283067503066250.06
210.253068583067603068090.03
单位质量响应值RSD%判断
29885.4829932.590.12数据可信
供试品溶液-2024090421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%
5min1176007-17600758.68352.4711.9658.6852.4711.95
2127491-12749142.50742.51
3149626-14962649.88749.89
4173575-17357557.87257.87
5168868-16886856.30256.30
6148725-14872549.58749.59
10min1266421-26642188.82888.880.4388.9388.970.44
2266200-26620088.75488.82
3267279-26727989.11489.20
4267823-26782389.29589.39
5267183-26718389.08289.18
6264625-26462588.22988.31
15min1284289-28428994.78595.580.6695.0395.820.65
2289862-28986296.64396.86
3287307-28730795.79196.02
4286770-28677095.61295.86
5286030-28603095.36695.61
6285769-28576995.27995.51
20min1289516-28951696.52897.650.8196.9398.050.80
2296745-29674598.93899.32
3292509-29250997.52697.92
4292035-29203597.36897.77
5292772-29277297.61398.01
6293799-29379997.95698.34
30min1292718-29271897.59599.030.9298.1699.590.91
2299735-29973599.935100.48
3296563-29656398.87799.43
4295201-29520198.42398.99
5299226-29922699.765100.33
6298667-29866799.579100.13
45min1294442-29444298.17099.550.8798.90100.280.85
2301604-301604100.558101.27
3298936-29893699.669100.39
4296864-29686498.97899.71
5299373-29937399.814100.54
6300347-300347100.139100.86
60min1294525-29452598.19899.420.8599.09100.300.83
2301385-301385100.485101.36
3297860-29786099.310100.19
4296197-29619798.75599.65
5299740-29974099.937100.83
6299375-29937599.815100.70
极限1299578-29957899.883100.270.52100.94101.320.51
2303631-303631101.234102.28
3301270-301270100.447101.50
4300021-300021100.030101.09
5300263-300263100.111101.17
6299691-29969199.920100.97
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