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%
19.892977662974942976602974832976342976070.05
29.932984312984592984450.01
单位质量响应值RSD%判断
30091.7130054.880.09数据可信
供试品溶液-24081401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%
5min1125497-12549741.61440.615.7241.6140.615.72
2119769-11976939.71439.71
3114562-11456237.98837.99
4127259-12725942.19842.20
5132203-13220343.83743.84
6115507-11550738.30138.30
10min1236073-23607378.27981.893.0778.3581.963.07
2243382-24338280.70380.77
3249928-24992882.87482.94
4243650-24365080.79280.86
5258003-25800385.55185.62
6250730-25073083.14083.20
15min1270638-27063889.74192.732.7689.9492.942.76
2277753-27775392.10092.30
3285224-28522494.57794.78
4273771-27377190.78090.98
5291684-29168496.71996.94
6278887-27888792.47692.68
20min1287325-28732595.27495.971.6395.6296.331.63
2290704-29070496.39596.75
3292853-29285397.10797.47
4282036-28203693.52093.88
5295435-29543597.96398.34
6288139-28813995.54495.90
30min1298248-29824898.89697.951.0699.4098.471.05
2297712-29771298.71899.23
3296095-29609598.18298.70
4291605-29160596.69397.21
5297323-29732398.58999.13
6291389-29138996.62297.14
45min1304423-304423100.94498.261.62101.6298.941.61
2298278-29827898.90699.59
3295964-29596498.13998.82
4292230-29223096.90197.57
5296117-29611798.18998.89
6290975-29097596.48497.16
60min1304866-304866101.09198.371.63101.9399.221.62
2298470-29847098.97099.81
3295688-29568898.04798.90
4292200-29220096.89197.73
5297058-29705898.50199.37
6291702-29170296.72597.56
极限1306184-306184101.52899.631.03102.54100.641.03
2298789-29878999.075100.08
3300382-30038299.604100.62
4297984-29798498.80999.80
5301213-30121399.879100.91
6298145-29814598.86299.86
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%
19.892976822976492976692976882977422976860.02
29.932974852974582974720.01
单位质量响应值RSD%判断
30099.7029956.900.34数据可信
供试品溶液-24081401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%
5min1142417-14241747.29544.425.6547.3044.425.66
2144115-14411547.85947.86
3131655-13165543.72143.72
4127026-12702642.18442.18
5129130-12913042.88342.88
6128134-12813442.55242.55
10min1274804-27480491.25990.851.7791.3490.921.77
2282645-28264593.86393.94
3271192-27119290.06090.13
4272748-27274890.57790.65
5270610-27061089.86789.94
6269385-26938589.46089.53
15min1295424-29542498.10798.530.3098.3498.750.30
2297419-29741998.76999.01
3296138-29613898.34498.57
4296314-29631498.40398.62
5297760-29776098.88399.10
6297091-29709198.66198.88
20min1301383-301383100.08699.350.60100.4899.740.60
2298949-29894999.27899.68
3296507-29650798.46798.85
4298216-29821699.03499.42
5300830-30083099.902100.29
6299105-29910599.32999.71
30min1302950-302950100.60699.610.69101.17100.170.69
2299307-29930799.39699.96
3297002-29700298.63199.18
4299187-29918799.35799.91
5301413-301413100.096100.65
6299896-29989699.592100.14
45min1303675-303675100.84799.640.69101.58100.360.69
2299736-29973699.539100.27
3298340-29834099.07599.79
4298721-29872199.20299.92
5301135-301135100.004100.72
6298584-29858499.15699.87
60min1303321-303321100.72999.480.73101.63100.370.73
2299327-29932799.403100.30
3298026-29802698.97199.85
4298452-29845299.11399.99
5300814-30081499.897100.78
6297438-29743898.77699.66
极限1306665-306665101.840100.210.88102.90101.260.87
2301661-301661100.178101.24
3299735-29973599.539100.58
4299666-29966699.516100.56
5302416-302416100.429101.48
6300481-30048199.786100.83
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