贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.053060543059963055943059283061403059420.07
210.013061793062363062080.02
单位质量响应值RSD%判断
30441.9930590.210.35数据可信
供试品溶液-24062501批-pH4.5(内含0.45%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min144322-4432228.96724.6415.6928.9724.6415.69
246076-4607630.11330.11
334687-3468722.67022.67
435010-3501022.88122.88
532180-3218021.03221.03
633947-3394722.18622.19
10min190491-9049159.14157.992.9559.4658.262.99
291185-9118559.59559.93
390879-9087959.39559.65
484940-8494055.51355.77
586267-8626756.38156.61
688628-8862857.92458.17
15min1110721-11072172.36371.062.2073.3471.972.24
2110895-11089572.47773.47
3110935-11093572.50373.41
4106176-10617669.39270.26
5106119-10611969.35570.22
6107474-10747470.24171.13
20min1121274-12127479.26078.052.0481.0479.762.08
2122981-12298180.37682.18
3119733-11973378.25379.97
4117446-11744676.75878.40
5116453-11645376.10977.74
6118663-11866377.55379.22
30min1133152-13315287.02385.981.2389.6988.561.26
2131757-13175786.11188.81
3133040-13304086.95089.54
4128715-12871584.12386.62
5131253-13125385.78288.26
6131445-13144585.90788.44
45min1138957-13895790.81791.131.7494.4594.661.74
2142591-14259193.19296.84
3140840-14084092.04795.60
4140312-14031291.70295.13
5135500-13550088.55791.99
6138454-13845490.48893.97
60min1139186-13918690.96692.111.6695.6196.661.66
2144775-14477594.61999.31
3142702-14270293.26497.84
4139184-13918490.96595.41
5139158-13915890.94895.36
6140622-14062291.90596.40
极限1143363-14336393.69693.791.8599.3599.361.76
2144481-14448194.427100.17
3140782-14078292.01097.62
4146781-14678195.930101.39
5140077-14007791.54996.97
6145540-14554095.119100.63
贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.053063243062513062813062243064333063030.03
210.013060973061413061190.02
单位质量响应值RSD%判断
30477.9130581.320.24数据可信
供试品溶液-24062401SP批-pH4.5(内含0.45%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min141463-4146327.08729.128.3727.0929.128.37
250282-5028232.84832.85
341614-4161427.18527.19
445251-4525129.56129.56
541421-4142127.05927.06
647431-4743130.98530.99
10min188694-8869457.94158.952.3358.2459.272.36
291463-9146359.75060.11
389518-8951858.47958.78
492764-9276460.60060.93
587244-8724456.99457.29
691764-9176459.94760.29
15min1108228-10822870.70270.561.4971.6571.541.46
2105806-10580669.12070.15
3107553-10755370.26171.21
4110769-11076972.36273.36
5108075-10807570.60271.54
6107664-10766470.33471.34
20min1116963-11696376.40877.612.2378.1479.382.22
2118772-11877277.59079.39
3114820-11482075.00876.74
4120873-12087378.96380.77
5119274-11927477.91879.64
6122156-12215679.80181.59
30min1128503-12850383.94784.401.4386.5387.031.42
2128530-12853083.96586.62
3126558-12655882.67685.24
4131866-13186686.14488.83
5130584-13058485.30787.89
6129151-12915184.37087.05
45min1138581-13858190.53189.621.8194.0493.181.73
2135625-13562588.60092.19
3134394-13439487.79591.28
4136702-13670289.30392.94
5141382-14138292.36195.89
6136434-13643489.12892.74
60min1140240-14024091.61490.411.6196.1394.971.56
2136586-13658689.22793.80
3135326-13532688.40492.86
4139411-13941191.07395.71
5141084-14108492.16696.72
6137738-13773889.98094.59
极限1141234-14123492.26492.351.2697.8097.911.20
2142269-14226992.94098.51
3140116-14011691.53396.98
4141294-14129492.30397.95
5144185-14418594.19299.77
6139064-13906490.84696.45
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