利伐沙班片项目信息
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
19.863153053156363155823162273155073156510.11
210.023154433161843158140.17
单位质量响应值RSD%判断
32013.2931518.361.11数据可信
供试品溶液-2批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min158483-5848316.50417.3622.1716.5017.3622.17
288163-8816324.88024.88
349468-4946813.96013.96
460553-6055317.08817.09
554172-5417215.28815.29
658296-5829616.45216.45
10min199142-9914227.97928.638.1528.0128.668.16
2117955-11795533.28833.33
396337-9633727.18727.21
4100178-10017828.27128.30
595967-9596727.08327.11
699071-9907127.95927.99
15min1122550-12255034.58435.124.6134.6635.194.62
2135921-13592138.35838.45
3122201-12220134.48634.55
4122201-12220134.48634.56
5120202-12020233.92233.99
6123599-12359934.88134.95
20min1140083-14008339.53239.993.3139.6640.123.33
2150773-15077342.54942.71
3139570-13957039.38839.51
4140069-14006939.52839.66
5137544-13754438.81638.94
6142091-14209140.09940.23
30min1165838-16583846.80146.991.9747.0047.191.99
2172416-17241648.65748.89
3166643-16664347.02847.22
4163774-16377446.21846.42
5163277-16327746.07846.27
6167097-16709747.15647.35
45min1190365-19036553.72253.921.3354.0054.201.35
2195268-19526855.10655.42
3190950-19095053.88754.16
4189032-18903253.34653.62
5188301-18830153.14053.41
6192553-19255354.34054.62
60min1207816-20781658.64758.631.0159.0159.001.02
2210927-21092759.52559.93
3207459-20745958.54658.91
4205551-20555158.00858.37
5205650-20565058.03658.39
6209232-20923259.04759.41
极限1227095-22709564.08863.930.7864.5564.400.79
2228874-22887464.59065.09
3226622-22662263.95464.41
4224393-22439363.32563.79
5224581-22458163.37863.83
6227641-22764164.24264.71
利伐沙班片项目信息
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
19.863157453164833162953160193163173161720.10
210.023162713159803161260.07
单位质量响应值RSD%判断
32066.1331549.501.15数据可信
供试品溶液-2批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1126629-12662935.68935.174.9135.6935.174.90
2115164-11516432.45732.46
3129383-12938336.46536.46
4119349-11934933.63733.64
5130348-13034836.73736.74
6127864-12786436.03736.04
10min1177562-17756250.04350.121.8750.1050.181.88
2173009-17300948.76048.81
3181312-18131251.10051.16
4174892-17489249.29149.35
5180307-18030750.81750.88
6180023-18002350.73750.80
15min1200428-20042856.48856.731.0356.6356.871.03
2197935-19793555.78555.92
3203738-20373857.42157.57
4200678-20067856.55856.70
5202556-20255657.08857.23
6202414-20241457.04857.19
20min1214729-21472960.51860.870.7360.7661.110.73
2213795-21379560.25560.48
3217447-21744761.28461.53
4215552-21555260.75060.98
5216705-21670561.07561.32
6217685-21768561.35161.59
30min1230635-23063565.00165.510.6065.3465.850.60
2230860-23086065.06565.39
3234072-23407265.97066.31
4232811-23281165.61565.95
5232907-23290765.64265.98
6233354-23335465.76866.11
45min1245348-24534869.14869.520.4469.5969.970.44
2245562-24556269.20869.65
3247994-24799469.89470.35
4247259-24725969.68770.13
5247389-24738969.72370.18
6246431-24643169.45369.90
60min1253988-25398871.58371.820.3072.1472.380.30
2254127-25412771.62272.17
3255869-25586972.11372.68
4255395-25539571.98072.54
5255162-25516271.91472.48
6254472-25447271.71972.29
极限1262217-26221773.90273.670.2774.5874.360.27
2260599-26059973.44674.12
3262017-26201773.84674.54
4261804-26180473.78674.47
5261121-26112173.59374.28
6260688-26068873.47174.16
利伐沙班片项目信息
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
19.863162743170623169593169823171043168760.11
210.023168633165393167010.08
单位质量响应值RSD%判断
32137.5331606.891.18数据可信
供试品溶液-2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%
5min187849-8784924.70925.933.9724.7125.933.96
294306-9430626.52526.53
387124-8712424.50524.51
494728-9472826.64426.64
594694-9469426.63426.63
694448-9444826.56526.57
10min1125951-12595135.42636.372.3535.4736.422.35
2129884-12988436.53236.58
3125501-12550135.29935.34
4129937-12993736.54736.59
5131623-13162337.02137.07
6133048-13304837.42237.47
15min1146484-14648441.20142.302.1141.3042.402.12
2153037-15303743.04443.15
3146874-14687441.31141.41
4149848-14984842.14742.25
5152294-15229442.83542.94
6153808-15380843.26143.37
20min1162044-16204445.57846.421.9345.7546.601.94
2165646-16564646.59146.77
3161255-16125545.35645.52
4164120-16412046.16246.34
5167813-16781347.20047.38
6169328-16932847.62647.81
30min1181488-18148851.04751.891.7151.2952.141.71
2185863-18586352.27752.53
3180911-18091150.88451.13
4182870-18287051.43551.69
5187828-18782852.83053.09
6187950-18795052.86453.12
45min1201839-20183956.77157.361.2857.1057.701.28
2204448-20444857.50557.85
3201121-20112156.56956.90
4202295-20229556.89957.24
5207271-20727158.29958.64
6206662-20666258.12758.47
60min1214810-21481060.41961.121.4460.8461.561.45
2219491-21949161.73662.17
3214265-21426560.26660.69
4214488-21448860.32960.76
5219607-21960761.76862.21
6221228-22122862.22462.67
极限1230402-23040264.80565.050.7165.3365.590.72
2232228-23222865.31865.86
3230243-23024364.76065.28
4229110-22911064.44164.97
5233502-23350265.67766.22
6232246-23224665.32365.87
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