利伐沙班口崩片项目信息
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)15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%
115.024833894835264839054837514841624837470.07
215.044823684820074821880.06
单位质量响应值RSD%判断
32206.8632060.370.33数据可信
供试品溶液-JPS8079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%
5min165135-6513512.11310.858.6712.1110.858.66
255649-5564910.34910.35
351089-510899.5019.50
455900-5590010.39610.40
561402-6140211.41911.42
660888-6088811.32411.32
10min194937-9493717.65616.695.6117.6816.715.64
286271-8627116.04416.06
381617-8161715.17915.19
490434-9043416.81816.84
594149-9414917.50917.53
691087-9108716.94016.96
15min1115350-11535021.45220.564.8721.5020.604.87
2106455-10645519.79819.84
3101696-10169618.91318.95
4112900-11290020.99721.04
5114886-11488621.36621.41
6111930-11193020.81620.86
20min1131542-13154224.46323.484.1524.5523.564.16
2121771-12177122.64622.72
3118174-11817421.97722.05
4129398-12939824.06524.15
5129934-12993424.16424.25
6126793-12679323.58023.66
30min1154745-15474528.77927.913.5828.9028.023.59
2146012-14601227.15427.27
3141443-14144326.30526.41
4154791-15479128.78728.91
5153058-15305828.46528.59
6150269-15026927.94628.07
45min1181219-18121933.70232.852.8133.8833.022.82
2173210-17321032.21332.37
3168980-16898031.42631.58
4181665-18166533.78533.95
5178944-17894433.27933.45
6175867-17586732.70732.87
60min1201134-20113437.40636.652.5137.6436.872.52
2193231-19323135.93636.15
3190113-19011335.35635.56
4203309-20330937.81038.04
5198562-19856236.92737.15
6196067-19606736.46336.69
极限1244478-24447845.46744.631.3145.7644.911.32
2237335-23733544.13844.41
3236911-23691144.05944.32
4243031-24303145.19845.49
5239584-23958444.55744.85
6238377-23837744.33244.61
利伐沙班口崩片项目信息
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)15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%
115.024816194820444828934828014829234824560.13
215.044840344837784839060.04
单位质量响应值RSD%判断
32120.9132174.600.12数据可信
供试品溶液-JPS8079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%
5min193820-9382017.44013.3519.6717.4413.3519.68
268734-6873412.77712.78
355269-5526910.27410.27
464210-6421011.93611.94
565579-6557912.19112.19
683393-8339315.50215.50
10min1114120-11412021.21418.2311.0121.2418.2511.03
295412-9541217.73617.76
384389-8438915.68715.70
491796-9179617.06417.08
595475-9547517.74817.77
6107290-10729019.94419.97
15min1127739-12773923.74621.437.1623.8121.497.18
2113129-11312921.03021.08
3104243-10424319.37819.42
4111651-11165120.75520.80
5113320-11332021.06521.12
6121742-12174222.63122.69
20min1139309-13930925.89624.005.7426.0024.085.77
2127588-12758823.71823.80
3118125-11812521.95822.03
4125996-12599623.42223.50
5128349-12834923.85923.94
6135190-13519025.13125.23
30min1159161-15916129.58728.183.8329.7328.303.85
2151147-15114728.09728.22
3142358-14235826.46326.58
4149819-14981927.85027.97
5150733-15073328.02028.14
6156220-15622029.04029.18
45min1181321-18132133.70632.912.1933.9033.082.22
2178092-17809233.10633.28
3170228-17022831.64431.80
4176002-17600232.71732.89
5176590-17659032.82733.00
6179866-17986633.43633.62
60min1199150-19915037.02036.551.4837.2736.781.51
2197728-19772836.75636.98
3191262-19126235.55435.76
4195826-19582636.40236.63
5196815-19681536.58636.81
6198892-19889236.97237.22
极限1238865-23886544.40344.451.1544.7244.741.16
2242530-24253045.08445.37
3235422-23542243.76344.03
4240084-24008444.63044.91
5236567-23656743.97644.26
6241336-24133644.86245.17
利伐沙班口崩片项目信息
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)15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%
115.024818254820084818574825874803394817230.18
215.044817454839144828300.32
单位质量响应值RSD%判断
32072.1032103.060.07数据可信
供试品溶液-JPS8079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%
5min1185378-18537834.52533.364.4534.5233.364.45
2173587-17358732.32932.33
3192333-19233335.82035.82
4176521-17652132.87532.88
5172322-17232232.09332.09
6174690-17469032.53432.53
10min1226785-22678542.23741.742.3442.2941.802.34
2222893-22289341.51241.57
3232707-23270743.33943.40
4224301-22430141.77441.83
5220061-22006140.98441.04
6217964-21796440.59440.65
15min1246730-24673045.95145.601.8746.0845.721.88
2244204-24420445.48145.60
3251984-25198446.93047.06
4245495-24549545.72145.85
5242299-24229945.12645.25
6238302-23830244.38144.50
20min1259649-25964948.35748.081.3748.5648.281.38
2257664-25766447.98748.19
3262914-26291448.96549.18
4260128-26012848.44648.65
5255446-25544647.57447.77
6253050-25305047.12847.32
30min1272890-27289050.82350.741.2151.1151.021.21
2272462-27246250.74351.02
3277217-27721751.62951.92
4273946-27394651.02051.30
5270608-27060850.39850.67
6267447-26744749.80950.08
45min1285323-28532353.13952.951.0353.5153.321.03
2285879-28587953.24253.61
3287906-28790653.62054.00
4285116-28511653.10053.47
5281557-28155752.43752.80
6280123-28012352.17052.53
60min1293756-29375654.70954.270.7855.1754.720.78
2291015-29101554.19954.65
3293908-29390854.73855.20
4291845-29184554.35354.81
5289249-28924953.87054.32
6288499-28849953.73054.17
极限1295346-29534655.00555.080.5055.5555.620.51
2296727-29672755.26355.81
3296864-29686455.28855.85
4296754-29675455.26855.81
5295669-29566955.06555.60
6293010-29301054.57055.10
利伐沙班口崩片项目信息
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)15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%
115.024847974838314833054832814830124836450.15
215.044834974839534837250.07
单位质量响应值RSD%判断
32200.0732162.570.09数据可信
供试品溶液-JPS8079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%
5min1187438-18743834.80733.733.6434.8133.733.64
2173380-17338032.19632.20
3191157-19115735.49735.50
4177212-17721232.90832.91
5181454-18145433.69633.70
6179109-17910933.26033.26
10min1228723-22872342.47341.822.0642.5341.872.06
2220408-22040840.92940.98
3232376-23237643.15243.21
4221129-22112941.06341.12
5225102-22510241.80141.86
6223425-22342541.49041.54
15min1251414-25141446.68745.741.6346.8245.861.63
2241304-24130444.81044.93
3250012-25001246.42746.56
4242566-24256645.04445.17
5245540-24554045.59645.72
6246966-24696645.86145.99
20min1259086-25908648.11247.941.0948.3248.141.09
2255157-25515747.38247.58
3262637-26263748.77148.98
4255802-25580247.50247.70
5259379-25937948.16648.37
6256765-25676547.68147.88
30min1274558-27455850.98550.591.1051.2750.871.10
2268808-26880849.91750.19
3277013-27701351.44151.73
4270315-27031550.19750.47
5272595-27259550.62050.90
6271382-27138250.39550.68
45min1284945-28494552.91452.740.7653.2953.100.76
2281758-28175852.32252.68
3287334-28733453.35753.73
4283018-28301852.55652.92
5284959-28495952.91653.28
6282012-28201252.36952.73
60min1291235-29123554.08253.940.5054.5454.400.51
2289103-28910353.68654.13
3292954-29295454.40154.87
4289553-28955353.76954.22
5289488-28948853.75754.21
6290607-29060753.96554.42
极限1296005-29600554.96754.710.6355.5255.260.63
2292226-29222654.26654.80
3296861-29686155.12655.68
4293151-29315154.43854.98
5295732-29573254.91755.46
6293758-29375854.55055.09
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