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)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%
19.863190173193803189453186923184163188900.12
210.023180803184593182700.09
单位质量响应值RSD%判断
32341.7831763.471.28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%
5min162011-6201117.34420.1823.9617.3420.1823.97
272641-7264120.31720.32
362802-6280217.56517.56
466387-6638718.56818.57
5106467-10646729.77829.78
662563-6256317.49817.50
10min1111066-11106631.06432.6610.0031.0932.6910.01
2120939-12093933.82533.86
3111398-11139831.15731.19
4109981-10998130.76030.79
5138807-13880738.82338.87
6108373-10837330.31130.34
15min1136514-13651438.18139.636.5138.2639.726.52
2145731-14573140.75940.85
3139213-13921338.93639.02
4136516-13651638.18238.26
5158526-15852644.33844.45
6133650-13365037.38037.46
20min1155619-15561943.52544.844.9643.6744.994.99
2164602-16460246.03746.20
3158256-15825644.26244.41
4155828-15582843.58343.73
5174437-17443748.78848.98
6153118-15311842.82542.97
30min1182908-18290851.15752.053.3151.3752.283.34
2189755-18975553.07253.31
3184719-18471951.66451.88
4182812-18281251.13051.35
5196721-19672155.02055.29
6179755-17975550.27550.49
45min1208127-20812758.21159.162.5458.5159.482.57
2215194-21519460.18760.51
3210248-21024858.80459.11
4209799-20979958.67858.98
5220347-22034761.62861.99
6205482-20548257.47157.77
60min1226607-22660763.37963.871.7363.7864.291.75
2230538-23053864.47964.90
3227059-22705963.50663.91
4226945-22694563.47463.88
5235155-23515565.77066.23
6223914-22391462.62663.02
极限1243029-24302967.97268.611.3768.4869.141.41
2247670-24767069.27069.80
3244144-24414468.28468.79
4244747-24474768.45368.96
5250791-25079170.14370.72
6241568-24156867.56468.06
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)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%
19.863184223182083181553180023177813181140.08
210.023186253181353183800.11
单位质量响应值RSD%判断
32263.0831774.451.08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%
5min1133383-13338337.34437.008.9137.3437.008.91
2134744-13474437.72537.73
3138162-13816238.68238.68
4119590-11959033.48233.48
5149088-14908841.74141.74
6117918-11791833.01433.01
10min1188384-18838452.74352.354.3352.8152.414.33
2186760-18676052.28952.35
3191361-19136153.57753.64
4179705-17970550.31350.37
5199029-19902955.72455.79
6176613-17661349.44849.50
15min1212090-21209059.38059.033.1459.5359.183.15
2211718-21171859.27659.43
3214097-21409759.94260.10
4205801-20580157.62057.76
5220143-22014361.63561.80
6201160-20116056.32056.46
20min1226863-22686363.51663.242.4263.7763.492.43
2227367-22736763.65863.91
3228451-22845163.96164.21
4221530-22153062.02362.26
5233318-23331865.32465.59
6217818-21781860.98461.22
30min1245626-24562668.77068.421.7569.1268.771.76
2245085-24508568.61868.97
3245723-24572368.79769.16
4243835-24383568.26868.61
5249429-24942969.83470.21
6236580-23658066.23766.57
45min1260143-26014372.83472.501.4273.3072.961.43
2261040-26104073.08573.55
3260351-26035172.89273.37
4257468-25746872.08572.54
5262393-26239373.46473.95
6252239-25223970.62171.06
60min1268681-26868175.22575.021.2975.8275.611.30
2270226-27022675.65776.25
3269519-26951975.45976.06
4266627-26662774.64975.22
5271008-27100875.87676.49
6261658-26165873.25873.82
极限1276598-27659877.44177.071.1078.1677.781.12
2276677-27667777.46378.18
3276184-27618477.32578.05
4274510-27451076.85777.55
5278013-27801377.83778.58
6269563-26956375.47176.15
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)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%
19.863204463204673204283202713202143203650.04
210.023202963200203201580.07
单位质量响应值RSD%判断
32491.3831951.901.19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%
5min188378-8837824.58826.315.3324.5926.315.32
297621-9762127.16027.16
398641-9864127.44427.44
493640-9364026.05226.05
5100076-10007627.84327.84
688980-8898024.75624.76
10min1131494-13149436.58437.583.1436.6237.623.14
2140232-14023239.01539.06
3137159-13715938.16038.21
4133661-13366137.18737.23
5138454-13845438.52038.57
6129396-12939636.00036.04
15min1153702-15370242.76343.812.3042.8643.922.31
2161955-16195545.05945.17
3158944-15894444.22144.33
4156760-15676043.61343.72
5160457-16045744.64244.75
6153049-15304942.58142.68
20min1170218-17021847.35848.191.8347.5348.371.84
2177210-17721049.30349.49
3174768-17476848.62448.81
4172345-17234547.94948.13
5175568-17556848.84649.03
6169183-16918347.07047.24
30min1191649-19164953.32054.161.3053.5754.421.31
2197689-19768955.00155.27
3196536-19653654.68054.94
4194479-19447954.10754.37
5195921-19592154.50954.78
6191766-19176653.35353.60
45min1213028-21302859.26859.940.9759.6160.290.97
2218299-21829960.73561.09
3217176-21717660.42260.78
4215376-21537659.92160.27
5215410-21541059.93160.29
6213338-21333859.35459.69
60min1226264-22626462.95163.560.8863.3964.010.89
2231399-23139964.37964.84
3230099-23009964.01864.47
4228398-22839863.54463.99
5228038-22803863.44463.90
6226546-22654663.02963.47
极限1240842-24084267.00667.570.6967.5568.120.69
2245324-24532468.25368.82
3244349-24434967.98268.54
4242464-24246467.45868.01
5242276-24227667.40567.97
6241886-24188667.29767.84
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