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%
19.983205363204853208193202943199473204160.11
29.913209893213493211690.08
单位质量响应值RSD%判断
32105.8132408.580.67数据可信
供试品溶液-JPS7638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%
5min121141-211415.8756.405.595.886.405.56
222190-221906.1676.17
324484-244846.8046.80
424063-240636.6876.69
522550-225506.2676.27
623812-238126.6176.62
10min144052-4405212.24212.572.5612.2512.582.57
244403-4440312.33912.35
347340-4734013.15613.17
444927-4492712.48512.50
545463-4546312.63412.64
645197-4519712.56012.57
15min158236-5823616.18416.653.0216.2116.683.04
258341-5834116.21316.24
363236-6323617.57317.61
459834-5983416.62816.66
560069-6006916.69316.72
659856-5985616.63416.67
20min169933-6993319.43420.395.1819.4920.455.18
270447-7044719.57719.63
380255-8025522.30322.37
474678-7467820.75320.81
571800-7180019.95320.01
673139-7313920.32520.38
30min188608-8860824.62425.604.1324.7125.694.12
289205-8920524.79024.88
399046-9904627.52527.62
493241-9324125.91126.01
590759-9075925.22225.31
691798-9179825.51025.60
45min1112114-11211431.15631.762.0931.2931.902.10
2112975-11297531.39531.53
3118683-11868332.98233.13
4112773-11277331.33931.48
5114200-11420031.73631.87
6114919-11491931.93632.07
60min1131171-13117136.45237.262.1136.6337.442.12
2131153-13115336.44736.63
3137964-13796438.34038.54
4133139-13313936.99937.19
5136667-13666737.97938.17
6134305-13430537.32337.51
极限1170167-17016747.28948.361.9047.5348.611.90
2171260-17126047.59347.84
3178797-17879749.68749.95
4175324-17532448.72248.97
5172398-17239847.90948.16
6176210-17621048.96849.22
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%
19.983209023209723199973203223202293204840.14
29.913211583199473205520.27
单位质量响应值RSD%判断
32112.6332346.320.52数据可信
供试品溶液-JPS7638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%
5min1120833-12083333.60833.784.2733.6133.784.28
2118766-11876633.03333.03
3112754-11275431.36131.36
4125656-12565634.94934.95
5124169-12416934.53634.54
6126555-12655535.19935.20
10min1166423-16642346.28847.012.4646.3447.062.47
2166126-16612646.20546.26
3164232-16423245.67945.73
4174553-17455348.54948.61
5173204-17320448.17448.23
6169540-16954047.15547.21
15min1186754-18675451.94352.732.0852.0852.872.09
2187933-18793352.27152.40
3184478-18447851.31051.44
4194174-19417454.00654.15
5193997-19399753.95754.10
6190155-19015552.88953.03
20min1200225-20022555.68957.091.9955.9157.311.98
2201212-20121255.96456.18
3209518-20951858.27458.49
4208769-20876958.06658.29
5208116-20811657.88458.11
6203654-20365456.64356.87
30min1218045-21804560.64661.621.6060.9661.941.60
2220339-22033961.28461.60
3218243-21824360.70161.01
4225852-22585262.81763.14
5225885-22588562.82663.15
6220953-22095361.45561.77
45min1234277-23427765.16066.421.3665.5766.841.36
2236057-23605765.65666.07
3241355-24135567.12967.54
4241937-24193767.29167.72
5241484-24148467.16567.59
6237747-23774766.12666.55
60min1245311-24531168.22969.511.8068.7570.041.79
2256946-25694671.46571.99
3246014-24601468.42568.95
4251945-25194570.07570.62
5251815-25181570.03870.58
6247359-24735968.79969.33
极限1256134-25613471.24071.631.0071.8872.281.01
2255982-25598271.19771.84
3255144-25514470.96471.60
4259486-25948672.17272.83
5261813-26181372.81973.48
6256634-25663471.37972.03
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%
19.983196583210563197703200353203483201730.18
29.913198453188703193580.22
单位质量响应值RSD%判断
32081.4632225.830.32数据可信
供试品溶液-JPS7638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%
5min129221-292218.1468.062.358.158.062.34
228005-280057.8077.81
329059-290598.1018.10
429960-299608.3528.35
528639-286397.9847.98
628486-284867.9427.94
10min161722-6172217.20716.833.7017.2216.843.70
258819-5881916.39816.41
362283-6228317.36417.38
458521-5852116.31516.33
563040-6304017.57517.59
657842-5784216.12616.14
15min181066-8106622.60022.273.5522.6422.323.53
279076-7907622.04522.09
384553-8455323.57223.61
476547-7654721.34021.38
577707-7770721.66421.71
680409-8040922.41722.46
20min196962-9696227.03226.362.0027.1126.441.99
294354-9435426.30526.38
396571-9657126.92327.00
492337-9233725.74225.82
592884-9288425.89525.97
694247-9424726.27526.35
30min1117515-11751532.76232.351.4832.8932.471.49
2115212-11521232.12032.24
3118321-11832132.98633.11
4113473-11347331.63531.75
5115769-11576932.27532.40
6115929-11592932.32032.44
45min1141773-14177339.52539.450.9939.7039.630.99
2139184-13918438.80338.98
3142810-14281039.81440.00
4141933-14193339.56939.74
5140589-14058939.19539.37
6142772-14277239.80339.98
60min1163552-16355245.59644.571.4745.8444.811.47
2158554-15855444.20344.44
3160464-16046444.73544.98
4156455-15645543.61843.86
5159941-15994144.59044.83
6160278-16027844.68444.93
极限1200135-20013555.79555.720.9056.1256.040.90
2197537-19753755.07155.38
3201237-20123756.10256.42
4198060-19806055.21755.53
5200141-20014155.79756.11
6202158-20215856.35956.68
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%
19.983208943197873203633202033193003201090.19
29.913201853198433200140.08
单位质量响应值RSD%判断
32075.0532292.030.48数据可信
供试品溶液-JPS7638批-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1280990-28099078.26479.111.5078.2679.111.50
2282000-28200078.54678.55
3281103-28110378.29678.30
4281236-28123678.33378.33
5288165-28816580.26380.26
6290607-29060780.94380.94
10min1328775-32877591.57491.801.1691.7091.931.16
2330098-33009891.94292.07
3323380-32338090.07190.20
4331012-33101292.19792.33
5329089-32908991.66191.80
6335171-33517193.35593.49
15min1343596-34359695.70296.201.3095.9996.491.30
2345851-34585196.33096.61
3339180-33918094.47294.75
4346808-34680896.59796.88
5344201-34420195.87196.16
6352770-35277098.25798.55
20min1347926-34792696.90897.851.2797.3598.301.27
2351334-35133497.85798.30
3345083-34508396.11696.55
4352891-35289198.29198.74
5352765-35276598.25698.70
6357904-35790499.687100.14
30min1355245-35524598.94799.902.1799.55100.512.16
2356425-35642599.27599.88
3349962-34996297.47598.07
4372379-372379103.719104.33
5355829-35582999.10999.72
6362143-362143100.868101.49
45min1355530-35553099.026101.181.6999.79101.961.69
2358880-35888099.959100.73
3361435-361435100.671101.43
4372436-372436103.735104.52
5363557-363557101.262102.04
6367830-367830102.452103.24
60min1356931-35693199.41699.911.41100.35100.861.41
2360619-360619100.443101.38
3350928-35092897.74498.67
4361225-361225100.612101.57
5356817-35681799.384100.33
6365731-365731101.867102.83
极限1357470-35747099.566100.081.29100.67101.191.29
2360093-360093100.297101.40
3351949-35194998.02999.12
4361070-361070100.569101.69
5359214-359214100.052101.16
6366028-366028101.950103.08
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