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%
1 9.983185323197093196043195903193523193570.16
2 9.913188923187583188250.03
单位质量响应值RSD%判断
31999.7032172.050.38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%
5min124045-240456.7186.596.246.726.596.27
220848-208485.8245.82
324617-246176.8776.88
424017-240176.7106.71
524843-248436.9416.94
623083-230836.4496.45
10min145825-4582512.80212.412.4312.8112.422.42
243314-4331412.10112.11
345017-4501712.57712.59
443729-4372912.21712.23
543380-4338012.11912.13
645248-4524812.64112.65
15min161636-6163617.22016.522.2717.2516.552.27
257926-5792616.18316.21
359511-5951116.62616.66
458693-5869316.39716.43
558564-5856416.36116.39
658385-5838516.31116.34
20min174007-7400720.67620.053.0120.7420.112.99
269979-6997919.55119.61
371639-7163920.01420.07
470225-7022519.61919.68
569967-6996719.54719.61
674825-7482520.90420.96
30min194706-9470626.45925.552.7226.5525.642.71
293563-9356326.13926.23
392376-9237625.80825.90
490260-9026025.21725.31
588992-8899224.86224.95
688735-8873524.79124.88
45min1117679-11767932.87731.632.0333.0231.762.03
2111498-11149831.15031.28
3113500-11350031.70931.85
4112208-11220831.34831.48
5112147-11214731.33131.46
6112186-11218631.34231.48
60min1137909-13790938.52936.892.3038.7237.072.30
2130389-13038936.42836.61
3132733-13273337.08337.27
4130639-13063936.49836.68
5130136-13013636.35736.54
6130367-13036736.42236.61
极限1178767-17876749.94348.191.8850.2048.441.88
2171071-17107147.79348.04
3172712-17271248.25248.50
4171023-17102347.78048.03
5171910-17191048.02848.27
6169554-16955447.37047.62
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%
1 9.983177423183943185493187763186963184310.13
2 9.913175633182653179140.16
单位质量响应值RSD%判断
31906.9132080.120.39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%
5min196209-9620926.95632.969.2226.9632.969.21
2122236-12223634.24934.25
3117685-11768532.97332.97
4120994-12099433.90133.90
5126091-12609135.32935.33
6122532-12253234.33134.33
10min1164914-16491446.20647.151.9146.2547.201.91
2168085-16808547.09547.15
3168136-16813647.10947.16
4168237-16823747.13747.19
5174209-17420948.81148.87
6166133-16613346.54846.60
15min1190703-19070353.43253.241.6753.5553.371.66
2187522-18752252.54152.68
3188178-18817852.72452.86
4191436-19143653.63753.77
5195330-19533054.72854.87
6186914-18691452.37052.51
20min1201946-20194656.58257.091.1156.7957.311.11
2202083-20208356.62056.84
3201749-20174956.52756.75
4204512-20451257.30157.53
5207391-20739158.10858.34
6204892-20489257.40757.63
30min1220085-22008561.66461.911.1261.9762.221.13
2219323-21932361.45161.77
3220002-22000261.64161.96
4222528-22252862.34962.67
5225198-22519863.09763.43
6218555-21855561.23661.55
45min1235767-23576766.05866.431.0066.4766.861.00
2235839-23583966.07866.50
3237586-23758666.56866.99
4238797-23879766.90767.33
5240575-24057567.40567.84
6234086-23408665.58766.01
60min1246454-24645469.05269.340.8169.5769.870.81
2246606-24660669.09569.63
3246446-24644669.05069.58
4249144-24914469.80670.34
5250708-25070870.24470.79
6245530-24553068.79469.32
极限1255364-25536471.54971.910.8372.1872.560.83
2255986-25598671.72372.37
3255516-25551671.59172.24
4256744-25674471.93672.59
5260823-26082373.07873.74
6255467-25546771.57872.22
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%
1 9.983196023185223183723182793194793188510.20
2 9.913185773192803189280.16
单位质量响应值RSD%判断
31949.0032182.440.52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%
5min131319-313198.7558.066.278.768.066.31
226019-260197.2747.27
329566-295668.2658.27
429551-295518.2618.26
527757-277577.7607.76
628710-287108.0268.03
10min160099-6009916.80117.143.5316.8217.153.51
261303-6130317.13817.15
358514-5851416.35816.37
464062-6406217.90917.92
560215-6021516.83316.85
663606-6360617.78117.79
15min180412-8041222.48023.053.3022.5223.093.30
281661-8166122.82922.87
382569-8256923.08323.12
487746-8774624.53024.57
580535-8053522.51422.55
681814-8181422.87122.91
20min194968-9496826.54927.021.9926.6327.101.99
297292-9729227.19827.28
395966-9596626.82826.91
4100098-10009827.98328.07
594984-9498426.55326.63
696637-9663727.01527.10
30min1118637-11863733.16633.182.1333.2933.302.13
2119571-11957133.42733.55
3114892-11489232.11932.24
4122523-12252334.25234.38
5117345-11734532.80432.93
6119122-11912233.30133.43
45min1140556-14055639.29340.011.0939.4740.191.09
2143959-14395940.24440.42
3142975-14297539.96940.15
4144965-14496540.52640.71
5142339-14233939.79239.97
6144002-14400240.25640.44
60min1158810-15881044.39645.081.5144.6445.321.51
2162840-16284045.52345.77
3158143-15814344.21044.45
4164335-16433545.94146.20
5160894-16089444.97945.22
6162494-16249445.42645.67
极限1199858-19985855.87156.191.3456.1956.511.34
2204865-20486557.27157.59
3198393-19839355.46255.78
4203883-20388356.99657.33
5199389-19938955.74056.06
6199561-19956155.78856.11
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%
1 9.983177173179493161663179863181073175850.26
2 9.913206673213723210200.16
单位质量响应值RSD%判断
31822.1432393.541.26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%
5min1276197-27619777.11676.862.0577.1276.862.05
2283810-28381079.24279.24
3273606-27360676.39276.39
4279139-27913977.93777.94
5269713-26971375.30675.31
6269247-26924775.17575.18
10min1324958-32495890.73089.261.8690.8689.391.86
2326138-32613891.06091.19
3320176-32017689.39589.52
4321652-32165289.80789.94
5314038-31403887.68187.81
6311282-31128286.91287.04
15min1341339-34133995.30493.412.0495.5893.682.04
2340678-34067895.11995.40
3334469-33446993.38693.66
4337830-33783094.32494.60
5328276-32827691.65791.93
6324685-32468590.65490.92
20min1346912-34691296.86095.241.9797.3095.681.97
2347022-34702296.89197.33
3340996-34099695.20895.64
4344621-34462196.22096.66
5337464-33746494.22294.65
6329709-32970992.05792.48
30min1350352-35035297.82096.661.6598.4297.251.65
2352640-35264098.45999.06
3345487-34548796.46297.05
4349338-34933897.53798.13
5341819-34181995.43896.02
6337603-33760394.26194.84
45min1350791-35079197.94397.752.0198.7198.502.00
2354054-35405498.85499.62
3348178-34817897.21397.96
4361353-361353100.892101.65
5343824-34382495.99896.74
6342349-34234995.58696.32
60min1352417-35241798.39797.391.0199.3298.301.02
2351721-35172198.20399.14
3347375-34737596.98997.90
4351465-35146598.13199.06
5345313-34531396.41497.31
6344475-34447596.18097.07
极限1353187-35318798.61297.670.9299.7098.750.92
2354166-35416698.88599.98
3346497-34649796.74497.82
4347592-34759297.05098.14
5349911-34991197.69798.76
6347522-34752297.03098.08
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