非布司他多替诺雷片项目信息
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241101对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.233434534559346533424734301344210.52
210.183445134275343630.37
单位质量响应值RSD%判断
3364.713375.540.23数据可信
供试品溶液-25121501批-多替诺雷-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19161-916124.38924.2311.7324.3924.2311.72
28822-882223.48623.49
310966-1096629.19429.19
49415-941525.06525.07
57868-786820.94720.95
68382-838222.31522.31
10min119892-1989252.95851.543.6153.0051.583.62
219514-1951451.95151.99
320119-2011953.56253.61
419628-1962852.25552.30
518428-1842849.06049.09
618574-1857449.44949.49
15min124171-2417164.34963.081.6464.4863.201.64
223659-2365962.98663.11
323910-2391063.65463.79
423939-2393963.73263.86
523212-2321261.79661.91
623269-2326961.94862.07
20min126138-2613869.58669.141.2969.8269.371.29
226529-2652970.62770.86
325669-2566968.33768.58
426020-2602069.27269.51
525662-2566268.31968.54
625803-2580368.69468.92
30min128625-2862576.20775.190.9776.5675.530.97
228469-2846975.79276.14
328050-2805074.67675.03
428124-2812474.87375.22
528286-2828675.30475.64
627899-2789974.27474.61
45min129923-2992379.66379.650.6880.1480.120.68
230013-3001379.90280.38
329531-2953178.61979.10
430092-3009280.11280.59
530049-3004979.99880.46
629892-2989279.58080.04
60min130730-3073081.81181.930.4582.4282.540.44
230764-3076481.90282.51
330626-3062681.53482.15
430783-3078381.95282.56
530716-3071681.77482.37
631033-3103382.61883.21
极限131590-3159084.10183.861.2084.8584.601.18
231585-3158584.08784.83
330792-3079281.97682.73
431852-3185284.79885.54
531745-3174584.51385.24
631441-3144183.70484.44
非布司他多替诺雷片项目信息
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C025-22401010对照品来源自制对照品使用方法直接使用
对照品含量(%)101.3对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.202432822434722427202414622426652427200.33
210.142458582449152453860.28
单位质量响应值RSD%判断
23796.0824199.801.19数据可信
供试品溶液-25121501批-非布司他-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min176091-7609128.91029.2111.5628.9129.2111.56
274614-7461428.34828.35
391937-9193734.93034.93
481521-8152130.97330.97
567285-6728525.56425.56
669917-6991726.56426.56
10min1150176-15017657.05756.143.4057.1156.193.41
2148671-14867156.48556.53
3154182-15418258.57958.64
4150007-15000756.99357.04
5141125-14112553.61853.66
6142378-14237854.09454.14
15min1178618-17861867.86366.871.5368.0167.011.54
2176109-17610966.91067.05
3178242-17824267.72067.88
4177529-17752967.44967.60
5172396-17239665.49965.63
6173064-17306465.75365.89
20min1192807-19280773.25472.671.1073.5172.921.10
2194312-19431273.82674.08
3191565-19156572.78273.05
4190828-19082872.50272.76
5188907-18890771.77272.01
6189201-18920171.88472.13
30min1209962-20996279.77278.900.6280.1579.280.63
2206563-20656378.48078.86
3208054-20805479.04779.44
4207867-20786778.97679.36
5206993-20699378.64479.00
6206606-20660678.49778.86
45min1223260-22326084.82484.360.3785.3484.870.37
2221124-22112484.01384.52
3221951-22195184.32784.85
4221770-22177084.25884.77
5222717-22271784.61885.11
6221452-22145284.13784.63
60min1230741-23074187.66687.350.3688.3288.000.35
2229279-22927987.11187.76
3229721-22972187.27987.94
4228918-22891886.97487.63
5231028-23102887.77688.41
6229813-22981387.31487.95
极限1237140-23714090.09889.690.9290.9090.480.91
2233869-23386988.85589.65
3233441-23344188.69289.50
4239242-23924290.89691.69
5236631-23663189.90490.68
6236004-23600489.66690.45
非布司他多替诺雷片项目信息
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241101对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.233500834915347543477434730348360.35
210.183466034657346580.01
单位质量响应值RSD%判断
3405.283404.520.02数据可信
供试品溶液-25121502批-多替诺雷-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110327-1032727.21219.3824.4227.2119.3824.42
27923-792320.87820.88
35962-596215.71015.71
48149-814921.47321.47
56054-605415.95315.95
65712-571215.05115.05
10min120107-2010752.98347.317.8253.0347.347.83
218753-1875349.41549.45
316841-1684144.37744.40
418541-1854148.85748.89
516611-1661143.77143.80
616868-1686844.44844.47
15min124035-2403563.33460.743.4463.4760.853.45
223793-2379362.69662.81
322805-2280560.09260.19
423298-2329861.39261.51
522207-2220758.51758.62
622165-2216558.40658.51
20min125925-2592568.31467.311.9568.5567.521.96
226172-2617268.96569.19
325598-2559867.45267.65
425526-2552667.26267.48
525282-2528266.61966.82
624757-2475765.23665.43
30min128597-2859775.35574.581.2075.7174.901.21
228769-2876975.80876.14
328280-2828074.51974.83
428137-2813774.14374.47
528202-2820274.31474.62
627824-2782473.31873.62
45min130322-3032279.90079.601.2280.3880.051.22
230600-3060080.63381.10
330651-3065180.76781.20
429950-2995078.92079.38
529885-2988578.74979.18
629835-2983578.61779.04
60min131140-3114082.05682.210.3282.6782.790.33
231394-3139482.72583.32
331187-3118782.18082.75
431132-3113282.03582.62
531192-3119282.19382.76
631144-3114482.06682.62
极限131857-3185783.94584.090.8284.6984.810.83
232326-3232685.18185.92
331898-3189884.05384.76
431791-3179183.77184.49
532057-3205784.47285.17
631552-3155283.14183.84
非布司他多替诺雷片项目信息
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C025-22401010对照品来源自制对照品使用方法直接使用
对照品含量(%)101.3对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.202462792460962463612481832469792467800.35
210.142484862485852485360.03
单位质量响应值RSD%判断
24194.1224510.450.92数据可信
供试品溶液-25121502批-非布司他-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min189899-8989933.65824.1623.6733.6624.1623.67
269860-6986026.15526.16
353219-5321919.92519.92
470504-7050426.39626.40
553998-5399820.21720.22
649723-4972318.61618.62
10min1155500-15550058.21852.836.7758.2752.876.78
2146544-14654454.86554.91
3134345-13434550.29850.33
4145560-14556054.49754.54
5131642-13164249.28649.32
6133083-13308349.82649.86
15min1180343-18034367.52064.923.0467.6765.053.05
2177776-17777666.55966.69
3171659-17165964.26864.39
4175242-17524265.61065.74
5167555-16755562.73262.85
6167900-16790062.86162.98
20min1195166-19516673.06971.181.8673.3371.421.87
2192669-19266972.13472.38
3189828-18982871.07171.29
4190493-19049371.32071.56
5186889-18688969.97070.19
6185710-18571069.52969.75
30min1211510-21151079.18878.210.9879.5878.571.00
2211292-21129279.10779.47
3207883-20788377.83078.17
4208641-20864178.11478.48
5207310-20731077.61677.95
6206773-20677377.41577.75
45min1226873-22687384.94084.421.3685.4684.901.36
2226328-22632884.73685.23
3230455-23045586.28186.75
4223935-22393583.84084.33
5223154-22315483.54884.01
6222108-22210883.15683.62
60min1234056-23405687.62987.300.3488.2987.920.36
2233802-23380287.53488.17
3233447-23344787.40188.02
4233052-23305287.25487.89
5231930-23193086.83487.44
6232691-23269187.11887.72
极限1240637-24063790.09389.500.5390.9090.270.55
2240475-24047590.03390.82
3238895-23889589.44190.20
4238512-23851289.29890.08
5237486-23748688.91489.66
6238229-23822989.19289.94
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