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对照品来源原料对照品使用方法直接使用
对照品含量(%)99.9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%
110.051226591224491227091228511222591225850.19
210.091229971228391229180.10
单位质量响应值RSD%判断
12197.5112182.160.09数据可信
供试品溶液-H046R批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min137662-3766227.77932.418.9927.7832.408.99
240680-4068030.00530.00
345305-4530533.41633.42
445154-4515433.30533.30
547900-4790035.33035.33
646913-4691334.60234.60
10min164287-6428747.41752.747.1047.4652.807.10
266797-6679749.26849.32
372074-7207453.16053.22
473818-7381854.44754.50
578002-7800257.53357.59
674070-7407054.63354.69
15min173016-7301653.85562.988.2853.9863.128.27
281694-8169460.25660.39
386299-8629963.65363.80
490278-9027866.58766.73
592163-9216367.97868.13
688878-8887865.55565.70
20min188524-8852465.29470.064.6765.5170.304.68
291399-9139967.41467.65
394362-9436269.60069.85
499154-9915473.13473.39
599763-9976373.58373.85
696698-9669871.32371.58
30min198937-9893772.97477.703.9873.3078.073.99
2103686-10368676.47776.82
3103988-10398876.70077.07
4110658-11065881.61982.00
5109063-10906380.44380.83
6105749-10574977.99978.38
45min1106977-10697778.90483.153.5879.3583.643.59
2111343-11134382.12582.60
3111484-11148482.22982.72
4118670-11867087.52988.04
5115743-11574385.37085.89
6112199-11219982.75683.26
60min1111072-11107281.92586.013.4282.5086.643.43
2115432-11543285.14185.75
3114901-11490184.74985.38
4122432-12243290.30490.96
5119786-11978688.35289.02
6116020-11602085.57486.22
90min1114016-11401684.09688.513.7484.8189.283.74
2119543-11954388.17388.92
3118045-11804587.06887.84
4127654-12765494.15594.97
5121247-12124789.43090.24
6119476-11947688.12388.91
120min1115180-11518084.95589.663.8885.8190.593.88
2121424-12142489.56090.46
3120083-12008388.57189.49
4129569-12956995.56896.54
5122937-12293790.67691.64
6120195-12019588.65489.59
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1118480-11848087.38991.203.3088.3892.273.30
2123445-12344591.05192.10
3122255-12225590.17391.24
4130542-13054296.28597.41
5125400-12540092.49393.61
6121758-12175889.80790.89
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对照品来源原料对照品使用方法直接使用
对照品含量(%)99.9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%
110.051228071226041225901228071226701226960.09
210.091239621230731235180.51
单位质量响应值RSD%判断
12208.5612241.630.20数据可信
供试品溶液-25012101批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min172020-7202052.96846.1518.1452.9746.1518.14
245929-4592933.77933.78
370978-7097852.20152.20
459596-5959643.83043.83
573942-7394254.38154.38
654043-5404339.74639.75
10min192890-9289068.31764.559.2968.4064.639.30
274085-7408554.48654.54
393614-9361468.84968.94
485216-8521662.67362.75
596049-9604970.64070.73
684754-8475462.33362.40
15min1100429-10042973.86171.876.0674.0672.066.08
287140-8714064.08864.23
3101700-10170074.79675.00
496143-9614370.70970.89
5103810-10381076.34876.56
697111-9711171.42171.59
20min1105651-10565177.70276.094.4678.0376.394.48
295476-9547670.21870.47
3107248-10724878.87679.20
4101327-10132774.52274.82
5107772-10777279.26279.60
6103272-10327275.95276.24
30min1111186-11118681.77280.662.6982.2381.092.72
2105264-10526477.41777.79
3112341-11234182.62283.08
4107268-10726878.89179.31
5112606-11260682.81783.28
6109384-10938480.44780.86
45min1114654-11465484.32383.532.0084.9184.092.03
2111610-11161082.08482.58
3116182-11618285.44786.04
4110457-11045781.23681.79
5115548-11554884.98085.59
6112991-11299183.10083.65
60min1115579-11557985.00384.861.9985.7385.572.01
2114615-11461584.29484.93
3118146-11814686.89187.63
4111506-11150682.00882.69
5117112-11711286.13186.88
6115374-11537484.85285.54
90min1117714-11771486.57386.251.9887.4587.101.98
2118142-11814286.88887.67
3120222-12022288.41889.30
4113154-11315483.22084.04
5117575-11757586.47187.36
6116865-11686585.94986.78
120min1119233-11923387.69186.712.4888.7187.702.48
2117903-11790386.71287.63
3121798-12179889.57790.61
4112856-11285683.00183.96
5118142-11814286.88887.92
6117461-11746186.38787.36
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1119359-11935987.78387.681.4788.9588.811.49
2117840-11784086.66687.73
3121939-12193989.68190.86
4116963-11696386.02187.12
5120108-12010888.33489.51
6119095-11909587.58988.71
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