托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号TAAF230001对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数10000
标示量(mg)15供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.689468894639947389461594646946650.06
216.849501395056950340.04
单位质量响应值RSD%判断
5675.365643.350.40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%
5min19206-92069.74110.118.009.7410.117.99
29747-974710.31310.31
310599-1059911.21511.21
48385-83858.8728.87
510053-1005310.63710.64
69336-93369.8789.88
10min120695-2069521.89722.256.2221.9522.316.22
220687-2068721.88821.95
322378-2237823.67823.74
421001-2100122.22122.27
522482-2248223.78823.85
618935-1893520.03520.09
15min128341-2834129.98732.754.3130.1632.934.31
231831-3183133.68033.86
331324-3132433.14333.34
431462-3146233.28933.46
531895-3189533.74733.94
630839-3083932.63032.80
20min135442-3544237.50038.983.1137.8439.343.08
236405-3640538.51938.89
336723-3672338.85639.23
438499-3849940.73541.09
536075-3607538.17038.55
637871-3787140.07140.42
30min144601-4460147.19149.443.1747.7450.023.15
246128-4612848.80749.39
346512-4651249.21349.81
449090-4909051.94152.53
546692-4669249.40449.99
647357-4735750.10750.68
45min153476-5347656.58258.292.9957.3959.142.95
256108-5610859.36760.22
353520-5352056.62857.50
454182-5418257.32958.20
555670-5567058.90359.77
657588-5758860.93361.78
60min159800-5980063.27365.182.4464.4066.362.42
260428-6042863.93865.12
362048-6204865.65266.83
463661-6366167.35868.55
560821-6082164.35365.55
662859-6285966.51067.70
90min163867-6386767.57671.024.1869.0672.564.12
266351-6635170.20571.74
364080-6408067.80269.35
468368-6836872.33973.90
569608-6960873.65175.20
670456-7045674.54876.10
120min170480-7048074.57375.612.2076.4377.552.18
269952-6995274.01575.94
371004-7100475.12877.05
474399-7439978.72080.69
571099-7109975.22877.19
671844-7184476.01777.99
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min175676-7567680.07184.132.8482.3486.482.82
278410-7841082.96485.30
379394-7939484.00586.35
481376-8137686.10288.51
580415-8041585.08587.46
681786-8178686.53688.93
240min179513-7951384.13185.502.8086.8488.322.76
278235-7823582.77985.58
379922-7992284.56487.37
484448-8444889.35392.24
580214-8021484.87387.72
682481-8248187.27190.15
极限181659-8165986.40286.512.0589.5889.802.03
281153-8115385.86689.12
379441-7944184.05587.33
484369-8436989.26992.65
581139-8113985.85289.17
682781-8278187.58990.95
托伐普坦口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号TAAF230001对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数10000
标示量(mg)15供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.689454894599945439437794443945020.10
216.849433394405943690.06
单位质量响应值RSD%判断
5665.595603.860.78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%
5min110559-1055911.22110.725.7411.2210.725.72
29880-988010.50010.50
39250-92509.8309.83
49748-974810.35910.36
510835-1083511.51511.51
610260-1026010.90410.90
10min121586-2158622.94023.211.2423.0023.271.24
221849-2184923.22023.28
321543-2154322.89422.95
421844-2184423.21423.27
521913-2191323.28823.35
622291-2229123.68923.75
15min129747-2974731.61332.192.0531.8032.382.05
230237-3023732.13432.32
329372-2937231.21431.40
430647-3064732.56932.76
530793-3079332.72532.92
630919-3091932.85833.05
20min135459-3545937.68338.150.9838.0538.510.98
235684-3568437.92238.29
335893-3589338.14538.50
435762-3576238.00538.37
536121-3612138.38738.76
636448-3644838.73439.11
30min144802-4480247.61247.572.0448.1948.152.03
243956-4395646.71347.29
343518-4351846.24846.81
444999-4499947.82248.40
545273-4527348.11348.70
646034-4603448.92249.51
45min152973-5297356.29656.471.2057.1457.321.21
252552-5255255.84856.68
352533-5253355.82856.65
453028-5302856.35457.20
554183-5418357.58258.44
653565-5356556.92557.79
60min160526-6052664.32361.984.1765.4763.144.11
256985-5698560.56061.71
354172-5417257.57058.70
458334-5833461.99363.15
559663-5966363.40664.58
660265-6026564.04565.22
90min163630-6363067.62169.291.2369.1370.801.21
265440-6544069.54571.03
365415-6541569.51870.97
465516-6551669.62671.13
565933-6593370.06971.60
665292-6529269.38870.92
120min168605-6860572.90873.132.4074.7975.022.34
268805-6880573.12174.99
369541-6954173.90375.74
465766-6576669.89171.78
569608-6960873.97475.89
670564-7056474.99076.91
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min175370-7537080.09879.942.7182.3982.242.65
271849-7184976.35678.63
375629-7562980.37382.62
475781-7578180.53582.81
574592-7459279.27181.60
678126-7812683.02785.36
240min175658-7565880.40483.742.6583.1486.482.59
278402-7840283.32086.02
379627-7962784.62287.32
478634-7863483.56786.29
578365-7836583.28186.05
682090-8209087.23990.04
极限179264-7926484.23685.371.5187.4288.571.49
279946-7994684.96188.12
378788-7878883.73086.90
481887-8188787.02490.21
580702-8070285.76489.00
681382-8138286.48789.77
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