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%
116.58999971000651000299994199814999690.10
216.56 1013201014321013760.08
单位质量响应值RSD%判断
6029.496121.741.08数据可信
供试品溶液-24051101批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min122880-2288022.55124.044.2122.5524.044.21
224064-2406423.71823.72
324456-2445624.10524.10
423927-2392723.58323.58
525172-2517224.81024.81
625819-2581925.44825.45
10min136911-3691136.38135.971.5836.5136.111.57
236087-3608735.56935.70
337266-3726636.73136.86
436209-3620935.68935.82
536773-3677336.24536.38
635743-3574335.23035.37
15min142964-4296442.34742.141.1042.6742.481.10
242405-4240541.79642.13
343549-4354942.92343.26
442244-4224441.63741.97
542833-4283342.21842.56
642554-4255441.94342.28
20min147777-4777747.09146.611.1247.6547.181.11
246766-4676646.09446.66
347962-4796247.27347.85
447120-4712046.44347.00
547415-4741546.73447.31
646677-4667746.00746.58
30min151244-5124450.50851.562.2951.3352.382.27
251873-5187351.12851.95
354122-5412253.34554.18
451634-5163450.89251.71
553496-5349652.72853.56
651476-5147650.73751.56
45min158553-5855357.71257.502.9658.8258.612.92
257511-5751156.68557.79
360930-6093060.05561.19
459570-5957058.71459.82
557292-5729256.46957.60
656142-5614255.33656.44
60min164435-6443563.50963.142.3564.9364.572.32
263076-6307662.17063.59
365149-6514964.21365.68
465410-6541064.47065.90
564816-6481663.88565.32
661484-6148460.60162.02
90min166373-6637365.42066.054.0067.2067.843.92
266931-6693165.97067.73
372206-7220671.16972.99
464796-6479663.86565.65
565162-6516264.22666.02
666627-6662765.67067.42
120min174238-7423873.17272.152.5075.3174.302.45
271577-7157770.54972.68
374856-7485673.78176.00
470829-7082969.81271.95
575219-7521974.13976.29
672495-7249571.45473.57
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175344-7534474.26273.833.3576.8176.383.29
272050-7205071.01573.54
377524-7752476.41079.04
474381-7438173.31375.84
577900-7790076.78179.34
672255-7225571.21773.73
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%
116.581011581013211017471016061015731014810.24
216.56 1023351026801025080.24
单位质量响应值RSD%判断
6120.696190.100.80数据可信
供试品溶液-24051102批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min113131-1313112.77411.897.4512.7711.897.44
212661-1266112.31712.32
313030-1303012.67612.68
410906-1090610.61010.61
511366-1136611.05711.06
612252-1225211.91911.92
10min121667-2166721.07821.453.1821.1521.523.19
222987-2298722.36322.43
322856-2285622.23522.31
421891-2189121.29621.36
521363-2136320.78320.84
621520-2152020.93521.00
15min128978-2897828.19128.612.2728.3828.792.26
230509-3050929.68029.87
329614-2961428.81029.00
429427-2942728.62828.80
529387-2938728.58928.77
628531-2853127.75627.94
20min134719-3471933.77633.564.4334.1233.904.41
237328-3732836.31436.67
334693-3469333.75134.10
433471-3347132.56232.90
533424-3342432.51632.85
633328-3332832.42332.76
30min139157-3915738.09339.041.9438.6339.571.92
240355-4035539.25939.82
340482-4048239.38239.92
440641-4064139.53740.05
540970-4097039.85740.37
639160-3916038.09638.61
45min147657-4765746.36246.502.6247.1147.252.61
250269-5026948.90449.68
347465-4746546.17646.94
447001-4700145.72446.46
546854-4685445.58146.32
647562-4756246.27047.00
60min151486-5148650.08751.053.7651.0952.053.71
255002-5500253.50854.56
351618-5161850.21651.23
449784-4978448.43249.42
552454-5245451.02952.02
654499-5449953.01954.00
90min159064-5906457.46057.431.4458.7458.721.41
259154-5915457.54758.89
358197-5819756.61657.91
458538-5853856.94858.21
558635-5863557.04258.32
660597-6059758.95160.23
120min161929-6192960.24762.233.1161.8563.843.07
266182-6618264.38466.05
364770-6477063.01164.62
461263-6126359.59961.18
564049-6404962.30963.90
665612-6561263.83065.44
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167233-6723365.40765.683.5167.3467.633.46
271221-7122169.28671.31
367341-6734165.51267.47
465627-6562763.84465.75
564629-6462962.87364.81
669013-6901367.13869.10
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%
116.5899588100019998139972399631997550.18
216.56 9952699557995420.03
单位质量响应值RSD%判断
6016.596010.990.07数据可信
供试品溶液-24051103批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min114213-1421314.15214.622.9714.1514.622.96
214429-1442914.36714.37
314244-1424414.18314.18
415088-1508815.02315.02
514958-1495814.89414.89
615160-1516015.09515.09
10min127840-2784027.72125.564.2527.8025.644.22
225221-2522125.11325.19
325567-2556725.45725.54
425408-2540825.29925.38
525100-2510024.99225.08
624890-2489024.78324.87
15min132741-3274132.60132.825.3532.8333.045.31
232498-3249832.35932.58
334611-3461134.46334.68
429791-2979129.66329.89
533909-3390933.76433.99
634224-3422434.07734.30
20min138271-3827138.10737.703.2838.5238.113.25
238750-3875038.58438.98
336525-3652536.36836.78
436334-3633436.17836.57
539471-3947139.30239.71
637849-3784937.68738.10
30min146420-4642046.22144.394.2446.8545.004.19
241258-4125841.08141.69
345453-4545345.25845.87
445168-4516844.97445.56
545657-4565745.46146.09
643527-4352743.34043.96
45min153887-5388753.65651.552.3054.5452.412.28
251166-5116650.94751.79
352500-5250052.27553.14
450970-5097050.75151.59
550947-5094750.72951.61
651163-5116350.94451.80
60min158823-5882358.57156.124.3459.7557.274.28
257503-5750357.25658.38
354775-5477554.54055.70
453400-5340053.17154.29
559168-5916858.91460.08
654520-5452054.28655.43
90min162652-6265262.38363.292.0463.8964.742.00
262065-6206561.79963.24
363065-6306562.79564.25
463340-6334063.06864.49
565407-6540765.12766.62
664817-6481764.53965.98
120min170096-7009669.79570.872.3271.6572.682.26
268343-6834368.05069.84
371751-7175171.44373.25
472654-7265472.34274.11
572406-7240672.09673.95
671787-7178771.47973.28
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170690-7069070.38772.012.1372.6374.212.07
270758-7075870.45572.62
371495-7149571.18873.39
474111-7411173.79375.96
573847-7384773.53075.78
673016-7301672.70374.90
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