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101242-201201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(%)100.0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%
116.124821748599483624838848164483460.36
216.174880248876488390.11
单位质量响应值RSD%判断
2999.133020.350.50数据可信
供试品溶液-2J95SDC1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%
5min11852-18523.6923.4150.313.693.4150.31
21876-18763.7403.74
32004-20043.9954.00
42139-21394.2644.26
5-0.0000.00
62384-23844.7534.75
10min16695-669513.34713.022.8013.3713.042.86
26682-668213.32113.34
36431-643112.82112.84
46663-666313.28313.31
56236-623612.43212.43
66485-648512.92812.95
15min112006-1200623.93522.862.8024.0322.952.80
211551-1155123.02823.12
311174-1117422.27622.37
411271-1127122.46922.57
511196-1119622.32022.39
611596-1159623.11723.22
20min115628-1562831.15531.021.9531.3831.241.93
215354-1535430.60930.83
315143-1514330.18830.41
415483-1548330.86631.09
515769-1576931.43631.63
615992-1599231.88132.11
30min121149-2114942.16241.402.3442.5641.792.33
220993-2099341.85142.24
319837-1983739.54639.93
420690-2069041.24741.64
520840-2084041.54641.91
621090-2109042.04442.45
45min127344-2734454.51254.141.7555.1554.771.74
227412-2741254.64755.27
326492-2649252.81353.42
426624-2662453.07653.70
527527-2752754.87755.48
627561-2756154.94455.58
60min131965-3196563.72463.601.7364.6664.521.73
232340-3234064.47265.40
330926-3092661.65362.55
431633-3163363.06263.98
532194-3219464.18065.08
632363-3236364.51765.46
90min135965-3596571.69873.393.3472.9974.673.28
235391-3539170.55471.84
336374-3637472.51473.75
436544-3654472.85274.12
538193-3819376.14077.40
638427-3842776.60677.91
120min141511-4151182.75482.771.5084.4484.451.49
241207-4120782.14883.83
340514-4051480.76782.41
441653-4165383.03784.71
542325-4232584.37786.06
641907-4190783.54485.27
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141757-4175783.24582.412.1585.3984.542.11
242204-4220484.13686.27
340150-4015080.04182.13
440862-4086281.46183.59
542332-4233284.39186.54
640711-4071181.16083.35
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101242-201201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(%)100.0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%
116.124858948539484814863548516485520.13
216.174843948347483930.14
单位质量响应值RSD%判断
3011.912992.760.46数据可信
供试品溶液-3B85SDC1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%
5min12345-23454.6864.384.244.694.384.25
22110-21104.2174.22
32181-21814.3594.36
42125-21254.2474.25
52260-22604.5174.52
62130-21304.2574.26
10min17772-777215.53214.744.3015.5614.764.30
27709-770915.40615.43
37212-721214.41314.44
46970-697013.92913.95
57412-741214.81314.84
67174-717414.33714.36
15min113685-1368527.34925.454.7127.4625.564.70
212995-1299525.97026.08
312544-1254425.06925.17
412142-1214224.26524.37
512940-1294025.86025.97
612108-1210824.19724.30
20min117624-1762435.22133.722.7535.4933.962.77
217025-1702534.02434.28
316390-1639032.75533.00
416372-1637232.71932.95
516935-1693533.84434.10
616879-1687933.73233.97
30min122882-2288245.72945.341.8546.1945.771.85
222701-2270145.36745.81
322578-2257845.12145.55
422050-2205044.06644.48
523324-2332446.61247.05
622585-2258545.13545.56
45min129986-2998659.92658.192.8060.6458.882.79
229474-2947458.90359.60
329457-2945758.86959.54
428177-2817756.31156.97
529587-2958759.12959.83
628017-2801755.99156.67
60min133604-3360467.15666.173.2468.2067.183.21
234080-3408068.10869.13
331178-3117862.30863.31
432661-3266165.27266.25
533894-3389467.73668.76
633245-3324566.43967.43
90min139169-3916978.27878.250.9979.7079.631.01
239529-3952978.99780.40
339321-3932178.58279.93
438568-3856877.07778.41
539517-3951778.97380.38
638828-3882877.59678.95
120min143064-4306486.06286.751.4287.9288.561.40
242884-4288485.70287.54
343355-4335586.64388.43
443449-4344986.83188.60
544588-4458889.10790.95
643100-4310086.13487.92
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142618-4261885.17185.821.9887.5088.111.96
243681-4368187.29589.61
342550-4255085.03587.30
441695-4169583.32685.57
544053-4405388.03890.37
643049-4304986.03288.30
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