熊去氧胆酸口服混悬液片项目信息
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110755-202306对照品来源原料对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)250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%
113.585362753447537995389353550536630.34
213.605310753571533390.62
单位质量响应值RSD%判断
3951.623921.990.54数据可信
供试品溶液-25052101批-pH1.2(内含0.3%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min121131-2113138.49232.7413.4338.4932.7413.42
216621-1662130.27730.28
317055-1705531.06731.07
420875-2087538.02638.03
516741-1674130.49530.50
615419-1541928.08728.09
10min125597-2559746.62843.999.1946.6944.049.19
224227-2422744.13244.18
323156-2315642.18142.23
427669-2766950.40250.47
522769-2276941.47641.53
621464-2146439.09939.15
15min129184-2918453.16251.287.6853.3051.417.68
227775-2777550.59550.72
327700-2770050.45850.58
431855-3185558.02758.17
526744-2674448.71748.84
625652-2565246.72846.84
20min132314-3231458.86357.137.4059.0957.347.41
230896-3089656.28056.49
330908-3090856.30256.51
435426-3542664.53264.78
529915-2991554.49354.69
628718-2871852.31352.50
30min136140-3614065.83362.928.0866.1663.238.07
236627-3662766.72067.02
330040-3004054.72155.02
437236-3723667.82968.18
534779-3477963.35463.65
632431-3243159.07659.35
45min139294-3929471.57871.465.7372.0271.875.74
239392-3939271.75772.17
338556-3855670.23470.63
443316-4331678.90579.37
538219-3821969.62070.02
636586-3658666.64567.02
极限143409-4340979.07479.215.4979.6379.745.50
243299-4329978.87479.41
342444-4244477.31677.82
448129-4812987.67288.27
542079-4207976.65177.16
641553-4155375.69376.18
熊去氧胆酸口服混悬液片项目信息
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110755-202306对照品来源原料对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)250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%
113.585374953521540225354053645536950.39
213.605356453805536840.32
单位质量响应值RSD%判断
3953.983947.350.12数据可信
供试品溶液-25052301批-pH1.2(内含0.3%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min116035-1603529.10724.7312.4229.1124.7312.43
214242-1424225.85225.85
311383-1138320.66220.66
411990-1199021.76421.76
513870-1387025.17725.18
614226-1422625.82325.82
10min120048-2004836.39136.948.0036.4436.987.99
219740-1974035.83235.87
321340-2134038.73638.77
417597-1759731.94231.98
521149-2114938.38938.43
622239-2223940.36840.41
15min124639-2463944.72444.376.0344.8344.476.03
223982-2398243.53243.63
325723-2572346.69246.79
421744-2174439.46939.56
524934-2493445.26045.37
625644-2564446.54946.66
20min126997-2699749.00549.596.1849.1949.776.17
226108-2610847.39147.57
328100-2810051.00751.18
424923-2492345.24045.40
528071-2807150.95451.14
629713-2971353.93554.12
30min130908-3090856.10456.784.2656.3757.044.26
230602-3060255.54855.80
331599-3159957.35857.62
429888-2988854.25254.48
530933-3093356.14956.42
633745-3374561.25461.53
45min134915-3491563.37764.095.8063.7464.445.80
233697-3369761.16661.51
336658-3665866.54166.90
432449-3244958.90159.22
536053-3605365.44365.80
638067-3806769.09969.48
极限140855-4085574.16076.064.4674.6276.524.46
241187-4118774.76275.21
342043-4204376.31676.78
439620-3962071.91872.34
542636-4263677.39277.86
645070-4507081.81182.31
熊去氧胆酸口服混悬液片项目信息
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110755-202306对照品来源原料对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)250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%
113.585362653774540695382453706538000.32
213.605378854107539480.42
单位质量响应值RSD%判断
3961.713966.760.10数据可信
供试品溶液-25052302批-pH1.2(内含0.3%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min120852-2085237.72129.5715.5637.7229.5715.55
217533-1753331.71731.72
314557-1455726.33326.33
416284-1628429.45729.46
514410-1441026.06726.07
614438-1443826.11826.12
10min123165-2316541.90538.695.2341.9738.745.24
220270-2027036.66836.72
322075-2207539.93339.98
421658-2165839.17939.23
520567-2056737.20537.25
620599-2059937.26337.31
15min127479-2747949.70944.416.8249.8444.526.83
223972-2397243.36543.48
324953-2495345.13945.25
424874-2487444.99645.11
522825-2282541.29041.40
623189-2318941.94842.05
20min129713-2971353.75048.516.0753.9748.706.09
226383-2638347.72647.91
327083-2708348.99249.18
427080-2708048.98749.18
525163-2516345.51945.69
625478-2547846.08946.26
30min134593-3459362.57855.426.8262.8855.686.82
229703-2970353.73254.00
330804-3080455.72455.99
430653-3065355.45055.72
528860-2886052.20752.46
629194-2919452.81153.06
45min136764-3676466.50561.774.7966.9162.134.80
232907-3290759.52859.88
334183-3418361.83662.20
435053-3505363.41063.77
532127-3212758.11758.45
633855-3385561.24361.58
极限147128-4712885.25380.153.6685.7780.623.68
243282-4328278.29678.75
343994-4399479.58480.05
444826-4482681.08981.56
542369-4236976.64477.08
644259-4425980.06380.51
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