比索洛尔片项目信息
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100711-202203对照品来源中检院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2000
标示量(mg)5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%
110.564213742143420974209542068421080.08
210.494215042208421790.10
单位质量响应值RSD%判断
3987.504020.880.59数据可信
供试品溶液-G01QCM批-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min128493-2849363.91556.0214.9363.9256.0214.93
218398-1839841.27041.27
323326-2332652.32552.32
428094-2809463.02063.02
525503-2550357.20857.21
626029-2602958.38858.39
10min134850-3485078.17572.9215.2878.2873.0115.28
223594-2359452.92652.99
330507-3050768.43368.52
436643-3664382.19782.30
536642-3664282.19582.29
632805-3280573.58873.69
15min139046-3904687.58882.1714.8087.8282.3814.80
226942-2694260.43660.59
334677-3467777.78777.99
440003-4000389.73489.98
542282-4228294.84795.08
636824-3682482.60382.82
20min140750-4075091.41087.0112.9491.7987.3612.95
229831-2983166.91767.17
337264-3726483.59083.92
441825-4182593.82194.21
544292-4429299.35599.75
638780-3878086.99187.35
30min142532-4253295.40792.898.9395.9493.388.96
235054-3505478.63379.00
339866-3986689.42789.90
444010-4401098.72399.27
545592-45592102.272102.83
641400-4140092.86893.37
45min143835-4383598.33097.155.2199.0297.805.26
239856-3985689.40589.90
341596-4159693.30893.93
444707-44707100.286101.00
546162-46162103.550104.28
643705-4370598.03998.70
极限144276-4427699.319101.012.14100.18101.832.18
244049-4404998.81099.46
344372-4437299.535100.31
445130-45130101.235102.11
546259-46259103.768104.67
646105-46105103.422104.24
比索洛尔片项目信息
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100711-202203对照品来源中检院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2000
标示量(mg)5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%
110.564219042185422364223542249422190.07
210.494220142185421930.03
单位质量响应值RSD%判断
3998.014022.210.43数据可信
供试品溶液-G01QCM批-pH2.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min129868-2986866.90061.0814.6666.9061.0814.66
227211-2721160.94960.95
327487-2748761.56761.57
420898-2089846.80946.81
532670-3267073.17673.18
625472-2547257.05457.05
10min137190-3719083.30080.447.1583.4180.547.15
236204-3620481.09281.19
332838-3283873.55273.66
433120-3312074.18474.26
539592-3959288.68088.80
636542-3654281.84981.94
15min141534-4153493.03088.997.4893.2889.227.48
239527-3952788.53588.77
335727-3572780.02380.25
436637-3663782.06282.26
542735-4273595.72095.99
642216-4221694.55894.79
20min143715-4371597.91593.416.5898.3293.806.58
241130-4113092.12592.51
337743-3774384.53984.90
439344-3934488.12588.46
544114-4411498.80999.24
644178-4417898.95299.34
30min145003-45003100.80098.063.53101.3798.613.55
242801-4280195.86896.41
341829-4182993.69194.19
442603-4260395.42595.91
545018-45018100.834101.43
645437-45437101.772102.33
45min145263-45263101.383100.282.05102.12100.982.07
243828-4382898.16998.87
343655-4365597.78198.44
444601-4460199.900100.54
545264-45264101.385102.15
646016-46016103.069103.79
极限145303-45303101.472101.360.98102.38102.230.99
245078-45078100.968101.83
345144-45144101.116101.93
444839-44839100.433101.24
545059-45059100.926101.86
646100-46100103.257104.15
比索洛尔片项目信息
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100711-202203对照品来源中检院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2000
标示量(mg)5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%
110.564212842145421334211642126421300.03
210.494213642157421460.04
单位质量响应值RSD%判断
3989.584017.730.50数据可信
供试品溶液-G01QCM批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min128568-2856864.09250.2936.6064.0950.2936.60
211872-1187226.63526.63
313451-1345130.17730.18
432286-3228672.43372.43
522819-2281951.19451.19
625509-2550957.22957.23
10min135959-3595980.67365.9630.8780.7866.0430.88
217396-1739639.02839.07
319947-1994744.75144.80
440295-4029590.40190.52
529345-2934565.83565.92
633470-3347075.08975.18
15min140903-4090391.76578.5119.6492.0178.7019.68
225337-2533756.84356.95
328600-2860064.16364.29
442529-4252995.41395.68
534440-3444077.26577.46
638165-3816585.62285.84
20min142213-4221394.70484.5114.2895.1084.8414.33
230476-3047668.37268.58
332053-3205371.91072.14
443411-4341197.39297.82
537440-3744083.99684.32
640434-4043490.71391.08
30min142812-4281296.04890.409.0796.6090.869.14
234720-3472077.89478.21
336906-3690682.79883.15
443904-4390498.49899.09
541104-4110492.21692.68
642310-4231094.92195.44
45min142438-4243895.20993.495.4995.9294.105.57
238278-3827885.87686.32
339403-3940388.40088.89
443694-4369498.02698.78
543687-4368798.01198.63
642528-4252895.41196.08
极限142196-4219694.66696.841.9195.5497.621.85
243575-4357597.75998.35
343114-4311496.72597.36
443179-4317996.87197.79
544493-4449399.819100.60
642443-4244395.22096.05
比索洛尔片项目信息
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100711-202203对照品来源中检院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2000
标示量(mg)5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%
110.564206442102420954208942078420860.04
210.494217242214421930.08
单位质量响应值RSD%判断
3985.424022.210.65数据可信
供试品溶液-G01QCM批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min122543-2254350.57336.7338.0950.5736.7338.09
215016-1501633.68733.69
319017-1901742.66342.66
49329-932920.92920.93
523166-2316651.97151.97
69175-917520.58320.58
10min132718-3271873.40055.8626.5073.4855.9226.51
222232-2223249.87549.93
325780-2578057.83557.91
417161-1716138.49938.53
532360-3236072.59772.68
619148-1914842.95742.99
15min137270-3727083.61268.9717.5983.8269.1317.61
227188-2718860.99461.13
330062-3006267.44167.61
424076-2407654.01254.11
537200-3720083.45583.66
628676-2867664.33264.44
20min140288-4028890.38278.5913.0690.7378.8613.09
230844-3084469.19669.44
332987-3298774.00374.28
430044-3004467.40167.59
540529-4052990.92391.27
635486-3548679.61079.82
30min141851-4185193.88987.968.9894.3988.369.00
235017-3501778.55778.91
336696-3669682.32482.73
436551-3655181.99982.30
543393-4339397.34897.85
641746-4174693.65394.00
45min142869-4286996.17393.256.0396.8393.806.06
238223-3822385.75086.24
339523-3952388.66689.21
440561-4056190.99591.43
544574-4457499.998100.66
643639-4363997.90098.40
极限143028-4302896.52996.791.7797.3497.501.83
242701-4270195.79696.43
343206-4320696.92997.62
442073-4207394.38794.98
544308-4430899.401100.23
643560-4356097.72398.39
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