坎地沙坦酯片项目信息
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100685-201903对照品来源中检所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)8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%
115.973772537645376363766037689376710.10
215.943792437890379070.07
单位质量响应值RSD%判断
2358.862378.110.58数据可信
供试品溶液-2025030321批-含0.35%吐温20的磷酸盐缓冲液(pH6.5)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min110347-1034724.52521.1923.9324.5221.1923.93
26566-656615.56315.56
311643-1164327.59727.60
47159-715916.96816.97
57420-742017.58717.59
610515-1051524.92324.92
10min126654-2665463.17654.1116.3963.2254.1516.40
220048-2004847.51847.54
327171-2717164.40164.45
419644-1964446.56146.59
518886-1888644.76444.79
624583-2458358.26758.31
15min136810-3681087.24878.069.8487.3978.189.85
231012-3101273.50573.61
335951-3595185.21285.37
430063-3006371.25671.36
529221-2922169.26069.36
634540-3454081.86882.01
20min139572-3957293.79590.313.4994.0990.573.51
237504-3750488.89389.12
338794-3879491.95192.25
437272-3727288.34388.57
536177-3617785.74885.97
639288-3928893.12193.40
30min140716-4071696.50695.561.0696.9595.961.06
239893-3989394.55594.93
339848-3984894.44994.90
440559-4055996.13496.51
540084-4008495.00895.37
640793-4079396.68997.12
45min141022-4102297.23196.450.8297.8497.020.82
240446-4044695.86696.40
340174-4017495.22295.83
440794-4079496.69197.22
540707-4070796.48597.01
641015-4101597.21597.81
60min141100-4110097.41696.971.0898.1997.701.06
241383-4138398.08798.78
340178-4017895.23196.00
440939-4093997.03597.73
540646-4064696.34097.02
641220-4122097.70198.45
极限141432-4143298.20397.580.8799.1498.480.86
241110-4111097.44098.30
340475-4047595.93596.86
441327-4132797.95498.81
541348-4134898.00498.85
641335-4133597.97398.89
坎地沙坦酯片项目信息
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100685-201903对照品来源中检所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)8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%
115.973780637921379523795237882379030.17
215.943814538115381300.06
单位质量响应值RSD%判断
2373.392392.100.56数据可信
供试品溶液-2025030421批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16920-692016.30416.7419.1316.3016.7419.13
26430-643015.14915.15
38010-801018.87218.87
49391-939122.12622.13
55868-586813.82513.83
66024-602414.19314.19
10min117306-1730640.77443.3914.6640.8043.4214.66
216623-1662339.16439.19
320499-2049948.29648.33
422944-2294454.05754.09
516938-1693839.90739.93
616196-1619638.15838.18
15min126100-2610061.49366.1111.2061.5966.2111.21
225332-2533259.68359.77
331310-3131073.76873.88
432711-3271177.06877.20
527046-2704663.72163.81
625862-2586260.93261.02
20min132859-3285977.41781.856.4477.6182.066.46
232285-3228576.06576.25
337258-3725887.78188.02
437639-3763988.67988.93
534452-3445281.17081.37
633954-3395479.99780.19
30min138797-3879791.40792.511.5591.7392.861.57
238476-3847690.65190.97
339468-3946892.98893.37
440228-4022894.77995.18
539226-3922692.41892.75
639407-3940792.84593.17
45min139894-3989493.99294.641.1094.4795.141.12
240034-4003494.32294.79
339707-3970793.55194.09
440970-4097096.52797.09
540108-4010894.49694.98
640304-4030494.95895.43
60min140053-4005394.36794.961.0795.0095.621.08
240280-4028094.90195.53
339756-3975693.66794.36
441033-4103396.67597.40
540261-4026194.85795.50
640440-4044095.27895.91
极限140291-4029194.92795.701.0995.7296.521.09
240908-4090896.38197.16
340050-4005094.35995.21
441231-4123197.14298.03
540422-4042295.23696.04
640811-4081196.15296.95
坎地沙坦酯片项目信息
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100685-201903对照品来源中检所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)8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%
115.973820938197381863816238162381830.06
215.943836638345383560.04
单位质量响应值RSD%判断
2390.922406.270.46数据可信
供试品溶液-2025030422批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17366-736617.24021.0215.8317.2421.0115.82
210379-1037924.29224.29
38718-871820.40420.40
47815-781518.29118.29
58623-862320.18220.18
610974-1097425.68425.68
10min120240-2024047.37153.6514.7247.4053.6814.72
226679-2667962.44162.48
325956-2595660.74960.78
418674-1867443.70643.74
520952-2095249.03749.07
625034-2503458.59158.63
15min131414-3141473.52376.478.8973.6376.598.90
235155-3515582.27982.42
335148-3514882.26282.40
428056-2805665.66465.77
531317-3131773.29673.41
634943-3494381.78381.92
20min138074-3807489.11089.224.2689.3489.474.27
238851-3885190.92991.21
338994-3899491.26491.54
434987-3498781.88582.10
538286-3828689.60789.84
639534-3953492.52892.80
30min140725-4072595.31595.571.1095.6995.961.10
240293-4029394.30494.74
340991-4099195.93896.36
440434-4043494.63494.98
541034-4103496.03896.43
641515-4151597.16497.59
45min142142-4214298.63197.501.1199.1798.061.09
240896-4089695.71596.31
341484-4148497.09197.68
441520-4152097.17697.68
541841-4184197.92798.47
642061-4206198.44299.03
60min141070-4107096.12297.251.1096.8297.961.09
240972-4097295.89396.64
341628-4162897.42898.17
441646-4164697.47198.14
541823-4182397.88598.59
642161-4216198.67699.43
极限141146-4114696.30097.941.6797.1698.821.65
241037-4103796.04596.95
341506-4150697.14398.05
442593-4259399.687100.52
542365-4236599.153100.03
642432-4243299.310100.23
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