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%
1 16.133875838974387003886938884388370.28
2 16.103893139023389770.17
单位质量响应值RSD%判断
2407.752420.930.39数据可信
供试品溶液-2025030422批-pH1.2(内含0.05%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114564-1456433.86428.3710.6033.8628.3710.59
212433-1243328.90928.91
311602-1160226.97726.98
411104-1110425.81925.82
511138-1113825.89825.90
612361-1236128.74228.74
10min126860-2686062.45554.798.6062.5154.848.60
223367-2336754.33354.38
321441-2144149.85449.90
422516-2251652.35452.40
525011-2501158.15558.20
622184-2218451.58251.63
15min134671-3467180.61774.705.8480.7874.845.84
232576-3257675.74575.88
329991-2999169.73569.86
431074-3107472.25372.38
533838-3383878.68078.82
630617-3061771.19071.32
20min137582-3758287.38584.063.1087.6884.333.11
236438-3643884.72584.99
334608-3460880.47080.71
435276-3527682.02382.27
537109-3710986.28586.56
635910-3591083.49783.75
30min139500-3950091.84589.642.0892.2990.042.09
238544-3854489.62290.03
337357-3735786.86287.24
437925-3792588.18388.57
538770-3877090.14790.56
639214-3921491.18091.57
45min139625-3962592.13690.442.1592.7390.992.15
239062-3906290.82691.38
337827-3782787.95588.48
438091-3809188.56989.10
538809-3880990.23890.80
639948-3994892.88793.43
60min138761-3876190.12789.222.1390.8789.922.13
238698-3869889.98090.69
337427-3742787.02587.69
437381-3738186.91887.60
538517-3851789.55990.27
639452-3945291.73392.43
极限137736-3773687.74389.001.7088.6489.841.69
238791-3879190.19691.05
337687-3768787.62988.44
437861-3786188.03488.86
538279-3827989.00689.87
639293-3929391.36492.21
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%
1 16.133897139138389793913639062390570.21
2 16.103927339264392680.02
单位质量响应值RSD%判断
2421.392439.010.52数据可信
供试品溶液-2025030422批-pH1.2(内含0.05%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min112859-1285929.70529.0910.6629.7029.0910.65
212880-1288029.75329.75
310310-1031023.81623.82
412696-1269629.32829.33
512332-1233228.48728.49
614477-1447733.44233.44
10min125908-2590859.84857.2210.2359.9057.2710.23
226033-2603360.13760.19
320712-2071247.84547.88
425123-2512358.03558.08
522999-2299953.12853.18
627846-2784664.32564.38
15min134130-3413078.84176.496.8278.9976.636.82
234072-3407278.70778.86
329311-2931167.70967.83
433839-3383978.16978.31
531671-3167173.16173.30
635649-3564982.35082.51
20min136915-3691585.27585.233.7885.5685.503.79
237162-3716285.84586.13
334468-3446879.62279.85
437731-3773187.16087.44
536505-3650584.32884.59
638587-3858789.13789.44
30min138063-3806387.92789.261.8888.3589.681.89
238343-3834388.57389.00
338024-3802487.83688.20
439288-3928890.75691.18
538344-3834488.57688.97
639782-3978291.89892.35
45min137980-3798087.73589.702.0788.3090.262.07
237947-3794787.65988.23
338854-3885489.75490.27
439625-3962591.53592.11
538723-3872389.45190.00
639858-3985892.07392.68
60min137428-3742886.46088.961.5887.1889.671.56
238151-3815188.13088.85
338791-3879189.60890.27
438831-3883189.70190.43
538989-3898990.06690.76
638866-3886689.78290.54
极限137713-3771387.11888.691.8687.9889.551.85
237513-3751386.65687.52
338863-3886389.77590.58
438401-3840188.70789.58
538447-3844788.81489.66
639429-3942991.08291.99
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%
1 16.133894738864390523894438871389360.20
2 16.103967839570396240.20
单位质量响应值RSD%判断
2413.892461.121.38数据可信
供试品溶液-KC031批-pH1.2(内含0.05%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17566-756617.42716.415.1317.4316.415.13
27502-750217.27917.28
37010-701016.14616.15
46680-668015.38615.39
57195-719516.57216.57
66787-678715.63215.63
10min115578-1557835.88135.133.6735.9135.163.66
214866-1486634.24134.27
314423-1442333.22033.25
415619-1561935.97536.00
515103-1510334.78734.81
615930-1593036.69136.72
15min124240-2424055.83255.475.8355.9255.555.82
223338-2333853.75453.84
322640-2264052.14752.23
425644-2564459.06659.15
522794-2279452.50152.59
625835-2583559.50659.59
20min130926-3092671.23271.616.6471.4171.796.63
230295-3029569.77869.95
328933-2893366.64166.81
433493-3349377.14477.33
529218-2921867.29867.47
633673-3367377.55977.75
30min137794-3779487.05187.914.1287.3588.214.12
238214-3821488.01888.31
336088-3608883.12183.40
439790-3979091.64891.96
536992-3699285.20385.49
640132-4013292.43692.75
45min140849-4084994.08792.991.9794.5393.441.98
240685-4068593.70994.15
338977-3897789.77590.19
440920-4092094.25194.72
539869-3986991.83092.26
640949-4094994.31794.79
60min140771-4077193.90792.811.3194.5193.411.32
240596-4059693.50494.10
339347-3934790.62891.20
440310-4031092.84693.47
540100-4010092.36292.94
640646-4064693.62094.25
极限140577-4057793.46192.141.8394.2292.891.83
241116-4111694.70295.45
339370-3937090.68191.40
439840-3984091.76392.54
539187-3918790.25990.99
639924-3992491.95792.74
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%
1 16.133945139600394953952939454395060.16
2 16.103879338524386580.50
单位质量响应值RSD%判断
2449.232401.121.41数据可信
供试品溶液-KC031批-pH1.2(内含0.05%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17029-702916.27216.152.7316.2716.152.72
27049-704916.31916.32
36902-690215.97815.98
46704-670415.52015.52
56904-690415.98315.98
67272-727216.83516.83
10min116684-1668438.62437.553.2938.6537.583.29
216022-1602237.09137.12
316171-1617137.43637.46
416152-1615237.39237.42
515387-1538735.62135.65
616903-1690339.13139.16
15min127003-2700362.51261.293.8962.6061.383.89
225809-2580959.74859.84
327307-2730763.21663.31
426761-2676161.95262.04
524693-2469357.16557.25
627269-2726963.12863.22
20min134544-3454479.97079.682.4480.1779.872.44
234218-3421879.21579.40
334613-3461380.13080.32
435395-3539581.94082.13
532907-3290776.18076.36
634841-3484180.65780.86
30min140117-4011792.87193.440.9693.2093.760.96
240018-4001892.64292.96
340824-4082494.50894.84
440878-4087894.63394.96
540218-4021893.10593.41
640115-4011592.86793.20
45min140832-4083294.52795.461.3595.0195.941.34
240700-4070094.22194.70
341938-4193897.08797.57
441624-4162496.36096.85
541622-4162296.35596.82
640694-4069494.20794.69
60min140247-4024793.17293.691.4593.8194.331.45
240253-4025393.18693.82
341283-4128395.57196.22
440855-4085594.58095.23
540603-4060393.99694.62
639580-3958091.62892.27
极限140005-4000592.61292.281.1193.4193.081.10
239392-3939291.19391.98
340158-4015892.96693.77
440135-4013592.91393.72
540255-4025593.19193.97
639223-3922390.80291.60
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