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 15.943907239069386523922939132390310.57
2 15.973835338363383580.02
单位质量响应值RSD%判断
2448.622401.881.37数据可信
供试品溶液-2025030422批-pH6.8(内含0.1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17593-759317.57715.7315.8317.5815.7315.82
27797-779718.04918.05
37678-767817.77417.77
46553-655315.17015.17
55186-518612.00512.01
65952-595213.77813.78
10min118521-1852142.87542.759.6142.9042.789.61
220016-2001646.33646.37
320425-2042547.28247.31
417660-1766040.88240.91
515503-1550335.88835.91
618677-1867743.23643.26
15min127267-2726763.12163.615.7863.2263.715.78
228664-2866466.35566.46
329347-2934767.93668.04
426528-2652861.41061.50
524958-2495857.77657.86
628107-2810765.06665.16
20min133002-3300276.39776.553.0976.6076.753.11
233839-3383978.33578.55
334165-3416579.08979.31
432419-3241975.04875.24
531413-3141372.71972.89
633565-3356577.70077.90
30min137731-3773187.34487.971.8687.6888.301.87
238132-3813288.27388.62
338663-3866389.50289.86
438203-3820388.43788.76
536729-3672985.02585.32
638539-3853989.21589.55
45min140243-4024393.16093.271.3293.6493.751.33
240243-4024393.16093.66
340526-4052693.81594.32
440661-4066194.12794.60
539302-3930290.98191.42
640775-4077594.39194.87
60min140713-4071394.24893.030.9594.8893.660.96
239890-3989092.34292.99
340311-4031193.31793.98
440414-4041493.55594.18
539648-3964891.78292.37
640149-4014992.94293.58
极限140854-4085494.57493.271.3095.3794.061.31
239954-3995492.49193.30
340569-4056993.91494.73
440540-4054093.84794.63
539408-3940891.22791.97
640431-4043193.59594.39
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 15.947640676294761977623176265762790.11
2 15.977618076115761480.07
单位质量响应值RSD%判断
4785.384768.190.26数据可信
供试品溶液-2025030221批-pH6.8(内含0.1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15831-58316.8538.7315.896.858.7415.90
26320-63207.4277.43
38371-83719.8389.84
48491-84919.9799.98
57116-71168.3638.36
68465-84659.9489.95
10min118722-1872222.00227.1314.7022.0127.1514.71
219218-1921822.58522.60
326365-2636530.98531.00
424969-2496929.34429.36
523118-2311827.16927.18
626130-2613030.70830.73
15min133363-3336339.20946.0512.5539.2646.1112.55
232919-3291938.68738.74
342018-4201849.38049.45
442234-4223449.63449.70
539917-3991746.91146.97
644653-4465352.47752.54
20min147079-4707955.32861.529.2855.4461.669.29
245634-4563453.63053.74
354397-5439763.92864.08
455697-5569765.45665.60
553664-5366463.06763.20
657634-5763467.73367.89
30min165196-6519676.62079.294.2276.8379.534.23
263689-6368974.84875.05
366984-6698478.72178.98
470860-7086083.27683.53
567574-6757479.41479.66
670494-7049482.84683.11
45min176552-7655289.96590.442.5790.3090.822.58
275813-7581389.09789.43
376044-7604489.36889.76
479950-7995093.95994.35
574688-7468887.77588.15
678703-7870392.49392.90
60min179777-7977793.75593.072.1294.2493.602.12
279165-7916593.03693.51
377045-7704590.54591.08
481538-8153895.82596.38
577537-7753791.12391.64
680123-8012394.16294.72
极限182313-8231396.73694.862.7597.3895.532.72
282079-8207996.46197.09
378286-7828692.00392.69
483277-8327797.86998.58
577978-7797891.64192.31
680353-8035394.43295.15
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 15.947600576189761087578675916760010.21
2 15.977736577389773770.03
单位质量响应值RSD%判断
4767.944845.151.14数据可信
供试品溶液-2025030221批-pH6.8(内含0.1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min18513-85139.9437.8721.579.947.8721.57
26672-66727.7937.79
34580-45805.3505.35
45619-56196.5636.56
57885-78859.2109.21
67177-71778.3838.38
10min127422-2742232.02925.8716.0532.0525.8816.05
223930-2393027.95127.96
317893-1789320.89920.91
418511-1851121.62121.63
523028-2302826.89726.91
622094-2209425.80625.82
15min145446-4544653.08245.0113.5353.1545.0613.53
243916-4391651.29551.35
333911-3391139.60939.65
432545-3254538.01338.06
538152-3815244.56244.62
637220-3722043.47343.53
20min157651-5765167.33760.229.1467.5060.359.16
256746-5674666.28066.43
347594-4759455.59055.70
446183-4618353.94254.05
550123-5012358.54458.68
651028-5102859.60159.73
30min170127-7012781.90978.144.2482.1878.374.26
270652-7065282.52382.78
364670-6467075.53575.74
463957-6395774.70374.90
565566-6556676.58276.81
666420-6642077.57977.81
45min176569-7656989.43489.431.6989.8489.801.70
278950-7895092.21592.61
376571-7657189.43689.76
475893-7589388.64488.97
575105-7510587.72488.08
676324-7632489.14889.51
60min178279-7827991.43191.151.6991.9991.661.70
280227-8022793.70694.25
378630-7863091.84192.32
477248-7724890.22790.70
576539-7653989.39989.90
677302-7730290.29090.80
极限179163-7916392.46492.511.2893.1793.171.28
280467-8046793.98794.69
380382-8038293.88794.52
478404-7840491.57792.20
578660-7866091.87692.53
678123-7812391.24991.91
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