缬沙坦氨氯地平片项目信息
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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.872383712383242383712384092382652383480.03
213.942408782406122407450.08
单位质量响应值RSD%判断
17184.4317270.090.36数据可信
加速6月-供试品溶液-BDJL7批-氨氯地平-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%
5min111047-110474.1574.9033.144.164.9033.13
210592-105923.9863.99
38741-87413.2893.29
416951-169516.3796.38
510981-109814.1324.13
619739-197397.4287.43
10min110094-100943.7984.2714.403.814.2814.37
211805-118054.4424.45
38670-86703.2623.27
412274-122744.6194.63
512383-123834.6604.67
612919-129194.8614.87
15min112937-129374.8685.4412.504.885.4512.53
215432-154325.8075.82
311486-114864.3224.33
415765-157655.9325.95
515773-157735.9355.95
615338-153385.7725.79
20min116244-162446.1136.7112.096.136.7312.14
219049-190497.1687.19
314151-141515.3255.34
419616-196167.3817.41
518932-189327.1247.15
618967-189677.1377.17
30min122026-220268.2889.0011.698.329.0411.69
225154-251549.4659.50
319244-192447.2417.27
426758-2675810.06910.11
524571-245719.2469.28
625817-258179.7159.76
45min129922-2992211.26011.829.6611.3011.879.68
231861-3186111.98912.04
326522-265229.98010.02
434235-3423512.88312.94
531169-3116911.72911.78
634829-3482913.10613.16
60min12363-23630.8892.88163.570.952.95159.38
22536-25360.9541.03
333238-3323812.50712.56
42743-27431.0321.11
52327-23270.8760.95
62761-27611.0391.12
90min14383-43831.6491.717.061.711.786.87
24589-45891.7271.80
33988-39881.5011.58
44843-48431.8221.90
54621-46211.7391.81
64830-48301.8181.90
120min15940-59402.2352.335.362.302.405.22
26278-62782.3622.44
35627-56272.1172.20
46434-64342.4212.50
56372-63722.3982.47
66450-64502.4272.51
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限17303-73032.7482.796.422.822.876.34
27871-78712.9623.04
36567-65672.4712.55
47813-78132.9403.03
57326-73262.7572.84
67570-75702.8492.94
缬沙坦氨氯地平片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
116.014756789475242247510034752010475256147529570.05
216.004793909479218347930460.03
单位质量响应值RSD%判断
296874.27299565.380.64数据可信
加速6月-供试品溶液-BDJL7批-缬沙坦-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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min136668-366680.6850.6249.460.690.6249.42
238763-387630.7250.72
3-0.0000.00
441807-418070.7810.78
538069-380690.7120.71
642510-425100.7950.79
90min149277-492770.9210.977.960.920.977.88
251601-516010.9650.97
345917-459170.8580.86
456302-563021.0521.05
551417-514170.9610.96
656635-566351.0591.06
120min163547-635471.1881.237.181.191.247.08
265066-650661.2161.22
359081-590811.1041.11
471662-716621.3401.34
565184-651841.2181.22
670893-708931.3251.33
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限175030-750301.4031.5411.641.411.5411.49
277409-774091.4471.45
3101036-1010361.8891.89
482830-828301.5481.55
576703-767031.4341.44
681579-815791.5251.53
缬沙坦氨氯地平片项目信息
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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9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0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.872398922399722402782401032402042400900.07
213.942424512424862424680.02
单位质量响应值RSD%判断
17310.0217393.690.35数据可信
加速6月-供试品溶液-BDJL7批-氨氯地平-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%
5min113377-133774.9985.5114.975.005.5114.99
216139-161396.0296.03
315654-156545.8485.85
411007-110074.1124.11
517097-170976.3876.39
615169-151695.6675.67
10min111277-112774.2134.595.304.224.605.33
213068-130684.8824.89
312279-122794.5874.60
411846-118464.4264.43
512814-128144.7874.80
612421-124214.6404.65
15min114391-143915.3765.713.215.395.723.21
215479-154795.7835.80
315757-157575.8875.90
415327-153275.7265.74
515608-156085.8315.85
615109-151095.6455.66
20min117670-176706.6017.104.676.637.134.62
218549-185496.9306.96
319747-197477.3777.40
419045-190457.1157.14
518854-188547.0447.07
620174-201747.5377.56
30min123430-234308.7539.376.198.799.416.18
224601-246019.1919.23
324732-247329.2409.28
425362-253629.4759.51
524428-244289.1269.17
627991-2799110.45710.50
45min130828-3082811.51710.2044.7911.5710.2544.55
232873-3287312.28112.34
331257-3125711.67711.73
433985-3398512.69712.75
532396-3239612.10312.16
62451-24510.9160.97
60min12132-21320.7970.9813.260.871.0511.92
22775-27751.0371.11
32298-22980.8590.93
42698-26981.0081.08
52699-26991.0081.08
63095-30951.1561.21
90min14187-41871.5641.7610.901.631.8310.26
24731-47311.7671.84
34174-41741.5591.64
44722-47221.7641.84
54846-48461.8101.89
65566-55662.0792.14
120min15876-58762.1952.439.432.272.519.00
26656-66562.4872.57
35774-57742.1572.24
46643-66432.4822.56
56637-66372.4802.56
67447-74472.7822.85
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限16839-68392.5552.857.912.632.937.58
27770-77702.9032.99
37033-70332.6272.71
48008-80082.9923.07
57660-76602.8622.95
68449-84493.1563.22
缬沙坦氨氯地平片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80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%
116.014768160477127447749004776320477855047738410.09
216.004797064479955147983080.04
单位质量响应值RSD%判断
298178.70299894.250.41数据可信
加速6月-供试品溶液-BDJL7批-缬沙坦-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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.12244.950.000.12244.95
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
638423-384230.7160.72
60min138292-382920.7140.767.880.710.768.24
240138-401380.7480.75
338314-383140.7140.71
440568-405680.7560.76
539980-399800.7450.75
646945-469450.8750.88
90min152701-527010.9821.026.660.981.026.74
254094-540941.0081.01
350989-509890.9500.95
454551-545511.0171.02
554106-541061.0091.01
661607-616071.1481.15
120min167525-675251.2591.295.121.261.295.13
268845-688451.2831.29
364515-645151.2031.21
469359-693591.2931.30
568616-686161.2791.28
675315-753151.4041.41
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限179033-790331.4731.504.331.481.504.35
280944-809441.5091.51
375987-759871.4161.42
480547-805471.5011.51
579706-797061.4861.49
686593-865931.6141.62
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