美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D209-20230901R1 对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.202046082048202045902039612036802043320.24
218.192031752033382032560.06
单位质量响应值RSD%判断
11227.0311174.050.34数据可信
长期24月-供试品溶液-2023082421批-pH7.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min15694-56942.6642.642.962.662.642.93
25411-54112.5322.53
35683-56832.6592.66
45663-56632.6492.65
55908-59082.7642.76
65535-55352.5902.59
10min18907-89074.1674.182.154.204.212.09
28789-87894.1124.14
39008-90084.2144.24
48716-87164.0784.11
58949-89494.1874.22
69264-92644.3344.36
15min112847-128476.0106.202.646.096.282.61
213254-132546.2016.27
313701-137016.4106.49
413159-131596.1566.23
513626-136266.3756.45
612946-129466.0576.13
20min115925-159257.4507.612.297.597.762.29
216026-160267.4987.64
316488-164887.7147.86
416250-162507.6037.75
516903-169037.9088.06
616021-160217.4957.64
30min126315-2631512.31112.491.6312.5412.721.61
226695-2669512.48912.72
327335-2733512.78913.02
426874-2687412.57312.80
526887-2688712.57912.81
626135-2613512.22712.45
45min134870-3487016.31416.631.2416.6817.001.22
235671-3567116.68917.05
335941-3594116.81517.19
435189-3518916.46316.83
535562-3556216.63817.01
636005-3600516.84517.21
60min146557-4655721.78222.261.2422.3322.821.23
247941-4794122.42922.98
348129-4812922.51723.08
447210-4721022.08722.64
547866-4786622.39422.95
647794-4779422.36022.91
极限151854-5185424.26024.390.8825.0525.190.85
252041-5204124.34725.15
352775-5277524.69125.50
452434-5243424.53125.33
551470-5147024.08024.89
652203-5220324.42325.22
美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D209-20230901R1 对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.202042812040412037642032652036852038070.19
218.192023802036352030080.44
单位质量响应值RSD%判断
11198.1911160.420.24数据可信
长期24月-供试品溶液-2023082521批-pH7.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min16700-67003.1413.093.463.143.093.45
26391-63912.9963.00
36882-68823.2263.23
46512-65123.0523.05
56317-63172.9612.96
66794-67943.1853.18
10min110213-102134.7874.742.274.824.782.33
29972-99724.6744.71
310495-104954.9194.96
49892-98924.6374.67
59941-99414.6604.69
610219-102194.7904.83
15min114560-145606.8256.752.126.916.832.10
214470-144706.7836.87
314602-146026.8446.93
413978-139786.5526.64
514054-140546.5886.67
614712-147126.8966.98
20min117277-172778.0988.022.578.268.182.58
217504-175048.2058.37
317620-176208.2598.43
416598-165987.7807.94
516609-166097.7857.94
617028-170287.9828.15
30min128339-2833913.28313.232.0513.5413.482.04
228155-2815513.19713.45
329107-2910713.64313.90
427586-2758612.93113.18
527633-2763312.95313.20
628566-2856613.39013.64
45min136820-3682017.25917.241.9117.6617.641.90
237338-3733817.50217.90
336486-3648617.10217.51
436195-3619516.96617.35
536028-3602816.88817.28
637857-3785717.74518.15
60min148628-4862822.79423.361.8323.3923.951.81
250793-5079323.80824.40
350115-5011523.49124.09
449126-4912623.02723.60
549471-4947123.18923.76
650850-5085023.83524.44
极限155013-5501325.78725.401.9526.6326.251.93
254516-5451625.55426.41
354954-5495425.75926.62
452683-5268324.69425.53
553037-5303724.86025.69
654940-5494025.75226.62
美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D209-20230901R1 对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.202019492013122007312003711998682008460.41
218.192010562012942011750.09
单位质量响应值RSD%判断
11035.4911059.650.16数据可信
长期24月-供试品溶液-2023082621批-pH7.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min15168-51682.4512.523.802.452.523.71
25050-50502.3952.40
35248-52482.4892.49
45440-54402.5802.58
55617-56172.6642.66
65299-52992.5132.51
10min18711-87114.1324.151.694.164.181.61
29011-90114.2744.30
38783-87834.1664.19
48717-87174.1354.16
58594-85944.0764.11
68638-86384.0974.13
15min113111-131116.2196.251.386.296.321.37
213159-131596.2426.32
313028-130286.1796.25
413181-131816.2526.33
513527-135276.4166.49
613059-130596.1946.27
20min116315-163157.7397.622.617.887.772.59
215978-159787.5797.72
315603-156037.4017.54
415877-158777.5317.67
516792-167927.9658.11
615883-158837.5347.68
30min125169-2516911.93811.781.9912.1712.011.96
225100-2510011.90612.13
324387-2438711.56711.79
424974-2497411.84612.07
525349-2534912.02412.26
624096-2409611.42911.66
45min134376-3437616.30516.372.1816.6716.732.14
234198-3419816.22116.58
334428-3442816.33016.68
435366-3536616.77517.13
535344-3534416.76417.13
633382-3338215.83416.19
60min146091-4609121.86221.422.3922.4021.972.35
243612-4361220.68621.23
345100-4510021.39221.93
444978-4497821.33421.88
546638-4663822.12222.68
644599-4459921.15421.68
极限151193-5119324.28224.411.5225.0725.191.48
250383-5038323.89824.67
352383-5238324.84725.62
452368-5236824.83925.62
551408-5140824.38425.18
651088-5108824.23225.00
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