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)40供试品稀释倍数2.5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.352040062042042039212039412039922040130.06
218.392028232028762028500.02
单位质量响应值RSD%判断
11117.8711030.450.56数据可信
长期24月-供试品溶液-2023082021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%
5min16861-68613.2473.037.803.253.047.83
26804-68043.2203.22
36907-69073.2683.27
46097-60972.8852.89
55792-57922.7412.74
66007-60072.8422.84
10min110310-103104.8794.773.254.914.803.25
210245-102454.8484.88
310443-104434.9424.98
49845-98454.6594.69
59564-95644.5264.56
610040-100404.7514.78
15min115375-153757.2757.231.987.377.322.00
215688-156887.4237.51
315488-154887.3297.42
415011-150117.1037.19
514875-148757.0397.12
615222-152227.2037.29
20min118277-182778.6498.661.708.828.831.74
218615-186158.8088.98
318695-186958.8469.02
417937-179378.4888.65
517991-179918.5138.67
618287-182878.6538.82
30min125593-2559312.11012.161.3512.3812.421.34
225707-2570712.16412.43
326336-2633612.46212.73
425728-2572812.17412.43
525427-2542712.03212.29
625379-2537912.00912.27
45min138666-3866618.29618.351.0718.7018.751.08
239273-3927318.58418.99
339316-3931618.60419.01
438566-3856618.24918.64
538314-3831418.13018.52
638556-3855618.24418.64
60min148629-4862923.01123.351.3223.6223.951.31
250087-5008723.70124.31
349687-4968723.51124.13
449897-4989723.61124.21
548569-4856922.98223.57
649180-4918023.27223.87
极限155159-5515926.10126.241.5026.9627.101.48
256354-5635426.66627.54
355396-5539626.21327.09
456332-5633226.65627.51
554134-5413425.61626.46
655301-5530126.16827.02
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)40供试品稀释倍数2.5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.352029952028312028572026482030292028720.08
218.391954411957601956000.12
单位质量响应值RSD%判断
11055.6910636.222.74数据不可信!(响应值差异过大,请重新称样测定!)
长期24月-供试品溶液-2023082021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%
5min16749-67493.2623.269.613.263.269.61
25808-58082.8072.81
36149-61492.9722.97
47202-72023.4813.48
57509-75093.6293.63
67006-70063.3863.39
10min110468-104685.0594.953.215.104.993.30
29730-97304.7034.73
310019-100194.8424.88
410548-105485.0985.14
510523-105235.0865.13
610181-101814.9214.96
15min115375-153757.4317.432.567.527.522.61
214845-148457.1757.26
315283-152837.3877.47
415521-155217.5027.60
516035-160357.7507.85
615208-152087.3507.44
20min118230-182308.8118.781.908.998.951.93
217639-176398.5258.69
317968-179688.6848.85
418495-184958.9399.12
518560-185608.9709.15
618088-180888.7428.92
30min126095-2609512.61212.631.7412.8912.901.72
226171-2617112.64912.91
326437-2643712.77813.04
425979-2597912.55612.83
526722-2672212.91513.20
625380-2538012.26712.54
45min138156-3815618.44218.540.4518.8518.950.47
238374-3837418.54718.95
338246-3824618.48518.89
438260-3826018.49218.91
538642-3864218.67619.10
638417-3841718.56818.98
60min148504-4850423.44324.042.7324.0624.652.65
249325-4932523.84024.44
352308-5230825.28225.89
449406-4940623.87924.50
549954-4995424.14424.78
648902-4890223.63524.25
极限155974-5597427.05327.271.4527.9328.151.40
257481-5748127.78228.65
357353-5735327.72028.61
456134-5613427.13128.02
556157-5615727.14228.04
655433-5543326.79227.67
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)40供试品稀释倍数2.5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.352036532035862031732032302033292033940.11
218.392028392028752028570.02
单位质量响应值RSD%判断
11084.1411030.830.35数据可信
长期24月-供试品溶液-2023082121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%
5min14475-44752.1212.296.862.122.296.89
24736-47362.2442.24
34714-47142.2342.23
44590-45902.1752.18
55138-51382.4352.43
65329-53292.5252.53
10min19032-90324.2804.392.054.304.412.03
29035-90354.2824.31
39289-92894.4024.43
49517-95174.5104.53
59334-93344.4234.45
69331-93314.4224.45
15min114013-140136.6416.681.786.716.761.77
214071-140716.6686.74
313995-139956.6326.71
414426-144266.8366.91
513753-137536.5186.59
614361-143616.8066.88
20min117433-174338.2628.323.408.418.473.34
217364-173648.2298.38
317448-174488.2698.42
418720-187208.8719.02
516992-169928.0538.20
617360-173608.2278.38
30min127842-2784213.19413.603.4813.4313.843.44
228034-2803413.28513.52
328778-2877813.63813.88
430607-3060714.50514.75
528356-2835613.43813.68
628573-2857313.54113.78
45min139872-3987218.89518.952.2119.2819.342.21
239413-3941318.67819.06
339983-3998318.94819.34
441632-4163219.72920.14
539080-3908018.52018.91
639902-3990218.91019.30
60min151645-5164524.47524.933.7825.0725.533.75
252332-5233224.80025.39
351650-5165024.47725.08
456546-5654626.79727.43
551127-5112724.22924.82
652339-5233924.80325.41
极限157264-5726427.13727.503.5228.0028.383.49
256848-5684826.94027.81
357019-5701927.02127.89
462071-6207129.41530.34
556817-5681726.92627.79
658134-5813427.55028.43
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)40供试品稀释倍数2.5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.352019122010102014142016912011652014380.19
218.392013512001682007600.42
单位质量响应值RSD%判断
10977.5510916.800.40数据可信
长期24月-供试品溶液-2023082121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%
5min15372-53722.5712.473.752.572.473.80
24878-48782.3352.33
35127-51272.4542.45
45357-53572.5642.56
55225-52252.5012.50
65022-50222.4042.40
10min19587-95874.5894.743.654.624.773.62
210360-103604.9594.99
39668-96684.6284.66
410321-103214.9404.97
59568-95684.5804.61
69897-98974.7374.76
15min113911-139116.6596.943.336.747.023.31
215211-152117.2817.36
314364-143646.8766.95
414922-149227.1437.23
514274-142746.8336.91
614255-142556.8246.90
20min117467-174678.3618.552.178.518.712.20
218485-184858.8489.01
317712-177128.4788.63
418180-181808.7028.87
517747-177478.4958.65
617601-176018.4258.58
30min128335-2833513.56313.561.4413.8113.811.45
228811-2881113.79114.05
327998-2799813.40213.65
428830-2883013.80014.06
528000-2800013.40313.65
627966-2796613.38713.64
45min138862-3886218.60218.622.7519.0019.022.72
240095-4009519.19319.61
337850-3785018.11818.52
439731-3973119.01819.43
537411-3741117.90818.31
639426-3942618.87219.27
60min151218-5121824.51724.611.4425.1225.221.45
252432-5243225.09825.72
350685-5068524.26224.86
452242-5224225.00725.63
550908-5090824.36824.97
650992-5099224.40925.02
极限157283-5728327.42027.460.8028.3028.340.78
258091-5809127.80728.71
357624-5762427.58328.45
456759-5675927.16928.07
557319-5731927.43728.30
657104-5710427.33428.21
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