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D211-4R701-2402002对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.5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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.102073002072912075522076122072122073930.09
218.032072952078302075620.19
单位质量响应值RSD%判断
11458.1811512.040.34数据可信
加速6月-供试品溶液-2025010421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%
5min17343-73433.5783.0921.243.583.0921.28
26046-60462.9462.95
37120-71203.4703.47
46841-68413.3343.33
53742-37421.8241.82
66946-69463.3853.38
10min110081-100814.9134.747.424.954.777.47
29614-96144.6854.72
310453-104535.0945.13
49999-99994.8734.91
58366-83664.0774.10
69797-97974.7744.81
15min112742-127426.2095.906.016.305.996.11
212165-121655.9286.01
312708-127086.1936.29
412250-122505.9706.06
510744-107445.2365.30
612077-120775.8855.98
20min119268-192689.3908.556.469.558.706.47
217654-176548.6038.75
318087-180878.8148.98
417336-173368.4488.61
515871-158717.7347.86
617017-170178.2938.45
30min122621-2262111.02410.854.2911.2911.104.35
222356-2235610.89411.14
323426-2342611.41611.68
422732-2273211.07811.33
520640-2064010.05810.27
621820-2182010.63310.88
45min133445-3344516.29816.442.7516.6916.812.80
234156-3415616.64517.01
334847-3484716.98217.37
434291-3429116.71117.09
532187-3218715.68516.01
633475-3347516.31316.68
60min146322-4632222.57422.282.6023.1422.832.64
246965-4696522.88723.44
346537-4653722.67823.26
446005-4600522.41922.98
544061-4406121.47221.97
644438-4443821.65522.20
极限151098-5109824.90124.912.6925.7225.712.71
252336-5233625.50426.31
353058-5305825.85626.69
450842-5084224.77625.59
549897-4989724.31625.05
649501-4950124.12324.91
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D211-4R701-2402002对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.5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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.102071822065972069042073282069852069990.14
218.032057822057922057870.01
单位质量响应值RSD%判断
11436.4111413.590.15数据可信
长期6月-供试品溶液-2025010421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%
5min16074-60742.9762.945.312.982.945.32
26007-60072.9432.94
36382-63823.1263.13
46169-61693.0223.02
55427-54272.6592.66
65982-59822.9302.93
10min19664-96644.7344.882.624.774.912.61
210102-101024.9494.98
310245-102455.0195.05
410182-101824.9885.02
59644-96444.7244.75
69940-99404.8694.90
15min112536-125366.1416.302.076.236.382.08
213249-132496.4906.58
312950-129506.3446.43
412949-129496.3436.43
512577-125776.1616.24
612890-128906.3156.40
20min117878-178788.7588.762.708.918.922.69
218225-182258.9289.09
318048-180488.8419.00
418330-183308.9809.14
516980-169808.3188.47
617830-178308.7358.89
30min123010-2301011.27211.453.3611.5211.713.34
224310-2431011.90912.17
324188-2418811.84912.11
423647-2364711.58411.84
522547-2254711.04511.29
622572-2257211.05811.31
45min134573-3457316.93717.322.6817.3117.702.67
236800-3680018.02818.42
335388-3538817.33617.73
435405-3540517.34417.73
534120-3412016.71517.08
635844-3584417.55917.94
60min148700-4870023.85723.802.1224.4224.372.12
248922-4892223.96624.56
349379-4937924.19024.77
449614-4961424.30524.89
546802-4680222.92723.48
648049-4804923.53824.11
极限153125-5312526.02526.101.6126.8526.941.56
254516-5451626.70627.56
353721-5372126.31727.17
452083-5208325.51426.37
553547-5354726.23227.04
652657-5265725.79626.63
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D211-4R701-2402002对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)99.5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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
118.102070032072332074092072992073132072510.08
218.032065312067292066300.07
单位质量响应值RSD%判断
11450.3311460.340.07数据可信
中间条件6月-供试品溶液-2025010421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%
5min14747-47472.3191.8016.112.321.8016.14
23391-33911.6571.66
33463-34631.6921.69
44050-40501.9791.98
53309-33091.6171.62
63202-32021.5641.56
10min18308-83084.0593.963.104.083.983.15
27826-78263.8243.84
38432-84324.1204.14
48196-81964.0044.03
57867-78673.8443.86
67949-79493.8843.90
15min111182-111825.4635.154.055.535.214.06
210400-104005.0815.14
310868-108685.3105.37
410518-105185.1395.21
510014-100144.8934.95
610231-102314.9995.06
20min116759-167598.1887.992.888.328.112.89
216257-162577.9438.06
316810-168108.2138.34
416499-164998.0618.18
515519-155197.5827.70
616270-162707.9498.07
30min122468-2246810.97710.653.1111.2010.863.13
221243-2124310.37910.58
322808-2280811.14411.36
421544-2154410.52610.74
521181-2118110.34910.55
621527-2152710.51810.72
45min138180-3818018.65418.461.2419.0018.791.25
237818-3781818.47718.80
338291-3829118.70819.05
437067-3706718.11018.44
537426-3742618.28618.60
637939-3793918.53618.86
60min145515-4551522.23822.122.3022.7922.662.26
246133-4613322.54023.07
345629-4562922.29422.84
444447-4444721.71622.25
543637-4363721.32021.84
646322-4632222.63223.16
极限150844-5084424.84125.433.6925.6426.213.57
252471-5247125.63626.41
351363-5136325.09525.89
455747-5574727.23728.01
551313-5131325.07125.82
650596-5059624.72025.50
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