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%
118.102080462077012082212075232075052077990.16
218.032075572066712071140.31
单位质量响应值RSD%判断
11480.6111487.190.05数据可信
加速6月-供试品溶液-2025010221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%
5min13697-36971.8021.688.321.801.688.28
23517-35171.7141.71
33208-32081.5631.56
43735-37351.8201.82
53010-30101.4671.47
63568-35681.7391.74
10min18489-84894.1373.974.374.163.994.39
27990-79903.8943.91
37736-77363.7703.79
48657-86574.2194.24
57906-79063.8533.87
68087-80873.9413.96
15min111574-115745.6415.552.275.715.622.24
211014-110145.3685.43
311398-113985.5555.61
411451-114515.5815.65
511739-117395.7215.78
611208-112085.4625.53
20min116908-169088.2408.211.488.378.341.46
216806-168068.1918.31
316553-165538.0678.19
416926-169268.2498.38
517247-172478.4068.53
616626-166268.1038.23
30min121859-2185910.65310.451.6610.8710.661.63
221461-2146110.45910.67
321096-2109610.28110.49
421413-2141310.43610.66
521804-2180410.62710.84
620993-2099310.23110.45
45min133779-3377916.46316.181.9116.8016.521.89
232761-3276115.96716.30
332771-3277115.97216.30
433242-3324216.20116.54
534124-3412416.63116.97
632548-3254815.86316.19
60min146423-4642322.62522.962.4423.1523.482.36
246126-4612622.48022.99
349176-4917623.96724.47
446411-4641122.61923.14
547663-4766323.22923.75
646869-4686922.84223.35
极限150734-5073424.72624.571.8225.5025.341.78
250640-5064024.68025.44
350593-5059324.65725.43
449178-4917823.96824.74
551768-5176825.23026.01
649612-4961224.17924.94
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%
118.102068152069822066342068252068572068230.07
218.032057632060792059210.11
单位质量响应值RSD%判断
11426.6911421.020.04数据可信
长期6月-供试品溶液-2025010221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%
5min13570-35701.7491.8513.801.751.8513.73
23517-35171.7231.72
34271-42712.0922.09
43634-36341.7801.78
54559-45592.2342.23
63163-31631.5501.55
10min18662-86624.2444.383.844.264.403.91
28839-88394.3304.35
39373-93734.5924.62
48690-86904.2574.28
59372-93724.5924.62
68692-86924.2584.28
15min111815-118155.7895.873.735.865.943.72
211953-119535.8565.92
312767-127676.2556.33
411392-113925.5815.65
511964-119645.8625.94
611949-119495.8545.92
20min119465-194659.5369.553.689.679.683.66
219654-196549.6299.76
320716-2071610.14910.29
418608-186089.1179.25
519521-195219.5649.70
618985-189859.3019.43
30min124881-2488112.19012.102.1012.4312.342.15
224693-2469312.09812.34
325423-2542312.45512.71
423991-2399111.75411.98
524938-2493812.21812.47
624219-2421911.86612.10
45min135943-3594317.61017.132.6917.9817.502.66
234427-3442716.86717.24
336120-3612017.69618.09
433648-3364816.48516.85
534686-3468616.99417.38
634946-3494617.12117.49
60min151229-5122925.09924.461.8225.6725.031.82
249839-4983924.41824.98
350819-5081924.89825.49
449366-4936624.18624.73
548885-4888523.95024.52
649467-4946724.23524.79
极限155580-5558027.23026.492.2628.0827.332.26
254084-5408426.49727.33
355515-5551527.19828.07
452795-5279525.86626.68
553351-5335126.13826.98
653100-5310026.01526.84
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%
118.102079232072082071842070612071352073020.17
218.032012022000832006420.40
单位质量响应值RSD%判断
11453.1511128.232.04数据不可信!(响应值差异过大,请重新称样测定!)
中间条件6月-供试品溶液-2025010221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%
5min13310-33101.6411.8713.061.641.8713.08
24440-44402.2012.20
33885-38851.9261.93
43378-33781.6751.67
53368-33681.6701.67
64243-42432.1042.10
10min19065-90654.4954.455.854.514.475.86
29600-96004.7604.78
39358-93584.6404.66
48098-80984.0154.03
58736-87364.3314.35
69018-90184.4714.49
15min111883-118835.8925.743.265.965.813.29
212032-120325.9666.04
311469-114695.6865.76
411152-111525.5295.59
511166-111665.5365.60
611794-117945.8485.92
20min119276-192769.5579.124.219.699.254.20
219213-192139.5269.67
318229-182299.0389.17
417803-178038.8278.95
517319-173198.5878.72
618525-185259.1859.32
30min123989-2398911.89411.303.9912.1311.533.96
223493-2349311.64811.90
322533-2253311.17211.41
422503-2250311.15711.38
521363-2136310.59210.82
622834-2283411.32111.56
45min135367-3536717.53516.873.2617.9117.243.28
235096-3509617.40117.78
333963-3396316.83917.20
433469-3346916.59416.94
532327-3232716.02816.37
633983-3398316.84917.21
60min147524-4752423.56322.413.1824.1322.963.18
245601-4560122.60923.18
345297-4529722.45923.01
443937-4393721.78422.32
543432-4343221.53422.05
645361-4536122.49023.04
极限153661-5366126.60625.593.9027.4326.393.85
251562-5156225.56526.39
349978-4997824.78025.58
451077-5107725.32426.10
549137-4913724.36325.12
654247-5424726.89627.70
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