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%
119.702011742012452015182013162022372014980.22
219.791985801993441989620.28
单位质量响应值RSD%判断
10228.3210053.661.22数据可信
供试品溶液-6087549批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min139459-3945920.39120.172.6620.3920.172.65
238824-3882420.06320.06
340041-4004120.69220.69
438435-3843519.86219.86
540079-4007920.71120.71
637401-3740119.32819.33
10min153059-5305927.41923.4343.2727.6523.6642.85
25307-53072.7422.97
353330-5333027.55927.79
453071-5307127.42527.65
553541-5354127.66827.90
653779-5377927.79128.01
15min153711-5371127.75628.812.3328.2929.302.28
256067-5606728.97329.23
356995-5699529.45329.99
454714-5471428.27428.80
556099-5609928.99029.53
656926-5692629.41729.94
20min157506-5750629.71729.911.7030.5630.711.98
256153-5615329.01829.59
358417-5841730.18831.05
458869-5886930.42131.26
557778-5777829.85830.72
658510-5851030.23631.09
30min156344-5634429.11730.211.9630.2931.341.91
258668-5866830.31831.22
359509-5950930.75231.95
458096-5809630.02231.20
558908-5890830.44231.63
659207-5920730.59631.78
45min15070-50702.6207.30154.774.118.77128.99
25054-50542.6123.85
35317-53172.7484.29
458754-5875430.36231.87
55186-51862.6804.21
65378-53782.7794.31
60min15761-57612.9773.113.614.504.664.85
25866-58663.0314.29
36126-61263.1664.74
45883-58833.0404.89
56312-63123.2624.82
66188-61883.1984.75
极限16552-65523.3863.482.984.945.064.37
26582-65823.4014.70
36883-68833.5575.16
46611-66113.4165.30
57058-70583.6475.24
66687-66873.4565.05
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%
119.702050252032672024402034362026532033640.50
219.792000182004992002580.17
单位质量响应值RSD%判断
10323.0510119.151.42数据可信
供试品溶液-6087549批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min133304-3330417.07617.283.6017.0817.283.60
233331-3333117.09017.09
334189-3418917.53017.53
432120-3212016.46916.47
533459-3345917.15517.16
635766-3576618.33818.34
10min147706-4770624.46024.670.9824.6524.860.96
248427-4842724.83025.02
347917-4791724.56824.76
448719-4871924.98025.16
548384-4838424.80825.00
647509-4750924.35924.56
15min151419-5141926.36427.052.2826.8327.522.25
253653-5365327.50927.98
351621-5162126.46826.94
452036-5203626.68027.14
553851-5385127.61128.08
654019-5401927.69728.17
20min156219-5621928.82528.581.2829.5829.351.22
256136-5613628.78229.55
355397-5539728.40429.17
455581-5558128.49829.25
556563-5656329.00129.77
654599-5459927.99428.78
30min156860-5686029.15429.371.2330.2330.461.19
258552-5855230.02131.11
357494-5749429.47930.56
457096-5709629.27530.35
556508-5650828.97330.07
657195-5719529.32530.42
45min157949-5794929.71220.8967.9131.1122.3063.61
25028-50282.5784.00
359004-5900430.25331.66
45026-50262.5773.98
558644-5864430.06831.49
658801-5880130.14931.57
60min15950-59503.0512.982.774.784.623.63
26001-60013.0774.53
35855-58553.0024.74
45672-56722.9084.34
55833-58332.9914.74
65583-55832.8634.62
极限16364-63643.2633.331.945.035.002.93
26389-63893.2764.76
36505-65053.3355.11
46716-67163.4434.90
56522-65223.3445.13
66455-64553.3105.10
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