利伐沙班口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数1000
标示量(mg)15供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.214860474864184856204858764857044859330.07
215.184849284847124848200.04
单位质量响应值RSD%判断
31948.2631938.080.03数据可信
供试品溶液-JPS7664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%
5min147334-473348.8557.947.058.867.947.06
238794-387947.2587.26
340363-403637.5517.55
443402-434028.1208.12
543482-434828.1358.13
641357-413577.7377.74
10min184425-8442515.79415.093.1215.8115.113.12
278450-7845014.67714.69
378116-7811614.61414.63
482917-8291715.51215.53
579764-7976414.92214.94
680343-8034315.03115.04
15min1105180-10518019.67718.922.7319.7218.962.72
2100006-10000618.70918.75
398077-9807718.34818.39
4103386-10338619.34219.38
598720-9872018.46918.51
6101381-10138118.96719.00
20min1121370-12137022.70621.942.5422.7822.012.53
2117246-11724621.93522.00
3113689-11368921.26921.34
4119413-11941322.34022.41
5114160-11416021.35721.43
6117665-11766522.01322.08
30min1143859-14385926.91326.371.9627.0326.481.97
2141379-14137926.45026.55
3138032-13803225.82325.93
4144281-14428126.99227.10
5137873-13787325.79425.90
6140290-14029026.24626.35
45min1169704-16970431.74931.361.7731.9131.521.77
2168954-16895431.60831.76
3164690-16469030.81130.96
4171825-17182532.14532.30
5164689-16468930.81030.96
6165972-16597231.05031.20
60min1191174-19117435.76535.441.7035.9735.641.70
2191374-19137435.80336.00
3186908-18690834.96735.16
4193894-19389436.27436.48
5185597-18559734.72234.92
6187507-18750735.07935.28
极限1238235-23823544.57044.260.8444.8444.520.85
2236618-23661844.26744.53
3235830-23583044.12044.38
4239472-23947244.80145.07
5234129-23412943.80144.06
6235184-23518443.99944.26
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