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D10291-20230504对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.2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%
115.104740004743694738574736844736584739140.07
215.114744794743984744380.02
单位质量响应值RSD%判断
31385.0331398.940.04数据可信
供试品溶液-1批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1310718-31071858.91356.873.6158.9156.873.60
2298323-29832356.56356.56
3288695-28869554.73754.74
4285907-28590754.20954.21
5310334-31033458.84058.84
6305684-30568457.95857.96
10min1436927-43692782.84280.781.7882.9480.881.78
2419501-41950179.53879.63
3418226-41822679.29779.39
4422087-42208780.02980.12
5432832-43283282.06682.16
6426756-42675680.91481.01
15min1475060-47506090.07388.341.3690.3188.571.36
2458990-45899087.02687.25
3460397-46039787.29287.52
4466104-46610488.37488.60
5471558-47155889.40989.64
6463391-46339187.86088.09
20min1493078-49307893.48991.751.3793.8892.131.38
2476516-47651690.34990.72
3479278-47927890.87291.24
4485390-48539092.03192.40
5489930-48993092.89293.28
6479347-47934790.88591.26
30min1512261-51226197.12695.371.3397.6795.901.33
2494730-49473093.80294.32
3499609-49960994.72795.25
4505521-50552195.84896.37
5507867-50786796.29396.83
6497999-49799994.42294.95
45min1524790-52479099.50297.631.38100.2198.321.38
2506392-50639296.01396.69
3511904-51190497.05897.74
4517778-51777898.17298.86
5519823-51982398.56099.26
6508806-50880696.47197.16
60min1529746-529746100.44198.591.28101.3199.441.28
2512546-51254697.18098.02
3516694-51669497.96698.81
4522531-52253199.07399.92
5524299-52429999.408100.27
6514137-51413797.48298.33
极限1535278-535278101.49099.011.51102.53100.021.51
2513134-51313497.29298.29
3518278-51827898.26799.27
4523091-52309199.179100.19
5526129-52612999.755100.78
6517233-51723398.06999.08
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D10291-20230504对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.2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%
115.104743704744154742254742204742864743030.02
215.114748504746904747700.03
单位质量响应值RSD%判断
31410.7931420.910.03数据可信
供试品溶液-2批-pH4.5(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1302799-30279957.36857.353.3757.3757.343.37
2315516-31551659.77759.78
3285780-28578054.14354.14
4303770-30377057.55257.55
5309750-30975058.68558.68
6298459-29845956.54656.55
10min1415712-41571278.76079.762.4178.8679.852.41
2431828-43182881.81381.91
3420511-42051179.66979.76
4428782-42878281.23681.33
5425123-42512380.54380.64
6403924-40392476.52776.62
15min1453540-45354085.92787.592.0486.1587.822.04
2470221-47022189.08789.32
3462501-46250187.62587.85
4472618-47261889.54189.77
5466133-46613388.31388.54
6448840-44884085.03785.26
20min1469960-46996089.03891.341.9689.4191.711.96
2488206-48820692.49592.88
3482477-48247791.40991.78
4494065-49406593.60593.99
5485769-48576992.03392.41
6472031-47203189.43089.79
30min1487765-48776592.41195.001.9892.9395.521.98
2506120-50612095.88996.43
3501907-50190795.09195.61
4514146-51414697.40997.95
5506695-50669595.99896.53
6491809-49180993.17793.69
45min1498997-49899794.53997.312.0295.2198.002.02
2521056-52105698.71899.42
3512877-51287797.16997.85
4526386-52638699.728100.43
5518015-51801598.14298.83
6504484-50448495.57996.25
60min1505324-50532495.73898.291.8196.5799.131.81
2524923-52492399.451100.31
3518050-51805098.14998.99
4530665-530665100.539101.40
5522741-52274199.03899.89
6510951-51095196.80497.63
极限1509334-50933496.49898.641.7097.4999.651.70
2528029-528029100.040101.07
3518612-51861298.25599.26
4532017-532017100.795101.83
5523305-52330599.145100.17
6512586-51258697.11498.10
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