贝派度酸片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数50
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.992996202997162998022993852996222996290.06
29.992972272971092971680.03
单位质量响应值RSD%判断
29992.8929746.550.59数据可信
供试品溶液-24070801批-pH6.6
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min174231-7423149.60544.8413.2449.6044.8413.24
271110-7111047.51947.52
365067-6506743.48143.48
450088-5008833.47133.47
569877-6987746.69546.70
672200-7220048.24748.25
10min1195476-195476130.626127.963.51130.90128.213.52
2194767-194767130.152130.42
3185751-185751124.127124.37
4180845-180845120.849121.04
5193695-193695129.436129.70
6198350-198350132.547132.81
15min1243606-243606162.789163.790.82163.79164.750.81
2244371-244371163.300164.29
3242364-242364161.959162.89
4246693-246693164.852165.71
5246018-246018164.401165.38
6247589-247589165.451166.45
20min1264773-264773176.934178.831.07178.84180.701.05
2266276-266276177.938179.83
3265144-265144177.182179.01
4272376-272376182.014183.79
5268035-268035179.113181.01
6269038-269038179.784181.71
30min1278965-278965186.417188.981.38189.31191.841.34
2281380-281380188.031190.91
3279751-279751186.943189.76
4289720-289720193.604196.39
5283130-283130189.201192.09
6283846-283846189.679192.60
45min1281689-281689188.238190.281.27192.16194.191.24
2283296-283296189.312193.24
3281742-281742188.273192.13
4291416-291416194.738198.60
5285000-285000190.450194.39
6285314-285314190.660194.64
60min1278185-278185185.896188.491.39190.87193.461.36
2280903-280903187.712192.69
3278982-278982186.429191.33
4289130-289130193.210198.15
5282323-282323188.661193.66
6282884-282884189.036194.07
极限1281926-281926188.396191.341.23194.40197.361.19
2286080-286080191.172197.19
3285194-285194190.580196.52
4292611-292611195.536201.55
5286730-286730191.606197.65
6285465-285465190.761196.85
贝派度酸片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数50
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.992973472974952974052974372975752974520.03
29.992984222988072986140.10
单位质量响应值RSD%判断
29774.9729891.290.28数据可信
供试品溶液-24070801批-pH4.5(内含0.45%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min17562-75625.0595.1537.425.065.1637.41
213433-134338.9878.99
35647-56473.7783.78
46720-67204.4964.50
56751-67514.5174.52
66099-60994.0814.08
10min129186-2918619.52723.0822.0219.5623.1122.03
249370-4937033.03133.08
335375-3537523.66823.69
430697-3069720.53820.56
532139-3213921.50321.53
630234-3023420.22820.25
15min154521-5452136.47840.4212.3036.6140.5812.34
274145-7414549.60749.84
363691-6369142.61342.77
456271-5627137.64937.79
556426-5642637.75237.90
657431-5743138.42538.56
20min171322-7132247.71951.007.5148.0651.387.57
284893-8489356.79857.31
381739-8173954.68855.08
472380-7238048.42648.77
572012-7201248.18048.53
675019-7501950.19250.54
30min191425-9142561.16964.455.5661.7765.125.62
2104727-10472770.06870.89
3100963-10096367.55068.24
492336-9233661.77862.40
593120-9312062.30362.92
695436-9543663.85264.48
45min1110092-11009273.65876.913.9074.6077.933.95
2118929-11892979.57080.78
3121476-12147681.27482.34
4111256-11125674.43775.40
5112833-11283375.49276.46
6115141-11514177.03678.02
60min1121223-12122381.10583.232.9282.4684.682.99
2128437-12843785.93287.59
3128952-12895286.27687.80
4120209-12020980.42781.80
5123351-12335182.52983.92
6124255-12425583.13484.54
极限1132053-13205388.35190.551.8290.1592.461.86
2135097-13509790.38892.52
3139650-13965093.43495.43
4134468-13446889.96791.79
5135226-13522690.47492.32
6135522-13552290.67292.54
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