依折麦布贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ333-221017对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.67对照品水分(%)0对照品稀释倍数2000
标示量(mg)10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%
111.365659915656695653465647215646575652770.11
211.485675075688055681560.17
单位质量响应值RSD%判断
49760.3049490.940.39数据可信
供试品溶液-24032601SP批-依折麦布-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%
5min121565-215653.8984.043.143.904.043.14
222890-228904.1384.14
322618-226184.0884.09
10min136909-369096.6726.711.396.726.761.38
236797-367976.6516.70
337734-377346.8216.87
15min139511-395117.1427.221.547.267.341.55
239659-396597.1697.29
340637-406377.3467.47
20min139761-397617.1877.231.257.387.431.29
239666-396667.1707.37
340573-405737.3347.54
30min138447-384476.9508.8620.377.239.1419.76
250280-502809.0899.37
358282-5828210.53510.82
45min141055-410557.42112.2835.107.7812.6534.16
286545-8654515.64416.02
376132-7613213.76214.16
60min145909-459098.29915.1840.048.7315.6939.18
2109617-10961719.81420.37
396344-9634417.41517.97
极限156965-5696510.29721.5045.1410.8322.1944.34
2149171-14917126.96427.74
3150721-15072127.24427.99
依折麦布贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数100
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%
110.011447831446371444351443811443191445110.14
210.041454261457751456000.17
单位质量响应值RSD%判断
14436.6614501.990.32数据可信
供试品溶液-24032601SP批-贝派度酸-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%
5min166724-6672445.98545.041.9545.9945.051.95
264214-6421444.25544.26
365132-6513244.88844.89
10min1107713-10771374.23475.983.1274.7576.483.08
2114152-11415278.67279.16
3108865-10886575.02875.53
15min1123179-12317984.89387.282.4086.2388.622.38
2128873-12887388.81790.18
3127858-12785888.11889.45
20min1131034-13103490.30792.222.0692.5994.532.04
2136524-13652494.09096.44
3133869-13386992.26194.57
30min1135835-13583593.61695.501.7796.9098.831.76
2140538-14053896.857100.25
3139315-13931596.01499.35
45min1141397-14139797.44998.410.94101.77102.810.98
2144056-14405699.281103.76
3142930-14293098.505102.91
60min1142076-14207697.91798.391.04103.32103.881.05
2144460-14446099.560105.14
3141752-14175297.693103.19
极限1143374-14337498.81197.830.88105.30104.410.75
2141335-14133597.406104.09
3141122-14112297.259103.84
依折麦布贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ333-221017对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.67对照品水分(%)0对照品稀释倍数2000
标示量(mg)10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%
111.365647115657765676485688995696555673380.37
211.485625455626365625900.02
单位质量响应值RSD%判断
49941.7349006.101.34数据可信
供试品溶液-24032601SP批-依折麦布-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%
5min1386309-38630970.04971.786.3270.0571.786.32
2424202-42420276.92176.92
3377042-37704268.36968.37
10min1453183-45318382.17685.174.4282.9585.964.44
2492981-49298189.39290.25
3462875-46287583.93384.69
15min1544223-54422398.684102.803.52100.38104.553.49
2575170-575170104.296106.14
3581430-581430105.431107.12
20min1573666-573666104.023106.342.37106.81109.222.33
2584451-584451105.978108.99
3601151-601151109.007111.87
30min1558115-558115101.203102.902.45105.15106.972.37
2560863-560863101.701105.89
3583390-583390105.786109.86
45min1564103-564103102.289103.341.36107.36108.551.35
2566944-566944102.804108.12
3578688-578688104.933110.18
60min1554039-554039100.464102.532.29106.67108.892.24
2562774-562774102.048108.50
3579459-579459105.073111.49
极限1549189-54918999.584101.302.36106.91108.802.28
2553135-553135100.300107.89
3573643-573643104.019111.60
依折麦布贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数100
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%
110.011451561454221457571459851460521456740.27
210.041438661438831438740.01
单位质量响应值RSD%判断
14552.8514330.081.10数据可信
供试品溶液-24032601SP批-贝派度酸-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%
5min142008-4200829.00927.6919.6029.0127.6919.61
246814-4681432.32832.33
331459-3145921.72421.72
10min183425-8342557.60957.868.8057.9358.178.85
291339-9133963.07463.43
376617-7661752.90853.15
15min1111594-11159477.06278.234.0078.0279.184.08
2118414-11841481.77182.83
3109850-10985075.85776.69
20min1124652-12465286.07986.731.8787.9088.551.99
2128268-12826888.57690.54
3123874-12387485.54287.21
30min1130089-13008989.83390.660.8592.6193.440.79
2131480-13148090.79493.75
3132276-13227691.34493.97
45min1136147-13614794.01794.790.7897.7998.580.71
2137366-13736694.85898.82
3138270-13827095.48399.12
60min1135497-13549793.56895.481.9998.39100.331.84
2138326-13832695.521100.54
3140994-14099497.364102.06
极限1135217-13521793.37495.102.1199.23101.001.92
2137018-13701894.618100.70
3140893-14089397.294103.07
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