贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75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%
119713409717929719359715519702109713660.08
219731939732299732110.01
单位质量响应值RSD%判断
971366.00973211.000.14数据可信
供试品溶液-2025112921批-依折麦布-pH4.5(内含%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1431943-4319433.9884.7213.733.994.7213.67
2594780-5947805.4925.49
3436114-4361144.0274.03
4485982-4859824.4874.49
5576567-5765675.3245.32
6538688-5386884.9744.97
10min1903142-9031428.3398.312.468.388.362.46
2939347-9393478.6738.73
3895470-8954708.2688.31
4877104-8771048.0998.15
5902628-9026288.3348.39
6881798-8817988.1428.20
15min1926161-9261618.5528.551.038.698.701.07
2939073-9390738.6718.83
3934500-9345008.6298.77
4918629-9186298.4828.62
5923826-9238268.5308.68
6913754-9137548.4378.58
20min1941696-9416968.6958.571.088.938.811.10
2931978-9319788.6058.86
3924057-9240578.5328.76
4911583-9115838.4178.65
5930300-9303008.5908.84
6930318-9303188.5908.83
30min1936287-9362878.6458.570.738.978.900.75
2933541-9335418.6208.97
3922835-9228358.5218.85
4922289-9222898.5168.84
5931800-9318008.6048.95
6920905-9209058.5038.84
45min1915754-9157548.4568.461.418.888.891.39
2924611-9246118.5378.98
3917561-9175618.4728.89
4899490-8994908.3058.73
5934864-9348648.6329.07
6905040-9050408.3578.79
60min1929453-9294538.5828.372.049.108.891.95
2895416-8954168.2688.81
3887091-8870918.1918.71
4890214-8902148.2208.73
5926667-9266678.5569.09
6909095-9090958.3948.92
极限1925585-9255858.5468.461.019.169.081.04
2922228-9222288.5159.15
3912410-9124108.4259.03
4900684-9006848.3168.92
5922247-9222478.5159.14
6913662-9136628.4369.05
贝派度酸依折麦布片项目信息
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%
112599712574692557532566142566542572920.63
212588992591872590430.08
单位质量响应值RSD%判断
257292.00259043.000.48数据可信
供试品溶液-2025112921批-贝派度酸-pH4.5(内含%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min144256-442561.7092.0913.951.712.0913.91
262667-626672.4212.42
346835-468351.8091.81
452994-529942.0472.05
561320-613202.3692.37
656954-569542.2002.20
10min1108206-1082064.1804.252.834.204.272.86
2116008-1160084.4814.51
3110562-1105624.2714.29
4109213-1092134.2194.24
5108478-1084784.1904.22
6107581-1075814.1554.18
15min1128817-1288174.9765.061.745.045.131.80
2135005-1350055.2155.29
3129345-1293454.9965.06
4130135-1301355.0275.10
5132175-1321755.1055.18
6130516-1305165.0415.11
20min1145990-1459905.6395.701.305.765.831.28
2149373-1493735.7705.90
3146725-1467255.6675.79
4147690-1476905.7055.83
5145539-1455395.6225.75
6150338-1503385.8075.93
30min1162630-1626306.2826.511.836.476.701.83
2171036-1710366.6076.81
3168710-1687106.5176.70
4170815-1708156.5986.79
5169420-1694206.5446.74
6168937-1689376.5256.72
45min1184866-1848667.1417.302.207.397.562.19
2192323-1923237.4297.70
3182793-1827937.0617.32
4193128-1931287.4607.72
5190422-1904227.3557.62
6189732-1897327.3297.59
60min1202253-2022537.8127.801.248.148.141.20
2197961-1979617.6478.00
3199755-1997557.7168.05
4204306-2043067.8928.24
5203248-2032487.8518.20
6203780-2037807.8718.22
极限1210151-2101518.1178.241.068.548.671.05
2212497-2124978.2088.65
3213580-2135808.2508.67
4217051-2170518.3848.82
5213010-2130108.2288.66
6214158-2141588.2728.70
贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75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%
119718809720669715879714309716319717190.03
219716399711999714190.04
单位质量响应值RSD%判断
971719.00971419.000.03数据可信
供试品溶液-2025112921批-依折麦布-pH4.5(内含%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1491387-4913874.5413.9327.724.543.9327.69
2370122-3701223.4203.42
3363771-3637713.3613.36
4527210-5272104.8724.87
5550821-5508215.0905.09
6246468-2464682.2772.28
10min1882687-8826878.1567.739.558.217.789.66
2820201-8202017.5797.62
3828600-8286007.6567.69
4867368-8673688.0158.07
5927499-9274998.5708.63
6694255-6942556.4156.44
15min1904936-9049368.3628.564.388.508.694.48
2924883-9248838.5468.67
3964238-9642388.9109.03
4941238-9412388.6978.84
5964955-9649558.9169.07
6858551-8585517.9338.03
20min1887959-8879598.2058.544.218.448.774.30
2922112-9221128.5218.74
3948511-9485118.7648.99
4933599-9335998.6278.87
5980293-9802939.0589.31
6875034-8750348.0858.27
30min1906760-9067608.3798.623.588.708.943.69
2921748-9217488.5178.83
3959150-9591508.8639.18
4928984-9289848.5848.92
5985635-9856359.1079.46
6897188-8971888.2908.56
45min1898261-8982618.3008.644.438.729.064.43
2922949-9229498.5288.93
3971236-9712368.9749.39
4917696-9176968.4808.91
51000993-10009939.2499.70
6901792-9017928.3338.70
60min1887916-8879168.2058.534.148.729.044.12
2913963-9139638.4458.95
3924632-9246328.5449.06
4908511-9085118.3958.92
5997492-9974929.2179.77
6908266-9082668.3938.85
极限1888013-8880138.2058.645.168.819.255.06
2917171-9171718.4759.07
3944500-9445008.7279.34
4913475-9134758.4419.06
51026380-10263809.48410.14
6921651-9216518.5169.07
贝派度酸依折麦布片项目信息
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%
112613422568892567882582202572972581070.74
212573182584212578700.31
单位质量响应值RSD%判断
258107.00257870.000.07数据可信
供试品溶液-2025112921批-贝派度酸-pH4.5(内含%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min153218-532182.0571.7926.312.061.7926.32
241769-417691.6141.61
338655-386551.4941.49
457489-574892.2222.22
558563-585632.2642.26
627924-279241.0791.08
10min1112051-1120514.3313.979.514.353.999.60
2102346-1023463.9563.97
397830-978303.7813.80
4103419-1034193.9974.02
5113893-1138934.4024.43
687193-871933.3703.38
15min1133568-1335685.1635.114.825.235.184.89
2133327-1333275.1535.22
3133539-1335395.1625.22
4136838-1368385.2895.36
5136673-1366735.2835.36
6119693-1196934.6264.68
20min1144359-1443595.5805.694.435.715.824.46
2146089-1460895.6475.77
3145937-1459375.6415.76
4150764-1507645.8275.96
5157855-1578556.1026.23
6138522-1385225.3545.46
30min1171665-1716656.6356.662.296.836.842.42
2172642-1726426.6736.86
3172813-1728136.6806.86
4171474-1714746.6286.82
5178741-1787416.9097.11
6166417-1664176.4326.59
45min1191294-1912947.3947.562.747.667.822.75
2195403-1954037.5537.81
3197353-1973537.6287.88
4191967-1919677.4207.69
5205209-2052097.9328.21
6191594-1915947.4067.64
60min1204593-2045937.9088.074.348.258.414.30
2208783-2087838.0708.41
3202932-2029327.8448.18
4204537-2045377.9068.25
5226860-2268608.7699.13
6205092-2050927.9278.24
极限1214397-2143978.2878.534.128.728.964.10
2219679-2196798.4918.92
3215185-2151858.3188.74
4217176-2171768.3948.83
5238671-2386719.2259.69
6218326-2183268.4398.84
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