氨溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.716799566808946800836800746809926804000.08
214.826795316794576794940.01
单位质量响应值RSD%判断
46254.2545849.800.63数据可信
供试品溶液-H043批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1193861-19386124.42827.637.0324.4327.637.02
2222428-22242828.02728.03
3209331-20933126.37726.38
4224033-22403328.23028.23
5237142-23714229.88229.88
6228755-22875528.82528.82
10min1553347-55334769.72671.742.1969.7771.782.19
2572681-57268172.16272.21
3553863-55386369.79169.83
4580493-58049373.14673.19
5577370-57737072.75372.80
6578099-57809972.84472.89
15min1757678-75767895.47397.381.3195.6397.551.32
2770225-77022597.05497.22
3766809-76680996.62396.78
4786493-78649399.10499.27
5777689-77768997.99498.17
6778227-77822798.06298.23
20min1797920-797920100.543100.850.49100.86101.180.49
2799913-799913100.795101.12
3797646-797646100.509100.83
4807087-807087101.699102.03
5802431-802431101.112101.45
6796982-796982100.425100.76
30min1796844-796844100.408100.530.56100.89101.030.56
2795723-795723100.267100.76
3795515-795515100.240100.73
4805387-805387101.484101.99
5800458-800458100.863101.37
6792960-79296099.918100.42
45min1794598-794598100.125100.350.80100.78101.020.80
2789434-78943499.474100.14
3796306-796306100.340101.00
4807123-807123101.703102.38
5799598-799598100.755101.43
6791333-79133399.713100.38
极限1791848-79184899.77899.770.49100.60100.600.49
2788045-78804599.299100.13
3788759-78875999.389100.21
4798338-798338100.596101.44
5793706-793706100.012100.85
6789927-78992799.536100.37
氨溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.716797876796466789586791376796026794260.06
214.826784856791556788200.07
单位质量响应值RSD%判断
46188.0445804.320.59数据可信
供试品溶液-H043批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1203879-20387925.72127.295.8825.7227.295.88
2197952-19795224.97424.97
3221387-22138727.93027.93
4219189-21918927.65327.65
5224787-22478728.35928.36
6230761-23076129.11329.11
10min1555417-55541770.07170.921.8970.1170.971.89
2545639-54563968.83868.88
3571117-57111772.05272.10
4559384-55938470.57270.62
5572833-57283372.26872.32
6568576-56857671.73171.78
15min1755461-75546195.30996.490.9495.4796.650.94
2758786-75878695.72895.88
3774461-77446197.70697.87
4765022-76502296.51596.68
5764164-76416496.40796.57
6771132-77113297.28697.45
20min1789511-78951199.60499.840.5099.92100.160.50
2789207-78920799.56699.88
3793161-793161100.065100.39
4790737-79073799.759100.08
5798400-798400100.726101.05
6787355-78735599.33299.66
30min1800542-800542100.996100.070.62101.48100.560.61
2789903-78990399.654100.14
3793055-793055100.052100.55
4786694-78669499.24999.74
5796325-796325100.464100.96
6792560-79256099.989100.48
45min1790337-79033799.70999.490.31100.36100.150.31
2787347-78734799.33199.98
3788643-78864399.495100.16
4788927-78892799.531100.19
5791644-79164499.874100.54
6784712-78471298.99999.66
极限1785437-78543799.09099.140.4099.9199.970.40
2780700-78070098.49399.31
3786451-78645199.218100.05
4785215-78521599.06299.88
5790277-79027799.701100.53
6787092-78709299.299100.13
氨溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.716755456753856757136753606759846755970.04
214.826758966744606751780.16
单位质量响应值RSD%判断
45927.7445558.570.58数据可信
供试品溶液-H043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%
5min1216487-21648727.46326.067.5527.4626.067.55
2199785-19978525.34425.34
3220081-22008127.91927.92
4216879-21687927.51327.51
5199746-19974625.33925.34
6179572-17957222.78022.78
10min1550843-55084369.87968.572.3569.9268.612.35
2535768-53576867.96668.01
3527147-52714766.87266.92
4555995-55599570.53270.58
5547209-54720969.41869.46
6526002-52600266.72766.77
15min1770157-77015797.70096.031.9397.8696.191.93
2761950-76195096.65996.81
3733269-73326993.02193.18
4769054-76905497.56097.72
5762149-76214996.68496.84
6745427-74542794.56394.71
20min1791094-791094100.356101.290.83100.68101.610.83
2810441-810441102.810103.13
3795110-795110100.866101.18
4798334-798334101.275101.60
5799732-799732101.452101.77
6796079-796079100.988101.30
30min1792080-792080100.481101.000.71100.97101.480.70
2807298-807298102.412102.90
3795304-795304100.890101.37
4793325-793325100.639101.13
5794865-794865100.834101.32
6794108-794108100.738101.21
45min1788086-78808699.975100.600.75100.63101.260.75
2804836-804836102.099102.76
3790804-790804100.319100.97
4791315-791315100.384101.05
5792283-792283100.507101.16
6790917-790917100.334100.98
极限1788034-78803499.968100.530.61100.79101.350.61
2801419-801419101.666102.49
3788872-788872100.074100.89
4792243-792243100.502101.33
5791273-791273100.379101.20
6792844-792844100.578101.39
氨溴酸替格列汀片项目信息
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DMAD-P/23001对照品来源自制对照品使用方法直接使用
对照品含量(%)95.04对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.6784
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.716759176748346772666756476762586759840.14
214.826751566752296751920.01
单位质量响应值RSD%判断
45954.0445559.510.61数据可信
供试品溶液-H043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%
5min1205340-20534026.04125.953.8626.0425.943.86
2216229-21622927.42227.42
3206060-20606026.13326.13
4208103-20810326.39226.39
5198166-19816625.13125.13
6193641-19364124.55824.56
10min1538048-53804868.23568.461.6168.2868.511.61
2535812-53581267.95268.00
3543738-54373868.95769.00
4533184-53318467.61867.66
5555549-55554970.45570.50
6532784-53278467.56867.61
15min1758996-75899696.25695.731.0396.4195.891.03
2743751-74375194.32294.48
3762533-76253396.70496.86
4748119-74811994.87695.03
5753621-75362195.57495.73
6762164-76216496.65896.81
20min1794830-794830100.800100.740.50101.12101.060.50
2789566-789566100.133100.45
3801081-801081101.593101.91
4794595-794595100.770101.09
5794762-794762100.792101.11
6791380-791380100.363100.68
30min1796786-796786101.048100.590.42101.53101.080.42
2792242-792242100.472100.96
3797195-797195101.100101.59
4792733-792733100.534101.02
5791389-791389100.364100.85
6788626-788626100.013100.50
45min1791316-791316100.355100.370.38101.01101.020.38
2789756-789756100.157100.81
3797232-797232101.105101.76
4791360-791360100.360101.01
5788951-788951100.055100.71
6789903-789903100.175100.82
极限1794201-794201100.720100.310.67101.54101.130.67
2782347-78234799.217100.03
3791395-791395100.365101.19
4792238-792238100.472101.29
5797683-797683101.162101.98
6788110-78811099.948100.76
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