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%
114.793395583393973396123393593394323394720.04
214.843392963392373392660.02
单位质量响应值RSD%判断
22952.8122861.590.29数据可信
供试品溶液-2025011321批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1224103-22410356.76952.026.1756.7752.026.18
2197832-19783250.11450.11
3196839-19683949.86349.86
4208371-20837152.78452.78
5190313-19031348.21048.21
6214656-21465654.37654.38
10min1362008-36200891.70390.721.6791.8090.811.68
2361843-36184391.66191.74
3352868-35286889.38889.47
4360643-36064391.35791.45
5348477-34847788.27588.36
6362892-36289291.92792.02
15min1388980-38898098.53599.872.2398.78100.112.22
2407677-407677103.272103.51
3393129-39312999.58699.82
4400752-400752101.517101.76
5382989-38298997.01897.25
6392024-39202499.30699.55
20min1386688-38668897.95599.812.8598.37100.212.84
2413653-413653104.785105.19
3390122-39012298.82599.22
4399241-399241101.135101.54
5382010-38201096.77097.16
6392282-39228299.37299.78
30min1388079-38807998.30799.452.0698.88100.022.06
2406553-406553102.987103.57
3392339-39233999.38699.95
4395386-395386100.158100.74
5382663-38266396.93597.49
6390564-39056498.93799.51
45min1384504-38450497.40199.622.3098.14100.362.29
2404825-404825102.549103.30
3393832-39383299.764100.49
4395687-395687100.234100.98
5381095-38109596.53897.25
6399705-399705101.252101.99
极限1383318-38331897.10198.962.3898.0099.862.37
2406854-406854103.063103.99
3390028-39002898.80199.70
4394820-394820100.015100.93
5381492-38149296.63897.51
6387332-38733298.11899.03
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%
114.793376163379513376743372773374283375890.08
214.843390613387713389160.07
单位质量响应值RSD%判断
22825.4922838.010.04数据可信
供试品溶液-2025011321批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1214081-21408154.40952.426.7354.4152.426.74
2207601-20760152.76252.76
3196921-19692150.04850.05
4207806-20780652.81552.81
5225644-22564457.34857.35
6185415-18541547.12447.12
10min1355458-35545890.34189.254.3490.4389.344.34
2354222-35422290.02790.11
3353092-35309289.73989.82
4359796-35979691.44391.53
5363393-36339392.35892.45
6321108-32110881.61181.69
15min1377002-37700295.81698.522.2196.0698.762.21
2397171-397171100.942101.18
3391511-39151199.50499.74
4393968-393968100.128100.37
5388841-38884198.82599.07
6377337-37733795.90196.12
20min1374967-37496795.29998.612.2395.7099.012.23
2397300-397300100.975101.38
3390483-39048399.24399.64
4395210-395210100.444100.85
5389491-38949198.99099.40
6380534-38053496.71497.09
30min1374544-37454495.19298.662.3095.7599.232.30
2399274-399274101.477102.05
3389776-38977699.06399.63
4394046-394046100.148100.72
5390320-39032099.20199.78
6381253-38125396.89797.43
45min1375191-37519195.35698.252.1096.0798.982.10
2395557-395557100.532101.28
3386948-38694898.34499.07
4393022-39302299.888100.63
5390083-39008399.14199.89
6378613-37861396.22696.92
极限1373127-37312794.83198.172.2595.7199.062.24
2394793-394793100.338101.25
3388219-38821998.66799.56
4393927-393927100.118101.03
5388956-38895698.85499.76
6378559-37855996.21297.07
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%
114.796792806782936785006780846800676788450.13
214.846787986790916789440.04
单位质量响应值RSD%判断
45898.9245750.940.23数据可信
供试品溶液-2025011221批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1234739-23473929.72532.745.0529.7232.745.05
2271840-27184034.42334.42
3258099-25809932.68332.68
4261564-26156433.12233.12
5256978-25697832.54132.54
6268286-26828633.97333.97
10min1523996-52399666.35369.653.1766.4069.703.17
2562213-56221371.19371.25
3531647-53164767.32267.38
4559122-55912270.80170.86
5560705-56070571.00271.06
6562360-56236071.21171.27
15min1726547-72654792.00293.951.8192.1694.121.81
2755851-75585195.71395.89
3728475-72847592.24692.41
4748134-74813494.73694.91
5736190-73619093.22393.40
6756582-75658295.80595.98
20min1784916-78491699.393100.600.7399.71100.930.74
2802272-802272101.591101.93
3793555-793555100.487100.81
4798047-798047101.056101.39
5793680-793680100.503100.83
6794220-794220100.571100.91
30min1790229-790229100.066100.740.58100.55101.230.57
2795177-795177100.693101.20
3803648-803648101.765102.25
4795002-795002100.671101.17
5792596-792596100.366100.86
6796472-796472100.857101.36
45min1785375-78537599.451100.330.60100.10100.990.60
2799117-799117101.192101.86
3792931-792931100.408101.07
4792696-792696100.379101.05
5788992-78899299.909100.57
6794573-794573100.616101.29
极限1783176-78317699.17399.960.6199.98100.790.62
2796858-796858100.906101.75
3786781-78678199.630100.45
4789962-789962100.032100.87
5787448-78744899.714100.54
6792275-792275100.325101.16
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%
114.796774016776566774466771556770106773340.04
214.846764546769086766810.05
单位质量响应值RSD%判断
45796.7545598.450.31数据可信
供试品溶液-2025011221批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1285770-28577036.28833.075.8036.2933.085.80
2255903-25590332.49532.50
3263835-26383533.50233.50
4262284-26228433.30533.31
5255384-25538432.42932.43
6239585-23958530.42330.42
10min1566985-56698571.99769.212.4372.0669.262.44
2539275-53927568.47868.53
3534895-53489567.92267.98
4555403-55540370.52670.58
5534095-53409567.82167.87
6539430-53943068.49868.55
15min1735999-73599993.45992.640.9593.6492.810.94
2726462-72646292.24892.42
3719369-71936991.34791.52
4734349-73434993.24993.42
5725153-72515392.08292.25
6735754-73575493.42893.59
20min1784955-78495599.67599.790.86100.01100.120.85
2783350-78335099.47299.79
3779222-77922298.94799.27
4779775-77977599.01899.35
5792451-792451100.627100.95
6795545-795545101.020101.34
30min1777661-77766198.74999.651.0999.25100.141.08
2787806-787806100.037100.53
3777391-77739198.71599.20
4779168-77916898.94199.43
5799330-799330101.501101.99
6787058-78705899.942100.43
45min1782527-78252799.36799.640.72100.03100.290.72
2783980-78398099.552100.21
3776597-77659798.61499.26
4782566-78256699.372100.03
5791659-791659100.527101.18
6790525-790525100.383101.04
极限1775436-77543698.46799.341.1899.30100.171.18
2782968-78296899.423100.24
3769546-76954697.71998.53
4780977-78097799.17099.99
5791515-791515100.508101.33
6793672-793672100.782101.61
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