氢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250
标示量(mg)40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%
114.55 6703566708916710736710916706886708200.05
214.586696816704716700760.09
单位质量响应值RSD%判断
46104.4745958.570.23数据可信
供试品溶液-第1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%
5min1164842-16484220.78022.2115.2020.7822.2015.20
2175411-17541122.11222.11
3205018-20501825.84525.84
4178585-17858522.51322.51
5201400-20140025.38925.39
6131676-13167616.59916.60
10min1346114-34611443.63145.6511.0943.6745.6911.09
2336329-33632942.39842.43
3412219-41221951.96552.01
4367127-36712746.28046.32
5403030-40303050.80650.85
6308014-30801438.82938.86
15min1485363-48536361.18563.629.8961.2963.749.89
2469223-46922359.15159.26
3565395-56539571.27471.40
4511040-51104064.42264.54
5557792-55779270.31670.44
6439400-43940055.39155.48
20min1594113-59411374.89477.368.8275.1077.578.83
2576668-57666872.69572.90
3676772-67677285.31585.56
4624211-62421178.68978.91
5670762-67076284.55784.80
6539265-53926567.98068.16
30min1744772-74477293.88793.654.7994.2294.004.81
2725502-72550291.45791.78
3766659-76665996.64697.04
4762219-76221996.08696.44
5777676-77767698.03598.42
6680692-68069285.80986.11
45min1784936-78493698.95098.241.4499.4498.751.47
2778607-77860798.15298.63
3773114-77311497.45998.01
4787672-78767299.29599.81
5791104-79110499.727100.28
6760605-76060595.88396.32
极限1785394-78539499.00898.291.2499.6698.961.25
2780497-78049798.39099.03
3774400-77440097.62298.34
4785385-78538599.00699.69
5789351-78935199.506100.22
6763158-76315896.20496.81
氢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250
标示量(mg)40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%
114.55 6701546706326698226698406699996700890.05
214.586685676694676690170.10
单位质量响应值RSD%判断
46054.2345885.940.26数据可信
供试品溶液-第2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%
5min1162231-16223120.47821.638.0820.4821.638.08
2189938-18993823.97623.98
3178374-17837422.51622.52
4151366-15136619.10719.11
5166942-16694221.07321.07
6179145-17914522.61322.61
10min1318962-31896240.26241.604.9340.3041.644.94
2350376-35037644.22844.27
3342859-34285943.27943.32
4309753-30975339.10039.13
5317783-31778340.11440.15
6337692-33769242.62742.66
15min1431156-43115654.42555.934.3254.5356.044.32
2464812-46481258.67358.79
3462666-46266658.40258.51
4420680-42068053.10253.20
5427335-42733553.94254.04
6452073-45207357.06557.17
20min1522708-52270865.98167.934.3166.1768.134.31
2562844-56284471.04871.26
3563373-56337371.11471.32
4511186-51118664.52764.71
5519493-51949365.57565.77
6549273-54927369.33469.54
30min1664351-66435183.86185.552.9984.1685.863.00
2694318-69431887.64387.97
3703893-70389388.85289.18
4654796-65479682.65582.95
5661007-66100783.43983.74
6687802-68780286.82187.14
45min1724452-72445291.44793.321.7491.8993.771.75
2745877-74587794.15294.63
3752605-75260595.00195.47
4730091-73009192.15992.59
5729370-72937092.06892.51
6753268-75326895.08595.55
极限1779579-77957998.40697.660.7699.0098.280.76
2772587-77258797.52398.16
3779103-77910398.34698.98
4771691-77169197.41097.99
5763813-76381396.41697.01
6775467-77546797.88798.51
氢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250
标示量(mg)40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%
114.55 6711856712236710046715626712786712500.04
214.586662846668756665800.07
单位质量响应值RSD%判断
46134.0245718.790.64数据可信
供试品溶液-第3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%
5min1167656-16765621.18421.402.1321.1821.402.14
2167323-16732321.14221.14
3164887-16488720.83420.83
4169093-16909321.36521.37
5173524-17352421.92521.93
6173878-17387821.97021.97
10min1302836-30283638.26439.152.0938.3039.192.09
2314703-31470339.76339.80
3306333-30633338.70638.74
4303558-30355838.35538.39
5318294-31829440.21740.25
6313508-31350839.61239.65
15min1400167-40016750.56251.752.5750.6651.852.58
2417200-41720052.71452.82
3409672-40967251.76351.86
4394651-39465149.86549.96
5422668-42266853.40553.51
6413091-41309152.19552.30
20min1478172-47817260.41862.382.7160.6062.562.71
2503258-50325863.58863.78
3497547-49754762.86663.05
4476673-47667360.22860.41
5509367-50936764.35964.55
6496996-49699662.79662.99
30min1605788-60578876.54279.332.7576.8379.622.75
2640787-64078780.96581.26
3632927-63292779.97180.26
4608547-60854776.89177.17
5648510-64851081.94082.24
6630468-63046879.66179.96
45min1698696-69869688.28189.181.0988.6989.601.09
2708204-70820489.48389.91
3711700-71170089.92590.35
4703486-70348688.88789.30
5716388-71638890.51790.95
6696479-69647988.00188.43
极限1765060-76506096.66797.960.8597.2398.530.85
2777830-77783098.28098.86
3784378-78437899.10899.68
4774875-77487597.90798.47
5777850-77785098.28398.87
6771644-77164497.49998.07
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