氨溴酸替格列净片项目信息
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%
114.776759936772366763356753976776906765300.14
214.796779296763706771500.17
单位质量响应值RSD%判断
45804.3345784.310.04数据可信
供试品溶液-2024090521-js1M-bc1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%
5min1245620-24562031.12325.1724.5231.1225.1824.52
2107083-10708313.56913.57
3220886-22088627.98927.99
4197917-19791725.07925.08
5226148-22614828.65628.66
6194377-19437724.63024.63
10min1506125-50612564.13354.4018.5064.1854.4418.50
2278383-27838335.27535.30
3464472-46447258.85558.90
4427091-42709154.11854.16
5469537-46953759.49759.54
6430419-43041954.54054.58
15min1681141-68114186.31075.0415.7386.4775.1715.74
2413928-41392852.45052.53
3630545-63054579.89980.04
4594358-59435875.31375.45
5639123-63912380.98681.13
6594161-59416175.28875.42
20min1782759-78275999.18688.6413.1999.4988.9013.20
2520820-52082065.99566.16
3734398-73439893.05893.34
4711286-71128690.13090.39
5747467-74746794.71495.00
6700654-70065488.78289.04
30min1810418-810418102.69197.186.86103.1697.586.90
2668028-66802884.64884.93
3777223-77722398.48598.92
4787032-78703299.728100.14
5805181-805181102.027102.47
6753540-75354095.48495.89
45min1810093-810093102.65099.362.67103.2999.932.69
2775443-77544398.25998.68
3775817-77581798.30798.90
4787596-78759699.799100.37
5803138-803138101.768102.38
6752722-75272295.38095.94
极限1807028-807028102.26199.602.64103.07100.332.64
2787656-78765699.807100.39
3774201-77420198.10298.86
4787661-78766199.807100.55
5806930-806930102.249103.03
6752628-75262895.36896.09
氨溴酸替格列净片项目信息
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%
114.776780536769666791796773156775726778170.13
214.796774106754176764140.21
单位质量响应值RSD%判断
45891.4745734.550.25数据可信
供试品溶液-2024090521-js1M-bc2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%
5min1227188-22718828.77630.718.8128.7830.718.81
2247337-24733731.32831.33
3258024-25802432.68232.68
4227552-22755228.82228.82
5219748-21974827.83427.83
6274727-27472734.79834.80
10min1481840-48184061.03162.044.0461.0862.104.04
2486714-48671461.64861.70
3500123-50012363.34763.40
4475502-47550260.22860.28
5470492-47049259.59459.64
6524375-52437566.41966.48
15min1650454-65045482.38882.862.4582.5483.012.45
2648058-64805882.08482.24
3656730-65673083.18383.34
4639503-63950381.00181.15
5645588-64558881.77281.92
6684621-68462186.71686.88
20min1750831-75083195.10295.131.1195.3995.431.11
2749438-74943894.92695.22
3751400-75140095.17495.47
4740425-74042593.78494.07
5748493-74849394.80695.09
6765866-76586697.00697.32
30min1786209-78620999.58399.091.29100.0399.541.28
2793066-793066100.452100.90
3765328-76532896.93897.40
4778079-77807998.55398.99
5790428-790428100.117100.56
6780837-78083798.90399.38
45min1789639-789639100.01799.071.37100.6399.681.36
2791413-791413100.242100.86
3763636-76363696.72497.34
4777178-77717898.43999.04
5789727-789727100.029100.64
6781219-78121998.95199.59
极限1784491-78449199.36598.721.16100.1499.501.15
2787723-78772399.775100.56
3762970-76297096.64097.42
4776070-77607098.29999.07
5784466-78446699.362100.14
6780735-78073598.89099.69
氨溴酸替格列净片项目信息
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%
114.776895166879736901376890906866036886640.21
214.796774796755636765210.21
单位质量响应值RSD%判断
46625.8645741.781.36数据可信
供试品溶液-2024090521-js1M-bc3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%
5min1197098-19709824.76723.9522.3424.7723.9522.35
2190721-19072123.96523.97
3222305-22230527.93427.93
4107059-10705913.45313.45
5215611-21561127.09327.09
6210952-21095226.50726.51
10min1411902-41190251.75853.5513.9351.8053.5913.93
2432297-43229754.32154.36
3481342-48134260.48460.53
4317661-31766139.91639.94
5475102-47510259.70059.74
6438787-43878755.13655.18
15min1569345-56934571.54274.8311.1971.6774.9611.20
2606040-60604076.15376.28
3656011-65601182.43282.58
4478196-47819660.08860.18
5657546-65754682.62582.77
6605871-60587176.13276.27
20min1683845-68384585.93088.858.6986.1889.108.70
2722556-72255690.79491.05
3755854-75585494.97895.26
4596610-59661074.96875.16
5764930-76493096.11896.40
6718598-71859890.29690.56
30min1779393-77939397.93697.992.5898.3398.392.61
2776066-77606697.51897.93
3788329-78832999.05999.50
4742845-74284593.34393.66
5800089-800089100.536100.98
6792024-79202499.52399.94
45min1780318-78031898.05298.780.9598.6199.350.98
2784340-78434098.55799.13
3785760-78576098.73699.34
4777533-77753397.70298.17
5798008-798008100.275100.88
6790846-79084699.37599.95
极限1780292-78029298.04998.430.9898.7799.171.01
2773791-77379197.23297.97
3784142-78414298.53299.31
4777899-77789997.74898.38
5794420-79442099.824100.60
6789628-78962899.22299.97
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