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%
1 14.696789736805666804606803506798426800380.10
214.636790486784046787260.07
单位质量响应值RSD%判断
46292.5846392.750.16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%
5min188854-8885411.12626.4031.5711.1326.4031.56
2180174-18017422.56022.56
3251793-25179331.52831.53
4237588-23758829.74929.75
5266087-26608733.31833.32
6240350-24035030.09530.10
10min1271101-27110133.94654.5821.3733.9654.6221.38
2379532-37953247.52347.56
3504670-50467063.19263.24
4475141-47514159.49459.54
5505961-50596163.35463.41
6478769-47876959.94960.00
15min1412783-41278351.68674.5417.5151.7674.6817.52
2529104-52910466.25166.37
3677594-67759484.84585.00
4635167-63516779.53279.68
5669049-66904983.77583.94
6648149-64814981.15881.31
20min1524691-52469165.69987.6914.1865.8687.9514.20
2640480-64048080.19780.42
3777726-77772697.38297.68
4738307-73830792.44792.73
5770002-77000296.41596.72
6750692-75069293.99794.28
30min1676038-67603884.65096.346.3184.9296.756.36
2767266-76726696.07396.43
3813350-813350101.843102.30
4777402-77740297.34297.78
5797948-79794899.915100.38
6784489-78448998.22998.67
45min1769424-76942496.34398.601.8696.7599.161.91
2786740-78674098.51199.03
3809636-809636101.378102.01
4776333-77633397.20897.81
5798256-79825699.953100.58
6784094-78409498.18098.79
极限1775145-77514597.05998.601.7497.6399.341.79
2783471-78347198.10298.79
3810024-810024101.427102.23
4775474-77547497.10197.86
5797379-79737999.843100.64
6783369-78336998.08998.86
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%
1 14.696784046799266800686781806780626789280.15
214.636778866776506777680.03
单位质量响应值RSD%判断
46217.0246327.270.17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%
5min1241124-24112430.23827.3028.7530.2427.3028.75
2231291-23129129.00529.01
3201224-20122425.23525.23
4100684-10068412.62612.63
5276666-27666634.69534.70
6255086-25508631.98931.99
10min1485115-48511560.83655.4820.6860.8955.5220.68
2465163-46516358.33458.38
3431669-43166954.13454.18
4265017-26501733.23533.26
5517847-51784764.94165.00
6489510-48951061.38761.44
15min1646380-64638081.05975.4817.1881.2175.6217.19
2630167-63016779.02679.17
3599366-59936675.16475.30
4399016-39901650.03950.12
5686896-68689686.14086.31
6649560-64956081.45881.61
20min1740949-74094992.91988.3113.8793.2188.5813.89
2733760-73376092.01792.29
3715753-71575389.75990.02
4509402-50940263.88264.04
5778910-77891097.67997.99
6746517-74651793.61793.91
30min1768928-76892896.42895.986.6296.8796.406.67
2779472-77947297.75098.18
3791450-79145099.25299.66
4665456-66545683.45283.72
5807005-807005101.203101.68
6780006-78000697.81798.26
45min1765981-76598196.05898.341.7696.6698.911.77
2779612-77961297.76798.36
3792213-79221399.34899.92
4780220-78022097.84498.25
5806616-806616101.154101.79
6780407-78040797.86798.48
极限1766273-76627396.09598.481.7396.8699.211.72
2778238-77823897.59598.35
3790312-79031299.10999.85
4790025-79002599.07399.64
5806248-806248101.108101.92
6780483-78048397.87798.65
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%
1 14.696775196781256767686770716771766773320.08
214.636774316779736777020.06
单位质量响应值RSD%判断
46108.3746322.760.33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%
5min1104281-10428113.09328.6528.4613.0928.6528.46
2253203-25320331.79231.79
3296226-29622637.19437.19
4244222-24422230.66430.66
5228321-22832128.66828.67
6242936-24293630.50330.50
10min1310068-31006838.93258.8617.4938.9558.9117.50
2504245-50424563.31363.37
3545778-54577868.52768.59
4496075-49607562.28762.34
5466472-46647258.57058.62
6490266-49026661.55761.61
15min1473220-47322059.41779.8113.1259.5079.9613.13
2675019-67501984.75584.91
3708148-70814888.91589.09
4665254-66525483.52983.68
5631016-63101679.23079.38
6661171-66117183.01683.17
20min1599509-59950975.27492.469.4675.4692.749.48
2770354-77035496.72597.02
3793624-79362499.64799.97
4765700-76570096.14196.43
5738906-73890692.77793.05
6750442-75044294.22594.52
30min1748452-74845293.97598.592.7594.2999.022.79
2796084-79608499.956100.42
3807455-807455101.383101.87
4800706-800706100.536100.99
5784013-78401398.44098.87
6774518-77451897.24897.70
45min1794998-79499899.81999.391.40100.2999.981.40
2796701-796701100.033100.66
3803967-803967100.946101.60
4796346-79634699.989100.61
5784315-78431598.47899.07
6772984-77298497.05597.67
极限1794517-79451799.75999.191.34100.3999.951.34
2794618-79461899.772100.57
3800795-800795100.547101.37
4794347-79434799.738100.53
5784058-78405898.44699.21
6771354-77135496.85197.62
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