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%
114.586676376645476664596656596650976658800.19
214.636673776647086660420.29
单位质量响应值RSD%判断
45670.7845525.770.23数据可信
稳定性3月-加速-供试品溶液-2025011021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%
5min1243567-24356730.99632.077.2331.0032.077.23
2260407-26040733.13933.14
3277406-27740635.30235.30
4260382-26038233.13633.14
5245738-24573831.27231.27
6224436-22443628.56128.56
10min1512328-51232865.19866.443.5465.2566.493.54
2539040-53904068.59868.65
3543188-54318869.12569.18
4532393-53239367.75267.81
5505796-50579664.36764.42
6499679-49967963.58863.64
15min1688576-68857687.62788.692.4787.7988.852.47
2720283-72028391.66291.83
3717594-71759491.32091.49
4686016-68601687.30187.47
5685056-68505687.17987.34
6683971-68397187.04187.19
20min1766954-76695497.60297.792.1097.9198.102.10
2794315-794315101.083101.41
3778998-77899899.13499.46
4751044-75104495.57795.89
5754687-75468796.04096.35
6764543-76454397.29597.59
30min1772698-77269898.33399.011.7198.8099.481.71
2799962-799962101.802102.29
3788408-788408100.332100.82
4766857-76685797.58998.06
5772196-77219698.26998.73
6767799-76779997.70998.17
45min1769543-76954397.93198.681.5998.5699.321.60
2796447-796447101.355102.02
3784178-78417899.793100.45
4767636-76763697.68898.32
5770191-77019198.01398.64
6764727-76472797.31897.94
极限1766599-76659997.55698.331.7398.3599.131.73
2795555-795555101.241102.07
3782048-78204899.522100.35
4762261-76226197.00497.80
5765412-76541297.40598.20
6764074-76407497.23598.02
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%
114.586646656659406664846643436654386653740.14
214.636665176639586652380.28
单位质量响应值RSD%判断
45636.0845470.810.26数据可信
稳定性3月-加速-供试品溶液-2025011121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%
5min1244875-24487531.19332.097.5531.1932.107.55
2259191-25919133.01733.02
3219389-21938927.94727.95
4251884-25188432.08632.09
5275882-27588235.14335.14
6260493-26049333.18333.18
10min1509825-50982564.94464.915.3865.0064.965.39
2504446-50444664.25864.31
3471078-47107860.00860.05
4498268-49826863.47163.52
5554588-55458870.64670.70
6519295-51929566.15066.21
15min1699997-69999789.16888.093.1489.3388.253.15
2685625-68562587.33887.50
3660006-66000684.07484.22
4676016-67601686.11486.27
5717402-71740291.38691.56
6710143-71014390.46190.63
20min1776464-77646498.90998.062.0599.2298.372.06
2768375-76837597.87998.19
3747333-74733395.19895.49
4760131-76013196.82997.13
5772316-77231698.38198.71
6794140-794140101.161101.48
30min1777544-77754499.04799.531.2299.52100.001.22
2784567-78456799.941100.41
3781341-78134199.53099.98
4773491-77349198.53098.99
5772634-77263498.42198.91
6798429-798429101.707102.19
45min1777126-77712698.99399.571.2899.63100.211.27
2782466-78246699.674100.31
3780555-78055599.430100.04
4778289-77828999.14299.77
5771209-77120998.24098.90
6800452-800452101.965102.62
极限1775574-77557498.79699.151.2899.6099.961.27
2777225-77722599.00699.81
3777984-77798499.10399.88
4771471-77147198.27399.07
5770375-77037598.13398.95
6797556-797556101.596102.42
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%
114.586759676716676712146728176729126729150.28
214.636678986680056679520.02
单位质量响应值RSD%判断
46153.2945656.320.77数据可信
稳定性3月-加速-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%
5min1250639-25063931.68431.803.6831.6831.803.68
2263214-26321433.27333.27
3235266-23526629.74129.74
4254982-25498232.23332.23
5254935-25493532.22732.23
6250139-25013931.62131.62
10min1521537-52153765.92966.032.2765.9866.082.26
2518203-51820365.50765.56
3511272-51127264.63164.68
4543065-54306568.65068.70
5512386-51238664.77264.83
6527706-52770666.70966.76
15min1691088-69108887.36288.491.5387.5288.661.53
2694278-69427887.76587.93
3699913-69991388.47888.63
4718358-71835890.80990.98
5690739-69073987.31887.48
6705844-70584489.22789.39
20min1764522-76452296.64597.521.6696.9597.841.66
2767945-76794597.07897.39
3787616-78761699.56499.87
4777538-77753898.29098.61
5751671-75167195.02095.33
6779542-77954298.54498.86
30min1785863-78586399.34399.731.8199.81100.201.80
2777615-77761598.30098.77
3806913-806913102.004102.47
4801152-801152101.275101.76
5769301-76930197.24997.71
6792524-792524100.185100.66
45min1776234-77623498.12699.101.3598.7699.741.35
2776342-77634298.13998.78
3800107-800107101.143101.78
4791519-791519100.058100.71
5773235-77323597.74698.37
6786188-78618899.384100.03
极限1779868-77986898.58598.821.4499.3899.621.44
2769081-76908197.22198.02
3799494-799494101.066101.88
4787392-78739299.536100.35
5770963-77096397.45998.25
6783642-78364299.06299.87
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