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%
114.476702666698706706736701896698396701670.06
214.566683586686806685190.04
单位质量响应值RSD%判断
46314.2445914.770.62数据可信
供试品溶液-2025011021批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1315383-31538339.68735.9324.5439.6935.9424.54
2316698-31669839.85239.85
3303317-30331738.16838.17
4300723-30072337.84237.84
5332820-33282041.88141.88
6144465-14446518.17918.18
10min1560904-56090470.58265.1318.6670.6565.1918.67
2557832-55783270.19570.26
3541083-54108368.08868.15
4543963-54396368.45068.51
5579177-57917772.88172.95
6322417-32241740.57240.60
15min1714505-71450589.91184.6614.7490.0984.8314.75
2711402-71140289.52089.70
3703453-70345388.52088.70
4698532-69853287.90188.08
5736721-73672192.70692.90
6472196-47219659.41959.52
20min1788794-78879499.25994.8810.9099.5995.2010.92
2791764-79176499.63399.97
3781996-78199698.40398.73
4770626-77062696.97397.30
5803207-803207101.072101.42
6587828-58782873.97074.17
30min1798993-798993100.54298.593.21101.0499.063.26
2791029-79102999.540100.04
3793403-79340399.839100.33
4773944-77394497.39097.88
5806211-806211101.450101.96
6737195-73719592.76693.09
45min1797584-797584100.36599.531.34101.03100.171.34
2789619-78961999.363100.03
3790412-79041299.462100.12
4773293-77329397.30897.96
5804959-804959101.293101.98
6789965-78996599.40699.88
极限1795198-795198100.06599.381.34100.90100.181.34
2787727-78772799.12599.95
3789937-78993799.403100.22
4770997-77099797.01997.83
5802579-802579100.993101.85
6792134-79213499.679100.32
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%
114.476686686680366685636685586682796684210.04
214.566687316678546682920.10
单位质量响应值RSD%判断
46193.5745899.180.46数据可信
供试品溶液-2025011021批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1299627-29962737.75939.115.1537.7639.115.15
2287318-28731836.20836.21
3329497-32949741.52441.52
4326070-32607041.09241.09
5312615-31261539.39639.40
6306915-30691538.67838.68
10min1554261-55426169.84971.274.4269.9171.344.43
2527948-52794866.53366.59
3596459-59645975.16775.24
4581009-58100973.21973.29
5580709-58070973.18273.25
6552993-55299369.68969.75
15min1719944-71994490.72891.763.6790.9191.943.67
2685907-68590786.43986.61
3755467-75546795.20595.40
4745238-74523893.91694.11
5749065-74906594.39894.59
6713025-71302589.85690.04
20min1793530-793530100.002100.692.12100.33101.022.12
2770625-77062597.11597.43
3813778-813778102.553102.91
4808003-808003101.826102.17
5814902-814902102.695103.04
6793053-79305399.942100.27
30min1796721-796721100.404101.421.80100.90101.921.81
2783268-78326898.70899.19
3823345-823345103.759104.28
4808628-808628101.904102.42
5816497-816497102.896103.41
6800251-800251100.849101.35
45min1794177-794177100.083101.091.66100.75101.761.67
2782050-78205098.55599.20
3817547-817547103.028103.73
4805504-805504101.511102.20
5814457-814457102.639103.33
6799039-799039100.696101.36
极限1792638-79263899.889100.891.69100.72101.731.71
2779854-77985498.27899.08
3816111-816111102.847103.72
4804272-804272101.355102.21
5813090-813090102.467103.33
6797366-797366100.485101.32
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