贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.143050423050953050693056713053453052440.09
210.243046123045583045850.02
单位质量响应值RSD%判断
30102.9629744.630.85数据可信
供试品溶液-2025102721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%
5min11503-15031.0021.0818.921.001.0818.83
22160-21601.4401.44
31547-15471.0311.03
41285-12850.8560.86
51736-17361.1571.16
61451-14510.9670.97
10min13610-36102.4062.7711.592.422.7811.52
24857-48573.2373.25
33865-38652.5762.59
44125-41252.7492.76
53867-38672.5772.59
64603-46033.0683.08
15min14896-48963.2633.325.913.303.365.84
24987-49873.3243.38
34776-47763.1833.22
44654-46543.1023.14
55495-54953.6633.70
65085-50853.3893.43
20min15052-50523.3673.463.153.443.543.15
25216-52163.4773.57
35046-50463.3633.44
45084-50843.3893.46
55360-53603.5733.65
65419-54193.6123.69
30min15380-53803.5863.645.133.703.764.92
25453-54533.6353.76
35434-54343.6223.73
45965-59653.9764.09
55099-50993.3993.52
65463-54633.6413.76
45min15582-55823.7203.834.943.873.984.79
25666-56663.7763.94
35718-57183.8113.96
45688-56883.7913.95
55505-55053.6693.83
66298-62984.1984.36
60min15983-59833.9883.862.024.184.061.86
25794-57943.8624.07
35822-58223.8804.08
45751-57513.8334.03
55629-56293.7523.95
65741-57413.8264.04
极限15502-55023.6673.802.413.904.042.41
25806-58063.8704.12
35815-58153.8764.11
45585-55853.7223.96
55691-56913.7934.04
65831-58313.8864.14
贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.143045143047413053863049033050513049190.11
210.243041993040683041340.04
单位质量响应值RSD%判断
30070.9129700.590.88数据可信
供试品溶液-2025102721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%
5min11202-12020.8021.1838.570.801.1838.64
22804-28041.8711.87
31468-14680.9800.98
42453-24531.6371.64
51516-15161.0121.01
61199-11990.8000.80
10min12974-29741.9852.4613.161.992.4713.24
23773-37732.5182.54
34015-40152.6792.69
44349-43492.9022.92
53363-33632.2442.26
63605-36052.4062.41
15min14879-48793.2563.317.673.293.357.74
25607-56073.7423.79
34985-49853.3273.37
45063-50633.3793.43
54471-44712.9843.02
64745-47453.1673.20
20min15080-50803.3903.9918.723.464.0718.46
26901-69014.6064.70
37821-78215.2195.30
45226-52263.4883.58
55523-55233.6863.76
65318-53183.5493.62
30min15456-54563.6413.662.683.753.782.83
25451-54513.6383.78
35649-56493.7703.91
45659-56593.7773.90
55363-53633.5793.69
65302-53023.5383.65
45min110446-104466.9714.3928.997.124.5627.85
26276-62764.1884.37
35785-57853.8614.04
45656-56563.7753.94
55754-57543.8403.99
65582-55823.7253.87
60min15687-56873.7953.902.904.024.122.83
25958-59583.9764.20
36104-61044.0744.29
45750-57503.8374.05
55911-59113.9454.14
65687-56873.7953.99
极限15791-57913.8654.013.764.134.273.78
26432-64324.2934.57
36056-60564.0424.31
45953-59533.9734.23
55972-59723.9864.22
65862-58623.9124.15
贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.143053003051703051833059373051143053410.12
210.243052033054433053230.06
单位质量响应值RSD%判断
30112.5229816.700.70数据可信
供试品溶液-2025102921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%
5min12834-28341.8861.3822.751.891.3822.77
21783-17831.1871.19
32119-21191.4101.41
41892-18921.2591.26
52349-23491.5631.56
61487-14870.9900.99
10min14328-43282.8812.5510.272.902.5710.32
23502-35022.3312.34
33951-39512.6302.65
43285-32852.1872.20
54153-41532.7642.78
63779-37792.5152.53
15min15034-50343.3513.204.723.403.254.79
24526-45263.0133.05
35070-50703.3753.42
44570-45703.0423.08
54820-48203.2083.26
64852-48523.2293.27
20min15265-52653.5043.494.113.593.564.01
25312-53123.5363.61
35091-50913.3893.47
44976-49763.3123.38
55189-51893.4543.54
65602-56023.7293.80
30min15533-55333.6833.661.023.813.781.11
25510-55103.6673.78
35552-55523.6953.82
45472-54723.6423.75
55519-55193.6733.80
65397-53973.5923.71
45min15803-58033.8623.811.304.033.961.34
25681-56813.7813.93
35623-56233.7433.90
45676-56763.7783.93
55725-57253.8113.97
65808-58083.8664.02
60min15720-57203.8073.841.394.024.041.32
25684-56843.7833.98
35706-57063.7984.00
45803-58033.8624.05
55867-58673.9054.11
65856-58563.8984.10
极限15524-55243.6774.017.123.934.266.62
26825-68254.5434.78
35894-58943.9234.17
45914-59143.9364.17
55999-59993.9934.24
66021-60214.0084.25
贝派度酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.143047183048573050553049093048893048860.04
210.243049923046523048220.08
单位质量响应值RSD%判断
30067.6529767.770.71数据可信
供试品溶液-2025102921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%
5min12380-23801.5871.4811.521.591.4811.52
22317-23171.5451.54
31752-17521.1681.17
42472-24721.6481.65
52220-22201.4801.48
62134-21341.4231.42
10min14239-42392.8262.9114.212.842.9314.10
24156-41562.7712.79
35617-56173.7453.76
44174-41742.7832.80
53918-39182.6122.63
64115-41152.7432.76
15min15246-52463.4973.254.853.553.304.75
24914-49143.2763.32
34594-45943.0633.12
44650-46503.1003.15
54886-48863.2573.30
64983-49833.3223.37
20min15492-54923.6613.7013.523.753.7813.19
27030-70304.6874.77
35055-50553.3703.46
45189-51893.4593.54
55067-50673.3783.46
65464-54643.6433.73
30min15781-57813.8543.653.133.983.773.02
25407-54073.6053.74
35284-52843.5233.65
45501-55013.6673.79
55492-54923.6613.78
65371-53713.5813.70
45min16003-60034.0023.832.964.174.002.92
25759-57593.8394.02
35545-55453.6973.86
45609-56093.7393.90
55691-56913.7943.95
65871-58713.9144.08
60min16176-61764.1173.913.824.334.123.70
25912-59123.9414.16
35633-56333.7553.96
45801-58013.8674.07
55635-56353.7573.96
66071-60714.0474.25
极限16165-61654.1103.923.454.374.173.45
26042-60424.0284.29
35793-57933.8624.11
45785-57853.8574.10
55595-55953.7303.97
65884-58843.9234.17
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