贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数2000
标示量(mg)10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%
110.969499339494039492489493309495899495010.03
210.959483489481389482430.02
单位质量响应值RSD%判断
86633.3086597.530.03数据可信
供试品溶液-2025112721批-依折麦布-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%
5min132651-326513.3844.0411.473.384.0411.51
242032-420324.3574.36
337836-378363.9223.92
436193-361933.7513.75
539721-397214.1174.12
645352-453524.7014.70
10min168734-687347.1247.341.727.167.381.77
272443-724437.5097.56
371139-711397.3737.42
471012-710127.3607.40
570371-703717.2947.34
670961-709617.3557.41
15min175085-750857.7827.831.797.907.961.74
276183-761837.8968.03
375591-755917.8357.96
477916-779168.0768.20
574371-743717.7087.84
674330-743307.7047.84
20min174585-745857.7317.790.907.938.000.91
276155-761557.8938.11
375805-758057.8578.07
474573-745737.7297.94
575202-752027.7958.01
674729-747297.7457.97
30min175364-753647.8117.870.868.108.170.88
276413-764137.9208.23
376961-769617.9778.28
475972-759727.8748.17
575797-757977.8568.16
675244-752447.7998.10
45min174954-749547.7697.831.318.148.211.28
276173-761737.8958.29
376084-760847.8868.27
476714-767147.9518.34
575174-751747.7928.18
674006-740067.6718.06
60min176228-762287.9017.901.578.368.371.51
277228-772288.0058.49
377731-777318.0578.53
476033-760337.8818.36
575272-752727.8028.27
674521-745217.7248.20
极限176653-766537.9457.861.678.498.431.56
276175-761757.8958.47
377419-774198.0248.59
476270-762707.9058.47
574638-746387.7368.30
674085-740857.6798.24
贝派度酸依折麦布片项目信息
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对照品来源中检院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100
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%
110.192576282582712580992577252575542578550.13
210.272576462576772576620.01
单位质量响应值RSD%判断
25304.7125088.800.61数据可信
供试品溶液-2025112721批-贝派度酸-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%
5min13319-33191.3141.6114.661.311.6114.71
24751-47511.8801.88
33897-38971.5421.54
43604-36041.4261.43
54006-40061.5851.59
64770-47701.8881.89
10min17886-78863.1213.389.223.143.409.19
28252-82523.2663.29
39191-91913.6383.65
48045-80453.1843.20
58014-80143.1723.19
69819-98193.8863.91
15min19235-92353.6553.614.203.703.663.94
28993-89933.5593.62
38936-89363.5373.59
49626-96263.8103.86
59403-94033.7213.77
68544-85443.3813.45
20min18985-89853.5563.551.663.653.651.64
29047-90473.5813.68
39055-90553.5843.68
48680-86803.4353.53
59075-90753.5923.69
68990-89903.5583.66
30min19520-95203.7683.741.243.903.871.11
29505-95053.7623.90
39297-92973.6793.82
49498-94983.7593.89
59527-95273.7713.90
69281-92813.6733.81
45min19566-95663.7863.771.073.963.940.96
29580-95803.7923.97
39396-93963.7193.90
49588-95883.7953.97
59589-95893.7953.97
69377-93773.7113.89
60min19668-96683.8263.822.264.044.042.05
29487-94873.7553.98
39937-99373.9334.15
49803-98033.8804.10
59618-96183.8074.02
69329-93293.6923.92
极限110012-100123.9623.862.104.224.121.93
29728-97283.8504.11
39625-96253.8094.07
49698-96983.8384.10
59964-99643.9434.20
69476-94763.7504.01
贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数2000
标示量(mg)10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%
110.969492349489779494659489549494049492070.03
210.959489879491999490930.02
单位质量响应值RSD%判断
86606.4886675.160.06数据可信
供试品溶液-2025112721批-依折麦布-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%
5min143712-437124.5293.8117.814.533.8117.82
237119-371193.8463.85
331388-313883.2523.25
426635-266352.7602.76
540059-400594.1514.15
641589-415894.3094.31
10min170989-709897.3567.221.947.417.262.03
269948-699487.2487.29
369733-697337.2267.26
467337-673376.9777.01
569170-691707.1677.21
670922-709227.3497.40
15min173105-731057.5757.631.997.717.751.88
274277-742777.6967.82
372323-723237.4947.61
476177-761777.8938.00
573599-735997.6267.75
672278-722787.4897.62
20min173882-738827.6557.611.797.877.821.78
274721-747217.7427.95
373613-736137.6287.83
472449-724497.5077.70
571318-713187.3907.60
674567-745677.7267.94
30min179176-791768.2047.812.968.518.102.93
274455-744557.7158.01
376684-766847.9468.23
473538-735387.6207.90
573256-732567.5917.88
675332-753327.8068.10
45min173632-736327.6307.631.188.028.001.07
274534-745347.7238.10
374411-744117.7108.08
473857-738577.6538.02
572385-723857.5007.88
672779-727797.5417.93
60min175680-756807.8427.661.928.328.121.88
275314-753147.8048.27
374429-744297.7128.17
472361-723617.4987.95
572968-729687.5618.02
672745-727457.5388.01
极限174773-747737.7487.611.488.318.161.44
274594-745947.7298.28
373111-731117.5768.12
473032-730327.5678.10
573174-731747.5828.13
671888-718887.4498.00
贝派度酸依折麦布片项目信息
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对照品来源中检院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100
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%
110.192579072579002577062575532579242577980.07
210.272580862581332581100.02
单位质量响应值RSD%判断
25299.1225132.420.47数据可信
供试品溶液-2025112721批-贝派度酸-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%
5min14541-45411.7961.4819.941.801.4819.91
23680-36801.4551.46
33256-32561.2881.29
42553-25531.0101.01
54177-41771.6521.65
64306-43061.7031.70
10min18045-80453.1823.074.323.203.084.36
27874-78743.1143.13
37657-76573.0283.04
47198-71982.8472.86
57667-76673.0323.05
68122-81223.2123.23
15min18480-84803.3543.421.923.413.471.90
28854-88543.5023.55
38422-84223.3313.38
48644-86443.4183.46
58711-87113.4453.50
68753-87533.4623.52
20min18963-89633.5453.552.103.643.642.13
29320-93203.6863.78
38830-88303.4923.58
48910-89103.5243.60
58796-87963.4793.57
69006-90063.5623.65
30min19531-95313.7693.732.093.903.862.07
29248-92483.6573.79
39642-96423.8133.94
49215-92153.6443.76
59631-96313.8093.94
69296-92963.6763.81
45min19062-90623.5843.691.923.763.861.82
29237-92373.6533.82
39584-95843.7903.96
49302-93023.6793.84
59419-94193.7253.90
69410-94103.7213.89
60min19452-94523.7383.701.653.953.911.64
29430-94303.7293.94
39236-92363.6533.86
49144-91443.6163.82
59547-95473.7763.99
69268-92683.6653.88
极限19771-97713.8643.751.734.124.001.61
29387-93873.7123.97
39500-95003.7574.01
49493-94933.7544.00
59318-93183.6853.94
69360-93603.7023.96
贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数2000
标示量(mg)10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%
110.969486009481479487399474589479359481760.06
210.959517499516339516910.01
单位质量响应值RSD%判断
86512.4186912.420.33数据可信
供试品溶液-2025112821批-依折麦布-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%
5min142009-420094.3493.7911.764.353.7911.71
234056-340563.5263.53
329521-295213.0563.06
438544-385443.9913.99
537250-372503.8573.86
638162-381623.9513.95
10min168349-683497.0766.902.787.126.942.82
266960-669606.9336.97
363041-630416.5276.56
467157-671576.9537.00
567229-672296.9607.00
667362-673626.9747.02
15min172563-725637.5137.490.677.647.610.68
272780-727807.5357.65
371882-718827.4427.55
472914-729147.5497.67
572424-724247.4987.62
671726-717267.4267.55
20min174820-748207.7467.622.437.967.822.38
273057-730577.5647.76
373969-739697.6587.85
474090-740907.6717.88
575370-753707.8038.01
670337-703377.2827.49
30min173299-732997.5897.711.177.898.001.08
275963-759637.8658.15
374345-743457.6977.97
474566-745667.7208.01
574542-745427.7188.01
674121-741217.6747.96
45min174016-740167.6637.772.178.048.142.01
276017-760177.8708.24
377622-776228.0368.40
474265-742657.6898.07
575389-753897.8058.18
673087-730877.5677.94
60min174820-748207.7467.791.668.218.251.54
275519-755197.8198.28
376874-768747.9598.41
476108-761087.8808.34
575013-750137.7668.23
673231-732317.5828.04
极限174119-741197.6747.761.778.238.301.63
276434-764347.9138.46
376437-764377.9148.45
474482-744827.7118.26
574900-749007.7558.30
673092-730927.5678.11
贝派度酸依折麦布片项目信息
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对照品来源中检院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100
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%
110.192575172576062576472576392575432575900.03
210.272588122587232587680.03
单位质量响应值RSD%判断
25278.7025196.490.24数据可信
供试品溶液-2025112821批-贝派度酸-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%
5min14667-46671.8441.6712.511.841.6612.45
23676-36761.4521.45
35012-50121.9801.98
44122-41221.6291.63
53733-37331.4751.48
64081-40811.6131.61
10min17578-75782.9942.864.663.012.884.57
27515-75152.9692.99
36677-66772.6382.66
47369-73692.9122.93
57256-72562.8672.88
67031-70312.7782.80
15min18183-81833.2333.281.333.293.331.29
28473-84733.3483.40
38190-81903.2363.29
48365-83653.3053.36
58319-83193.2873.34
68289-82893.2753.32
20min18989-89893.5523.501.663.643.581.57
28955-89553.5383.62
38851-88513.4973.58
48752-87523.4583.55
58959-89593.5403.62
68616-86163.4043.49
30min19203-92033.6363.672.523.773.802.49
29195-91953.6333.76
39744-97443.8503.98
49204-92043.6373.76
59085-90853.5903.71
69317-93173.6813.80
45min19698-96983.8323.712.924.003.882.83
29381-93813.7073.87
39720-97203.8414.01
49293-92933.6723.84
59066-90663.5823.75
69153-91533.6173.78
60min19448-94483.7333.712.033.953.921.96
29552-95523.7743.98
39277-92773.6663.88
49675-96753.8234.03
59238-92383.6503.85
69204-92043.6373.84
极限19376-93763.7053.802.703.964.052.61
29523-95233.7634.01
39958-99583.9354.19
49845-98453.8904.14
59315-93153.6813.92
69726-97263.8434.09
贝派度酸依折麦布片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DSMF-387-240606对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.75对照品水分(%)0对照品稀释倍数2000
标示量(mg)10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%
110.969547119544039538109533169528149538110.09
210.959531289531619531440.01
单位质量响应值RSD%判断
87026.5587045.110.02数据可信
供试品溶液-2025112821批-依折麦布-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%
5min131037-310373.2014.0811.383.204.0811.40
239161-391614.0394.04
340476-404764.1754.17
440973-409734.2264.23
544371-443714.5774.58
641041-410414.2334.23
10min163815-638156.5826.882.576.626.922.62
267343-673436.9466.99
365615-656156.7686.81
466933-669336.9046.95
567939-679397.0087.06
668450-684507.0607.11
15min170538-705387.2767.421.397.387.541.46
272891-728917.5197.64
371991-719917.4267.55
470932-709327.3167.44
572604-726047.4897.62
672718-727187.5017.63
20min172297-722977.4577.582.307.657.792.27
273585-735857.5907.80
373441-734417.5757.78
476516-765167.8928.10
571576-715767.3837.59
673592-735927.5917.80
30min172521-725217.4807.601.677.757.891.64
274315-743157.6657.96
375562-755627.7948.08
473864-738647.6197.91
573584-735847.5907.88
672208-722087.4487.74
45min173219-732197.5527.721.817.918.091.78
275384-753847.7768.15
375819-758197.8218.20
475517-755177.7898.17
575997-759977.8398.22
672997-729977.5297.91
60min175261-752617.7637.671.728.208.131.59
275772-757727.8168.28
375292-752927.7668.23
474248-742487.6588.12
573033-730337.5338.00
672718-727187.5017.96
极限173081-730817.5387.641.618.068.191.55
275666-756667.8058.35
375265-752657.7638.31
474327-743277.6678.22
572789-727897.5088.06
673441-734417.5758.12
贝派度酸依折麦布片项目信息
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对照品来源中检院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100
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%
110.192596522592072591202594272589172592650.11
210.272592172591042591600.04
单位质量响应值RSD%判断
25443.0825234.660.59数据可信
供试品溶液-2025112821批-贝派度酸-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%
5min13781-37811.4881.7010.351.491.7010.26
24259-42591.6761.68
34039-40391.5901.59
45062-50621.9921.99
54579-45791.8021.80
64220-42201.6611.66
10min16801-68012.6772.915.502.692.935.55
27095-70952.7922.81
37908-79083.1123.13
47419-74192.9202.94
57740-77403.0463.07
67434-74342.9262.94
15min18246-82463.2453.271.253.293.321.25
28273-82733.2563.31
38474-84743.3353.39
48163-81633.2133.27
58329-83293.2783.33
68321-83213.2753.33
20min18538-85383.3603.462.803.443.552.82
28737-87373.4383.52
39139-91393.5973.69
48946-89463.5213.61
58514-85143.3513.44
68905-89053.5053.59
30min18798-87983.4623.531.483.583.661.57
28867-88673.4903.61
39142-91423.5983.73
49099-90993.5813.71
58982-89823.5353.66
68955-89553.5243.65
45min19264-92643.6463.692.963.803.862.89
29213-92133.6263.79
39813-98133.8624.03
49242-92423.6373.81
59660-96603.8023.97
69137-91373.5963.76
60min19641-96413.7943.763.493.993.963.25
210146-101463.9934.20
39585-95853.7723.98
49369-93693.6873.90
59245-92453.6383.85
69302-93023.6613.87
极限111211-112114.4123.955.954.654.205.48
29864-98643.8824.13
39786-97863.8514.11
49753-97533.8384.09
510012-100123.9404.19
69563-95633.7644.01
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