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%
111.239722129726119743609730599724399729360.09
211.299751109734729742910.12
单位质量响应值RSD%判断
86637.2286296.810.28数据可信
供试品溶液-24091202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%
5min150665-506655.2604.868.935.264.868.93
247320-473204.9134.91
342975-429754.4624.46
450014-500145.1935.19
549403-494035.1295.13
640449-404494.2004.20
10min168076-680767.0687.072.537.137.122.60
267510-675107.0097.06
367064-670646.9637.01
468801-688017.1437.20
570976-709767.3697.43
665950-659506.8476.89
15min173536-735367.6357.442.357.777.572.35
274011-740117.6847.82
370364-703647.3067.43
470302-703027.2997.44
571181-711817.3907.53
670501-705017.3207.44
20min173695-736957.6517.502.277.877.712.19
273520-735207.6337.85
370102-701027.2787.49
472356-723567.5127.73
570309-703097.3007.52
673373-733737.6187.82
30min173370-733707.6187.502.267.927.802.23
273827-738277.6657.97
369242-692427.1897.48
472666-726667.5457.85
571835-718357.4587.76
672558-725587.5337.82
45min173494-734947.6317.552.138.027.931.98
274206-742067.7058.09
374088-740887.6928.06
471308-713087.4047.79
570411-704117.3117.70
672701-727017.5487.92
60min173683-736837.6507.501.798.137.971.68
270884-708847.3607.83
373573-735737.6398.09
470632-706327.3337.80
572419-724197.5197.99
672312-723127.5087.96
极限172165-721657.4937.593.488.058.143.28
277670-776708.0648.62
373960-739607.6798.22
473025-730257.5828.13
570408-704087.3107.86
671507-715077.4247.96
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%
19.922391442386122417242398212371402392880.71
29.932398412418282408340.59
单位质量响应值RSD%判断
24121.7724253.170.39数据可信
供试品溶液-24091202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%
5min14843-48431.9971.847.322.001.847.25
24570-45701.8841.88
34143-41431.7081.71
44658-46581.9201.92
54573-45731.8851.89
63991-39911.6451.65
10min17234-72342.9822.934.983.002.954.95
26916-69162.8512.87
36737-67372.7782.80
47274-72742.9993.02
57664-76643.1603.18
66794-67942.8012.82
15min18424-84243.4733.322.653.533.382.67
28129-81293.3513.40
37959-79593.2813.33
47827-78273.2273.28
58111-81113.3443.40
67907-79073.2603.31
20min18516-85163.5113.532.543.603.622.53
28721-87213.5963.69
38156-81563.3633.45
48719-87193.5953.69
58600-86003.5463.64
68696-86963.5853.67
30min18840-88403.6453.653.573.783.783.47
28893-88933.6663.80
38303-83033.4233.55
48838-88383.6443.77
59268-92683.8213.95
69003-90033.7123.84
45min19141-91413.7693.741.313.943.901.30
29249-92493.8133.98
39030-90303.7233.88
48944-89443.6873.86
59081-90813.7443.92
68946-89463.6883.85
60min19474-94743.9063.792.914.124.012.77
28887-88873.6643.88
39168-91683.7803.98
48886-88863.6643.88
59456-94563.8994.12
69335-93353.8494.06
极限19122-91223.7613.863.984.024.123.71
210054-100544.1454.40
39304-93043.8364.08
49483-94833.9104.16
59186-91863.7874.05
69035-90353.7253.98
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%
111.239750269725709731399724449748829736120.13
211.299731559750519741030.14
单位质量响应值RSD%判断
86697.4286280.160.35数据可信
供试品溶液-24091202批-依折麦布-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min137715-377153.9157.3282.923.917.3282.95
255369-553695.7475.75
354639-546395.6725.67
450302-503025.2215.22
536525-365253.7913.79
6188808-18880819.59819.60
10min165410-654106.79011.06103.146.8311.14102.98
261742-617426.4096.47
368280-682807.0877.15
447086-470864.8884.95
566367-663676.8896.93
6330217-33021734.27734.49
15min171327-713277.40411.6094.147.5211.8094.17
267864-678647.0447.18
365513-655136.8006.94
472183-721837.4937.60
567269-672696.9837.10
6326493-32649333.89034.49
20min172102-721027.48411.45104.047.6911.79103.74
247363-473634.9165.13
364139-641396.6586.87
468303-683037.0907.29
566127-661276.8647.06
6343996-34399635.70736.68
30min168378-683787.09811.36104.837.3811.82104.54
258124-581246.0336.30
360608-606086.2916.58
466944-669446.9497.22
559010-590106.1256.40
6343310-34331035.63637.01
45min159154-591546.14011.6799.226.5012.2699.20
270775-707757.3467.68
368423-684237.1027.46
468386-683867.0987.45
567944-679447.0537.39
6340043-34004335.29737.06
60min163405-634056.58110.6495.427.0111.3695.64
270581-705817.3267.74
362442-624426.4816.92
459355-593556.1616.59
557388-573885.9576.38
6302014-30201431.34933.51
极限172789-727897.55612.09103.638.0612.92103.28
263533-635336.5957.09
370881-708817.3577.87
456958-569585.9126.41
572109-721097.4857.97
6362485-36248537.62640.13
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%
19.922517262509982514322504552503912510000.24
29.932507382512532509960.15
单位质量响应值RSD%判断
25302.4225276.540.08数据可信
供试品溶液-24091202批-贝派度酸-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1-0.0002.21109.910.002.21109.92
210581-105814.1724.17
312098-120984.7704.77
4-0.0000.00
5-0.0000.00
610940-109404.3144.31
10min113396-133965.2825.6220.075.285.6420.40
214219-142195.6075.65
315707-157076.1936.25
410230-102304.0344.03
513135-131355.1795.18
618790-187907.4097.46
15min115914-159146.2756.438.956.336.529.10
215761-157616.2156.32
315710-157106.1956.32
416795-167956.6236.67
514682-146825.7895.85
618943-189437.4697.60
20min116785-167856.6196.2818.816.756.4418.52
211014-110144.3434.52
315947-159476.2886.48
416201-162016.3886.51
515296-152966.0316.15
620346-203468.0238.24
30min116944-169446.6816.4512.766.886.6812.81
214999-149995.9146.14
315736-157366.2056.47
416137-161376.3636.55
514155-141555.5825.77
620135-201357.9408.24
45min115171-151715.9827.1010.096.267.4110.20
218905-189057.4557.75
318240-182407.1927.52
417817-178177.0257.29
517311-173116.8267.08
620666-206668.1498.54
60min116446-164466.4856.709.146.837.089.19
219043-190437.5097.88
316906-169066.6667.08
416282-162826.4206.76
514785-147855.8306.16
618459-184597.2797.76
极限118468-184687.2827.1810.267.707.6410.22
217254-172546.8037.26
319220-192207.5798.06
415133-151335.9676.38
518608-186087.3377.73
620626-206268.1338.70
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