依折麦布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%
111.159648169683109679949648549659979663940.18
211.179623809644089633940.15
单位质量响应值RSD%判断
86672.1186248.340.35数据可信
供试品溶液-2024092721批-依折麦布-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min162977-629776.5396.286.886.546.286.90
259885-598856.2186.22
358077-580776.0306.03
458792-587926.1056.10
567474-674747.0067.01
655755-557555.7895.79
10min182578-825788.5748.762.788.658.832.78
286000-860008.9309.00
383735-837358.6958.76
483447-834478.6658.73
588375-883759.1769.25
682313-823138.5478.61
15min183453-834538.6658.761.708.838.921.71
286811-868119.0149.18
384265-842658.7508.91
484270-842708.7508.91
584710-847108.7968.98
682578-825788.5748.73
20min179135-791358.2178.371.878.488.631.85
283063-830638.6258.89
379877-798778.2948.55
481377-813778.4508.71
580865-808658.3978.67
679213-792138.2258.48
30min177081-770818.0048.201.828.368.561.82
280369-803698.3458.71
377763-777638.0748.43
480225-802258.3308.69
580025-800258.3098.68
678163-781638.1168.46
45min176205-762057.9138.174.758.368.624.58
282780-827808.5959.05
375644-756447.8548.30
478247-782478.1258.57
583788-837888.7009.16
675312-753127.8208.26
60min179706-797068.2768.374.128.818.914.00
283990-839908.7219.27
376924-769247.9878.52
480386-803868.3478.88
585146-851468.8419.40
677663-776638.0648.59
极限178541-785418.1558.484.968.789.124.81
288081-880819.1469.80
377875-778758.0868.70
483369-833698.6579.29
583754-837548.6979.35
678601-786018.1618.77
依折麦布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%
110.162569572570972567882566732565412568110.09
210.192563452566362564900.09
单位质量响应值RSD%判断
25276.6725170.760.30数据可信
供试品溶液-2024092721批-贝派度酸-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min118994-189947.5096.9511.657.516.9511.65
215901-159016.2866.29
315690-156906.2036.20
415759-157596.2306.23
520421-204218.0738.07
618655-186557.3757.38
10min127229-2722910.76511.0310.7610.8511.1010.73
225657-2565710.14310.21
326379-2637910.42910.50
425057-250579.9069.98
530294-3029411.97712.07
632731-3273112.94013.02
15min129528-2952811.67411.869.1511.8812.069.13
228217-2821711.15511.34
329039-2903911.48011.67
427727-2772710.96211.14
530127-3012711.91112.13
635304-3530413.95714.18
20min129157-2915711.52711.869.8711.8612.199.85
228409-2840911.23111.54
328610-2861011.31111.62
428080-2808011.10111.40
529766-2976611.76812.12
635904-3590414.19414.58
30min129400-2940011.62311.9711.0212.0812.4410.94
228555-2855511.28911.72
328695-2869511.34411.78
428217-2821711.15511.58
529864-2986411.80712.29
636980-3698014.62015.16
45min129191-2919111.54011.9510.7812.1312.5510.72
229182-2918211.53712.09
327624-2762410.92111.49
428086-2808611.10411.65
530845-3084512.19412.81
636485-3648514.42415.13
60min130168-3016811.92712.0311.7112.6412.7611.60
228474-2847411.25711.94
328080-2808011.10111.79
427889-2788911.02611.70
530609-3060912.10112.85
637325-3732514.75615.62
极限129523-2952311.67212.1310.7912.5213.0010.71
228926-2892611.43612.25
328171-2817111.13711.95
429675-2967511.73212.53
530617-3061712.10412.99
637247-3724714.72515.75
依折麦布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%
111.159682459681869679159671809676279678310.05
211.179634479632359633410.02
单位质量响应值RSD%判断
86800.9986243.600.46数据可信
供试品溶液-2024092721批-依折麦布-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min161552-615526.3875.0023.366.395.0023.37
260194-601946.2466.25
340975-409754.2524.25
441410-414104.2974.30
551015-510155.2935.29
633903-339033.5183.52
10min181641-816418.4718.196.238.548.246.36
285842-858428.9078.98
374635-746357.7447.79
474448-744487.7257.77
582165-821658.5258.58
674832-748327.7657.80
15min182135-821358.5228.552.798.698.702.90
285893-858938.9129.08
380561-805618.3598.49
480145-801458.3168.45
584531-845318.7718.92
681366-813668.4438.57
20min178545-785458.1508.431.848.418.671.79
281942-819428.5028.77
381833-818338.4918.72
480976-809768.4028.63
582947-829478.6078.86
681108-811088.4168.63
30min175553-755537.8398.182.528.198.522.41
279331-793318.2318.59
380341-803418.3368.66
477409-774098.0328.35
580761-807618.3808.73
679654-796548.2658.58
45min176007-760077.8878.263.768.328.683.70
284946-849468.8149.27
380009-800098.3028.71
477888-778888.0828.49
579191-791918.2178.66
679465-794658.2458.65
60min175867-758677.8728.535.088.409.054.88
285678-856788.8909.44
383934-839348.7099.21
479730-797308.2738.77
587135-871359.0419.57
680976-809768.4028.90
极限177849-778498.0788.907.088.699.516.80
291614-916149.50610.16
390174-901749.3569.96
479741-797418.2748.86
591054-910549.44810.08
683931-839318.7099.30
依折麦布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%
110.162572262565242563982570582569452568300.14
210.192558252555562556900.08
单位质量响应值RSD%判断
25278.5425092.250.53数据可信
供试品溶液-2024092721批-贝派度酸-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min117931-179317.1005.1830.837.105.1830.81
217075-170756.7616.76
310378-103784.1094.11
49398-93983.7213.72
514834-148345.8745.87
68857-88573.5073.51
10min127511-2751110.8939.4414.9010.979.5014.97
226978-2697810.68210.76
320735-207358.2108.26
419987-199877.9147.96
526663-2666310.55710.62
621148-211488.3748.41
15min128973-2897311.47210.829.5311.6710.999.68
229553-2955311.70111.90
324754-247549.8019.94
424007-240079.5069.63
530164-3016411.94312.13
626580-2658010.52410.66
20min129705-2970511.76211.168.0512.0911.448.18
229448-2944811.66011.98
325813-2581310.22110.47
425543-2554310.11410.35
531137-3113712.32912.64
627488-2748810.88411.13
30min128622-2862211.33311.336.6411.7911.746.75
229054-2905411.50411.96
327224-2722410.77911.14
426096-2609610.33310.68
531683-3168312.54513.00
629013-2901311.48811.86
45min129019-2901911.49011.486.4112.0712.016.53
229612-2961211.72512.31
327475-2747510.87911.36
426369-2636910.44110.90
531631-3163112.52413.12
629845-2984511.81712.31
60min128776-2877611.39411.606.9412.1112.266.99
229677-2967711.75112.46
328043-2804311.10411.70
426608-2660810.53511.11
532576-3257612.89813.63
630139-3013911.93412.56
极限129246-2924611.58011.767.1812.4212.557.20
229881-2988111.83112.67
329442-2944211.65812.38
426538-2653810.50811.20
533217-3321713.15214.03
629952-2995211.85912.62
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