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%
111.25 9858359857319852869843159839059850140.09
211.26 9834339838039836180.03
单位质量响应值RSD%判断
87556.8087355.060.17数据可信
供试品溶液-1996048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%
5min148906-489065.0204.916.865.024.916.88
241419-414194.2524.25
349103-491035.0415.04
450558-505585.1905.19
549364-493645.0675.07
647493-474934.8754.88
10min169119-691197.0956.932.317.156.982.34
265197-651976.6936.74
367797-677976.9597.02
469196-691967.1037.16
566414-664146.8186.87
667235-672356.9026.96
15min172012-720127.3927.381.717.537.511.73
270903-709037.2787.40
373470-734707.5427.68
472838-728387.4777.61
571940-719407.3857.52
670122-701227.1987.33
20min173770-737707.5737.551.177.797.761.18
273394-733947.5347.74
374536-745367.6517.87
473527-735277.5487.77
573999-739997.5967.81
671992-719927.3907.60
30min174502-745027.6487.523.517.957.823.37
273632-736327.5587.84
375743-757437.7758.08
470568-705687.2447.55
575358-753587.7368.03
669585-695857.1437.44
45min174379-743797.6357.791.798.028.171.72
275861-758617.7878.16
378060-780608.0138.40
476511-765117.8548.24
574583-745837.6568.04
675682-756827.7698.14
60min175752-757527.7767.741.038.258.210.99
275761-757617.7778.23
376007-760077.8028.28
475755-757557.7768.25
573930-739307.5898.06
675110-751107.7108.17
极限176037-760377.8057.751.528.368.301.41
277008-770087.9058.45
376357-763577.8388.40
474760-747607.6748.23
573965-739657.5938.15
674915-749157.6908.23
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%
110.12 2562742565992564122561622561122563120.08
210.162566182563972565080.07
单位质量响应值RSD%判断
25327.2725246.850.23数据可信
供试品溶液-1996048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%
5min11922-19220.7580.7389.700.760.7389.78
2-0.0000.00
3-0.0000.00
41812-18120.7150.71
53978-39781.5691.57
63425-34251.3511.35
10min13419-34191.3481.307.481.361.307.81
22938-29381.1591.16
33079-30791.2141.21
43612-36121.4241.43
53405-34051.3431.36
63258-32581.2851.30
15min14505-45051.7771.774.281.801.794.45
24221-42211.6651.68
34413-44131.7401.75
44785-47851.8871.91
54575-45751.8041.84
64381-43811.7281.76
20min15212-52122.0552.045.282.102.085.29
24813-48131.8981.93
35141-51412.0272.06
45602-56022.2092.25
55247-52472.0692.12
64950-49501.9522.00
30min16108-61082.4092.333.872.472.403.79
25775-57752.2772.33
36138-61382.4212.48
45904-59042.3282.40
56023-60232.3752.45
65537-55372.1842.25
45min16662-66622.6272.653.692.722.743.57
26435-64352.5382.62
37084-70842.7942.88
46954-69542.7422.84
56612-66122.6072.71
66571-65712.5912.69
60min17380-73802.9102.821.843.032.941.83
27068-70682.7872.89
37151-71512.8202.93
47170-71702.8282.95
57133-71332.8132.94
66988-69882.7562.88
极限17703-77033.0383.001.383.193.161.25
27564-75642.9833.12
37768-77683.0633.21
47558-75582.9813.14
57480-74802.9503.11
67619-76193.0053.16
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%
111.25 9825719838709824459829229828399829290.06
211.26 9833969824329829140.07
单位质量响应值RSD%判断
87371.4787292.540.07数据可信
供试品溶液-1996048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%
5min149781-497815.1174.886.475.124.886.51
241581-415814.2744.27
350019-500195.1425.14
448109-481094.9454.95
547674-476744.9014.90
647934-479344.9274.93
10min167691-676916.9586.891.287.026.941.30
265552-655526.7396.79
367875-678756.9777.03
467049-670496.8926.95
566508-665086.8376.89
667315-673156.9206.97
15min172462-724627.4497.360.927.587.490.96
270815-708157.2807.40
372223-722237.4247.56
471579-715797.3587.49
571047-710477.3037.43
671248-712487.3247.46
20min174170-741707.6247.471.047.847.681.03
272399-723997.4427.65
372443-724437.4477.66
472056-720567.4077.62
572565-725657.4597.67
672418-724187.4447.66
30min173925-739257.5997.452.647.907.752.54
274623-746237.6717.96
372239-722397.4267.73
473287-732877.5347.83
569315-693157.1257.42
671553-715537.3557.65
45min174977-749777.7077.691.798.098.061.69
277416-774167.9588.33
374199-741997.6278.01
474075-740757.6157.99
573891-738917.5967.97
674182-741827.6268.00
60min174770-747707.6867.720.998.168.180.91
276452-764527.8598.32
375392-753927.7508.22
474451-744517.6538.12
574682-746827.6778.14
674764-747647.6868.15
极限174887-748877.6987.751.098.268.301.01
277048-770487.9208.47
375303-753037.7418.29
475323-753237.7438.29
575248-752487.7358.28
674824-748247.6928.24
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%
110.12 2560372562732562222563922563012562450.06
210.162574192571032572610.09
单位质量响应值RSD%判断
25320.6525320.960.01数据可信
供试品溶液-1996048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%
5min11616-16160.6360.22154.950.640.22154.95
2-0.0000.00
31669-16690.6570.66
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min13098-30981.2201.159.371.231.169.25
22476-24760.9750.98
32890-28901.1381.15
42998-29981.1811.18
53280-32801.2921.29
62821-28211.1111.11
15min14021-40211.5841.573.911.601.593.89
23744-37441.4741.49
34195-41951.6521.67
44101-41011.6151.63
53967-39671.5621.58
63923-39231.5451.56
20min14877-48771.9211.825.221.961.865.43
24313-43131.6991.73
34944-49441.9471.99
44555-45551.7941.82
54469-44691.7601.79
64607-46071.8141.84
30min15388-53882.1222.102.362.182.162.47
25390-53902.1232.17
35534-55342.1792.24
45319-53192.0952.15
55204-52042.0492.10
65208-52082.0512.10
45min16417-64172.5272.491.342.612.561.42
26419-64192.5282.60
36296-62962.4802.56
46314-63142.4872.56
56196-61962.4402.51
66299-62992.4812.55
60min16919-69192.7252.621.912.842.732.10
26620-66202.6072.70
36645-66452.6172.73
46605-66052.6012.70
56603-66032.6002.70
66587-65872.5942.69
极限17227-72272.8462.902.182.993.042.08
27554-75542.9753.10
37572-75722.9823.12
47367-73672.9013.03
57196-71962.8342.96
67312-73122.8803.01
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%
111.25 9834279851809829729845119832759838730.10
211.26 9873569873519873540.01
单位质量响应值RSD%判断
87455.3887686.860.19数据可信
供试品溶液-1996048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%
5min156828-568285.8265.895.445.835.895.48
260137-601376.1656.17
355841-558415.7255.72
454124-541245.5495.55
562283-622836.3856.39
655420-554205.6815.68
10min172824-728247.4667.431.987.537.501.98
274024-740247.5897.66
374119-741197.5987.66
471104-711047.2897.35
571961-719617.3777.45
670770-707707.2557.32
15min175189-751897.7087.711.507.867.861.50
276922-769227.8868.04
375578-755787.7487.90
473610-736107.5467.69
574375-743757.6257.78
675329-753297.7227.87
20min175856-758567.7777.701.788.017.941.77
276469-764697.8398.08
376326-763267.8258.06
473060-730607.4907.72
574657-746577.6547.89
674359-743597.6237.85
30min173055-730557.4897.632.147.817.952.07
273819-738197.5687.90
375996-759967.7918.11
472929-729297.4767.79
576721-767217.8658.19
673852-738527.5717.89
45min174744-747447.6637.671.828.078.081.81
275666-756667.7578.17
376784-767847.8728.28
472746-727467.4587.85
574929-749297.6818.09
674275-742757.6148.01
60min175129-751297.7027.692.588.198.182.50
275578-755787.7488.25
378185-781858.0158.51
472308-723087.4137.89
574096-740967.5968.09
674702-747027.6588.14
极限175587-755877.7497.681.808.328.251.77
274222-742227.6098.19
376746-767467.8688.45
472989-729897.4838.04
575669-756697.7578.34
674238-742387.6118.18
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%
110.12 2573392575052573092575572574132574250.05
210.162592192592052592120.01
单位质量响应值RSD%判断
25437.2525512.990.22数据可信
供试品溶液-1996048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%
5min13514-35141.3761.339.431.381.339.39
23384-33841.3251.32
33703-37031.4501.45
42834-28341.1091.11
53686-36861.4431.44
63319-33191.2991.30
10min16623-66232.5932.583.832.612.593.93
26612-66122.5882.60
36948-69482.7202.74
46176-61762.4182.43
56666-66662.6092.63
66490-64902.5402.55
15min18681-86813.3983.313.753.443.353.69
28568-85683.3543.40
38809-88093.4483.49
48105-81053.1733.21
58025-80253.1413.19
68522-85223.3363.38
20min110039-100393.9303.843.494.013.923.46
29935-99353.8893.97
310224-102244.0024.09
49456-94563.7013.78
59344-93443.6583.74
69798-97983.8353.92
30min114818-148185.8004.6811.855.934.8011.63
211287-112874.4184.54
311697-116974.5794.71
411197-111974.3834.50
511548-115484.5204.64
611190-111904.3804.50
45min113109-131095.1315.072.445.325.252.48
212832-128325.0235.20
313476-134765.2755.46
412736-127364.9855.15
512584-125844.9265.10
613016-130165.0955.27
60min113752-137525.3835.432.255.635.662.18
214071-140715.5085.74
314370-143705.6255.86
413895-138955.4395.66
513565-135655.3105.54
613574-135745.3135.54
极限114992-149925.8685.761.856.186.061.87
214298-142985.5975.89
315039-150395.8876.19
414716-147165.7606.04
514665-146655.7406.03
614612-146125.7206.01
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%
111.25 9862939869899865169870709863979866530.04
211.26 9888779899009893880.08
单位质量响应值RSD%判断
87702.4987867.500.14数据可信
供试品溶液-1996048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%
5min146159-461594.7215.538.904.725.528.91
253845-538455.5075.51
357397-573975.8705.87
450785-507855.1945.19
558279-582795.9605.96
657735-577355.9045.90
10min171100-711007.2717.371.147.327.431.21
272042-720427.3687.43
372597-725977.4247.49
471754-717547.3387.40
573354-733547.5027.57
671461-714617.3087.37
15min175082-750827.6787.590.857.817.740.83
273752-737527.5427.69
374711-747117.6407.79
473367-733677.5037.64
574200-742007.5887.74
674444-744447.6137.76
20min176076-760767.7807.651.748.007.881.68
274616-746167.6317.86
376521-765217.8268.06
473388-733887.5057.73
574539-745397.6237.86
673477-734777.5147.75
30min175532-755327.7247.591.468.037.911.41
274549-745497.6247.94
375253-752537.6968.02
473755-737557.5437.85
573879-738797.5557.87
672590-725907.4247.74
45min176836-768367.8587.533.018.257.932.84
273572-735727.5247.92
374512-745127.6208.03
473169-731697.4837.87
570005-700057.1597.56
673693-736937.5367.93
60min176311-763117.8047.492.388.287.972.24
273452-734527.5127.99
373695-736957.5378.03
471590-715907.3217.79
571608-716087.3237.81
672976-729767.4637.94
极限176660-766607.8407.462.738.408.022.54
272758-727587.4418.00
372600-726007.4258.00
470930-709307.2547.81
571652-716527.3287.89
673152-731527.4818.05
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%
110.12 2578622584212584492585582584532583490.11
210.162594982597472596220.07
单位质量响应值RSD%判断
25528.5625553.350.07数据可信
供试品溶液-1996048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%
5min11994-19940.7791.1115.370.781.1115.35
22910-29101.1361.14
32787-27871.0881.09
43017-30171.1781.18
53203-32031.2511.25
63091-30911.2071.21
10min15847-58472.2832.435.932.292.446.01
26640-66402.5922.61
35951-59512.3232.34
46248-62482.4392.45
56692-66922.6132.63
65960-59602.3272.34
15min17666-76662.9933.195.333.033.235.37
28925-89253.4853.53
37943-79433.1013.14
48262-82623.2263.27
58282-82823.2343.28
67949-79493.1043.14
20min19198-91983.5913.713.173.663.793.21
29948-99483.8843.96
39297-92973.6303.70
49606-96063.7503.83
59741-97413.8033.88
69273-92733.6203.69
30min110503-105034.1014.353.914.214.473.94
211692-116924.5654.69
311045-110454.3124.43
411455-114554.4724.59
511366-113664.4384.56
610855-108554.2384.35
45min112847-128475.0165.033.035.175.203.01
213441-134415.2485.42
312339-123394.8184.98
413212-132125.1585.33
512673-126734.9485.12
612836-128365.0125.17
60min113539-135395.2865.312.875.495.532.87
214359-143595.6065.84
313249-132495.1735.39
413478-134785.2625.49
513495-134955.2695.49
613423-134235.2415.46
极限115600-156006.0915.703.836.365.983.67
214831-148315.7906.09
313991-139915.4635.73
414460-144605.6465.93
514417-144175.6295.91
614310-143105.5875.86
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