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%
110.969769579735449746529740129748249747980.14
210.959725909729389727640.03
单位质量响应值RSD%判断
88941.4288836.890.09数据可信
供试品溶液-2025112721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%
5min149452-494524.9944.988.674.994.988.70
248432-484324.8914.89
347413-474134.7894.79
442919-429194.3354.33
555537-555375.6095.61
652022-520225.2545.25
10min174050-740507.4797.511.517.537.561.51
275309-753097.6067.66
373596-735967.4337.49
473653-736537.4397.49
573337-733377.4077.47
676121-761217.6887.75
15min174712-747127.5467.732.147.687.872.09
279047-790477.9838.12
377116-771167.7887.92
476286-762867.7057.84
574897-748977.5647.71
677337-773377.8117.95
20min176053-760537.6817.722.127.907.952.07
278403-784037.9188.15
377225-772257.7998.02
475565-755657.6327.85
573934-739347.4677.70
677642-776427.8428.07
30min174784-747847.5537.591.277.867.901.22
276420-764207.7188.03
375682-756827.6447.95
474895-748957.5647.87
573622-736227.4367.75
675465-754657.6227.94
45min173441-734417.4177.611.997.818.011.86
277040-770407.7818.18
374182-741827.4927.89
477002-770027.7778.16
575860-758607.6628.06
674795-747957.5547.96
60min172974-729747.3707.541.657.848.021.58
274787-747877.5538.04
375662-756627.6428.12
475755-757557.6518.12
573367-733677.4107.89
675543-755437.6308.12
极限172256-722567.2987.562.837.858.122.67
275040-750407.5798.15
378329-783297.9118.47
473655-736557.4398.00
573881-738817.4628.02
675892-758927.6658.24
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%
110.192569592587412573362578992574062576680.27
210.272573082580002576540.19
单位质量响应值RSD%判断
25286.3625088.020.56数据可信
供试品溶液-2025112721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%
5min18197-81973.2453.3013.043.253.3013.03
27518-75182.9772.98
38148-81483.2263.23
47018-70182.7792.78
510023-100233.9683.97
69116-91163.6093.61
10min115712-157126.2216.292.346.266.322.34
215870-158706.2836.32
316207-162076.4176.45
415323-153236.0676.10
516364-163646.4796.52
615801-158016.2566.30
15min117631-176316.9806.981.467.097.091.49
217850-178507.0677.17
317794-177947.0457.15
417231-172316.8226.92
517857-178577.0707.19
617417-174176.8967.01
20min118202-182027.2077.233.637.397.413.51
219361-193617.6657.85
317752-177527.0287.21
418558-185587.3487.52
517466-174666.9157.11
618204-182047.2077.39
30min118385-183857.2797.351.317.547.611.27
218979-189797.5147.78
318354-183547.2677.53
418553-185537.3467.60
518407-184077.2887.56
618710-187107.4087.67
45min118267-182677.2327.533.627.587.883.45
218986-189867.5177.87
318226-182267.2167.56
419829-198297.8518.19
519728-197287.8118.16
619100-191007.5627.91
60min118993-189937.5207.570.707.948.000.68
219172-191727.5918.02
319141-191417.5788.00
419211-192117.6068.03
519285-192857.6358.07
618937-189377.4987.93
极限118836-188367.4587.652.067.978.161.89
219103-191037.5638.08
319938-199387.8948.40
419497-194977.7198.23
519059-190597.5468.07
619489-194897.7168.23
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%
110.969730299733929730849726529730569730430.03
210.959717179725959721560.07
单位质量响应值RSD%判断
88781.3088781.370.01数据可信
供试品溶液-2025112721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%
5min152322-523225.2915.207.415.295.207.43
248913-489134.9464.95
352896-528965.3495.35
445128-451284.5634.56
555550-555505.6175.62
654018-540185.4625.46
10min172788-727887.3607.441.407.427.501.39
273914-739147.4747.53
372859-728597.3677.43
474126-741267.4967.55
572598-725987.3417.40
675229-752297.6077.67
15min174126-741267.4967.551.427.647.691.40
273394-733947.4227.56
375275-752757.6127.75
474340-743407.5177.65
576454-764547.7317.87
674447-744477.5287.67
20min174087-740877.4927.501.297.727.721.24
274359-743597.5197.74
375792-757927.6647.89
473778-737787.4607.68
572863-728637.3687.60
674026-740267.4857.71
30min172282-722827.3097.391.157.627.701.03
274135-741357.4967.80
373414-734147.4247.73
473792-737927.4627.76
572149-721497.2967.61
672564-725647.3387.65
45min172588-725887.3407.401.247.737.781.18
273337-733377.4167.80
374251-742517.5087.90
472640-726407.3457.73
571957-719577.2767.67
674059-740597.4897.88
60min174145-741457.4977.441.687.977.911.58
274587-745877.5428.01
374306-743067.5147.99
473621-736217.4447.91
571182-711827.1987.67
673421-734217.4247.90
极限172613-726137.3437.390.757.907.940.73
273248-732487.4077.96
374061-740617.4898.05
472959-729597.3787.93
572576-725767.3397.89
672910-729107.3737.93
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%
110.192585212576102586862564762590012580590.40
210.272579592574462577020.15
单位质量响应值RSD%判断
25324.7325092.700.66数据可信
供试品溶液-2025112721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%
5min19307-93073.6823.6411.073.683.6411.05
28662-86623.4273.43
39358-93583.7023.70
47552-75522.9872.99
510557-105574.1764.18
69744-97443.8553.85
10min116065-160656.3556.311.906.406.351.94
215703-157036.2126.25
315546-155466.1506.19
415828-158286.2616.29
516156-161566.3916.44
616352-163526.4696.51
15min117372-173726.8726.892.006.987.002.01
217498-174986.9227.03
317121-171216.7736.88
417269-172696.8316.93
518065-180657.1467.26
617159-171596.7886.90
20min118334-183347.2537.012.067.447.202.02
217266-172666.8307.01
317560-175606.9467.13
417866-178667.0687.25
517553-175536.9447.14
617767-177677.0287.22
30min117827-178277.0527.191.367.327.461.32
218475-184757.3087.57
318200-182007.2007.46
418050-180507.1407.40
518447-184477.2977.57
618104-181047.1627.43
45min118684-186847.3917.371.137.747.711.03
218716-187167.4047.74
318429-184297.2907.63
418896-188967.4757.81
518319-183197.2477.60
618687-186877.3927.74
60min118914-189147.4827.501.497.917.921.33
219123-191237.5657.99
319087-190877.5517.97
419260-192607.6198.04
518461-184617.3037.74
618857-188577.4607.89
极限118629-186297.3697.401.687.887.901.56
218270-182707.2277.73
319000-190007.5168.02
418946-189467.4958.00
518394-183947.2767.79
618934-189347.4908.00
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%
110.969719869726029720759728759707149720500.09
210.959737919742879740390.04
单位质量响应值RSD%判断
88690.6988953.330.21数据可信
供试品溶液-2025112821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%
5min154251-542515.4834.829.415.484.829.40
243725-437254.4194.42
349171-491714.9704.97
450951-509515.1505.15
544550-445504.5034.50
643338-433384.3804.38
10min173331-733317.4127.291.947.477.341.95
272393-723937.3177.37
370414-704147.1177.17
473785-737857.4587.51
572362-723627.3147.36
670549-705497.1317.18
15min177115-771157.7947.720.857.947.860.93
276748-767487.7577.89
376468-764687.7297.86
476861-768617.7697.91
575501-755017.6317.76
675737-757377.6557.78
20min176610-766107.7437.751.457.977.981.40
275047-750477.5857.80
377738-777387.8578.08
476375-763757.7197.95
576401-764017.7227.94
678171-781717.9018.11
30min176610-766107.7437.832.138.068.142.07
276627-766277.7458.05
380650-806508.1528.46
477722-777227.8568.17
576299-762997.7128.01
676786-767867.7618.06
45min178837-788377.9687.842.608.378.242.46
280903-809038.1778.56
375621-756217.6438.04
477809-778097.8648.26
575876-758767.6698.06
676649-766497.7478.13
60min176653-766537.7487.781.558.248.261.44
276453-764537.7278.21
377368-773687.8208.30
476823-768237.7658.25
575413-754137.6228.10
678981-789817.9838.46
极限175120-751207.5937.712.248.178.282.05
275858-758587.6678.23
374528-745287.5338.10
476409-764097.7238.30
576249-762497.7078.26
679430-794308.0288.59
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%
110.192569412575842577102579022577822575840.15
210.272587952585912586930.06
单位质量响应值RSD%判断
25278.1225189.190.25数据可信
供试品溶液-2025112821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%
5min110248-102484.0503.3813.014.053.3813.01
27894-78943.1203.12
38782-87823.4713.47
49328-93283.6863.69
57769-77693.0703.07
67285-72852.8792.88
10min115303-153036.0485.783.846.095.823.88
214089-140895.5685.60
314690-146905.8055.84
414994-149945.9255.97
514860-148605.8725.91
613828-138285.4655.50
15min116536-165366.5356.511.536.656.611.53
216775-167756.6296.73
316036-160366.3376.44
416578-165786.5516.66
516545-165456.5386.64
616354-163546.4636.56
20min117179-171796.7896.811.976.976.981.91
217126-171266.7686.94
317416-174166.8837.06
416686-166866.5946.77
517706-177066.9977.17
617250-172506.8176.98
30min117381-173816.8696.992.517.137.242.44
217722-177227.0047.25
318399-183997.2717.52
417930-179307.0867.34
517490-174906.9127.16
617153-171536.7797.02
45min118582-185827.3437.252.437.687.582.36
219005-190057.5117.83
318254-182547.2147.54
418255-182557.2147.55
518378-183787.2637.59
617653-176536.9767.29
60min117938-179387.0897.201.587.517.601.42
218272-182727.2217.63
318163-181637.1787.59
418553-185537.3327.74
517840-178407.0507.46
618489-184897.3077.70
极限117997-179977.1127.162.537.617.652.35
218483-184837.3047.79
317282-172826.8307.32
418507-185077.3147.81
518125-181257.1637.65
618347-183477.2517.72
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%
110.969719539723089719469719159714839719210.04
210.959764289761649762960.02
单位质量响应值RSD%判断
88678.9289159.450.39数据可信
供试品溶液-2025112821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%
5min148914-489144.9395.559.674.945.559.66
250623-506235.1115.11
352775-527755.3285.33
463388-633886.4006.40
556129-561295.6675.67
657848-578485.8415.84
10min171817-718177.2517.472.677.317.542.60
275425-754257.6157.67
374571-745717.5297.59
471272-712727.1967.27
575845-758457.6587.72
675215-752157.5947.66
15min177821-778217.8577.721.777.997.871.68
277900-779007.8658.01
376306-763067.7047.85
475501-755017.6237.77
577004-770047.7757.92
674469-744697.5197.67
20min176608-766087.7357.680.977.967.910.92
276645-766457.7387.97
376947-769477.7698.00
475740-757407.6477.88
575348-753487.6077.84
675240-752407.5967.83
30min174698-746987.5427.570.977.857.890.93
275847-758477.6587.97
375218-752187.5947.91
474114-741147.4837.80
575766-757667.6507.97
674385-743857.5107.83
45min175471-754717.6207.561.888.017.961.78
275289-752897.6018.00
375296-752967.6028.00
473690-736907.4407.84
576841-768417.7588.16
672903-729037.3617.76
60min176667-766677.7417.611.598.228.091.49
274724-747247.5448.03
376016-760167.6758.16
474846-748467.5578.04
576379-763797.7118.20
673547-735477.4267.91
极限175288-752887.6017.601.168.168.171.10
275330-753307.6068.17
376952-769527.7698.34
474794-747947.5518.12
575149-751497.5878.16
674411-744117.5138.08
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%
110.192576052602212566492575722573482578790.53
210.272588742582892585820.16
单位质量响应值RSD%判断
25307.0725178.380.37数据可信
供试品溶液-2025112821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%
5min18904-89043.5173.8510.503.523.8510.44
29068-90683.5823.58
38923-89233.5253.53
411448-114484.5224.52
59678-96783.8233.82
610437-104374.1234.12
10min114110-141105.5745.723.125.615.773.09
215111-151115.9706.01
313913-139135.4965.54
414368-143685.6765.73
514568-145685.7555.80
614849-148495.8665.91
15min115939-159396.2976.222.226.406.332.12
216066-160666.3476.45
315980-159806.3136.41
415159-151595.9896.10
515880-158806.2736.38
615511-155116.1286.24
20min115929-159296.2936.451.736.466.631.74
216532-165326.5316.71
316441-164416.4956.67
416503-165036.5196.70
516027-160276.3316.51
616574-165746.5486.73
30min115983-159836.3146.522.366.556.772.36
216884-168846.6706.92
316227-162276.4106.65
416954-169546.6986.95
516355-163556.4616.71
616700-167006.5976.85
45min116799-167996.6366.632.796.956.952.61
216893-168936.6747.00
317614-176146.9587.27
416246-162466.4186.74
516728-167286.6086.93
616471-164716.5076.83
60min117288-172886.8306.770.887.217.160.80
217151-171516.7757.17
317159-171596.7797.17
416931-169316.6897.09
517014-170146.7217.11
617313-173136.8397.24
极限116773-167736.6266.761.777.097.221.69
217241-172416.8117.28
317253-172536.8167.28
417535-175356.9277.40
516768-167686.6247.09
617035-170356.7307.20
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