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DJ333-221017对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.67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%
110.435235645248605259005259725257905252170.20
210.445189735183245186480.09
单位质量响应值RSD%判断
50356.3849678.930.96数据可信
供试品溶液-24040801批-依折麦布-pH6.6
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min125139-251394.5094.447.614.514.447.58
223353-233534.1884.19
325526-255264.5784.58
421887-218873.9253.93
525468-254684.5684.57
627266-272664.8904.89
10min141025-410257.3587.522.837.417.572.82
242938-429387.7017.75
341927-419277.5207.57
440693-406937.2987.34
541268-412687.4017.45
643712-437127.8407.89
15min142854-428547.6868.267.977.828.407.86
244604-446048.0008.13
350632-506329.0819.22
442945-429457.7027.83
550782-507829.1089.24
644633-446338.0058.15
20min143715-437157.8409.9129.868.0610.1329.29
245104-451048.0898.31
378282-7828214.04014.28
444274-442747.9418.15
574644-7464413.38713.62
645396-453968.1428.37
30min154807-548079.83012.8936.9410.1313.2336.29
272197-7219712.94913.26
3102879-10287918.45118.84
447671-476718.5508.85
5105487-10548718.91919.30
648279-482798.6598.98
45min161767-6176711.07815.7336.8511.4916.2036.32
289501-8950116.05216.51
3122409-12240921.95422.55
466837-6683711.98712.38
5130546-13054623.41424.01
655029-550299.87010.29
60min1110973-11097319.90319.8529.3420.4420.5029.10
2103997-10399718.65219.29
3147344-14734426.42627.27
482416-8241614.78115.31
5148844-14884426.69527.55
670391-7039112.62513.15
极限1172997-17299731.02728.4119.0931.7829.2819.09
2159035-15903528.52329.36
3181447-18144732.54333.68
4146693-14669326.31027.00
5185914-18591433.34434.49
6104278-10427818.70219.37
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%
19.461357601352481355791358211354101355640.18
29.431335641337921336780.13
单位质量响应值RSD%判断
14330.2314175.820.77数据可信
供试品溶液-24040801批-贝派度酸-pH6.6
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min126610-2661018.61816.4014.8218.6216.4014.82
216966-1696611.87011.87
324631-2463117.23317.23
422247-2224715.56515.57
525269-2526917.68017.68
624914-2491417.43117.43
10min161292-6129242.88442.805.9743.0942.986.00
254939-5493938.43938.57
364710-6471045.27545.47
459101-5910141.35141.52
563702-6370244.57044.77
663293-6329344.28444.48
15min176900-7690053.80454.773.0354.4955.433.08
274615-7461552.20552.76
381359-8135956.92457.62
477872-7787254.48455.12
579203-7920355.41556.11
679767-7976755.81056.50
20min182839-8283957.95958.322.3859.2459.592.36
282720-8272057.87659.02
386397-8639760.44961.78
484194-8419458.90760.15
580361-8036156.22557.53
683621-8362158.50659.81
30min188537-8853761.94662.731.3063.8764.651.30
289313-8931362.48964.27
391371-9137163.92965.93
490597-9059763.38765.28
589744-8974462.79064.72
688423-8842361.86663.82
45min195379-9537966.73365.421.9669.3568.031.97
290626-9062663.40865.88
395308-9530866.68369.39
494197-9419765.90668.50
592883-9288364.98767.62
692634-9263464.81267.46
60min194235-9423565.93364.813.5569.2968.153.44
291337-9133763.90567.09
396583-9658367.57571.03
488500-8850061.92065.25
595489-9548966.81070.16
689648-8964862.72366.09
极限191447-9144763.98264.962.3968.0769.022.33
290039-9003962.99766.89
394965-9496566.44370.64
495845-9584567.05971.08
592986-9298665.05969.15
691805-9180564.23268.29
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DJ333-221017对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.67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%
110.435177975170665169445168305173715172020.08
210.445287195276975282080.14
单位质量响应值RSD%判断
49587.9250594.641.43数据可信
供试品溶液-24040801SP批-依折麦布-pH6.6
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min130768-307685.5105.513.015.515.513.00
230833-308335.5225.52
329483-294835.2805.28
431122-311225.5745.57
530125-301255.3955.40
632207-322075.7685.77
10min141785-417857.4847.440.527.547.500.52
241367-413677.4097.47
341309-413097.3987.46
441521-415217.4367.50
541533-415337.4387.50
641829-418297.4917.56
15min141991-419917.5207.934.967.668.074.89
246568-465688.3408.48
342588-425887.6277.77
444577-445777.9848.13
542690-426907.6467.79
647120-471208.4398.59
20min141331-413317.40210.9233.927.6311.1533.26
285718-8571815.35215.59
345297-452978.1138.34
467135-6713512.02412.26
542600-426007.6307.86
683746-8374614.99915.24
30min143256-432567.74713.1045.088.0613.4644.24
2101747-10174718.22318.63
346187-461878.2728.59
484102-8410215.06215.43
544883-448838.0388.35
6118750-11875021.26821.68
45min143317-433177.75817.3254.588.1517.8253.68
2150996-15099627.04327.65
354690-546909.79510.20
4106491-10649119.07219.61
558601-5860110.49510.90
6166112-16611229.75030.39
60min147994-479948.59622.0048.909.0822.7048.32
2186390-18639033.38234.29
368944-6894412.34812.86
4158839-15883928.44829.19
594076-9407616.84917.37
6180943-18094332.40633.38
极限178990-7899014.14730.0836.9514.7231.0236.87
2235121-23512142.11043.39
3126383-12638322.63523.29
4205712-20571236.84237.90
5139890-13989025.05425.76
6221618-22161839.69141.03
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%
19.461334721333391336651330161339331334850.26
29.431349421331671340540.94
单位质量响应值RSD%判断
14110.4714215.690.53数据可信
供试品溶液-24040801SP批-贝派度酸-pH6.6
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min136323-3632325.57526.944.3025.5726.944.30
239833-3983328.04628.05
337990-3799026.74926.75
439871-3987128.07328.07
536339-3633925.58625.59
639205-3920527.60427.60
10min168204-6820448.02249.682.1148.3149.982.11
270348-7034849.53249.84
372449-7244951.01151.31
469916-6991649.22749.54
570693-7069349.77550.06
671767-7176750.53150.84
15min178261-7826155.10355.781.7855.9256.631.76
279696-7969656.11356.98
381091-8109157.09657.96
478992-7899255.61856.48
580150-8015056.43357.27
677133-7713354.30955.18
20min182351-8235157.98358.771.9059.4160.241.87
282646-8264658.19159.68
385821-8582160.42661.92
483171-8317158.56060.04
584987-8498759.83961.30
681848-8184857.62959.10
30min188897-8889762.59262.012.3164.6764.142.24
286183-8618360.68162.81
389399-8939962.94565.12
486869-8686961.16463.29
591068-9106864.12066.25
686018-8601860.56562.68
45min189050-8905062.70063.621.8365.4766.431.80
288407-8840762.24765.05
392560-9256065.17168.04
489796-8979663.22566.03
592071-9207164.82767.67
690252-9025263.54666.33
60min192682-9268265.25764.092.5668.7267.612.46
289071-8907162.71466.21
392770-9277065.31968.91
489610-8961063.09466.60
593799-9379966.04369.61
688258-8825862.14265.63
极限190544-9054463.75163.862.0467.9468.091.98
287990-8799061.95366.15
392388-9238865.05069.37
492174-9217464.89969.11
592050-9205064.81269.11
689018-8901862.67766.86
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