多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D241101对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 9.816108061054609766093360868609820.15
2 9.916132661329613280.01
单位质量响应值RSD%判断
6216.316188.500.32数据可信
中间条件6月-供试品溶液-2025072121批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min129344-2934442.44839.188.2942.4539.188.29
228008-2800840.51540.52
326542-2654238.39538.39
423019-2301933.29833.30
526974-2697439.01939.02
628629-2862941.41441.41
10min143712-4371263.23262.234.3963.3062.304.40
245211-4521165.40065.47
343293-4329362.62662.69
439499-3949957.13857.19
543285-4328562.61462.68
643136-4313662.39962.47
15min150244-5024472.68172.992.5872.8673.162.58
251646-5164674.70974.89
350563-5056373.14273.31
448141-4814169.63969.79
551714-5171474.80774.98
650454-5045472.98573.16
20min154047-5404778.18278.402.1978.4878.692.19
256179-5617981.26681.57
353956-5395678.05178.34
452752-5275276.30976.58
554792-5479279.26079.55
653453-5345377.32377.62
30min157894-5789483.74783.911.9484.1784.331.94
259448-5944885.99586.43
357095-5709582.59183.01
457338-5733882.94383.34
559339-5933985.83786.26
656932-5693282.35682.78
45min160187-6018787.06487.522.5087.6388.082.49
262155-6215589.91190.49
359125-5912585.52886.09
460625-6062587.69888.23
562289-6228990.10590.67
658648-5864884.83885.40
60min161366-6136688.77089.382.2689.4890.092.25
263689-6368992.13092.86
360620-6062087.69088.39
462087-6208789.81390.49
562941-6294191.04891.77
660026-6002686.83187.53
90min162017-6201789.71190.812.0890.5791.662.07
263254-6325491.50192.38
361528-6152889.00489.85
464137-6413792.77893.61
564311-6431193.03093.90
661392-6139288.80789.65
120min162617-6261790.57992.483.3891.5993.483.35
266545-6654596.26197.30
361657-6165789.19190.19
465854-6585495.26296.24
565089-6508994.15595.18
661813-6181389.41690.41
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限164316-6431693.03794.281.6294.2095.441.62
266572-6657296.30097.50
363943-6394392.49793.64
466099-6609995.61696.76
565544-6554494.81396.00
664568-6456893.40194.55
多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D241101对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 9.816204862395621116203261708620590.40
2 9.916205962282621700.26
单位质量响应值RSD%判断
6326.106273.460.60数据可信
中间条件6月-供试品溶液-2025072221批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min127930-2793039.77836.5110.5539.7836.5110.55
227856-2785639.67339.67
325777-2577736.71236.71
424609-2460935.04935.05
526873-2687338.27338.27
620761-2076129.56829.57
10min143526-4352661.99160.114.8262.0660.174.83
243261-4326161.61361.68
343152-4315261.45861.52
442456-4245660.46760.53
542703-4270360.81860.88
638130-3813054.30554.35
15min150420-5042071.80970.662.6071.9870.822.61
250000-5000071.21171.38
350026-5002671.24871.41
450199-5019971.49471.65
550032-5003271.25671.42
647005-4700566.94567.09
20min154261-5426177.27976.272.1577.5776.552.15
253805-5380576.63076.92
354724-5472477.93978.22
454030-5403076.95077.23
552965-5296575.43475.72
651538-5153873.40173.65
30min157989-5798982.58982.191.7483.0182.601.74
257537-5753781.94582.36
359059-5905984.11384.53
458469-5846983.27383.68
556606-5660680.61981.03
656580-5658080.58280.96
45min160867-6086786.68886.081.8987.2486.621.88
259945-5994585.37585.93
362332-6233288.77489.33
460642-6064286.36786.91
559018-5901884.05484.60
659818-5981885.19485.70
60min161914-6191488.17988.081.6888.8888.771.67
261258-6125887.24587.94
363539-6353990.49391.19
462499-6249989.01289.70
560791-6079186.58087.26
661078-6107886.98887.64
90min162789-6278989.42589.272.2190.2790.112.20
261110-6111087.03487.87
365024-6502492.60893.46
463329-6332990.19491.03
562061-6206188.38889.22
661784-6178487.99488.79
120min163397-6339790.29190.252.3391.2991.232.31
261690-6169087.86088.84
365758-6575893.65494.66
463554-6355490.51591.50
561940-6194088.21689.19
663882-6388290.98291.92
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限164822-6482292.32192.680.9493.4793.820.94
264889-6488992.41693.55
366093-6609394.13195.29
465137-6513792.76993.91
564245-6424591.49992.62
665280-6528092.97394.07
多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D241101对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 9.816239862587623996236462182623860.24
2 9.916329863233632660.08
单位质量响应值RSD%判断
6359.436384.060.28数据可信
中间条件6月-供试品溶液-2025072321批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min121778-2177830.66629.887.0830.6729.887.09
219739-1973927.79527.79
323035-2303532.43632.44
421219-2121929.87929.88
519174-1917426.99927.00
622356-2235631.48031.48
10min138510-3851054.22653.154.5954.2853.204.59
236372-3637251.21651.26
339124-3912455.09155.15
437984-3798453.48653.54
534993-3499349.27449.32
639472-3947255.58155.63
15min147527-4752766.92366.182.9067.0666.322.91
246300-4630065.19665.33
348207-4820767.88168.03
447449-4744966.81466.95
544565-4456562.75362.88
647955-4795567.52667.67
20min152655-5265574.14473.322.1374.4073.572.13
251960-5196073.16673.41
352714-5271474.22774.49
452512-5251273.94374.19
549886-4988670.24570.48
652686-5268674.18874.45
30min158249-5824982.02181.121.3582.4081.501.35
258003-5800381.67582.04
357923-5792381.56281.94
457682-5768281.22381.60
556090-5609078.98179.33
657722-5772281.27981.66
45min161745-6174586.94486.561.1087.4687.061.10
262154-6215487.52088.02
361108-6110886.04786.57
461197-6119786.17286.68
560456-6045685.12985.61
662162-6216287.53188.05
60min163668-6366889.65288.910.9590.3189.560.94
263757-6375789.77790.42
362873-6287388.53289.19
462144-6214487.50688.16
563040-6304088.76789.39
663348-6334889.20189.86
90min165192-6519291.79891.490.7592.6192.280.75
265687-6568792.49593.29
364575-6457590.92991.74
465245-6524591.87292.67
564422-6442290.71391.48
664703-6470391.10991.92
120min165810-6581092.66892.270.7293.6393.220.71
266061-6606193.02193.97
364788-6478891.22992.19
465528-6552892.27193.22
565190-6519091.79592.72
665785-6578592.63393.60
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限166549-6654993.70992.830.9694.8293.930.96
266425-6642593.53494.64
365536-6553692.28293.40
466360-6636093.44294.55
564943-6494391.44792.52
665721-6572192.54393.66
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