培哚普利左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DPAEA-2-05221204-B对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.87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1.000
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.734137841377414044144741338413890.10
29.694103941278411580.42
单位质量响应值RSD%判断
4253.754247.470.11数据可信
影响因素30天-供试品溶液-2024052721批-培哚普利-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min148423-4842398.29499.671.3298.2999.671.32
248440-4844098.32898.33
349367-49367100.210100.21
449213-4921399.89799.90
550146-50146101.791101.79
649019-4901999.50499.50
10min148550-4855098.55299.150.6399.64100.260.63
248834-4883499.128100.22
349019-4901999.504100.62
448409-4840998.26599.38
549093-4909399.654100.78
649161-4916199.792100.90
15min147250-4725095.91399.362.0998.10101.572.06
248372-4837298.190100.38
348963-4896399.390101.61
449306-49306100.086102.29
550089-50089101.676103.91
649708-49708100.902103.12
20min146230-4623093.84297.292.4797.10100.602.42
246640-4664094.67497.96
348869-4886999.199102.52
448775-4877599.008102.32
548770-4877098.998102.37
648276-4827697.995101.33
30min146491-4649194.37295.280.8998.6799.680.89
247045-4704595.49799.83
347299-4729996.012100.44
446562-4656294.51698.93
547520-4752096.461100.93
646713-4671394.82399.25
45min145856-4585693.08393.460.8098.4398.920.80
245607-4560792.57897.98
345697-4569792.76098.25
446367-4636794.12099.58
546429-4642994.24699.79
646299-4629993.98299.46
极限144787-4478790.91393.161.5797.2999.661.53
245391-4539192.13998.57
346802-4680295.003101.53
445958-4595893.29099.80
546044-4604493.465100.05
646396-4639694.179100.70
培哚普利左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5 供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.513742237750372403724437582374480.59
213.473739937221373100.34
单位质量响应值RSD%判断
2771.872769.860.06数据可信
影响因素30天-供试品溶液-2024052721批-左氨氯地平-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min118748-1874842.72046.2218.3742.7246.2218.37
214061-1406132.04032.04
320665-2066547.08847.09
422771-2277151.88751.89
520502-2050246.71746.72
624963-2496356.88256.88
10min129281-2928166.72161.216.2967.2061.726.29
224725-2472556.33956.70
325963-2596359.16059.68
428411-2841164.73865.31
526717-2671760.87861.40
626072-2607259.40960.04
15min130353-3035369.16368.565.0970.3869.765.14
227948-2794863.68364.67
328824-2882465.67966.86
432329-3232973.66674.96
530444-3044469.37170.57
630641-3064169.82071.11
20min132119-3211973.18872.145.6975.1774.095.73
228461-2846164.85266.54
331447-3144771.65673.57
433984-3398477.43779.55
531744-3174472.33374.30
632196-3219673.36375.43
30min133695-3369576.77974.963.3379.5877.713.44
231265-3126571.24273.65
332193-3219373.35676.06
434376-3437678.33081.31
532938-3293875.05477.82
632906-3290674.98177.86
45min135484-3548480.85578.913.1684.5182.503.27
233040-3304075.28678.49
334104-3410477.71181.23
436077-3607782.20686.05
534133-3413377.77781.38
634952-3495279.64383.36
极限137394-3739485.20784.823.8289.7689.293.88
235244-3524480.30884.35
337011-3701184.33588.72
439520-3952090.05294.81
536466-3646683.09387.56
637711-3771185.93090.53
培哚普利左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DPAEA-2-05221204-B对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.87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1.000
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.734137741353413334133441336413470.05
29.694131841313413160.01
单位质量响应值RSD%判断
4249.434263.780.24数据可信
影响因素30天-供试品溶液-2024052721批-培哚普利-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min149030-4903099.386100.100.8099.39100.100.80
249382-49382100.099100.10
349855-49855101.058101.06
449804-49804100.955100.95
549343-49343100.020100.02
648879-4887999.08099.08
10min148754-4875498.82698.310.6399.9399.430.62
248033-4803397.36598.48
348600-4860098.51499.64
448447-4844798.20499.33
548859-4885999.039100.15
648310-4831097.92699.03
15min148234-4823497.77297.461.0499.9799.671.02
247602-4760296.49198.69
348957-4895799.238101.46
447826-4782696.94599.16
548153-4815397.60899.82
647710-4771096.71098.90
20min147368-4736896.01795.821.1199.3199.111.08
246943-4694395.15598.42
348017-4801797.333100.65
446558-4655894.37597.67
547090-4709095.45398.75
647646-4764696.58199.84
30min147050-4705095.37295.301.0499.7399.661.02
246923-4692395.11599.44
347922-4792297.140101.54
446713-4671394.68999.03
546979-4697995.22899.59
646501-4650194.26098.60
45min146613-4661394.48794.541.0099.9099.950.96
247011-4701195.293100.67
346848-4684894.963100.44
446926-4692695.121100.51
546696-4669694.655100.07
645741-4574192.71998.10
极限146407-4640794.06993.331.97100.5399.801.89
245722-4572292.68099.12
347672-4767296.633103.17
445615-4561592.46498.91
545799-4579992.83799.30
645053-4505391.32497.74
培哚普利左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5 供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.513731937258372433706037103371970.30
213.473715637057371060.19
单位质量响应值RSD%判断
2753.292754.710.04数据可信
影响因素30天-供试品溶液-2024052721批-左氨氯地平-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min118299-1829941.95241.225.3741.9541.225.37
217253-1725339.55439.55
318967-1896743.48443.48
418829-1882943.16743.17
518067-1806741.42041.42
616458-1645837.73137.73
10min123061-2306152.86952.982.6553.3453.442.67
222944-2294452.60153.04
323727-2372754.39654.88
423410-2341053.66954.15
523502-2350253.88054.34
622010-2201050.46050.88
15min125255-2525557.89958.102.5258.9559.152.53
225284-2528457.96658.99
325803-2580359.15660.24
426008-2600859.62660.70
525523-2552358.51459.57
624190-2419055.45856.44
20min127021-2702161.94861.602.8463.6463.292.84
227003-2700361.90763.57
327535-2753563.12664.87
427112-2711262.15763.90
527178-2717862.30864.02
625366-2536658.15459.75
30min129550-2955067.74667.743.0970.1370.113.07
230017-3001768.81771.17
330534-3053470.00272.45
429267-2926767.09769.53
529994-2999468.76471.17
627910-2791063.98666.23
45min131206-3120671.54372.033.3574.6875.163.31
232513-3251374.53977.66
332051-3205173.48076.70
431463-3146372.13275.31
531791-3179172.88476.05
629483-2948367.59270.55
极限133121-3312175.93376.703.4479.8780.633.40
234075-3407578.12082.07
335028-3502880.30584.35
433263-3326376.25880.23
533663-3366377.17581.15
631574-3157472.38676.09
培哚普利左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DPAEA-2-05221204-B对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.87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1.000
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.734139041435413864139141348413900.08
29.694127241193412320.14
单位质量响应值RSD%判断
4253.854255.110.03数据可信
影响因素30天-供试品溶液-2024052721批-培哚普利-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min148563-4856398.48899.311.6498.4999.311.64
248142-4814297.63497.63
348595-4859598.55398.55
448574-4857498.51098.51
549815-49815101.027101.03
650124-50124101.654101.65
10min147779-4777996.89899.402.3897.99100.502.37
248380-4838098.11799.20
348389-4838998.13599.23
448939-4893999.251100.35
549530-49530100.449101.57
651060-51060103.552104.68
15min147957-4795797.25998.281.2899.43100.481.29
248350-4835098.056100.23
348435-4843598.229100.41
447668-4766896.67398.87
549120-4912099.618101.86
649221-4922199.823102.10
20min147535-4753596.40396.982.1099.65100.282.07
246513-4651394.33197.60
349053-4905399.482102.76
446888-4688895.09198.36
548323-4832398.001101.35
648599-4859998.561101.95
30min146843-4684395.00096.231.5799.32100.611.56
246563-4656394.43298.74
347116-4711695.55499.94
447567-4756796.468100.80
548230-4823097.813102.25
648381-4838198.119102.60
45min146154-4615493.60395.341.7098.98100.791.68
246630-4663094.56899.93
346747-4674794.805100.25
446767-4676794.846100.25
547322-4732295.971101.49
648444-4844498.247103.82
极限145023-4502391.30993.511.9997.73100.021.96
246054-4605493.40099.81
345918-4591893.12499.62
445367-4536792.00798.46
546784-4678494.880101.47
647518-4751896.369103.04
培哚普利左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5 供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.513712637066370213709337005370620.14
213.473681036753367820.11
单位质量响应值RSD%判断
2743.302730.660.33数据可信
影响因素30天-供试品溶液-2024052721批-左氨氯地平-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min116507-1650738.07938.434.5538.0838.444.55
215563-1556335.90235.90
317377-1737740.08640.09
416261-1626137.51237.51
517641-1764140.69540.70
616617-1661738.33338.33
10min121506-2150649.61150.145.2250.0350.565.20
221273-2127349.07449.47
322392-2239251.65552.10
419804-1980445.68546.10
522545-2254552.00852.46
622889-2288952.80253.23
15min124290-2429056.03455.474.6557.0156.464.64
222804-2280452.60653.55
325102-2510257.90758.93
422513-2251351.93452.86
524595-2459556.73757.77
624978-2497857.62158.63
20min126515-2651561.16657.768.7062.7659.368.56
223835-2383554.98456.51
326636-2663661.44663.11
421202-2120248.91050.41
525381-2538158.55060.21
626669-2666961.52263.17
30min127594-2759463.65563.185.5365.9365.425.50
225609-2560959.07661.22
328383-2838365.47667.82
425817-2581759.55661.60
527339-2733963.06765.38
629573-2957368.22170.56
45min129645-2964568.38767.385.9271.3770.325.88
227704-2770463.90966.71
330413-3041370.15973.23
427065-2706562.43565.14
528715-2871566.24169.25
631698-3169873.12376.22
极限131982-3198273.77873.214.3577.5276.904.38
230045-3004569.31072.82
332540-3254075.06578.92
430261-3026169.80873.21
531929-3192973.65677.40
633663-3366377.65681.56
培哚普利左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DPAEA-2-05221204-B对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.87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1.000
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.734107541098410894119641167411250.13
29.694123841290412640.09
单位质量响应值RSD%判断
4226.624258.410.53数据可信
-供试品溶液-2024052721批-培哚普利-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min148828-4882899.30699.600.5399.3199.600.53
249196-49196100.055100.05
349090-4909099.83999.84
448726-4872699.09999.10
548698-4869899.04299.04
649297-49297100.260100.26
10min148790-4879099.22999.310.90100.33100.420.89
249306-49306100.278101.39
349252-49252100.169101.28
448966-4896699.587100.69
548208-4820898.04599.15
648462-4846298.56299.68
15min147971-4797197.56397.541.7599.7799.751.73
249190-49190100.043102.27
348360-4836098.355100.58
446655-4665594.88797.09
547587-4758796.78298.97
647984-4798497.59099.80
20min146879-4687995.34295.581.0398.6398.871.01
247465-4746596.53499.87
347003-4700395.59598.91
446872-4687295.32898.59
546213-4621393.98897.25
647533-4753396.67399.97
30min146330-4633094.22695.871.0098.58100.220.97
247382-4738296.365100.78
347702-4770297.016101.39
447156-4715695.906100.23
547318-4731896.235100.54
646930-4693095.44699.81
45min146500-4650094.57293.842.5299.9799.262.41
247022-4702295.633101.11
346749-4674995.078100.53
446074-4607493.70599.09
543859-4385989.20094.58
646643-4664394.862100.29
极限146368-4636894.30393.791.16100.75100.261.12
246530-4653094.633101.18
346674-4667494.926101.44
445344-4534492.22198.65
546194-4619493.949100.32
645587-4558792.71599.20
培哚普利左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5 供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.513678336741367823678636800367780.07
213.473692136852368860.14
单位质量响应值RSD%判断
2722.282738.380.42数据可信
-供试品溶液-2024052721批-左氨氯地平-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114882-1488234.41431.1725.5934.4131.1725.59
215043-1504334.78734.79
317313-1731340.03640.04
414889-1488934.43134.43
57848-784818.14818.15
610899-1089925.20425.20
10min124770-2477057.28056.1212.8857.6656.4612.95
225098-2509858.03958.43
329026-2902667.12267.57
425087-2508758.01358.40
520258-2025846.84647.05
621359-2135949.39249.67
15min127929-2792964.58564.5011.3565.6065.4711.44
229377-2937767.93468.97
332812-3281275.87777.07
428290-2829065.42066.45
524245-2424556.06656.79
624694-2469457.10557.93
20min130444-3044470.40168.4010.6472.1470.0910.73
230676-3067670.93872.72
333767-3376778.08680.12
430918-3091871.49773.25
525583-2558359.16060.51
626084-2608460.31961.78
30min131836-3183673.62073.709.0576.1476.149.17
233684-3368477.89480.47
335482-3548282.05284.95
433264-3326476.92379.47
528785-2878566.56568.57
628167-2816765.13667.27
45min133846-3384678.26876.209.4981.6179.479.58
235020-3502080.98384.42
335752-3575282.67686.49
434762-3476280.38783.79
527740-2774064.14866.89
630602-3060270.76773.62
极限136130-3613083.55081.217.0287.7685.327.23
236683-3668384.82989.17
337684-3768487.14491.88
436173-3617383.65087.95
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