美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D69223050102 对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.132019402017842016162015852014412016730.10
219.192014302017872016080.13
单位质量响应值RSD%判断
10542.2410505.890.25数据可信
稳定性考察-加速6月-供试品溶液-2023082421批-80mg规格-pH7.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16463-64633.2183.192.523.223.192.47
26159-61593.0673.07
36349-63493.1613.16
46653-66533.3133.31
56368-63683.1713.17
66412-64123.1933.19
10min110001-100014.9804.982.035.025.012.01
210075-100755.0175.05
39923-99234.9414.98
410315-103155.1365.17
59970-99704.9645.00
69694-96944.8274.86
15min113267-132676.6066.621.996.706.721.92
213278-132786.6116.70
313823-138236.8836.97
413159-131596.5526.65
513166-131666.5566.65
613108-131086.5276.62
20min116289-162898.1118.162.348.288.332.34
216611-166118.2718.43
316589-165898.2608.43
416889-168898.4098.58
516165-161658.0498.21
615810-158107.8728.03
30min126593-2659313.24112.942.2613.5013.202.25
226355-2635513.12313.38
325839-2583912.86613.12
426274-2627413.08213.34
525968-2596812.93013.18
624930-2493012.41312.66
45min135663-3566317.75717.802.1918.1618.202.17
237088-3708818.46718.87
335642-3564217.74718.15
436101-3610117.97518.38
535008-3500817.43117.83
634990-3499017.42217.81
60min147902-4790223.85124.052.6324.4524.652.61
249450-4945024.62225.23
348712-4871224.25524.85
449611-4961124.70225.31
548028-4802823.91424.50
646154-4615422.98123.56
极限155271-5527127.52127.222.6828.3828.082.65
255813-5581327.79028.67
354917-5491727.34428.21
455990-5599027.87928.76
553844-5384426.81027.67
652116-5211625.95026.79
美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D69223050102 对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.132016152018142017122014212013492015820.10
219.192017862017782017820.01
单位质量响应值RSD%判断
10537.4810514.960.16数据可信
稳定性考察-加速6月-供试品溶液-2023082421批-80mg规格-pH7.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16422-64223.1973.230.953.203.230.93
26419-64193.1953.20
36563-65633.2673.27
46471-64713.2213.22
56549-65493.2603.26
66470-64703.2213.22
10min19971-99714.9645.121.765.005.151.74
210163-101635.0595.09
310397-103975.1765.21
410459-104595.2075.24
510356-103565.1555.19
610315-103155.1355.17
15min113187-131876.5656.782.356.666.882.29
213723-137236.8326.92
314163-141637.0517.14
413568-135686.7546.85
513605-136056.7736.87
613502-135026.7226.81
20min116642-166428.2858.401.318.458.571.34
216893-168938.4108.58
317164-171648.5458.72
417113-171138.5198.69
516765-167658.3468.51
616686-166868.3078.47
30min125604-2560412.74612.931.5413.0013.191.53
226099-2609912.99313.25
326702-2670213.29313.56
425897-2589712.89213.16
525721-2572112.80413.07
625773-2577312.83013.09
45min135356-3535617.60117.621.4518.0018.021.42
234451-3445117.15017.56
335922-3592217.88318.30
435397-3539717.62118.03
535447-3544717.64618.05
635754-3575417.79918.20
60min148281-4828124.03523.991.2524.6324.601.23
248032-4803223.91124.51
348615-4861524.20124.81
448664-4866424.22624.83
548534-4853424.16124.76
647074-4707423.43424.03
极限153350-5335026.55926.620.8127.4227.490.81
252927-5292726.34827.21
354164-5416426.96427.85
453709-5370926.73727.61
553196-5319626.48227.35
653537-5353726.65227.51
美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D69223050102 对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.132029352025122025452023252024422025520.12
219.192017652012362015000.19
单位质量响应值RSD%判断
10588.1910500.260.59数据可信
稳定性考察-加速6月-供试品溶液-2023082521批-80mg规格-pH7.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16520-65203.2403.281.973.243.281.90
26389-63893.1753.18
36745-67453.3523.35
46561-65613.2613.26
56662-66623.3113.31
66682-66823.3213.32
10min19895-98954.9184.911.454.954.951.44
210053-100534.9965.03
39960-99604.9504.99
49845-98454.8934.93
59629-96294.7854.82
69910-99104.9254.96
15min113747-137476.8327.132.676.927.222.64
214576-145767.2447.33
314528-145287.2207.31
414080-140806.9977.09
514285-142857.0997.19
614808-148087.3597.45
20min117510-175108.7028.523.018.878.692.95
217378-173788.6368.81
317074-170748.4858.66
416156-161568.0298.20
517540-175408.7178.89
617160-171608.5288.70
30min126123-2612312.98213.252.3513.2513.522.29
227178-2717813.50713.77
327472-2747213.65313.92
426240-2624013.04113.30
527002-2700213.41913.68
625994-2599412.91813.19
45min136468-3646818.12418.021.5818.5318.441.59
236940-3694018.35818.78
336432-3643218.10618.52
435217-3521717.50217.90
536183-3618317.98218.40
636368-3636818.07418.49
60min148206-4820623.95724.082.2324.5724.702.19
249959-4995924.82825.45
349047-4904724.37524.99
448611-4861124.15824.76
548222-4822223.96524.58
646705-4670523.21123.82
极限153989-5398926.83126.014.1727.7126.894.03
254735-5473527.20228.10
350570-5057025.13226.02
453654-5365426.66527.53
549129-4912924.41625.30
651975-5197525.83026.70
美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D69223050102 对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.132021342021472021582019282020352020800.05
219.192023092023442023260.02
单位质量响应值RSD%判断
10563.5110543.300.14数据可信
稳定性考察-加速6月-供试品溶液-2023082521批-80mg规格-pH7.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16705-67053.3293.264.713.333.264.74
26991-69913.4713.47
36654-66543.3043.30
46050-60503.0043.00
56523-65233.2393.24
66513-65133.2343.23
10min19931-99314.9314.953.214.974.983.27
210385-103855.1575.20
310257-102575.0935.13
49928-99284.9304.96
59742-97424.8374.87
69522-95224.7284.76
15min114269-142697.0857.241.877.187.331.83
214602-146027.2507.35
314885-148857.3917.48
414906-149067.4017.49
514333-143337.1177.21
614468-144687.1847.27
20min117508-175088.6938.722.838.868.892.82
218218-182189.0469.22
317848-178488.8629.04
417729-177298.8038.97
517321-173218.6008.77
616769-167698.3268.49
30min127500-2750013.65513.343.5113.9213.613.46
227676-2767613.74214.02
326852-2685213.33313.61
427418-2741813.61413.88
526638-2663813.22713.49
625128-2512812.47712.74
45min136060-3606017.90518.132.2318.3218.552.20
237242-3724218.49218.92
337442-3744218.59119.01
436129-3612917.93918.36
535323-3532317.53917.95
636889-3688918.31718.72
60min150297-5029724.97424.124.1625.5924.744.06
249923-4992324.78825.42
346571-4657123.12423.75
449414-4941424.53625.15
545498-4549822.59123.20
649768-4976824.71125.31
极限153813-5381326.72026.810.5127.6227.700.50
254216-5421626.92027.83
353974-5397426.80027.69
453726-5372626.67727.57
553812-5381226.71927.58
654429-5442927.02627.90
美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D69223050102 对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.132022742022832021182020382019652021360.07
219.192024382024572024480.01
单位质量响应值RSD%判断
10566.4410549.660.12数据可信
稳定性考察-加速6月-供试品溶液-2023082621批-80mg规格-pH7.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15682-56822.8202.875.062.822.885.06
25295-52952.6282.63
35964-59642.9602.96
45782-57822.8702.87
55866-58662.9112.91
66158-61583.0563.06
10min18384-83844.1614.262.024.194.302.07
28493-84934.2154.24
38873-88734.4044.44
48615-86154.2764.31
58502-85024.2204.25
68686-86864.3114.34
15min112403-124036.1566.392.026.236.472.03
212918-129186.4116.49
313057-130576.4806.56
413070-130706.4876.57
512763-127636.3346.41
613041-130416.4726.55
20min115319-153197.6037.791.507.757.941.48
215869-158697.8768.02
315938-159387.9108.06
415701-157017.7937.94
515523-155237.7047.85
615819-158197.8518.00
30min125789-2578912.79913.302.0613.0313.542.04
226842-2684213.32213.56
327387-2738713.59313.83
427103-2710313.45213.69
527007-2700713.40413.64
626690-2669013.24713.49
45min135190-3519017.46518.052.2217.8418.442.21
236477-3647718.10418.49
337041-3704118.38418.78
437352-3735218.53818.93
535711-3571117.72418.11
636413-3641318.07218.46
60min145595-4559522.62923.863.1823.2024.443.14
246827-4682723.24123.82
349281-4928124.45925.06
448430-4843024.03724.63
549358-4935824.49725.08
648936-4893624.28824.88
极限154492-5449227.04526.591.0427.8627.440.95
253685-5368526.64527.49
353330-5333026.46827.34
453694-5369426.64927.51
553462-5346226.53427.39
652805-5280526.20827.07
美阿沙坦钾片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号D69223050102 对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数1000
标示量(mg)80供试品稀释倍数5系数0.9372
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
119.132038162034642024932029412017222028870.41
219.192013782012862013320.04
单位质量响应值RSD%判断
10605.7010491.510.77数据可信
稳定性考察-加速6月-供试品溶液-2023082621批-80mg规格-pH7.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16048-60483.0042.971.743.002.971.71
26127-61273.0443.04
35857-58572.9102.91
45887-58872.9252.92
55955-59552.9582.96
66040-60403.0013.00
10min18428-84284.1874.332.174.224.372.16
28989-89894.4664.50
38695-86954.3194.35
48671-86714.3084.34
58851-88514.3974.43
68718-87184.3314.36
15min113214-132146.5646.451.346.646.531.30
213045-130456.4806.56
312929-129296.4236.50
413109-131096.5126.59
512793-127936.3556.44
612788-127886.3536.43
20min115500-155007.7007.831.047.857.981.04
215779-157797.8397.99
315621-156217.7607.91
415910-159107.9048.06
515860-158607.8798.03
615876-158767.8878.04
30min126607-2660713.21813.372.1213.4613.612.08
227925-2792513.87214.11
326731-2673113.27913.52
427259-2725913.54213.78
526452-2645213.14113.38
626538-2653813.18313.42
45min137369-3736918.56418.092.1318.9518.482.09
237165-3716518.46318.86
335808-3580817.78818.17
436067-3606717.91718.31
536646-3664618.20518.59
635428-3542817.60017.99
60min148521-4852124.10423.573.9424.7024.163.86
248425-4842524.05624.66
348706-4870624.19624.78
444070-4407021.89322.48
548580-4858024.13324.72
646424-4642423.06223.64
极限153785-5378526.71926.271.9027.5827.131.81
251578-5157825.62326.49
353371-5337126.51327.37
453482-5348226.56827.40
551645-5164525.65626.51
653486-5348626.57027.41
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