坎地沙坦酯片项目信息
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100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.553863638268383123836638463384090.39
216.593824138335382880.18
单位质量响应值RSD%判断
2320.792307.900.40数据可信
长期6月-供试品溶液-2025030321批-含0.35%吐温20的pH6.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19635-963523.37123.7120.0423.3723.7120.03
210157-1015724.63724.64
37621-762118.48618.49
410091-1009124.47724.48
58019-801919.45119.45
613119-1311931.82231.82
10min124271-2427158.87357.8011.1358.9157.8411.13
223782-2378257.68757.73
320591-2059149.94749.98
425718-2571862.38362.42
521111-2111151.20851.24
627503-2750366.71366.77
15min134048-3404882.58981.463.8382.7381.603.85
234019-3401982.51882.66
331931-3193177.45477.57
434655-3465584.06184.21
532027-3202777.68677.80
634828-3482884.48184.64
20min137807-3780791.70791.001.3791.9891.271.38
238112-3811292.44792.72
336755-3675589.15589.40
437752-3775291.57391.86
537047-3704789.86390.11
637625-3762591.26591.57
30min139365-3936595.48695.490.6195.9195.920.61
239794-3979496.52796.96
339329-3932995.39995.79
439324-3932495.38695.82
539347-3934795.44295.84
639049-3904994.71995.18
45min139550-3955095.93596.160.7596.5296.750.73
240106-4010697.28397.87
339807-3980796.55897.11
439664-3966496.21196.81
539501-3950195.81696.37
639241-3924195.18595.80
60min139549-3954995.93296.230.4196.6896.980.42
239876-3987696.72597.48
339622-3962296.10996.82
439509-3950995.83596.59
539613-3961396.08796.80
639870-3987096.71197.48
极限139681-3968196.25296.830.8897.1697.740.85
239980-3998096.97897.89
340236-4023697.59998.47
440191-4019197.49098.41
540098-4009897.26498.14
639338-3933895.42096.36
坎地沙坦酯片项目信息
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100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.553816838413381513832138268382640.29
216.593874238593386680.28
单位质量响应值RSD%判断
2312.022330.800.58数据可信
长期6月-供试品溶液-2025030421批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114007-1400733.87323.7731.4633.8723.7731.46
27534-753418.21918.22
35972-597214.44214.44
410201-1020124.66924.67
58539-853920.65020.65
612729-1272930.78230.78
10min128582-2858269.11958.9016.8969.1858.9416.90
221221-2122151.31851.35
317962-1796243.43743.46
426286-2628663.56763.61
524240-2424058.61958.65
627855-2785567.36167.41
15min136192-3619287.52380.589.4587.6980.729.46
231602-3160276.42376.54
327806-2780667.24367.34
434402-3440283.19483.34
534158-3415882.60482.74
635769-3576986.50086.66
20min138716-3871693.62690.734.9293.9491.014.95
237069-3706989.64389.89
334252-3425282.83183.04
437552-3755290.81191.10
537874-3787491.59091.86
639656-3965695.90096.21
30min139239-3923994.89195.091.5095.3695.511.53
239629-3962995.83496.23
338480-3848093.05693.40
438991-3899194.29194.73
539359-3935995.18195.60
640220-4022097.26397.73
45min139690-3969095.98296.221.5996.6196.801.61
239767-3976796.16896.72
339189-3918994.77095.27
439292-3929295.01995.61
539839-3983996.34296.92
640956-4095699.04399.67
60min139870-3987096.41796.942.0397.2197.682.05
239843-3984396.35297.06
339447-3944795.39496.05
439667-3966795.92696.68
539994-3999496.71797.46
641698-41698100.838101.63
极限141167-4116799.55497.581.45100.5198.491.47
240301-4030197.45998.33
339862-3986296.39897.22
439584-3958495.72596.64
540402-4040297.70498.61
640795-4079598.65499.62
坎地沙坦酯片项目信息
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100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.553872838864385923837338596386310.48
216.593865938316384880.64
单位质量响应值RSD%判断
2334.202319.950.44数据可信
长期6月-供试品溶液-2025030422批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min111369-1136927.42620.3724.2827.4320.3724.28
28194-819419.76719.77
37458-745817.99217.99
45557-555713.40613.41
510129-1012924.43524.44
67953-795319.18619.19
10min127008-2700865.15450.6917.4065.2050.7217.40
219833-1983347.84547.88
318305-1830544.15944.19
417129-1712941.32241.34
523550-2355056.81256.85
620247-2024748.84448.88
15min135177-3517784.86073.8710.4685.0173.9810.47
229488-2948871.13671.25
327341-2734165.95766.06
427326-2732665.92166.01
533346-3334680.44380.58
631044-3104474.89075.00
20min138259-3825992.29587.285.1592.5987.525.18
235684-3568486.08486.31
333707-3370781.31481.53
434540-3454083.32483.52
538066-3806691.83092.10
636828-3682888.84389.08
30min139890-3989096.23095.462.8196.6895.842.82
238513-3851392.90893.28
338940-3894093.93894.29
438636-3863693.20593.54
540004-4000496.50596.93
641432-4143299.950100.34
45min139808-3980896.03296.802.0996.6497.352.08
239735-3973595.85696.39
340365-4036597.37697.88
439282-3928294.76395.26
539896-3989696.24596.83
641684-41684100.558101.11
60min140175-4017596.91896.802.0497.6997.502.04
239487-3948795.25895.95
340269-4026997.14497.81
439493-3949395.27295.93
539679-3967995.72196.46
641643-41643100.459101.18
极限140178-4017896.92596.912.1097.8697.782.09
239283-3928394.76695.61
340604-4060497.95298.78
439554-3955495.41996.23
539809-3980996.03596.94
641600-41600100.355101.24
坎地沙坦酯片项目信息
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100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.553811238195382373812938248381840.17
216.593842338279383510.27
单位质量响应值RSD%判断
2307.192311.690.14数据可信
长期6月-供试品溶液-KC031批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min14664-466411.33710.684.0111.3410.684.03
24392-439210.67610.68
34514-451410.97310.97
44320-432010.50110.50
54157-415710.10510.10
64315-431510.48910.49
10min114260-1426034.66334.903.5534.6834.923.55
213614-1361433.09333.11
315027-1502736.52736.55
414606-1460635.50435.52
513991-1399134.00934.03
614654-1465435.62135.64
15min123744-2374457.71759.334.9757.7959.404.97
222623-2262354.99255.06
326240-2624063.78463.86
424711-2471160.06760.14
524238-2423858.91758.99
624892-2489260.50760.58
20min131104-3110475.60779.325.7875.7879.505.77
230060-3006073.06973.23
335420-3542086.09886.28
433539-3353981.52681.70
532607-3260779.26179.43
633064-3306480.37180.55
30min139167-3916795.20796.782.9595.5197.092.95
238111-3811192.64092.93
341388-41388100.605100.93
440818-4081899.22099.53
539575-3957596.19896.50
639838-3983896.83897.15
45min141395-41395100.622100.991.61101.08101.461.61
241147-41147100.019100.46
342556-42556103.444103.94
442147-42147102.450102.93
540794-4079499.16199.63
641249-41249100.267100.74
60min141654-41654101.252100.971.02101.88101.611.03
241280-41280100.343100.95
342200-42200102.579103.25
441743-41743101.468102.12
541001-4100199.665100.29
641356-41356100.528101.17
极限141562-41562101.028101.550.77101.82102.350.78
241733-41733101.444102.22
342267-42267102.742103.58
442071-42071102.266103.08
541503-41503100.885101.68
641519-41519100.924101.73
坎地沙坦酯片项目信息
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100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.553841738312381243835838301383020.29
216.593870738521386140.35
单位质量响应值RSD%判断
2314.322327.550.41数据可信
加速6月-供试品溶液-2025030321批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min18429-842920.38817.8518.2020.3917.8518.21
29039-903921.86321.86
35924-592414.32914.33
47017-701716.97216.97
55814-581414.06314.06
68063-806319.50319.50
10min121630-2163052.31848.5011.2652.3548.5311.26
222446-2244654.29254.33
317431-1743142.16242.19
420369-2036949.26849.30
517110-1711041.38541.41
621317-2131751.56151.59
15min130280-3028073.24072.884.6573.3672.994.66
230884-3088474.70174.83
328494-2849468.92069.01
431604-3160476.44376.55
528332-2833268.52868.62
631189-3118975.43975.56
20min136054-3605487.20687.632.1287.4587.862.13
236367-3636787.96388.21
335609-3560986.13086.34
437463-3746390.61490.85
535306-3530685.39785.60
636583-3658388.48688.73
30min139431-3943195.37495.210.6895.7695.590.69
239389-3938995.27395.67
339341-3934195.15795.51
439698-3969896.02096.41
538888-3888894.06194.41
639438-3943895.39195.78
45min140130-4013097.06597.201.0297.6197.741.02
240079-4007996.94297.50
340311-4031197.50398.01
440920-4092098.97699.52
539724-3972496.08396.59
639955-3995596.64297.19
60min140256-4025697.37097.460.9298.0898.160.92
240377-4037797.66398.38
340644-4064498.30898.98
440726-4072698.50799.22
539996-3999696.74197.41
639768-3976896.18996.90
极限139986-3998696.71797.510.9697.5998.370.96
240394-4039497.70498.58
340391-4039197.69698.53
441009-4100999.191100.07
540067-4006796.91397.74
640031-4003196.82697.70
坎地沙坦酯片项目信息
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100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.553848838379385563860538780385620.39
216.593868638518386020.31
单位质量响应值RSD%判断
2330.032326.820.10数据可信
加速6月-供试品溶液-2025030421批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17531-753118.15713.9424.7218.1613.9524.73
24781-478111.52711.53
34377-437710.55310.55
47634-763418.40518.41
55034-503412.13712.14
65346-534612.88912.89
10min119791-1979147.71538.6617.6647.7538.6817.67
213925-1392533.57333.59
314728-1472835.50935.53
419554-1955447.14447.17
514156-1415634.13034.15
614056-1405633.88933.91
15min129930-2993072.16060.6914.0572.2760.7714.06
222072-2207253.21553.29
324200-2420058.34558.42
429278-2927870.58870.70
523459-2345956.55956.64
622085-2208553.24653.32
20min136450-3645087.88077.399.4388.1177.589.45
229294-2929470.62770.79
331762-3176276.57776.75
435157-3515784.76284.99
530458-3045873.43373.60
629486-2948671.09071.26
30min139957-3995796.33592.073.1596.7192.393.18
236924-3692489.02289.30
337623-3762390.70891.01
439370-3937094.92095.29
537881-3788191.33091.62
637372-3737290.10390.39
45min140834-4083498.44995.891.5798.9996.361.60
239352-3935294.87695.31
339297-3929794.74495.20
440190-4019096.89797.42
539317-3931794.79295.24
639644-3964495.58096.02
60min141205-4120599.34496.751.51100.0497.381.53
239722-3972295.76896.36
339549-3954995.35195.96
440151-4015196.80397.49
539807-3980795.97396.58
640352-4035297.28797.88
极限140569-4056997.81097.891.2098.6898.691.18
240927-4092798.67499.42
339877-3987796.14296.91
440597-4059797.87898.73
540356-4035697.29798.06
641294-4129499.558100.32
坎地沙坦酯片项目信息
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100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.553852938548385393840938585385220.18
216.593885238580387160.50
单位质量响应值RSD%判断
2327.612333.690.19数据可信
加速6月-供试品溶液-2025030422批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16206-620614.94813.964.5814.9513.964.58
26026-602614.51514.51
35547-554713.36113.36
45593-559313.47213.47
55767-576713.89113.89
65634-563413.57013.57
10min116688-1668840.19637.905.5540.2237.925.54
215575-1557537.51537.54
315228-1522836.67936.70
416578-1657839.93139.95
515954-1595438.42838.45
614375-1437534.62534.65
15min126033-2603362.70560.526.2962.8060.616.29
224744-2474459.60059.69
323880-2388057.51957.60
427005-2700565.04665.13
526245-2624563.21563.30
622849-2284955.03655.12
20min133463-3346380.60178.315.7880.8078.495.78
231722-3172276.40876.59
330590-3059073.68173.86
434205-3420582.38882.59
534722-3472283.63483.83
630357-3035773.12073.29
30min138595-3859592.96294.012.0893.2994.332.08
238690-3869093.19193.50
338102-3810291.77592.08
439600-3960095.38395.72
540350-4035097.19097.52
638840-3884093.55293.85
45min140223-4022396.88497.271.6897.3797.741.68
239412-3941294.93095.40
339883-3988396.06596.52
441078-4107898.94399.44
541115-4111599.03299.53
640586-4058697.75898.21
60min140240-4024096.92596.941.3697.5797.581.36
239608-3960895.40296.03
339811-3981195.89196.51
440941-4094198.61399.27
540839-4083998.36799.03
640034-4003496.42897.04
极限140062-4006296.49696.921.5597.3097.721.56
239476-3947695.08495.87
339805-3980595.87796.65
441094-4109498.98299.80
540867-4086798.43599.26
640123-4012396.64397.42
坎地沙坦酯片项目信息
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100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.553851338723385933857438354385510.35
216.593891538874388940.08
单位质量响应值RSD%判断
2329.372344.420.46数据可信
加速6月-供试品溶液-KC031批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13374-33748.1058.648.708.118.648.69
23736-37368.9758.97
34133-41339.9299.93
43617-36178.6898.69
53470-34708.3368.34
63256-32567.8227.82
10min112262-1226229.45629.3910.8729.4729.4010.87
211780-1178028.29928.31
314448-1444834.70834.72
412971-1297131.16031.17
510994-1099426.41026.42
610951-1095126.30726.32
15min122131-2213153.16453.4412.0753.2353.5112.07
221106-2110650.70250.76
326084-2608462.66062.73
424828-2482859.64359.71
519539-1953946.93847.00
619796-1979647.55547.61
20min131372-3137275.36375.3710.1675.5175.5210.16
230555-3055573.40173.55
335820-3582086.04986.23
434146-3414682.02782.19
527125-2712565.16165.30
629224-2922470.20370.34
30min140970-4097098.42096.924.0798.7097.204.08
239881-3988195.80496.07
341878-41878100.601100.92
441734-41734100.256100.56
537426-3742689.90790.15
640179-4017996.52096.77
45min142270-42270101.543101.981.43101.98102.421.44
242199-42199101.373101.80
342405-42405101.867102.36
442847-42847102.929103.40
541605-4160599.946100.34
643384-43384104.219104.63
60min141926-41926100.717101.771.69101.33102.381.68
242296-42296101.606102.20
342069-42069101.060101.72
442504-42504102.105102.75
541697-41697100.167100.73
643706-43706104.993105.58
极限142170-42170101.303102.571.39102.08103.351.37
243139-43139103.631104.40
342000-42000100.895101.72
442894-42894103.042103.85
542455-42455101.988102.72
643525-43525104.558105.32
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