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%
115.947715376744764977736176772769050.46
215.977870678677786920.03
单位质量响应值RSD%判断
4824.654927.491.50数据可信
供试品溶液-2025022821批-pH6.8(内含0.1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min112540-1254014.43911.7315.4714.4411.7315.47
28926-892610.27810.28
39082-908210.45710.46
411017-1101712.68512.69
58548-85489.8429.84
611012-1101212.67912.68
10min134032-3403239.18533.8912.4439.2133.9112.44
224881-2488128.64828.67
328309-2830932.59532.61
432636-3263637.57837.60
525994-2599429.93029.95
630756-3075635.41335.43
15min151153-5115358.89854.738.4858.9954.818.48
241300-4130047.55347.62
346605-4660553.66253.73
451934-5193459.79759.88
545031-4503151.84951.92
649187-4918756.63556.71
20min162756-6275672.25870.315.7272.4570.485.73
256157-5615764.66064.80
358632-5863267.51067.67
463798-6379873.45873.64
559662-5966268.69668.85
665382-6538275.28275.46
30min178412-7841290.28588.982.2590.5989.262.26
276136-7613687.66487.92
374747-7474786.06586.34
477501-7750189.23689.54
577140-7714088.82089.09
679736-7973691.80992.11
45min188130-88130101.47499.172.17101.9399.602.18
284965-8496597.83098.23
383206-8320695.80496.22
485791-8579198.78199.24
586849-8684999.999100.41
687839-87839101.139101.59
60min186713-8671399.843100.151.42100.47100.751.43
285765-8576598.75199.31
386050-8605099.07999.66
488359-88359101.738102.36
586351-8635199.426100.01
688667-88667102.092102.71
极限185479-8547998.42295.651.8099.2296.421.81
282052-8205294.47695.20
381254-8125493.55794.30
482578-8257895.08195.87
583126-8312695.71296.46
683947-8394796.65897.45
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%
115.947819978381783607903579155786260.56
215.977766977469775690.19
单位质量响应值RSD%判断
4932.624857.171.09数据可信
供试品溶液-2025022821批-pH6.8(内含0.1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min111217-1121712.86512.449.8512.8712.449.83
28724-872410.00610.01
311570-1157013.27013.27
411511-1151113.20213.20
511141-1114112.77812.78
610905-1090512.50712.51
10min132023-3202336.72836.3410.0036.7536.369.99
225390-2539029.12029.14
333474-3347438.39238.41
433838-3383838.81038.83
533194-3319438.07138.09
632189-3218936.91836.94
15min149593-4959356.88056.397.2556.9656.477.26
242129-4212948.31948.38
349798-4979857.11557.20
450294-5029457.68357.77
551117-5111758.62758.71
652052-5205259.70059.78
20min162526-6252671.71370.534.1671.8970.704.17
256725-5672565.05965.21
360931-6093169.88370.06
461875-6187570.96671.15
562833-6283372.06572.25
664072-6407273.48673.67
30min175107-7510786.14284.451.8586.4484.741.86
272034-7203482.61882.87
372534-7253483.19183.49
472684-7268483.36383.66
574858-7485885.85786.16
674564-7456485.51985.82
45min181566-8156693.55091.851.9093.9992.281.90
279507-7950791.18991.58
378432-7843289.95690.39
478321-7832189.82890.27
581139-8113993.06093.51
681520-8152093.49793.94
60min182861-8286195.03593.691.4795.6394.281.47
281388-8138893.34693.89
380431-8043192.24892.83
480160-8016091.93892.53
582702-8270294.85395.45
682580-8258094.71395.32
极限182422-8242294.53294.231.2095.2994.981.20
282013-8201394.06394.76
381108-8110893.02593.76
481016-8101692.91993.66
583461-8346195.72496.48
682952-8295295.14095.90
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%
115.947709476928775817754676509771320.59
215.977696576783768740.17
单位质量响应值RSD%判断
4838.904813.650.37数据可信
供试品溶液-2025030121批-pH6.8(内含0.1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19143-914310.6358.6313.7910.638.6313.78
26963-69638.0998.10
36443-64437.4947.49
46857-68577.9767.98
56954-69548.0898.09
68174-81749.5089.51
10min126170-2617030.44025.6611.5630.4625.6811.56
222029-2202925.62425.64
320907-2090724.31824.33
419512-1951222.69622.71
519914-1991423.16323.18
623839-2383927.72927.74
15min144547-4454751.81644.5211.1851.8844.5811.18
238826-3882645.16145.22
336669-3666942.65242.71
433585-3358539.06539.12
534336-3433639.93939.99
641704-4170448.50948.57
20min157786-5778667.21560.508.6467.3760.638.64
252385-5238560.93361.06
350455-5045558.68858.81
447107-4710754.79454.91
547659-4765955.43655.55
656688-5668865.93866.08
30min172144-7214483.91680.134.5084.1880.364.52
270268-7026881.73481.97
367018-6701877.95378.18
466051-6605176.82977.04
565459-6545976.14076.35
672379-7237984.18984.44
45min178907-7890791.78291.511.9492.1991.871.95
280318-8031893.42493.79
377246-7724689.85090.20
478660-7866091.49591.83
576624-7662489.12789.46
680278-8027893.37793.77
60min180868-8086894.06394.661.3894.6295.181.39
282930-8293096.46296.99
380177-8017793.26093.76
481437-8143794.72595.21
580384-8038493.50093.99
682471-8247195.92896.48
极限181898-8189895.26296.391.3195.9897.071.30
283257-8325796.84297.53
382752-8275296.25596.91
484508-8450898.29798.94
581499-8149994.79795.44
683308-8330896.90297.61
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%
115.947732276694767587741676685769750.48
215.977798877608777980.35
单位质量响应值RSD%判断
4829.054871.510.62数据可信
供试品溶液-2025030121批-pH6.8(内含0.1%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17176-71768.3069.8014.758.319.8014.73
29871-987111.42511.42
37307-73078.4578.46
49893-989311.45011.45
58867-886710.26310.26
67680-76808.8898.89
10min123367-2336727.04628.7711.2927.0628.7811.29
228229-2822932.67332.69
323520-2352027.22327.24
428241-2824132.68732.71
524415-2441528.25928.28
621346-2134624.70724.72
15min140561-4056146.94748.538.5547.0148.608.55
245829-4582953.04453.12
341385-4138547.90047.96
446244-4624453.52453.60
540823-4082347.25047.31
636739-3673942.52342.58
20min154403-5440362.96864.335.8063.1064.475.81
258749-5874967.99868.16
355667-5566764.43164.57
459255-5925568.58468.75
554959-5495963.61163.75
650425-5042558.36358.49
30min170293-7029381.35982.351.7081.6082.601.72
272216-7221683.58583.86
370889-7088982.04982.30
472942-7294284.42584.70
570808-7080881.95582.20
669733-6973380.71180.94
45min178278-7827890.60191.960.9790.9892.350.98
279681-7968192.22592.64
379935-7993592.51992.90
480477-8047793.14793.56
579004-7900491.44291.83
679358-7935891.85192.21
60min180203-8020392.82994.641.1293.3695.181.12
282046-8204694.96395.53
382318-8231895.27795.81
482356-8235695.32195.89
581134-8113493.90794.44
682524-8252495.51696.03
极限180675-8067593.37695.181.3094.0695.881.28
282197-8219795.13795.86
382633-8263395.64296.34
482551-8255195.54796.28
581544-8154494.38195.08
683806-8380697.00097.67
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