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%
116.013864638742387473878538696387230.14
216.083894738734388400.39
单位质量响应值RSD%判断
2418.682415.420.10数据可信
供试品溶液-KF021批-pH1.2(内含0.05%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16447-644714.97416.579.2614.9716.579.25
27583-758317.61217.61
36224-622414.45614.46
47600-760017.65117.65
57812-781218.14418.14
67143-714316.59016.59
10min118575-1857543.14241.844.1143.1741.874.11
218478-1847842.91642.95
317289-1728940.15540.18
418265-1826542.42242.45
518591-1859143.17943.21
616882-1688239.21039.24
15min129438-2943868.37263.255.2668.4763.345.25
227290-2729063.38363.48
326923-2692362.53062.62
427224-2722463.22963.33
527556-2755664.00164.10
624961-2496157.97458.07
20min136466-3646684.69578.305.4484.9178.505.43
234227-3422779.49479.70
333509-3350977.82778.02
433600-3360078.03878.24
533728-3372878.33578.54
630737-3073771.38971.58
30min141267-4126795.84590.343.6796.2090.673.68
238873-3887390.28590.62
338282-3828288.91289.24
439072-3907290.74791.08
539024-3902490.63690.98
636861-3686185.61285.92
45min141505-4150596.39893.642.1396.9194.122.14
240332-4033293.67494.16
339599-3959991.97192.44
440477-4047794.01094.50
540864-4086494.90995.40
639123-3912390.86691.32
60min141061-4106195.36792.801.7996.0493.441.80
239544-3954491.84392.49
339738-3973892.29492.92
439576-3957691.91892.56
540602-4060294.30194.95
639214-3921491.07791.68
极限140284-4028493.56292.031.0594.3992.831.05
239252-3925291.16591.96
339166-3916690.96691.75
439572-3957291.90992.71
539874-3987492.61093.42
639601-3960191.97692.73
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%
116.013890338806387723873938612387660.28
216.083892739111390190.34
单位质量响应值RSD%判断
2421.362426.550.16数据可信
供试品溶液-KF021批-pH1.2(内含0.05%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17243-724316.77415.556.2216.7715.556.20
26303-630314.59714.60
36325-632514.64814.65
46774-677415.68815.69
56475-647514.99615.00
67173-717316.61216.61
10min118089-1808941.89339.815.3941.9239.845.39
216792-1679238.88938.91
316935-1693539.22139.24
417138-1713839.69139.72
515826-1582636.65236.68
618368-1836842.53942.57
15min127529-2752963.75660.845.5063.8560.935.50
226036-2603660.29860.39
325838-2583859.83959.93
425948-2594860.09460.19
524074-2407455.75455.84
628187-2818765.28065.38
20min133871-3387178.44375.754.0678.6575.954.07
232992-3299276.40876.60
332218-3221874.61574.80
431984-3198474.07374.27
530782-3078271.28971.47
634414-3441479.70179.91
30min139185-3918590.75088.812.5691.0989.132.57
239083-3908390.51490.83
338149-3814988.35188.66
437894-3789487.76088.08
536683-3668384.95685.25
639082-3908290.51290.85
45min140439-4043993.65592.361.8694.1492.821.87
240362-4036293.47693.94
339963-3996392.55293.01
439097-3909790.54791.01
538836-3883689.94290.38
640575-4057593.97094.46
60min140025-4002592.69691.261.8293.3491.881.83
239952-3995292.52793.15
339312-3931291.04491.66
438952-3895290.21190.82
538242-3824288.56689.16
639956-3995692.53693.18
极限139793-3979392.15891.271.4092.9692.041.41
239879-3987992.35893.14
338836-3883689.94290.71
439296-3929691.00791.77
538695-3869589.61690.35
639952-3995292.52793.33
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%
116.017797377610778237784977834778180.17
216.087957779378794780.18
单位质量响应值RSD%判断
4860.594942.661.19数据可信
供试品溶液-12423607批-pH1.2(内含0.05%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min111810-1181013.52713.868.3813.5313.878.38
213941-1394115.96815.97
311855-1185513.57813.58
411521-1152113.19613.20
511036-1103612.64012.64
612465-1246514.27714.28
10min129380-2938033.65133.605.4633.6733.635.46
231665-3166536.26836.29
329742-2974234.06534.09
430165-3016534.55034.57
527312-2731231.28231.30
627774-2777431.81131.84
15min145887-4588752.55752.724.9252.6452.804.93
248926-4892656.03856.13
346991-4699153.82253.90
447569-4756954.48454.56
543127-4312749.39649.47
643684-4368450.03450.11
20min158362-5836266.84667.094.8667.0167.254.86
261668-6166870.63270.81
360567-6056769.37169.54
460481-6048169.27369.44
554994-5499462.98863.14
655356-5535663.40363.56
30min172659-7265983.22183.612.7583.5083.882.76
275405-7540586.36686.66
375020-7502085.92586.21
473356-7335684.01984.31
570773-7077381.06181.32
670757-7075781.04381.31
45min179881-7988191.49390.821.6791.9191.241.67
279422-7942290.96791.41
381542-8154293.39593.82
478137-7813789.49589.92
578841-7884190.30290.70
677952-7795289.28389.68
60min179409-7940990.95290.871.4391.5291.441.43
279376-7937690.91491.51
381432-8143293.26993.85
478165-7816589.52790.10
579018-7901890.50491.05
678625-7862590.05490.60
极限178007-7800789.34689.601.7090.0790.321.70
278778-7877890.22990.97
380429-8042992.12092.86
476402-7640287.50888.23
578092-7809289.44490.14
677687-7768788.98089.68
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%
116.017809178362780657779478080780780.26
216.087924579032791380.20
单位质量响应值RSD%判断
4876.834921.520.65数据可信
供试品溶液-12423607批-pH1.2(内含0.05%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min112423-1242314.23513.246.1714.2413.246.18
211030-1103012.63912.64
311858-1185813.58813.59
410911-1091112.50312.50
512273-1227314.06314.06
610857-1085712.44112.44
10min131400-3140035.98132.436.3136.0032.456.31
226879-2687930.80030.82
328753-2875332.94832.97
426406-2640630.25830.28
527688-2768831.72731.75
628681-2868132.86532.89
15min149049-4904956.20451.095.8356.2951.175.83
243086-4308649.37149.44
345950-4595052.65352.73
441914-4191448.02848.10
542983-4298349.25349.33
644537-4453751.03451.11
20min161952-6195270.99065.455.5071.1765.615.50
255816-5581663.95864.11
359924-5992468.66668.83
453998-5399861.87562.03
554658-5465862.63262.79
656364-5636464.58664.75
30min176014-7601487.10383.103.5187.4083.373.52
272997-7299783.64683.91
374757-7475785.66385.94
469692-6969279.85980.11
570040-7004080.25780.52
671624-7162482.07382.34
45min179640-7964091.25890.290.9491.7090.700.95
278439-7843989.88290.28
379799-7979991.44091.86
478083-7808389.47489.86
578263-7826389.68090.08
678552-7855290.01190.42
60min179712-7971291.34090.530.9691.9391.080.97
278427-7842789.86890.42
380152-8015291.84592.42
478390-7839089.82690.36
578482-7848289.93190.48
678842-7884290.34490.90
极限178651-7865190.12589.871.1190.8790.581.11
277126-7712688.37789.08
379695-7969591.32192.05
477900-7790089.26489.95
578402-7840289.83990.54
678780-7878090.27290.98
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