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%
116.107703277142770947706376996770650.08
216.127779777609777030.18
单位质量响应值RSD%判断
4786.654820.290.50数据可信
供试品溶液-2025022821批-tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min117600-1760020.56924.0112.7820.5724.0112.78
218017-1801721.05621.06
321318-2131824.91424.91
422985-2298526.86326.86
523937-2393727.97527.98
619396-1939622.66822.67
10min142161-4216149.27457.249.9949.3157.289.99
244387-4438751.87551.91
349988-4998858.42158.46
455542-5554264.91264.96
551418-5141860.09260.14
650370-5037058.86858.91
15min164964-6496475.92480.944.8776.0481.084.88
266028-6602877.16777.29
369893-6989381.68481.82
474332-7433286.87287.02
569926-6992681.72381.87
670396-7039682.27282.41
20min176011-7601188.83491.782.8589.0892.052.86
277127-7712790.13890.39
377637-7763790.73491.01
482387-8238796.28696.58
579507-7950792.92093.20
678524-7852491.77192.04
30min180643-8064394.24896.172.1094.6496.592.12
281381-8138195.11095.51
381099-8109994.78195.21
485417-8541799.827100.29
582537-8253796.46196.90
682634-8263496.57597.00
45min181553-8155395.31196.832.0495.8697.412.05
282034-8203495.87396.43
381543-8154395.29995.88
485970-85970100.473101.10
583390-8339097.45898.06
682604-8260496.53997.13
60min181426-8142695.16396.842.0795.8797.592.08
282254-8225496.13096.85
381379-8137995.10895.85
486020-86020100.532101.32
583181-8318197.21497.97
682925-8292596.91597.66
极限181681-8168195.46197.021.8396.3397.931.84
282145-8214596.00396.88
382516-8251696.43797.34
485946-85946100.445101.40
583093-8309397.11198.03
682726-8272696.68297.59
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%
116.107780277744778887778677719777880.09
216.127835478671785120.29
单位质量响应值RSD%判断
4831.554870.470.57数据可信
供试品溶液-2025022821批-tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min129819-2981934.50830.5323.7934.5130.5323.79
230265-3026535.02435.02
327575-2757531.91131.91
428566-2856633.05833.06
513732-1373215.89115.89
628334-2833432.79032.79
10min158590-5859067.80363.5617.8567.8663.6217.85
255953-5595364.75264.81
358867-5886768.12468.18
459407-5940768.74968.80
535254-3525440.79840.82
661492-6149271.16271.22
15min174210-7421085.88082.0012.1886.0582.1512.19
272911-7291184.37684.54
374335-7433586.02486.19
474320-7432086.00786.18
553366-5336661.75861.85
675986-7598687.93588.11
20min179924-7992492.49290.316.5092.8190.606.53
280314-8031492.94393.25
379563-7956392.07492.38
479139-7913991.58491.90
567819-6781978.48478.68
681449-8144994.25794.58
30min181997-8199794.89193.852.6995.3694.302.73
282088-8208894.99695.46
381328-8132894.11794.58
480813-8081393.52193.99
577017-7701789.12889.46
683355-8335596.46396.94
45min182156-8215695.07594.222.0595.7094.822.09
281978-8197894.86995.49
381455-8145594.26494.88
480327-8032792.95993.58
578862-7886291.26391.74
683706-8370696.86997.51
60min182227-8222795.15794.292.0295.9495.052.07
282090-8209094.99995.78
381341-8134194.13294.91
480632-8063293.31194.09
578863-7886391.26491.89
683721-8372196.88697.69
极限182178-8217895.10194.431.7696.0495.351.80
281936-8193694.82195.76
381362-8136294.15695.09
481219-8121993.99194.92
579275-7927591.74192.52
683641-8364196.79497.75
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%
116.107750278576784997737978048780010.71
216.127883278773788020.06
单位质量响应值RSD%判断
4844.784888.460.64数据可信
供试品溶液-2025022821批-tw20
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min121485-2148524.78421.6929.3024.7821.6929.29
215886-1588618.32518.33
314059-1405916.21816.22
423857-2385727.52027.52
525398-2539829.29829.30
612137-1213714.00114.00
10min147799-4779955.13850.9917.9255.1851.0317.93
239444-3944445.50045.53
338153-3815344.01144.04
452621-5262160.70160.75
552825-5282560.93660.98
634392-3439239.67339.70
15min168689-6868979.23672.9411.5079.3773.0611.51
258867-5886767.90668.01
357597-5759766.44166.54
471092-7109282.00882.15
569197-6919779.82279.97
653954-5395462.23862.33
20min178161-7816190.16285.235.7190.4385.485.74
272389-7238983.50483.72
370614-7061481.45681.67
477949-7794989.91890.20
576283-7628387.99688.28
667940-6794078.37278.56
30min181863-8186394.43392.671.7794.8593.061.81
280619-8061992.99893.36
379148-7914891.30191.65
481306-8130693.79094.22
580972-8097293.40593.83
678124-7812490.11990.44
45min182779-8277995.48994.411.3896.0694.951.41
282555-8255595.23195.74
380516-8051692.87993.38
482042-8204294.63995.23
582813-8281395.52896.11
680355-8035592.69393.17
60min182717-8271795.41894.401.3696.1595.101.40
282182-8218294.80195.47
380550-8055092.91893.57
482466-8246695.12895.88
582789-8278995.50196.25
680312-8031292.64393.27
极限182968-8296895.70795.310.6696.6096.170.70
282223-8222394.84895.68
381890-8189094.46495.27
482730-8273095.43396.34
583414-8341496.22297.13
682538-8253895.21195.99
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