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%
116.067531975260753027515675174752420.10
216.247562875661756440.04
单位质量响应值RSD%判断
4685.064657.880.42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%
5min111206-1120613.46618.4418.1213.4718.4418.11
214055-1405516.89016.89
316734-1673420.11020.11
417575-1757521.12021.12
513881-1388116.68116.68
618633-1863322.39222.39
10min135501-3550142.66248.9512.1342.6848.9812.13
238555-3855546.33246.36
342659-4265951.26451.30
446745-4674556.17456.21
535487-3548742.64542.67
645472-4547254.64554.68
15min157840-5784069.50773.266.5169.6073.376.52
260008-6000872.11372.22
362173-6217374.71574.83
465384-6538478.57378.70
555397-5539766.57266.67
664963-6496378.06778.20
20min170708-7070884.97187.192.4985.1887.422.51
273297-7329788.08288.31
372918-7291887.62787.87
474854-7485489.95490.21
570092-7009284.23184.44
673450-7345088.26688.52
30min177927-7792793.64694.300.7694.0094.680.78
279054-7905495.00195.37
378341-7834194.14494.53
479269-7926995.25995.67
577786-7778693.47793.83
678437-7843794.25994.66
45min179760-7976095.84995.700.9996.3696.241.00
280125-8012596.28896.82
379411-7941195.43095.98
480850-8085097.15997.73
579005-7900594.94295.45
678677-7867794.54895.11
60min179735-7973595.81995.900.7796.4996.600.77
279988-7998896.12396.81
379776-7977695.86896.57
480838-8083897.14597.88
579478-7947895.51096.17
679002-7900294.93895.66
极限179590-7959095.64595.910.9596.4796.760.96
280201-8020196.37997.23
379760-7976095.84996.71
481079-8107997.43498.33
579225-7922595.20696.03
678992-7899294.92695.80
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%
116.067529775224750627510475199751770.13
216.247793877325776320.56
单位质量响应值RSD%判断
4681.014780.301.49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%
5min124634-2463429.23623.6921.2929.2423.7021.29
225391-2539130.13430.13
316321-1632119.37019.37
415283-1528318.13818.14
520155-2015523.92023.92
618006-1800621.37021.37
10min152760-5276062.61654.5111.0462.6654.5511.04
250902-5090260.41160.46
341887-4188749.71249.74
440131-4013147.62847.66
546533-4653355.22655.27
643356-4335651.45551.49
15min168614-6861481.43276.964.9481.5877.094.95
268758-6875881.60281.75
361695-6169573.22073.34
461744-6174473.27873.39
564919-6491977.04677.18
663355-6335575.19075.31
20min176769-7676991.11088.911.9891.4089.172.00
276240-7624090.48290.77
373433-7343387.15187.39
473301-7330186.99487.23
575557-7555789.67289.93
674189-7418988.04888.29
30min180496-8049695.53395.591.1495.9795.991.15
280531-8053195.57596.01
380048-8004895.00195.38
479243-7924394.04694.42
580943-8094396.06496.47
681995-8199597.31297.71
45min181435-8143596.64896.331.0497.2596.901.04
280924-8092496.04196.64
380501-8050195.53996.08
480079-8007995.03895.57
581709-8170996.97397.54
682376-8237697.76498.32
60min180848-8084895.95195.861.1896.7196.591.18
280773-8077395.86296.62
379839-7983994.75395.45
479690-7969094.57795.27
581198-8119896.36697.10
682281-8228197.65298.37
极限181188-8118896.35496.211.5297.2897.101.52
280713-8071395.79196.71
379492-7949294.34295.20
480380-8038095.39596.24
581494-8149496.71897.61
683137-8313798.66899.55
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%
116.067690176621767967679276434767090.24
216.247819577856780260.31
单位质量响应值RSD%判断
4776.404804.560.42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%
5min118478-1847821.65417.4221.3221.6517.4221.33
215222-1522217.83817.84
311157-1115713.07513.07
410847-1084712.71112.71
516478-1647819.31019.31
616990-1699019.91019.91
10min150338-5033858.98947.9118.3359.0347.9418.34
240831-4083147.84847.88
332744-3274438.37238.39
431375-3137536.76736.79
544456-4445652.09652.13
645557-4555753.38753.42
15min170544-7054482.66871.5914.0082.8071.7014.00
260220-6022070.57070.68
352304-5230461.29361.38
449669-4966958.20558.29
567001-6700178.51678.64
666796-6679678.27678.40
20min178571-7857192.07584.638.4892.3584.868.50
271480-7148083.76583.99
366328-6632877.72877.92
463693-6369374.64074.82
576810-7681090.01190.26
676444-7644489.58289.83
30min181114-8111495.05592.244.0895.4892.614.12
278937-7893792.50492.87
376110-7611089.19189.51
473622-7362286.27586.58
580956-8095694.87095.27
681541-8154195.55595.96
45min182234-8223496.36794.362.5596.9594.882.59
280361-8036194.17294.69
379299-7929992.92893.39
477110-7711090.36390.81
581833-8183395.89796.46
682287-8228796.42996.99
60min182068-8206896.17394.742.0996.9295.422.14
280048-8004893.80694.48
379152-7915292.75693.38
478887-7888792.44593.04
582151-8215196.27096.99
682774-8277497.00097.72
极限182593-8259396.78896.790.8297.6997.620.85
281858-8185895.92796.76
381954-8195496.03996.81
482512-8251296.69397.45
582936-8293697.19098.07
683696-8369698.08098.96
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