替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100309-202205对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.205267852669526155259652533526180.12
214.185263552670526520.05
单位质量响应值RSD%判断
3705.493713.120.15数据可信
供试品溶液-23K2033批-氢氯噻嗪-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min137662-3766272.88571.952.8172.8971.952.81
235197-3519768.11568.11
336929-3692971.46771.47
438135-3813573.80173.80
537605-3760572.77572.77
637537-3753772.64372.64
10min145260-4526087.58985.861.5287.9986.261.50
244703-4470386.51186.89
344193-4419385.52485.92
443603-4360384.38284.79
544806-4480686.71187.11
643641-4364184.45684.86
15min148627-4862794.10594.892.0395.0095.772.02
247464-4746491.85492.71
348732-4873294.30895.18
449676-4967696.13597.01
549375-4937595.55396.44
650329-5032997.39998.27
20min150573-5057397.87196.141.0699.2997.551.06
249256-4925695.32296.69
349686-4968696.15497.55
449258-4925895.32696.74
549317-4931795.44096.86
649993-4999396.74998.16
30min152214-52214101.04798.692.45103.00100.632.41
251061-5106198.815100.71
348786-4878694.41396.34
450854-5085498.415100.36
550889-5088998.483100.43
652174-52174100.969102.92
45min151847-51847100.33798.581.85102.86101.061.82
251246-5124699.173101.62
349304-4930495.41597.87
451342-5134299.359101.85
551525-5152599.713102.21
650361-5036197.46199.97
60min152205-52205101.02999.941.53104.11102.971.51
251944-51944100.524103.52
350251-5025197.248100.23
451427-5142799.524102.56
552484-52484101.569104.62
651543-5154399.748102.80
极限153477-53477103.491102.543.44107.13106.133.32
256279-56279108.914112.47
350863-5086398.432101.96
452573-52573101.742105.34
552291-52291101.196104.81
652429-52429101.463105.07
替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100629-202204对照品来源中检所对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.108930689566893078915688940892550.26
2 11.168952589152893380.30
单位质量响应值RSD%判断
8040.998005.200.32数据可信
供试品溶液-23K2033批-替米沙坦-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min129507-2950733.10029.8512.1233.1029.8512.12
221638-2163824.27324.27
324261-2426127.21527.22
429497-2949733.08933.09
526003-2600329.16929.17
628764-2876432.26732.27
10min153884-5388460.44561.207.2360.6361.377.23
248524-4852454.43354.57
352838-5283859.27259.42
454300-5430060.91261.10
558629-5862965.76865.93
659162-5916266.36666.55
15min167715-6771575.96081.258.8576.4881.758.83
264193-6419372.01072.45
369936-6993678.45278.93
473161-7316182.07082.59
579362-7936289.02689.55
680196-8019689.96190.51
20min185778-8577896.22394.592.7597.1695.542.68
286974-8697497.56598.40
384975-8497595.32296.24
480217-8021789.98590.96
584199-8419994.45295.47
683773-8377393.97495.02
30min187456-8745698.10596.432.9099.5897.922.88
287202-8720297.82099.20
381541-8154191.47092.92
485058-8505895.41596.89
585951-8595196.41797.96
688585-8858599.372100.94
45min184952-8495295.29694.662.6097.3296.682.58
285864-8586496.31998.24
380052-8005289.80091.75
484342-8434294.61296.62
585716-8571696.15398.24
685372-8537295.76897.89
60min185644-8564496.07395.722.2098.6298.262.19
287059-8705997.660100.12
382211-8221192.22294.67
483984-8398494.21196.74
586377-8637796.89599.51
686698-8669897.25599.91
极限186839-8683997.41398.144.95100.50101.224.78
295910-95910107.589110.59
383319-8331993.46596.43
485864-8586496.31999.38
586343-8634396.857100.01
686641-8664197.191100.39
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