坎地沙坦酯氨氯地平片项目信息
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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.746560065523655456556965455655380.09
213.786557165617655940.05
单位质量响应值RSD%判断
4769.874760.090.15数据可信
长期12月-供试品溶液-2023022521批-pH2.0盐酸溶液
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min152999-5299972.11372.208.5272.1172.208.52
247260-4726064.30464.30
348985-4898566.65166.65
453729-5372973.10673.11
555657-5565775.72975.73
659738-5973881.28281.28
10min171281-7128196.98895.302.0597.1195.422.06
267433-6743391.75291.86
370033-7003395.29095.40
469670-6967094.79694.92
570541-7054195.98196.11
671298-7129897.01197.15
15min171907-7190797.83996.630.9498.1296.910.94
271495-7149597.27997.54
370822-7082296.36396.63
470304-7030495.65895.94
570274-7027495.61895.90
671326-7132697.04997.35
20min171767-7176797.64996.511.1998.0996.951.18
271279-7127996.98597.41
371026-7102696.64197.07
469922-6992295.13995.58
569894-6989495.10195.55
671704-7170497.56398.02
30min171348-7134897.07996.120.7497.6996.720.75
270961-7096196.55297.14
370340-7034095.70796.30
470111-7011195.39695.99
570121-7012195.40996.01
670985-7098596.58597.21
45min171760-7176097.63995.791.2198.4196.551.20
270897-7089796.46597.21
370308-7030895.66496.41
469382-6938294.40495.16
569723-6972394.86895.63
670336-7033695.70296.48
60min171461-7146197.23395.351.1598.1696.271.14
270144-7014495.44196.35
369723-6972394.86895.78
469209-6920994.16895.08
569526-6952694.60095.52
670408-7040895.80096.74
极限171443-7144397.20895.331.3598.3096.411.34
270822-7082296.36397.43
369812-6981294.98996.06
469053-6905393.95695.03
569140-6914094.07595.15
670099-7009995.37996.48
坎地沙坦酯氨氯地平片项目信息
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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.746569165610655246562365639656170.10
213.786579265791657920.01
单位质量响应值RSD%判断
4775.624774.460.02数据可信
长期12月-供试品溶液-2023022721批-pH2.0盐酸溶液
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min158165-5816578.97573.3010.2178.9773.3010.21
247275-4727564.18964.19
361521-6152183.53183.53
455013-5501374.69574.70
548398-4839865.71365.71
653531-5353172.68372.68
10min171481-7148197.05596.472.0997.1996.592.09
268349-6834992.80292.91
372337-7233798.21798.36
470676-7067695.96296.09
571123-7112396.56996.68
672334-7233498.21398.33
15min171166-7116696.62797.711.0196.9298.001.01
272381-7238198.27798.54
372455-7245598.37798.68
471185-7118596.65396.94
571693-7169397.34397.61
672908-7290898.99299.28
20min170981-7098196.37697.691.0196.8398.141.00
272109-7210997.90898.33
372676-7267698.67799.14
471329-7132996.84897.29
571827-7182797.52597.96
672786-7278698.82799.28
30min170874-7087496.23197.191.0096.8597.790.99
272415-7241598.32398.91
371954-7195497.69798.33
470842-7084296.18796.79
571131-7113196.58097.17
672250-7225098.09998.71
45min170507-7050795.73296.621.1496.5197.391.14
271638-7163897.26898.02
371264-7126496.76097.55
470193-7019395.30696.07
570935-7093596.31497.07
672434-7243498.34999.13
60min170335-7033595.49996.321.1396.4397.251.13
270943-7094396.32497.24
371376-7137696.91297.87
470138-7013895.23196.16
570544-7054495.78396.70
672290-7229098.15399.10
极限169742-6974294.69496.071.3895.7997.161.36
271645-7164597.27898.35
370804-7080496.13697.25
469800-6980094.77295.86
570409-7040995.59996.68
672115-7211597.91699.02
坎地沙坦酯氨氯地平片项目信息
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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.746582065894659166586565827658640.07
213.786558165577655790.01
单位质量响应值RSD%判断
4793.604759.000.52数据可信
长期12月-供试品溶液-2023022821批-pH2.0盐酸溶液
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min135949-3594948.79872.0317.0648.8072.0317.06
257179-5717977.61777.62
358751-5875179.75079.75
457810-5781078.47378.47
549780-4978067.57367.57
658897-5889779.94979.95
10min164822-6482287.99195.283.8688.0795.403.88
271831-7183197.50697.64
371710-7171097.34197.47
471793-7179397.45497.58
570273-7027395.39195.50
670723-7072396.00296.13
15min171082-7108296.48997.391.2296.7297.671.22
271961-7196197.68297.97
373086-7308699.20999.50
472245-7224598.06898.36
571417-7141796.94497.22
670676-7067695.93896.23
20min171745-7174597.38996.961.6897.7897.401.67
270446-7044695.62696.08
372960-7296099.03899.50
472107-7210797.88098.34
571668-7166897.28497.72
669630-6963094.51894.97
30min171405-7140596.92796.951.0097.4897.561.00
271533-7153397.10197.72
372178-7217897.97798.60
471828-7182897.50298.12
571496-7149697.05197.65
670093-7009395.14695.76
45min171633-7163397.23796.821.0797.9597.591.06
271341-7134196.84197.62
372012-7201297.75198.54
471629-7162997.23198.01
571519-7151997.08297.84
669843-6984394.80795.58
60min171284-7128496.76396.521.4597.6497.441.45
270711-7071195.98596.92
372474-7247498.37899.33
471636-7163697.24198.19
571134-7113496.56097.48
669384-6938494.18495.11
极限170860-7086096.18896.230.9197.2297.320.92
270683-7068395.94797.04
371701-7170197.32998.44
471414-7141496.94098.05
570861-7086196.18997.27
669840-6984094.80395.89
坎地沙坦酯氨氯地平片项目信息
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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.746627766241662366622266185662320.06
213.786736567324673440.05
单位质量响应值RSD%判断
4820.384887.080.98数据可信
长期12月-供试品溶液-GH011批-pH2.0盐酸溶液
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min128937-2893738.65541.2415.7638.6541.2415.76
230771-3077141.10541.10
327777-2777737.10537.11
426621-2662135.56135.56
540191-4019153.68853.69
630930-3093041.31741.32
10min164122-6412285.65687.033.7285.7287.103.72
265742-6574287.82087.89
365529-6552987.53587.60
462359-6235983.30083.36
569384-6938492.68592.77
663751-6375185.16085.23
15min171202-7120295.11396.402.6095.3296.612.60
270973-7097394.80795.02
374453-7445399.45699.66
473299-7329997.91498.11
573500-7350098.18398.43
669544-6954492.89893.11
20min173325-7332597.94997.571.7698.3197.941.76
272395-7239596.70797.08
374237-7423799.16799.54
473732-7373298.49398.85
573782-7378298.56098.97
670755-7075594.51694.88
30min173277-7327797.88597.601.3298.4198.131.32
273077-7307797.61898.15
374221-7422199.14699.68
473454-7345498.12198.65
573034-7303497.56098.13
671308-7130895.25595.78
45min172723-7272397.14597.231.8397.8497.931.83
273089-7308997.63498.33
374249-7424999.18399.89
473547-7354798.24698.93
572767-7276797.20497.94
670329-7032993.94794.63
60min172214-7221496.46597.091.3297.3297.951.33
272408-7240896.72497.58
373833-7383398.62899.50
473198-7319897.77998.63
573291-7329197.90498.80
671154-7115495.04995.89
极限172692-7269297.10496.661.3498.1297.681.34
272686-7268697.09598.12
373647-7364798.37999.41
472045-7204596.23997.25
572384-7238496.69297.75
670713-7071394.46095.46
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