坎地沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.251732171731581725121725971725441728060.21
216.261729451732741731100.14
单位质量响应值RSD%判断
10634.2210646.370.09数据可信
供试品溶液-24092401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%
5min191235-9123548.13550.384.5248.1450.384.52
296724-9672451.03151.03
3101992-10199253.81053.81
491593-9159348.32448.32
598535-9853551.98651.99
692912-9291249.02049.02
10min1147390-14739077.76278.222.5078.3078.782.50
2153743-15374381.11481.68
3147728-14772877.94078.54
4143133-14313375.51676.05
5151050-15105079.69380.27
6146471-14647177.27777.82
15min1164091-16409186.57383.802.8687.9785.232.78
2159079-15907983.92985.40
3151642-15164280.00581.47
4159531-15953184.16885.54
5155990-15599082.29983.76
6162687-16268785.83387.24
20min1166201-16620187.68788.212.6890.0590.572.59
2161680-16168085.30187.70
3162252-16225285.60387.96
4171442-17144290.45292.76
5171295-17129590.37492.75
6170247-17024789.82192.18
30min1168326-16832688.80890.411.1692.1493.751.14
2171053-17105390.24693.60
3170176-17017689.78493.09
4172803-17280391.17094.49
5173934-17393491.76695.15
6171861-17186190.67394.03
45min1166169-16616987.67090.113.6491.9994.453.47
2177212-17721293.49697.85
3174972-17497292.31496.62
4172434-17243490.97595.30
5173326-17332691.44695.85
6160610-16061084.73789.10
60min1170269-17026989.83387.622.3495.1392.972.19
2170044-17004489.71495.10
3165302-16530287.21292.54
4161363-16136385.13490.47
5161962-16196285.45090.87
6167538-16753888.39293.70
极限1159329-15932984.06187.222.1990.3693.542.03
2163550-16355086.28892.67
3166968-16696888.09194.39
4170076-17007689.73196.02
5165857-16585787.50593.87
6166119-16611987.64393.93
坎地沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.251730781731271728431729391727881729550.09
216.261737651736711737180.04
单位质量响应值RSD%判断
10643.3810683.760.27数据可信
供试品溶液-1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%
5min198354-9835451.77849.204.8951.7849.214.89
293620-9362049.28649.29
386270-8627045.41645.42
498154-9815451.67351.67
590889-9088947.84847.85
693505-9350549.22549.23
10min1129309-12930968.07468.642.3368.6569.192.32
2135098-13509871.12171.67
3126075-12607566.37166.88
4129020-12902067.92268.50
5131311-13131169.12869.66
6131504-13150469.22969.78
15min1151100-15110079.54677.902.6180.8879.212.56
2148678-14867878.27179.61
3149685-14968578.80180.04
4150566-15056679.26580.59
5147171-14717177.47778.78
6140646-14064674.04275.36
20min1148598-14859878.22880.241.8980.4482.421.83
2154018-15401881.08283.29
3151014-15101479.50081.62
4150336-15033679.14381.35
5154442-15444281.30583.47
6156144-15614482.20184.34
30min1155918-15591882.08281.402.2785.1784.472.16
2154410-15441081.28884.40
3156514-15651482.39685.40
4147764-14776477.78980.88
5157316-15731682.81885.88
6155859-15585982.05185.10
45min1155344-15534481.78082.932.0485.7886.901.91
2152112-15211280.07884.09
3160352-16035284.41688.33
4158224-15822483.29687.25
5159192-15919283.80687.79
6159979-15997984.22088.18
60min1156349-15634982.30980.433.2287.2185.323.03
2150613-15061379.28984.19
3152633-15263380.35385.21
4160257-16025784.36689.25
5150493-15049379.22684.14
6146305-14630577.02181.92
极限1159315-15931583.87082.171.9989.6987.951.87
2156374-15637482.32288.10
3157904-15790483.12888.87
4155267-15526781.73987.56
5157200-15720082.75788.55
6150412-15041279.18384.94
坎地沙坦酯左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.251726351730341729231727341729181728490.10
216.261736071734821735440.06
单位质量响应值RSD%判断
10636.8610673.060.25数据可信
供试品溶液-2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%
5min195089-9508950.09951.434.6750.1051.434.67
296015-9601550.58750.59
3101047-10104753.23953.24
4102855-10285554.19154.19
590574-9057447.72147.72
6100079-10007952.72852.73
10min1130138-13013868.56673.473.5069.1274.043.49
2143985-14398575.86176.42
3140283-14028373.91174.50
4139735-13973573.62274.22
5139760-13976073.63574.17
6142749-14274975.21075.80
15min1148064-14806478.01080.892.8879.3382.282.88
2154288-15428881.29082.69
3156312-15631282.35683.77
4153278-15327880.75782.18
5149296-14929678.65980.01
6159973-15997384.28585.71
20min1156274-15627482.33683.821.8084.5286.101.80
2162799-16279985.77488.08
3162498-16249885.61587.94
4157391-15739182.92485.24
5157014-15701482.72684.95
6158563-15856383.54285.90
30min1160695-16069584.66586.043.2587.7789.263.12
2166465-16646587.70590.97
3163841-16384186.32389.60
4168263-16826388.65391.89
5166640-16664087.79790.94
6153962-15396281.11884.40
45min1153565-15356580.90985.234.5184.9589.404.37
2163369-16336986.07490.31
3169899-16989989.51493.75
4170389-17038989.77394.00
5155426-15542681.88986.01
6157957-15795783.22387.41
60min1160465-16046584.54487.101.5289.4892.221.51
2166269-16626987.60292.79
3164920-16492086.89192.12
4166414-16641487.67892.90
5167322-16732288.15793.18
6166494-16649487.72092.83
极限1159469-15946984.01985.271.7389.9091.361.64
2164351-16435186.59192.76
3160580-16058084.60590.80
4158900-15890083.71989.91
5161788-16178885.24191.25
6165954-16595487.43693.52
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