左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.671925241917311924601917861919291920860.20
217.721926191920431923310.22
单位质量响应值RSD%判断
10870.7410853.890.11数据可信
供试品溶液-24042601批-左氨氯地平-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1110553-110553102.816102.860.89102.82102.860.89
2111606-111606103.795103.79
3111074-111074103.300103.30
4110089-110089102.384102.38
5111349-111349103.556103.56
6108951-108951101.326101.33
10min1109056-109056101.423102.261.39102.57103.401.37
2107726-107726100.186101.34
3111477-111477103.675104.82
4111484-111484103.681104.82
5110754-110754103.003104.15
6109210-109210101.567102.69
15min1108281-108281100.703101.061.18102.97103.341.17
2106274-10627498.836101.10
3109713-109713102.034104.33
4109597-109597101.926104.22
5109223-109223101.579103.87
6108918-108918101.295103.55
20min1108566-108566100.968100.211.20104.36103.621.18
2105490-10549098.107101.47
3109244-109244101.598105.03
4108091-108091100.526103.95
5107796-107796100.252103.68
6107336-10733699.824103.20
30min1105798-10579898.39399.261.66102.90103.781.63
2103879-10387996.609101.06
3108955-108955101.329105.89
4106586-10658699.126103.67
5107936-107936100.382104.92
6107247-10724799.741104.23
45min1105478-10547898.09697.731.37103.70103.341.35
2102621-10262195.439100.97
3106557-10655799.099104.79
4105657-10565798.262103.90
5105987-10598798.569104.22
6104181-10418196.890102.49
60min1103726-10372696.46696.281.67103.16102.981.62
2100166-10016693.15699.74
3104741-10474197.410104.20
4104759-10475997.427104.16
5103496-10349696.252103.00
6104246-10424696.950103.62
90min1101761-10176194.63995.781.39102.40103.551.36
2101135-10113594.057101.68
3104523-10452397.208105.08
4104329-10432997.027104.84
5103800-10380096.535104.35
6102366-10236695.202102.95
极限1102172-10217295.02195.470.78103.84104.300.81
2101415-10141594.317102.99
3103528-10352896.282105.23
4103312-10331296.081104.97
5103068-10306895.854104.74
6102417-10241795.249104.06
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
117.671920911916191914231920601912931916970.20
217.721919071916931918000.08
单位质量响应值RSD%判断
10848.7310823.930.17数据可信
供试品溶液-1批-左氨氯地平-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min192809-9280986.52193.327.8086.5293.327.81
2108177-108177100.847100.85
398921-9892192.21892.22
4110879-110879103.366103.37
597623-9762391.00891.01
692186-9218685.94085.94
10min1109555-109555102.132101.671.10103.09102.701.11
2108515-108515101.162102.28
3108134-108134100.807101.83
4110910-110910103.395104.54
5107635-107635100.342101.35
6109595-109595102.169103.12
15min1108696-108696101.331100.321.49103.43102.491.42
2108476-108476101.126103.37
3107458-107458100.177102.32
4105962-10596298.782101.08
5105540-10554098.389100.52
6109550-109550102.127104.22
20min1106651-10665199.42599.601.50102.65102.881.50
2106828-10682899.590102.96
3105533-10553398.382101.64
4109335-109335101.927105.32
5104883-10488397.776101.00
6107800-107800100.496103.72
30min1107643-107643100.34997.801.61104.68102.191.54
2106020-10602098.836103.31
3104147-10414797.090101.44
4103631-10363196.609101.14
5103098-10309896.112100.42
6104939-10493997.829102.17
45min1104124-10412497.06997.522.57102.51103.002.49
2103478-10347896.467102.04
3102822-10282295.855101.28
4109504-109504102.084107.69
5102121-10212195.202100.58
6105622-10562298.465103.89
60min1104104-10410497.05096.381.15103.57102.941.16
2102774-10277495.810102.46
3102580-10258095.629102.12
4105345-10534598.207104.94
5102098-10209895.180101.61
6103406-10340696.400102.92
90min1103215-10321596.22195.801.66103.82103.441.62
2101681-10168194.791102.50
3101615-10161594.730102.29
4105144-10514498.020105.85
5100748-10074893.922101.41
6104202-10420297.142104.74
极限1102183-10218395.25995.251.02103.93103.941.05
2102396-10239695.458104.22
3101388-10138894.518103.13
4103495-10349596.482105.40
5100625-10062593.807102.34
6102937-10293795.962104.64
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