非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
1 10.843717483724513711783731633724573721990.21
2 10.813700433715873708150.30
单位质量响应值RSD%判断
34335.7034302.960.07数据可信
供试品溶液-2025083121批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1187520-18752049.13638.2017.8949.1438.2017.89
2129947-12994734.05034.05
3110372-11037228.92128.92
4142855-14285537.43337.43
5157745-15774541.33441.33
6146241-14624138.32038.32
10min1257416-25741667.45263.526.0767.5363.586.08
2243665-24366563.84863.91
3216281-21628156.67356.72
4249262-24926265.31565.38
5251611-25161165.93066.00
6236164-23616461.88361.95
15min1283639-28363974.32372.104.5974.5272.264.60
2280154-28015473.41073.57
3253713-25371366.48166.62
4284430-28443074.53074.70
5283200-28320074.20874.39
6265701-26570169.62269.79
20min1299703-29970378.53276.853.5478.8577.143.55
2298281-29828178.16078.45
3274933-27493372.04272.30
4300861-30086178.83679.13
5299213-29921378.40478.71
6286701-28670175.12575.41
30min1317298-31729883.14381.892.9183.5982.302.93
2319897-31989783.82484.24
3297143-29714377.86178.23
4317946-31794683.31283.74
5317181-31718183.11283.55
6305560-30556080.06780.48
45min1329671-32967186.38585.542.5986.9786.092.60
2333053-33305387.27187.83
3312442-31244281.87082.37
4332609-33260987.15587.72
5331137-33113786.76987.34
6319673-31967383.76584.31
60min1335653-33565387.95287.382.6488.6888.082.65
2341256-34125689.42090.12
3319408-31940883.69584.34
4340420-34042089.20189.91
5338048-33804888.58089.30
6326107-32610785.45186.13
极限1345568-34556890.55090.661.1491.4391.511.17
2350586-35058691.86592.72
3339474-33947488.95389.73
4348456-34845691.30792.17
5347937-34793791.17192.03
6343972-34397290.13290.96
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
1 10.843722253722953713013718773704333716260.21
2 10.813710733727653719190.33
单位质量响应值RSD%判断
34282.8434405.090.26数据可信
供试品溶液-2025083121批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1167845-16784543.95038.1416.6843.9538.1416.68
2124597-12459732.62532.63
3124458-12445832.58932.59
4167898-16789843.96343.96
5167683-16768343.90743.91
6121491-12149131.81231.81
10min1247891-24789164.90963.485.8864.9863.555.89
2238893-23889362.55362.61
3219445-21944557.46157.52
4258060-25806067.57267.65
5254797-25479766.71866.79
6235612-23561261.69461.75
15min1278702-27870272.97772.264.2373.1672.424.24
2272855-27285571.44671.60
3257591-25759167.44967.60
4291138-29113876.23376.42
5284387-28438774.46674.65
6270995-27099570.95971.11
20min1290964-29096476.18876.563.4776.4976.853.48
2290391-29039176.03876.32
3277863-27786372.75773.02
4306415-30641580.23480.55
5301075-30107578.83579.14
6287646-28764675.31975.59
30min1310217-31021781.22981.492.7981.6681.912.81
2309895-30989581.14581.55
3298589-29858978.18478.57
4323368-32336884.67385.12
5318231-31823183.32883.77
6307040-30704080.39780.80
45min1324022-32402284.84485.042.4485.4185.592.46
2322051-32205184.32884.87
3313864-31386482.18482.70
4335824-33582487.93488.52
5331826-33182686.88787.47
6320960-32096084.04284.58
60min1333423-33342387.30587.192.3588.0187.882.37
2332227-33222786.99287.67
3321434-32143484.16684.82
4344321-34432190.15990.89
5337822-33782288.45789.18
6328626-32862686.04986.72
极限1343747-34374790.00990.201.2890.8691.041.30
2344489-34448990.20391.03
3339817-33981788.98089.77
4350849-35084991.86892.75
5348106-34810691.15092.02
6339969-33996989.02089.84
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