厄贝沙坦非奈利酮片项目信息
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5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.051314791311921309341312361310481311780.16
215.081306991306031306510.06
单位质量响应值RSD%判断
8716.158663.860.43数据可信
供试品溶液-1批-非奈利酮-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%
5min110864-1086411.24311.8412.7211.2411.8412.73
212469-1246912.90412.90
39588-95889.9229.92
411722-1172212.13112.13
510417-1041710.78010.78
613593-1359314.06714.07
10min131070-3107032.15332.445.2732.2832.575.29
233465-3346534.63134.77
329129-2912930.14430.25
432791-3279133.93434.07
529954-2995430.99831.12
631669-3166932.77332.93
15min145929-4592947.53047.651.0648.0148.141.09
245808-4580847.40547.93
345732-4573247.32647.77
446849-4684948.48248.99
545544-4554447.13147.60
646395-4639548.01248.53
20min155843-5584357.78958.162.0858.8059.182.10
256634-5663458.60859.66
354756-5475656.66457.64
457215-5721559.20960.26
555091-5509157.01158.00
657665-5766559.67560.73
30min171579-7157974.07474.562.2375.7376.232.24
272455-7245574.98076.69
370445-7044572.90074.50
473775-7377576.34678.05
570169-7016972.61574.24
673898-7389876.47478.19
45min189253-8925392.36491.452.3194.8493.952.22
286067-8606789.06791.61
391499-9149994.68897.10
489161-8916192.26994.83
586393-8639389.40491.83
687863-8786390.92593.49
60min199569-99569103.039106.133.95106.54109.643.81
299698-99698103.173106.70
399469-99469102.936106.40
4102665-102665106.243109.83
5109840-109840113.668117.09
6104082-104082107.710111.29
90min1115199-115199119.214120.213.14123.86124.903.06
2114622-114622118.617123.29
3113840-113840117.808122.41
4123459-123459127.762132.52
5114058-114058118.033122.72
6115798-115798119.834124.61
120min1124339-124339128.673131.254.69134.64137.284.50
2119520-119520123.686129.68
3125282-125282129.649135.56
4123702-123702128.013134.20
5134187-134187138.864144.86
6133943-133943138.611144.72
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限1129048-129048133.546132.202.94140.95139.682.78
2130371-130371134.915142.28
3127222-127222131.656139.01
4128137-128137132.603140.21
5120647-120647124.852132.39
6131041-131041135.608143.25
厄贝沙坦非奈利酮片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)150供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.056842616827566823256825516815696826920.15
215.086811766810516811140.02
单位质量响应值RSD%判断
45361.5945166.710.31数据可信
供试品溶液-1批-厄贝沙坦-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%
5min1138997-13899718.42523.8237.8318.4223.8237.84
2131751-13175117.46417.46
3142117-14211718.83818.84
4305953-30595340.55640.56
5149760-14976019.85219.85
6209690-20969027.79627.80
10min1551207-55120773.06672.906.2773.2773.176.35
2537147-53714771.20271.40
3560688-56068874.32274.53
4605553-60555380.27080.72
5499478-49947866.20966.43
6545845-54584572.35572.66
15min1679520-67952090.07489.133.4891.0990.203.47
2640970-64097084.96485.95
3711634-71163494.33195.37
4672481-67248189.14190.48
5660099-66009987.50088.46
6669636-66963688.76489.88
20min1711907-71190794.36793.172.4096.3895.232.37
2685848-68584890.91392.84
3724613-72461396.05298.13
4690100-69010091.47793.81
5688005-68800591.19993.13
6716770-71677095.01297.11
30min1722162-72216295.72794.752.5398.7997.852.50
2700910-70091092.91095.85
3735387-73538797.480100.63
4701584-70158492.99996.35
5694631-69463192.07795.02
6734243-73424397.328100.48
45min1724389-72438996.02293.884.54100.1598.034.39
2681059-68105990.27894.25
3763589-763589101.218105.45
4682201-68220190.43094.81
5688083-68808391.20995.17
6710040-71004094.12098.36
60min1699173-69917392.67994.744.2297.8899.933.94
2689239-68923991.36396.34
3711675-71167594.33799.69
4688380-68838091.24996.64
5765364-765364101.453106.43
6734262-73426297.331102.61
90min1686463-68646390.99591.351.9397.2297.601.96
2674610-67461089.42395.41
3687518-68751891.13597.54
4708012-70801293.851100.25
5676789-67678989.71295.82
6701330-70133092.96599.33
120min1684821-68482190.77792.636.3498.0199.895.90
2652019-65201986.42993.41
3693733-69373391.95899.38
4657722-65772287.18594.63
5752443-75244399.741106.84
6751863-75186399.664107.06
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
极限1707752-70775293.81791.743.77102.06100.033.45
2712948-71294894.505102.45
3695083-69508392.137100.58
4668464-66846488.60997.02
5652393-65239386.47994.69
6715874-71587494.893103.40
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