奥美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070220417对照品来源原料药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1000
标示量(mg)10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%
115.973744337365373303743937319373790.16
216.033770737634376700.14
单位质量响应值RSD%判断
2340.582349.970.29数据可信
供试品溶液-2批-氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min130514-3051484.27180.732.8384.2780.732.83
228956-2895679.96879.97
329356-2935681.07381.07
427958-2795877.21277.21
529153-2915380.51280.51
629461-2946181.36381.36
10min132740-3274090.41890.910.6590.5691.050.65
232775-3277590.51590.65
333314-3331492.00392.14
432993-3299391.11791.25
532835-3283590.68190.81
632853-3285390.73090.87
15min134917-3491796.43092.172.3096.7292.462.29
233014-3301491.17591.46
333183-3318391.64291.93
433177-3317791.62591.91
533104-3310491.42391.71
632858-3285890.74491.03
20min135248-3524897.34594.211.8997.8094.651.89
234362-3436294.89895.33
333949-3394993.75794.20
433690-3369093.04293.48
533398-3339892.23592.67
634029-3402993.97894.42
30min134980-3498096.60493.442.2997.2294.032.28
234410-3441095.03095.62
333855-3385593.49794.09
433697-3369793.06193.65
533147-3314791.54292.13
632912-3291290.89391.49
45min134807-3480796.12790.296.5296.9091.046.47
228852-2885279.68180.43
333668-3366892.98193.73
433914-3391493.66094.40
533135-3313591.50992.25
631793-3179387.80388.55
60min134649-3464995.69093.491.8296.6394.391.81
234123-3412394.23895.12
333977-3397793.83494.74
433901-3390193.62494.52
532791-3279190.55991.46
633669-3366992.98493.88
极限134515-3451595.32090.139.0296.4191.188.92
234674-3467495.75996.80
334007-3400793.91794.98
427048-2704874.69975.75
533890-3389093.59494.64
631676-3167687.48088.53
奥美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OM230503W对照品来源原料药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250
标示量(mg)40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%
110.514396634400494404854406154397134401050.10
210.574434704440094437400.09
单位质量响应值RSD%判断
41874.8841981.080.18数据可信
供试品溶液-2批-奥美沙坦酯-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1111872-11187223.99023.307.1523.9923.307.15
293162-9316219.97819.98
3113235-11323524.28224.28
4111455-11145523.90023.90
5108833-10883323.33823.34
6113355-11335524.30824.31
10min1166781-16678135.76434.753.4435.8034.793.44
2151567-15156732.50232.54
3165118-16511835.40835.45
4163824-16382435.13035.17
5160395-16039534.39534.43
6164749-16474935.32935.37
15min1189939-18993940.73039.452.0440.8339.542.04
2179024-17902438.39038.48
3184819-18481939.63239.73
4184444-18444439.55239.65
5181035-18103538.82138.92
6184485-18448539.56139.66
20min1199897-19989742.86641.442.2443.0341.602.24
2189287-18928740.59140.74
3195222-19522241.86342.03
4194108-19410841.62441.79
5187908-18790840.29540.46
6193123-19312341.41341.58
30min1206712-20671244.32743.101.7644.5743.331.77
2197907-19790742.43942.66
3201376-20137643.18343.42
4203064-20306443.54543.78
5197285-19728542.30642.53
6199580-19958042.79843.03
45min1208242-20824244.65543.222.2644.9743.522.26
2197073-19707342.26042.55
3201288-20128843.16443.47
4205535-20553544.07544.38
5197080-19708042.26242.56
6200076-20007642.90443.21
60min1206216-20621644.22143.101.7944.6143.471.79
2198277-19827742.51842.88
3201076-20107643.11943.50
4204245-20424543.79844.18
5197280-19728042.30542.67
6198742-19874242.61843.00
极限1209714-20971444.97143.841.3445.4344.291.34
2204050-20405043.75644.19
3204897-20489743.93844.39
4203008-20300843.53343.99
5202706-20270643.46843.91
6202399-20239943.40243.85
奥美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070220417对照品来源原料药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1000
标示量(mg)10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%
115.973751237555375283751637638375500.14
216.033749737474374860.05
单位质量响应值RSD%判断
2351.282338.490.39数据可信
供试品溶液-2批-氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min126953-2695374.44974.914.9774.4574.914.97
228098-2809877.61177.61
327080-2708074.79974.80
424603-2460367.95867.96
528324-2832478.23678.24
627663-2766376.41076.41
10min132666-3266690.22989.212.5990.3589.332.60
232898-3289890.87091.00
331825-3182587.90688.03
430853-3085385.22185.33
532417-3241789.54189.67
633120-3312091.48391.61
15min133939-3393993.74591.372.6194.0291.642.61
233972-3397293.83694.12
332405-3240589.50889.78
431967-3196788.29888.55
533588-3358892.77693.06
632601-3260190.04990.33
20min134664-3466495.74894.092.6296.1894.512.62
234715-3471595.88996.33
332592-3259290.02590.44
433409-3340992.28192.68
534181-3418194.41494.85
634817-3481796.17096.60
30min135094-3509496.93595.202.5197.5395.782.51
235350-3535097.64398.24
333238-3323891.80992.38
433550-3355092.67193.23
534761-3476196.01696.61
634792-3479296.10196.69
45min135224-3522497.29594.364.0298.0595.104.00
235504-3550498.06898.83
332973-3297391.07791.80
433535-3353592.62993.34
532365-3236589.39890.15
635363-3536397.67898.43
60min134898-3489896.39495.872.4397.3196.772.43
235569-3556998.24899.17
333173-3317391.62992.50
434402-3440295.02495.89
535064-3506496.85397.75
635149-3514997.08798.00
极限135948-3594899.29497.962.18100.3799.022.18
236526-36526100.891101.98
334915-3491596.44197.47
434326-3432694.81495.84
535565-3556598.23699.30
635499-3549998.05499.13
奥美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OM230503W对照品来源原料药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250
标示量(mg)40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%
110.514411714419844418924416564418404417090.08
210.574407194408714407950.03
单位质量响应值RSD%判断
42027.5041702.460.55数据可信
供试品溶液-2批-奥美沙坦酯-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min175106-7510616.13017.486.8716.1317.486.87
279379-7937917.04817.05
387254-8725418.73918.74
475854-7585416.29116.29
588196-8819618.94118.94
682553-8255317.73017.73
10min1124489-12448926.73627.222.8426.7627.252.85
2126262-12626227.11727.15
3130024-13002427.92527.96
4121498-12149826.09426.12
5131324-13132428.20428.24
6126931-12693127.26027.29
15min1149154-14915432.03331.701.9232.1031.771.92
2145662-14566231.28331.36
3149856-14985632.18432.26
4143339-14333930.78430.85
5150742-15074232.37432.45
6146860-14686031.54031.62
20min1159971-15997134.35634.101.3934.4834.231.39
2156169-15616933.54033.67
3159917-15991734.34534.48
4155981-15598133.49933.62
5161326-16132634.64734.78
6159326-15932634.21834.35
30min1173247-17324737.20736.371.5137.3936.551.51
2169452-16945236.39236.57
3168559-16855936.20136.39
4165735-16573535.59435.77
5170895-17089536.70236.89
6168226-16822636.12936.31
45min1179014-17901438.44637.521.6738.6937.761.67
2173987-17398737.36637.61
3171702-17170236.87637.12
4172755-17275537.10237.34
5177545-17754538.13038.38
6173120-17312037.18037.42
60min1180746-18074638.81837.722.0439.1338.032.03
2175860-17586037.76938.07
3170985-17098536.72237.03
4174610-17461037.50037.80
5178602-17860238.35738.67
6173091-17309137.17437.48
极限1191656-19165641.16140.431.0941.5340.801.08
2186452-18645240.04340.41
3188440-18844040.47040.84
4188492-18849240.48140.84
5188642-18864240.51440.89
6185826-18582639.90940.28
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