替普瑞酮颗粒项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50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%
1 111.45375175389375354205371275368005371600.24
2110.25388815388215388510.01
单位质量响应值RSD%判断
4821.904889.750.99数据可信
供试品溶液-2批-pH6.8(内含2%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1465389-46538984.88184.442.4384.8884.442.44
2470614-47061485.83485.83
3456074-45607483.18283.18
4472664-47266486.20886.21
5443416-44341680.87480.87
6469599-46959985.64985.65
10min1500215-50021591.23390.110.9991.3790.250.99
2496558-49655890.56690.71
3491626-49162689.66789.81
4497978-49797890.82590.97
5490350-49035089.43489.57
6487702-48770288.95189.09
15min1504592-50459292.03190.881.4892.3291.171.48
2503535-50353591.83992.13
3498205-49820590.86691.15
4503862-50386291.89892.19
5493469-49346990.00390.29
6486091-48609188.65788.95
20min1507041-50704192.47891.291.6392.9291.731.63
2507254-50725492.51792.96
3500377-50037791.26391.70
4506164-50616492.31892.77
5495492-49549290.37290.81
6486868-48686888.79989.24
30min1510311-51031193.07492.101.2193.6892.701.21
2510505-51050593.11093.71
3502763-50276391.69892.29
4509290-50929092.88893.49
5501695-50169591.50392.09
6495340-49534090.34490.93
45min1515279-51527993.98192.911.4594.7493.661.45
2515452-51545294.01294.77
3509881-50988192.99693.74
4513789-51378993.70994.47
5505191-50519192.14192.88
6496716-49671690.59591.33
60min1511160-51116093.22993.101.1794.1494.001.17
2517587-51758794.40195.31
3511274-51127493.25094.15
4515495-51549594.02094.93
5505562-50556292.20893.10
6501749-50174991.51392.40
极限1522382-52238295.27693.901.4896.3494.961.47
2523007-52300795.39096.46
3512433-51243393.46194.52
4518041-51804194.48495.55
5509096-50909692.85393.90
6504090-50409091.94092.98
替普瑞酮颗粒项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50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%
1 111.45415635432005423495420925423315423070.11
2110.25449335445635447480.05
单位质量响应值RSD%判断
4868.114943.271.09数据可信
供试品溶液-25052801批-pH6.8(内含2%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1491245-49124588.68788.361.0688.6988.361.06
2495328-49532889.42489.42
3492312-49231288.88088.88
4488343-48834388.16388.16
5489202-48920288.31888.32
6480202-48020286.69486.69
10min1513336-51333692.67692.050.7992.8292.200.78
2511396-51139692.32592.47
3514636-51463692.91093.06
4506480-50648091.43891.58
5509066-50906691.90592.05
6504392-50439291.06191.21
15min1519290-51929093.75093.170.7694.0593.470.76
2517234-51723493.37993.68
3520849-52084994.03294.33
4513804-51380492.76093.06
5515340-51534093.03793.34
6510055-51005592.08392.38
20min1523500-52350094.51093.820.7494.9794.270.74
2521972-52197294.23594.69
3522812-52281294.38694.85
4517017-51701793.34093.79
5518942-51894293.68894.14
6513704-51370492.74293.19
30min1528084-52808495.33894.800.6095.9595.410.60
2526442-52644295.04295.66
3528006-52800695.32495.94
4522878-52287894.39895.01
5524998-52499894.78195.39
6520215-52021593.91794.52
45min1531022-53102295.86895.550.8096.6496.320.79
2531773-53177396.00496.78
3533844-53384496.37897.15
4526677-52667795.08495.85
5529895-52989595.66596.43
6522192-52219294.27495.04
60min1535363-53536396.65295.860.8797.5996.790.87
2532701-53270196.17297.11
3535274-53527496.63697.57
4528224-52822495.36396.29
5530760-53076095.82196.75
6523468-52346894.50595.42
极限1541055-54105597.68096.541.0598.7897.631.05
2537183-53718396.98198.08
3538457-53845797.21198.31
4530459-53045995.76796.85
5535326-53532696.64697.73
6525865-52586594.93796.01
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