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%
1110.05322865319685328995328095314935322910.12
2113.15416135409835412980.09
单位质量响应值RSD%判断
4839.014786.010.78数据可信
供试品溶液-49G03N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%
5min1395308-39530872.74773.600.7972.7573.600.79
2400112-40011273.63173.63
3397549-39754973.15973.16
4400424-40042473.68873.69
5404172-40417274.37874.38
6402030-40203073.98473.98
10min1439708-43970880.91882.231.2181.0482.351.21
2444837-44483781.86281.98
3443625-44362581.63981.76
4446476-44647682.16382.29
5453751-45375183.50283.63
6452530-45253083.27783.40
15min1467999-46799986.12486.961.0086.3887.211.00
2468781-46878186.26886.53
3468716-46871686.25686.51
4474254-47425487.27587.53
5479227-47922788.19088.45
6476141-47614187.62287.88
20min1486236-48623689.48090.260.8789.8890.660.87
2487451-48745189.70490.11
3487392-48739289.69390.09
4491814-49181490.50790.91
5497338-49733891.52391.93
6492489-49248990.63191.04
30min1505576-50557693.03993.820.9993.5994.380.99
2506557-50655793.22093.77
3505117-50511792.95593.51
4511156-51115694.06694.62
5517934-51793495.31395.88
6512631-51263194.33794.90
45min1517287-51728795.19496.080.9295.9096.790.92
2519015-51901595.51296.22
3517544-51754495.24295.95
4523825-52382596.39797.11
5527930-52793097.15397.87
6526898-52689896.96397.68
60min1523073-52307396.25997.000.9597.1297.870.95
2524482-52448296.51897.39
3521619-52161995.99196.86
4528981-52898197.34698.22
5534934-53493498.44299.33
6529456-52945697.43498.31
极限1527888-52788897.14597.550.8698.1798.580.86
2529550-52955097.45198.48
3526263-52626396.84697.87
4528012-52801297.16898.20
5538920-53892099.175100.22
6529856-52985697.50798.55
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%
1110.05373875383065384225389475397775385680.17
2113.15419835426185423000.09
单位质量响应值RSD%判断
4896.074794.871.48数据可信
供试品溶液-25080601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%
5min1482034-48203488.11088.110.8588.1188.110.85
2480066-48006687.75187.75
3481196-48119687.95787.96
4476717-47671787.13887.14
5482976-48297688.28288.28
6489080-48908089.39889.40
10min1501054-50105491.58791.090.9391.7391.230.93
2493121-49312190.13790.28
3495974-49597490.65890.80
4493874-49387490.27490.42
5501697-50169791.70491.85
6504231-50423192.16892.32
15min1508424-50842492.93491.830.8393.2392.130.83
2499674-49967491.33591.63
3497990-49799091.02791.32
4498956-49895691.20391.50
5505604-50560492.41992.72
6503674-50367492.06692.37
20min1511410-51141093.48092.800.7393.9393.250.73
2504876-50487692.28692.73
3507307-50730792.73093.18
4502046-50204691.76892.22
5510842-51084293.37693.83
6509638-50963893.15693.61
30min1516897-51689794.48393.170.7895.0993.780.77
2510579-51057993.32893.93
3505469-50546992.39493.00
4507286-50728692.72693.33
5508658-50865892.97793.59
6509553-50955393.14093.75
45min1510061-51006193.23393.700.8394.0094.460.83
2508489-50848992.94693.70
3513524-51352493.86694.62
4508735-50873592.99193.75
5516305-51630594.37595.14
6518733-51873394.81895.58
60min1517761-51776194.64194.300.6695.5695.220.65
2511718-51171893.53694.45
3518218-51821894.72495.64
4512243-51224393.63294.54
5519968-51996895.04495.97
6515610-51561094.24895.17
极限1523790-52379095.74394.711.1496.8295.781.13
2520359-52035995.11696.18
3511332-51133293.46694.54
4510138-51013893.24794.31
5522439-52243995.49696.58
6520664-52066495.17196.25
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