左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.387126870940709047087570986709950.23
216.697075070901708260.16
单位质量响应值RSD%判断
4334.254243.621.50数据可信
供试品溶液-24091401批-左氨氯地平-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%
5min135738-3573884.18687.303.4484.1987.303.45
238837-3883791.48691.49
337862-3786289.18989.19
435728-3572884.16284.16
536470-3647085.91085.91
637735-3773588.89088.89
10min141147-4114796.92898.921.4797.8699.891.48
241809-4180998.48799.50
342435-4243599.962100.95
441499-4149997.75798.69
542282-4228299.601100.56
642778-42778100.770101.76
15min140990-4099096.55897.882.5998.5799.952.56
242310-4231099.667101.78
340776-4077696.05498.16
440093-4009394.44596.47
542354-4235499.771101.83
642776-42776100.765102.87
20min139602-3960293.28898.504.2496.37101.654.17
242158-4215899.309102.53
342807-42807100.838104.01
439815-3981593.79096.86
542355-4235599.773102.94
644142-44142103.983107.21
30min139420-3942092.85997.152.4996.98101.402.47
241479-4147997.710102.03
341529-4152997.828102.12
440804-4080496.120100.23
542301-4230199.646103.92
641921-4192198.751103.13
45min139087-3908792.07595.762.3797.23101.092.36
241236-4123697.137102.54
341571-4157197.926103.30
440018-4001894.26899.45
540573-4057395.576100.96
641421-4142197.573103.05
60min139179-3917992.29295.312.5798.47101.712.54
240908-4090896.365102.85
340138-4013894.551101.02
439440-3944092.90799.13
541586-4158697.962104.41
641521-4152197.809104.37
90min138372-3837290.39191.784.8697.5999.244.63
238670-3867091.09398.65
340211-4021194.723102.24
435592-3559283.84291.10
540393-4039395.152102.69
640542-4054295.503103.15
极限136752-3675286.57590.602.8694.7899.072.80
239063-3906392.019100.59
339292-3929292.558101.13
437613-3761388.60396.79
539621-3962193.333101.93
638420-3842090.50499.22
左氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217 对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.219386893719937819424294041939300.23
216.259360593686936460.07
单位质量响应值RSD%判断
5794.575762.830.39数据可信
供试品溶液-24091401批-叶酸-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%
5min111353-1135320.15720.196.1220.1620.196.13
210839-1083919.24519.24
312422-1242222.05522.06
410979-1097919.49319.49
510655-1065518.91818.92
611972-1197221.25621.26
10min120888-2088837.08738.125.7537.3138.345.74
221199-2119937.63937.85
323885-2388542.40842.65
420349-2034936.13036.35
521300-2130037.81838.03
621190-2119037.62337.86
15min126561-2656147.15948.343.4647.8048.983.46
228309-2830950.26350.89
328348-2834850.33251.05
426771-2677147.53248.15
526065-2606546.27846.91
627286-2728648.44649.10
20min130151-3015153.53353.103.2154.6954.283.21
230185-3018553.59354.78
331572-3157256.05657.33
429338-2933852.09053.24
529198-2919851.84152.99
628987-2898751.46652.66
30min134340-3434060.97161.522.2862.7363.302.28
234854-3485461.88363.67
335795-3579563.55465.45
435209-3520962.51464.24
534005-3400560.37662.10
633688-3368859.81361.58
45min138665-3866568.65068.592.3571.0871.052.33
239088-3908869.40171.87
339216-3921669.62872.23
438160-3816067.75370.17
537078-3707865.83268.22
639594-3959470.29972.73
60min140139-4013971.26772.581.3874.4675.801.37
241629-4162973.91277.16
341064-4106472.90976.29
440384-4038471.70274.87
540774-4077472.39475.52
641293-4129373.31676.53
90min142228-4222874.97676.832.6278.9680.862.55
244271-4427178.60382.67
343362-4336276.98981.18
442900-4290076.16980.14
542008-4200874.58578.51
644873-4487379.67283.70
极限146900-4690083.27182.771.2688.0987.651.24
245885-4588581.46986.41
347598-4759884.51089.55
446582-4658282.70687.52
546411-4641182.40387.16
646317-4631782.23687.15
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