氨氯地平阿托伐他汀钙片项目信息
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100374-202106 对照品来源中检院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2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.399724597273972429720397292972510.04
215.459687096875968720.01
单位质量响应值RSD%判断
6319.106270.030.56数据可信
供试品溶液-LA6362批-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%
5min189360-8936092.03091.750.2992.0391.750.29
288793-8879391.44691.45
389219-8921991.88491.88
489013-8901391.67291.67
588818-8881891.47191.47
689346-8934692.01592.02
10min194593-9459397.41997.180.4197.5797.340.41
294359-9435997.17897.33
393679-9367996.47896.63
494798-9479897.63097.78
594509-9450997.33297.48
694251-9425197.06797.22
15min195915-9591598.78098.610.2699.1098.930.26
295835-9583598.69899.01
395299-9529998.14698.46
495787-9578798.64998.96
595709-9570998.56898.88
695964-9596498.83199.15
20min196504-9650499.38798.980.3699.8799.460.36
296266-9626699.14299.62
395582-9558298.43798.91
496074-9607498.94499.42
595857-9585798.72199.20
696351-9635199.22999.71
30min196311-9631199.18898.970.2099.8399.610.20
296006-9600698.87499.52
395806-9580698.66899.31
496248-9624899.12399.77
596025-9602598.89499.54
696194-9619499.06899.71
45min195590-9559098.44698.151.4899.2698.961.46
296257-9625799.13399.94
395172-9517298.01598.82
492564-9256495.32996.14
596145-9614599.01799.83
696093-9609398.96499.77
极限195590-9559098.44698.400.3399.4299.370.33
295483-9548398.33599.31
395173-9517398.01698.99
495824-9582498.68799.66
595242-9524298.08799.06
695956-9595698.82399.80
氨氯地平阿托伐他汀钙片项目信息
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100590-202005 对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.333546713548443550743547113550163548630.06
211.303566573564893565730.04
单位质量响应值RSD%判断
31320.6531555.130.53数据可信
供试品溶液-LA6362批-阿托伐他汀钙-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%
5min1187384-18738449.23447.932.2149.2347.922.21
2181554-18155447.70247.70
3183694-18369448.26448.26
4183940-18394048.32948.33
5175220-17522046.03846.04
6182642-18264247.98847.99
10min1281062-28106273.84772.231.2273.9372.311.22
2271370-27137071.30171.38
3273447-27344771.84771.93
4275818-27581872.47072.55
5274294-27429472.06972.15
6273494-27349471.85971.94
15min1324936-32493685.37584.340.7185.5884.540.71
2318238-31823883.61583.81
3319655-31965583.98784.19
4320322-32032284.16384.36
5321524-32152484.47884.68
6321282-32128284.41584.61
20min1349545-34954591.84190.230.9292.1990.570.92
2341151-34115189.63589.97
3341815-34181589.81090.15
4341484-34148489.72390.06
5343345-34334590.21290.55
6343224-34322490.18090.52
30min1359829-35982994.54394.140.3595.0494.630.35
2357099-35709993.82694.31
3358366-35836694.15894.65
4357188-35718893.84994.34
5359738-35973894.51995.01
6357536-35753693.94094.43
45min1365205-36520595.95595.471.3496.6196.111.33
2365280-36528095.97596.62
3363157-36315795.41796.06
4353728-35372892.94093.59
5365975-36597596.15896.80
6366692-36669296.34696.99
极限1364255-36425595.70696.110.4496.5296.910.43
2364736-36473695.83296.64
3365502-36550296.03396.84
4364873-36487395.86896.67
5366860-36686096.39097.20
6368445-36844596.80797.61
氨氯地平阿托伐他汀钙片项目信息
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100374-202106 对照品来源中检院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2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.399698897056970469726697254971220.14
215.459680396136964700.49
单位质量响应值RSD%判断
6310.726244.010.76数据可信
供试品溶液-LA6362批-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%
5min189034-8903491.94691.930.8791.9591.930.87
288761-8876191.66491.66
388209-8820991.09491.09
490314-9031493.26893.27
589415-8941592.34092.34
688374-8837491.26591.26
10min193769-9376996.83697.111.0796.9997.261.07
293919-9391996.99197.14
393172-9317296.22096.37
495359-9535998.47898.63
595098-9509898.20998.36
692881-9288195.91996.07
15min195360-9536098.47998.670.9198.7998.980.91
294961-9496198.06798.38
394579-9457997.67397.98
496768-9676899.933100.25
596439-9643999.59399.91
695151-9515198.26398.58
20min195255-9525598.37198.830.8398.8599.310.83
295186-9518698.29998.78
395250-9525098.36698.84
497037-97037100.211100.70
596317-9631799.46799.95
695147-9514798.25998.73
30min195200-9520098.31498.720.6798.9699.360.67
295603-9560398.73099.37
394774-9477497.87498.51
496123-9612399.26799.92
596500-9650099.656100.31
695334-9533498.45299.09
45min196064-9606499.20698.811.25100.0199.621.25
295062-9506298.17198.98
394556-9455697.64998.45
497443-97443100.630101.45
596517-9651799.674100.49
694457-9445797.54798.35
极限195356-9535698.47598.840.5099.4599.810.51
295476-9547698.59999.57
395079-9507998.18999.15
496328-9632899.479100.47
596023-9602399.164100.15
695985-9598599.125100.09
氨氯地平阿托伐他汀钙片项目信息
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100590-202005 对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.333573253567973572373571313573463571670.07
211.303555593578513567050.46
单位质量响应值RSD%判断
31524.0131566.810.10数据可信
供试品溶液-LA6362批-阿托伐他汀钙-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%
5min1180571-18057147.28246.342.0147.2846.342.01
2175421-17542145.93345.93
3177577-17757746.49846.50
4181064-18106447.41147.41
5175519-17551945.95945.96
6171652-17165244.94644.95
10min1276119-27611972.30071.121.7472.3871.191.74
2270409-27040970.80570.88
3271464-27146471.08171.16
4276258-27625872.33772.42
5271933-27193371.20471.28
6263399-26339968.97069.04
15min1321111-32111184.08183.291.0684.2883.491.06
2314440-31444082.33582.53
3317346-31734683.09583.29
4322573-32257384.46484.66
5318647-31864783.43683.63
6314477-31447782.34482.53
20min1342506-34250689.68389.090.6790.0289.420.67
2336895-33689588.21488.55
3340130-34013089.06189.40
4342979-34297989.80790.15
5339090-33909088.78989.12
6339752-33975288.96289.29
30min1357659-35765993.65193.020.6794.1493.500.66
2352300-35230092.24892.73
3353735-35373592.62493.11
4357011-35701193.48293.97
5353431-35343192.54493.03
6357349-35734993.57094.05
45min1364873-36487395.54094.780.5496.1995.420.54
2361018-36101894.53195.16
3363359-36335995.14495.78
4361891-36189194.75995.41
5359260-35926094.07094.71
6361521-36152194.66295.29
极限1367745-36774596.29295.890.3897.1096.680.38
2365324-36532495.65896.45
3366338-36633895.92496.72
4367477-36747796.22297.03
5364075-36407595.33196.12
6366202-36620295.88896.68
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