富马酸比索洛尔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10071-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.098165781713816148163681615816470.06
210.128145881355814060.09
单位质量响应值RSD%判断
8091.878044.070.42数据可信
长期18月-供试品溶液-2022110111批-富马酸比索洛尔-0.005Hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min189811-8981199.98799.440.7299.9999.440.72
289085-8908599.17899.18
389772-8977299.94399.94
488645-8864598.68998.69
590048-90048100.250100.25
688568-8856898.60398.60
10min189757-8975799.927100.180.50100.09100.340.50
289964-89964100.157100.32
390348-90348100.584100.75
489550-8955099.69699.86
590669-90669100.942101.11
689623-8962399.77799.94
15min190351-90351100.588100.100.72100.92100.440.72
289808-8980899.983100.32
390237-90237100.461100.80
488929-8892999.00599.34
590698-90698100.974101.31
689478-8947899.61699.95
20min189696-8969699.85999.990.56100.36100.490.56
289732-8973299.899100.40
390032-90032100.233100.73
489364-8936499.48999.98
590696-90696100.972101.48
689385-8938599.512100.01
30min190034-90034100.23599.690.74100.90100.360.74
288664-8866498.71099.38
389971-89971100.165100.83
488990-8899099.07399.73
590314-90314100.547101.22
689297-8929799.414100.08
45min189515-8951599.65799.460.48100.49100.300.49
289226-8922699.335100.17
389561-8956199.708100.54
488800-8880098.86199.69
589972-89972100.166101.01
688972-8897299.05399.88
极限189576-8957699.72599.310.59100.73100.310.60
288818-8881898.88199.88
389423-8942399.555100.56
488665-8866598.71199.70
589959-89959100.151101.16
688773-8877398.83199.82
富马酸比索洛尔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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.941031191032111029191032071032081031330.13
213.961026661027301026980.05
单位质量响应值RSD%判断
7398.357356.590.41数据可信
长期18月-供试品溶液-2022110111批-氨氯地平-0.005Hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1115793-115793101.76197.952.42101.7697.952.42
2109139-10913995.91395.91
3108394-10839495.25995.26
4110669-11066997.25897.26
5112818-11281899.14799.15
6111937-11193798.37298.37
10min1117333-117333103.114100.331.81103.28100.501.81
2112128-11212898.54098.70
3111678-11167898.14598.30
4114231-114231100.388100.55
5114776-114776100.867101.03
6114873-114873100.953101.12
15min1118436-118436104.084100.402.16104.43100.732.16
2112688-11268899.03299.36
3111633-11163398.10598.43
4112758-11275899.09499.42
5114772-114772100.864101.20
6115186-115186101.228101.56
20min1117609-117609103.357100.421.90103.87100.921.90
2112262-11226298.65899.15
3111567-11156798.04798.53
4114401-114401100.538101.03
5114744-114744100.839101.34
6115052-115052101.110101.61
30min1117628-117628103.37499.942.15104.06100.602.15
2110744-11074497.32497.98
3111724-11172498.18598.83
4113167-11316799.453100.12
5114450-114450100.581101.25
6114592-114592100.706101.38
45min1117559-117559103.313100.022.04104.17100.852.04
2112022-11202298.44799.26
3110834-11083497.40398.22
4113760-11376099.974100.80
5114105-114105100.278101.11
6114603-114603100.715101.55
极限1117423-117423103.19499.672.21104.23100.672.21
2111152-11115297.68398.66
3110468-11046897.08198.06
4113024-11302499.328100.32
5114151-114151100.318101.32
6114274-114274100.426101.43
富马酸比索洛尔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10071-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.098168381812816918160281699816970.10
210.128248682423824540.06
单位质量响应值RSD%判断
8096.838147.630.45数据可信
长期18月-供试品溶液-5543C0421批-富马酸比索洛尔-0.005Hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min192271-92271102.03999.622.78102.0499.622.78
287751-8775197.04197.04
387907-8790797.21397.21
489450-8945098.92098.92
589165-8916598.60498.60
693956-93956103.903103.90
10min193755-93755103.680100.832.52103.85101.002.52
289110-8911098.54498.71
388823-8882398.22698.39
490746-90746100.353100.52
590424-9042499.997100.16
694196-94196104.168104.34
15min193718-93718103.639100.672.56103.98101.012.56
288956-8895698.37398.70
388741-8874198.13698.46
490396-9039699.966100.30
590310-9031099.871100.20
694097-94097104.059104.41
20min193481-93481103.377100.432.63103.89100.922.63
288503-8850397.87298.36
388613-8861397.99498.48
490125-9012599.666100.16
590139-9013999.682100.18
694010-94010103.962104.48
30min193372-93372103.257100.442.71103.94101.102.71
288516-8851697.88798.54
388310-8831097.65998.31
489974-8997499.499100.16
590566-90566100.154100.82
694191-94191104.163104.86
45min193331-93331103.211100.752.41104.07101.582.42
289421-8942198.88899.70
388678-8867898.06698.88
490600-90600100.191101.02
590393-9039399.962100.79
694211-94211104.185105.05
极限193427-93427103.318100.502.56104.35101.502.56
288704-8870498.09599.08
388613-8861397.99498.97
490490-90490100.070101.07
590046-9004699.579100.58
693986-93986103.936104.98
富马酸比索洛尔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0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.941030671029271029751029041029721029690.07
213.961035311032601033960.19
单位质量响应值RSD%判断
7386.597406.590.20数据可信
长期18月-供试品溶液-5543C0421批-氨氯地平-0.005Hcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1105129-10512992.15092.713.4292.1592.713.42
2103012-10301290.29490.29
3102580-10258089.91689.92
4104163-10416391.30391.30
5107524-10752494.24994.25
6112190-11219098.33998.34
10min1113536-11353699.51998.011.6399.6798.171.63
2110725-11072597.05597.21
3110177-11017796.57596.72
4110222-11022296.61496.77
5111766-11176697.96898.12
6114479-114479100.346100.51
15min1115027-115027100.82698.881.42101.1599.201.43
2112203-11220398.35198.66
3112112-11211298.27198.58
4111009-11100997.30497.62
5111942-11194298.12298.44
6114552-114552100.410100.74
20min1115238-115238101.01199.021.64101.5099.511.64
2112118-11211898.27698.75
3112812-11281298.88499.36
4110913-11091397.22097.70
5111558-11155897.78598.27
6115185-115185100.965101.46
30min1115607-115607101.33499.131.74101.9999.781.74
2111932-11193298.11398.75
3112655-11265598.74799.39
4110844-11084497.15997.80
5112108-11210898.26798.91
6115424-115424101.174101.84
45min1112969-11296999.02298.761.0999.8599.581.09
2112730-11273098.81399.62
3112625-11262598.72199.52
4110876-11087697.18897.99
5112196-11219698.34599.16
6114648-114648100.494101.33
极限1115284-115284101.05198.951.65102.0499.931.65
2112067-11206798.23199.20
3112186-11218698.33699.30
4110887-11088797.19798.16
5111749-11174997.95398.93
6115144-115144100.929101.93
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