阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
111.102964492959872959632959292958092960270.09
211.162963432960582962000.07
单位质量响应值RSD%判断
26669.1026541.220.34数据可信
供试品溶液-2024010921批-氨氯地平-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1216303-21630372.95272.7411.4272.9572.7411.42
2195261-19526165.85565.86
3180589-18058960.90760.91
4243148-24314882.00682.01
5240570-24057081.13681.14
6218188-21818873.58873.59
10min1271749-27174991.65293.345.8492.0693.745.86
2259254-25925487.43887.80
3257261-25726186.76687.10
4289929-28992997.78498.24
5292514-29251498.65599.11
6289816-28981697.74598.15
15min1284169-28416995.84196.284.1996.7697.204.22
2266546-26654689.89790.75
3277266-27726693.51394.33
4297914-297914100.477101.48
5295026-29502699.503100.50
6291933-29193398.45999.41
20min1289243-28924397.55297.964.4599.0099.424.47
2272594-27259491.93793.29
3281027-28102794.78196.12
4299575-299575101.037102.59
5308885-308885104.177105.73
6291424-29142498.28899.79
30min1288659-28865997.35596.602.4499.3498.602.46
2277592-27759293.62395.48
3286499-28649996.62798.49
4298028-298028100.515102.63
5286424-28642496.60198.73
6281335-28133594.88596.93
45min1290158-29015897.86198.232.71100.39100.772.77
2279371-27937194.22396.60
3286467-28646796.61699.02
4299503-299503101.013103.69
5300036-300036101.192103.86
6291986-29198698.477101.05
60min1289278-28927897.56498.572.53100.64101.662.59
2281709-28170995.01197.92
3287886-28788697.095100.03
4300984-300984101.512104.75
5299527-299527101.021104.25
6294178-29417899.217102.34
极限1302553-302553102.041102.230.50105.66105.860.49
2301989-301989101.851105.28
3305081-305081102.894106.37
4304501-304501102.698106.50
5301145-301145101.566105.36
6303397-303397102.326106.00
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.857412274021740347405173989740430.07
215.887423574259742470.03
单位质量响应值RSD%判断
4671.484675.500.07数据可信
供试品溶液-2024010921批-阿齐沙坦-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min155967-5596777.64277.717.4077.6477.717.39
254925-5492576.19676.20
360665-6066584.15984.16
450918-5091870.63770.64
552590-5259072.95772.96
661036-6103684.67484.67
10min164033-6403388.83185.766.7689.2686.196.76
262555-6255586.78187.20
365408-6540890.73991.21
455201-5520176.57976.97
558322-5832280.90981.31
665404-6540490.73391.20
15min166136-6613691.74988.425.4292.6789.335.43
263468-6346888.04788.95
367186-6718693.20594.18
459401-5940182.40583.22
559785-5978582.93883.79
666448-6644892.18293.16
20min166647-6664792.45889.964.3793.8991.354.40
264926-6492690.07091.46
367532-6753293.68595.17
459964-5996483.18684.46
563307-6330787.82489.14
666685-6668592.51094.00
30min164787-6478789.87789.385.2591.8391.285.24
265706-6570691.15293.05
369486-6948696.39698.41
461506-6150685.32687.06
559892-5989283.08784.89
665202-6520290.45392.45
45min167910-6791094.21091.634.5896.6694.034.60
266684-6668492.50994.91
369107-6910795.87098.42
461916-6191685.89488.11
562673-6267386.94589.21
668024-6802494.36896.87
60min165869-6586991.37891.974.6294.3594.884.63
266208-6620891.84994.76
370678-7067898.050101.13
463038-6303887.45190.14
563120-6312087.56590.31
668875-6887595.54898.58
极限168515-6851595.04992.854.9698.5396.264.97
267109-6710993.09996.52
370619-7061997.968101.59
462201-6220186.29089.46
563710-6371088.38391.62
669418-6941896.30299.86
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