奥美沙坦酯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070220417对照品来源原料药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1000
标示量(mg)10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%
1 16.163826238218382013808438110381750.20
2 16.233814238153381480.03
单位质量响应值RSD%判断
2362.312350.460.36数据可信
供试品溶液-24112201批-奥美沙坦酯-pH4.5(内含%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min133245-3324591.38079.689.6491.3879.689.64
230683-3068384.33884.34
327942-2794276.80476.80
429623-2962381.42481.42
525462-2546269.98769.99
626973-2697374.14074.14
10min134849-3484995.78988.215.6095.9488.345.61
232343-3234388.90189.04
331252-3125285.90286.03
433276-3327691.46591.60
529814-2981481.94982.07
631008-3100885.23185.35
15min134313-3431394.31688.904.2094.6389.184.20
232222-3222288.56888.86
331504-3150486.59486.87
433545-3354592.20592.49
530646-3064684.23684.49
631828-3182887.48587.75
20min134312-3431294.31389.793.5694.7890.223.56
232375-3237588.98989.42
331947-3194787.81288.23
433868-3386893.09293.53
531362-3136286.20486.60
632145-3214588.35688.77
30min134393-3439394.53590.413.2095.1690.993.21
232477-3247789.26989.85
332007-3200787.97788.54
433984-3398493.41194.01
531867-3186787.59288.13
632630-3263089.68990.25
45min134365-3436594.45890.952.9495.2491.682.96
232571-3257189.52790.26
332151-3215188.37389.08
434208-3420894.02794.78
532259-3225988.67089.35
632978-3297890.64691.35
60min134223-3422394.06891.322.5495.0192.202.55
232563-3256389.50590.39
332148-3214888.36589.22
434180-3418093.95094.86
532993-3299390.68791.52
633227-3322791.33092.19
极限136059-3605999.11597.870.82100.2198.900.83
235469-3546997.49398.52
335468-3546897.49098.49
435627-3562797.92798.99
535786-3578698.36499.35
635226-3522696.82597.84
奥美沙坦酯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OM230503W对照品来源原料药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250
标示量(mg)40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%
1 11.322229092231392230052231052226672229650.09
2 11.292238012235032236520.10
单位质量响应值RSD%判断
19696.5519809.740.41数据可信
供试品溶液-24112201批-氨氯地平-pH4.5(内含%SDS)
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1190605-19060586.75873.7510.9186.7673.7410.92
2168787-16878776.82776.83
3148043-14804367.38567.38
4168313-16831376.61176.61
5154539-15453970.34270.34
6141819-14181964.55264.55
10min1275493-275493125.397115.175.41125.54115.305.41
2252833-252833115.082115.21
3242011-242011110.157110.27
4262309-262309119.396119.52
5245283-245283111.646111.76
6240272-240272109.365109.47
15min1310964-310964141.542133.783.86141.90134.093.87
2290711-290711132.323132.64
3284627-284627129.554129.85
4304982-304982138.819139.15
5288156-288156131.160131.46
6283996-283996129.267129.56
20min1330344-330344150.363144.333.18150.95144.873.19
2312103-312103142.060142.60
3310162-310162141.177141.69
4329278-329278149.878150.44
5313336-313336142.622143.14
6307310-307310139.879140.38
30min1348401-348401158.582154.172.64159.42154.952.65
2332800-332800151.481152.26
3330774-330774150.559151.31
4351095-351095159.808160.62
5337700-337700153.711154.47
6331482-331482150.881151.62
45min1358083-358083162.989160.272.27164.09161.312.27
2345617-345617157.315158.34
3344048-344048156.601157.60
4363674-363674165.534166.61
5354883-354883161.533162.55
6346392-346392157.668158.66
60min1362465-362465164.984163.762.29166.36165.062.29
2350785-350785159.667160.96
3350335-350335159.463160.72
4368959-368959167.940169.29
5368235-368235167.610168.90
6357864-357864162.890164.14
极限1403993-403993183.886182.080.94185.54183.650.96
2397006-397006180.706182.26
3397623-397623180.987182.51
4401380-401380182.697184.33
5404402-404402184.072185.64
6395709-395709180.116181.64
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