阿齐沙坦左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6250
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%
111.694605646041460064599045950460090.10
211.734581045616457130.31
单位质量响应值RSD%判断
3935.763897.100.70数据可信
供试品溶液-24042901批-左氨氯地平-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%
5min138399-3839979.23981.713.3379.2481.713.33
239161-3916180.81280.81
341948-4194886.56386.56
438945-3894580.36680.37
540303-4030383.16883.17
638829-3882980.12780.13
10min144342-4434291.50394.073.2991.9494.523.29
246180-4618095.29695.74
347948-4794898.94499.43
443669-4366990.11490.56
545829-4582994.57295.03
645554-4555494.00494.45
15min144611-4461192.05894.463.2693.0195.443.25
245336-4533693.55494.53
347803-4780398.64599.68
443800-4380090.38591.33
546167-4616795.26996.26
646940-4694096.86497.83
20min145214-4521493.30395.373.5594.7696.873.53
245715-4571594.33695.83
348098-4809899.254100.83
443875-4387590.53991.99
546421-4642195.79397.31
647974-4797498.998100.50
30min144476-4447691.78093.913.0193.7695.943.01
244679-4467992.19994.22
347107-4710797.20999.34
443784-4378490.35292.30
546248-4624895.43697.49
646742-4674296.45698.51
45min144661-4466192.16194.263.1694.6596.823.15
245882-4588294.68197.22
347608-4760898.243100.91
443466-4346689.69592.15
546058-4605895.04497.62
646401-4640195.75298.34
60min144410-4441091.64393.182.1494.6496.262.14
245369-4536993.62296.68
345316-4531693.51396.73
443655-4365590.08593.04
546085-4608595.10098.21
646098-4609895.12798.25
极限145525-4552593.94498.272.6297.45101.872.61
247895-4789598.835102.42
349192-49192101.512105.25
447150-4715097.298100.75
547590-4759098.206101.84
648386-4838699.848103.50
阿齐沙坦左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%
111.223953563953433956613948753952813953030.08
211.303945343946983946160.03
单位质量响应值RSD%判断
35232.0034921.770.63数据可信
供试品溶液-24042901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%
5min1139292-13929235.63335.185.3035.6335.185.29
2138173-13817335.34735.35
3130349-13034933.34533.35
4150199-15019938.42338.42
5130574-13057433.40333.40
6136650-13665034.95734.96
10min1300570-30057076.89076.431.7277.0976.621.71
2298955-29895576.47776.67
3296279-29627975.79275.98
4290065-29006574.20374.42
5301942-30194277.24177.43
6304760-30476077.96278.16
15min1326816-32681683.60482.612.8384.2383.232.81
2315782-31578280.78281.40
3324531-32453183.02083.63
4311399-31139979.66080.29
5321497-32149782.24482.86
6337464-33746486.32886.96
20min1336826-33682686.16584.933.0987.2586.013.06
2325706-32570683.32084.39
3333124-33312485.21886.29
4319720-31972081.78982.86
5327694-32769483.82984.90
6349032-34903289.28790.39
30min1349561-34956189.42386.232.7290.9987.782.70
2329722-32972284.34885.88
3336490-33649086.07987.62
4328190-32819083.95685.48
5331466-33146684.79486.33
6347010-34701088.77090.37
45min1347083-34708388.78986.982.1890.8589.012.17
2338587-33858786.61588.62
3337856-33785686.42888.45
4331558-33155884.81786.81
5334321-33432185.52487.53
6350632-35063289.69791.79
60min1348542-34854289.16287.701.9291.7290.211.93
2339993-33999386.97589.46
3342371-34237187.58390.08
4335638-33563885.86188.32
5337691-33769186.38688.87
6352706-35270690.22792.82
极限1388962-38896299.50297.911.25102.56100.921.23
2383799-38379998.181101.15
3381715-38171597.648100.63
4385920-38592098.724101.66
5374982-37498295.92698.89
6381136-38113697.500100.60
阿齐沙坦左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6250
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%
111.694639545903457304577045969459530.58
211.734633446377463560.07
单位质量响应值RSD%判断
3930.973951.920.38数据可信
供试品溶液-24042901批-左氨氯地平-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%
5min142553-4255387.25384.842.5287.2584.842.53
240372-4037282.78182.78
341620-4162085.34085.34
440231-4023182.49282.49
542574-4257487.29687.30
640894-4089483.85183.85
10min146679-4667995.71394.312.3696.2094.782.36
245702-4570293.71094.17
346101-4610194.52895.00
444401-4440191.04291.50
547583-4758397.56698.05
645501-4550193.29793.76
15min147886-4788698.18895.532.6899.2096.532.67
246657-4665795.66896.65
346078-4607894.48095.48
445000-4500092.27093.23
548187-4818798.80599.83
645737-4573793.78194.77
20min148091-4809198.60896.122.89100.1797.652.89
246143-4614394.61496.13
346786-4678695.93297.46
445233-4523392.74894.22
548858-48858100.181101.76
646155-4615594.63896.14
30min147657-4765797.71894.802.6499.8396.862.64
246172-4617294.67396.71
346048-4604894.41996.48
444657-4465791.56793.56
547619-4761997.64099.77
645254-4525492.79194.82
45min147374-4737497.13894.372.9399.7996.962.92
246204-4620494.73997.30
345585-4558593.47096.05
444116-4411690.45892.96
547672-4767297.749100.42
645196-4519692.67295.22
60min147977-4797798.37494.334.74101.5797.444.66
246491-4649195.32798.42
345814-4581493.93997.04
442163-4216386.45389.46
548118-4811898.663101.88
645457-4545793.20796.27
极限149677-49677101.86098.922.05105.60102.562.06
247359-4735997.107100.73
348708-4870899.873103.50
446931-4693196.23099.71
548559-4855999.568103.33
648237-4823798.907102.49
阿齐沙坦左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%
111.223930273943693948983947923949813944130.21
211.304010624007634009120.06
单位质量响应值RSD%判断
35152.6735478.940.66数据可信
供试品溶液-24042901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%
5min1126749-12674932.20532.375.2932.2032.365.29
2114319-11431929.04729.05
3132647-13264733.70433.70
4129109-12910932.80532.80
5129529-12952932.91132.91
6131929-13192933.52133.52
10min1310941-31094179.00576.135.5579.1876.315.54
2277094-27709470.40570.57
3293687-29368774.62174.81
4288129-28812973.20973.39
5323094-32309482.09382.28
6304726-30472677.42677.61
15min1349907-34990788.90683.514.7789.5284.124.76
2318295-31829580.87481.43
3313602-31360279.68180.28
4316169-31616980.33480.92
5345576-34557687.80588.44
6328581-32858183.48784.10
20min1346020-34602087.91885.223.6989.0386.293.70
2323475-32347582.19083.19
3327804-32780483.29084.33
4325264-32526482.64483.68
5354061-35406189.96191.09
6335891-33589185.34586.42
30min1350529-35052989.06485.882.7290.6687.422.74
2331007-33100784.10485.56
3329943-32994383.83385.34
4329992-32999283.84685.34
5347086-34708688.18989.82
6339513-33951386.26587.82
45min1351616-35161689.34087.302.2091.4489.322.24
2337533-33753385.76287.69
3336052-33605285.38687.36
4337851-33785185.84387.80
5353119-35311989.72291.84
6345266-34526687.72789.76
60min1358390-35839091.06188.412.3593.6590.922.37
2344765-34476587.59990.00
3340107-34010786.41688.86
4338604-33860486.03488.47
5355672-35567290.37192.99
6350276-35027689.00091.52
极限1381530-38153096.94197.781.59100.04100.771.48
2388259-38825998.651101.54
3382550-38255097.200100.13
4389402-38940298.941101.86
5375424-37542495.38998.51
6391772-39177299.543102.56
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