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%
116.167397973930741727372273611738830.30
2 16.237514575105751250.04
单位质量响应值RSD%判断
4571.974628.770.88数据可信
供试品溶液-1批-奥美沙坦酯-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%
5min153519-5351975.35375.953.8775.3575.943.87
249953-4995370.33270.33
354542-5454276.79376.79
454668-5466876.97176.97
555485-5548578.12178.12
655480-5548078.11478.11
10min166052-6605292.99993.041.3093.1293.161.30
264900-6490091.37791.49
366687-6668793.89394.02
465870-6587092.74392.87
565614-6561492.38292.51
667357-6735794.83694.97
15min168292-6829296.15395.771.2096.4396.051.21
266673-6667393.87394.14
368603-6860396.59196.88
467934-6793495.64995.93
567634-6763495.22695.51
668992-6899297.13897.43
20min166337-6633793.40096.201.9393.8496.641.93
267438-6743894.95095.38
369320-6932097.60098.05
468641-6864196.64497.09
568211-6821196.03996.48
670007-7000798.56799.02
30min169419-6941997.74097.031.2998.3497.631.29
267619-6761995.20595.79
369537-6953797.90698.51
468712-6871296.74497.35
568231-6823196.06796.67
669964-6996498.50799.12
45min168525-6852596.48196.210.7197.2496.970.71
268085-6808595.86196.60
367774-6777495.42496.19
468520-6852096.47497.24
567971-6797195.70196.46
669104-6910497.29698.07
60min168727-6872796.76596.541.2597.6997.461.24
268265-6826596.11597.02
368535-6853596.49597.43
467540-6754095.09496.02
568239-6823996.07897.00
670097-7009798.69499.63
极限171169-71169100.20499.361.27101.29100.451.27
269363-6936397.66198.72
371327-71327100.426101.52
469780-6978098.24899.33
570272-7027298.941100.02
671521-71521100.699101.80
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%
111.324375724380484386214368404346364371430.36
211.294442344437214439780.09
单位质量响应值RSD%判断
38616.8739324.891.29数据可信
供试品溶液-1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%
5min1192157-19215744.33643.063.6144.3443.063.61
2173830-17383040.10840.11
3185786-18578642.86642.87
4187300-18730043.21643.22
5189033-18903343.61643.62
6191625-19162544.21444.21
10min1279454-27945464.47863.861.2864.5563.931.28
2273388-27338863.07963.15
3280150-28015064.63964.71
4273187-27318763.03263.10
5274134-27413463.25163.32
6280310-28031064.67664.75
15min1319712-31971273.76773.060.9973.9573.240.99
2313312-31331272.29072.46
3320983-32098374.06074.24
4316709-31670973.07473.25
5314221-31422172.50072.68
6314929-31492972.66372.84
20min1339176-33917678.25878.300.8778.5678.600.87
2338387-33838778.07678.37
3342658-34265879.06179.36
4337146-33714677.79078.09
5335773-33577377.47377.77
6343051-34305179.15279.45
30min1358431-35843182.70182.451.0383.1482.881.03
2355699-35569982.07082.49
3361712-36171283.45883.89
4355809-35580982.09682.52
5351712-35171281.15081.58
6360577-36057783.19683.63
45min1364028-36402883.99283.801.3984.5684.361.39
2364340-36434084.06484.62
3368815-36881585.09785.67
4360294-36029483.13183.70
5354743-35474381.85082.41
6366871-36687184.64885.22
60min1362327-36232783.60084.151.0784.3184.861.07
2365459-36545984.32285.02
3368213-36821384.95885.67
4362595-36259583.66184.37
5359698-35969882.99383.69
6369991-36999185.36886.08
极限1380614-38061487.81987.971.2288.6788.821.21
2380284-38028487.74388.58
3387417-38741789.38990.25
4376396-37639686.84687.69
5376749-37674986.92787.77
6386088-38608889.08289.94
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%
116.167487475052750727521375110750640.17
2 16.237593275396756640.51
单位质量响应值RSD%判断
4645.054661.980.26数据可信
供试品溶液-2批-奥美沙坦酯-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%
5min155855-5585577.74178.571.5477.7478.561.54
255133-5513376.73676.74
356293-5629378.35178.35
456853-5685379.13079.13
557537-5753780.08280.08
657014-5701479.35479.35
10min167043-6704393.31393.650.9693.4493.780.96
266464-6646492.50792.64
366919-6691993.14093.27
467193-6719393.52293.65
567919-6791994.53294.67
668184-6818494.90195.03
15min168972-6897295.99895.760.6896.2896.040.68
268109-6810994.79795.08
368723-6872395.65195.94
468828-6882895.79796.09
569531-6953196.77697.07
668629-6862995.52095.81
20min169624-6962496.90596.860.5897.3597.310.58
268850-6885095.82896.27
369558-6955896.81397.26
469659-6965996.95497.40
569955-6995597.36697.82
669906-6990697.29897.75
30min169528-6952896.77296.870.7597.3897.480.75
269495-6949596.72697.33
368918-6891895.92396.53
469230-6923096.35796.97
570222-7022297.73898.35
670187-7018797.68998.30
45min168739-6873995.67496.951.2096.4497.721.19
268871-6887195.85796.62
369901-6990197.29198.06
469550-6955096.80297.57
571029-7102998.86199.64
669854-6985497.22598.00
60min169629-6962996.91296.811.1397.8497.741.12
268750-6875095.68996.61
369162-6916296.26297.19
469692-6969297.00097.93
569106-6910696.18497.13
670975-7097598.78699.72
极限170320-7032097.87498.811.3998.9699.901.38
269964-6996497.37998.46
370756-7075698.48199.57
470471-7047198.08499.18
572234-72234100.538101.64
672194-72194100.482101.58
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%
111.324428704437964439884446044447944440100.18
211.294496094461894478990.54
单位质量响应值RSD%判断
39223.5039672.190.81数据可信
供试品溶液-2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%
5min1187363-18736342.70543.001.5942.7143.001.59
2190903-19090343.51243.51
3193655-19365544.14044.14
4185994-18599442.39342.39
5186541-18654142.51842.52
6187452-18745242.72642.73
10min1278040-27804063.37363.660.8163.4463.730.81
2277850-27785063.33063.40
3281483-28148364.15864.23
4278601-27860163.50163.57
5282690-28269064.43364.50
6277117-27711763.16363.23
15min1322938-32293873.60772.831.2273.7873.001.22
2318649-31864972.62972.81
3320592-32059273.07273.25
4319406-31940672.80272.98
5322998-32299873.62073.80
6312487-31248771.22571.40
20min1343327-34332778.25477.980.7278.5578.280.72
2338959-33895977.25877.56
3341590-34159077.85878.16
4341255-34125577.78278.08
5346220-34622078.91379.21
6341328-34132877.79878.09
30min1363167-36316782.77681.940.8783.2182.370.87
2359103-35910381.85082.28
3358436-35843681.69882.13
4354687-35468780.84381.27
5362656-36265682.66083.09
6358974-35897481.82082.25
45min1369628-36962884.24983.920.8684.8284.480.86
2365230-36523083.24683.81
3366803-36680383.60584.17
4365145-36514583.22783.79
5373409-37340985.11185.68
6368817-36881784.06484.63
60min1371480-37148084.67183.810.9685.3884.520.96
2363790-36379082.91883.62
3365452-36545283.29784.00
4364799-36479983.14883.85
5371907-37190784.76885.48
6368780-36878084.05684.76
极限1380619-38061986.75486.860.8787.6087.710.87
2375953-37595385.69086.53
3380426-38042686.71087.56
4380437-38043786.71287.55
5385821-38582187.94088.79
6383316-38331687.36988.21
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