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%
112.444884148873488054886548782488330.08
212.414884248817488300.04
单位质量响应值RSD%判断
3925.483934.730.17数据可信
供试品溶液-24041504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%
5min114319-1431929.44554.2844.2429.4454.2844.25
232484-3248466.79866.80
336916-3691675.91275.91
440334-4033482.94182.94
520580-2058042.32042.32
613742-1374228.25828.26
10min141761-4176185.87589.803.0586.0490.103.17
243675-4367589.81190.18
344809-4480992.14392.56
445329-4532993.21293.67
543838-4383890.14690.38
642616-4261687.63387.79
15min144523-4452391.55591.761.6692.2092.561.68
244469-4446991.44492.31
343618-4361889.69490.63
445757-4575794.09295.07
545125-4512592.79393.53
644232-4423290.95691.60
20min145342-4534293.23992.312.1694.3993.622.09
243822-4382290.11391.49
343582-4358289.62091.05
445962-4596294.51496.02
545054-4505492.64793.90
645571-4557193.71094.86
30min143465-4346589.37993.562.8891.0595.382.89
244254-4425491.00292.88
346251-4625195.10897.04
446589-4658995.80397.83
546429-4642995.47497.24
645998-4599894.58896.26
45min145439-4543993.43894.390.8795.6096.740.92
245502-4550293.56895.95
346005-4600594.60297.06
446361-4636195.33497.89
545795-4579594.17196.47
646323-4632395.25697.45
60min144132-4413290.75194.282.7993.4397.142.79
244321-4432191.13994.04
346591-4659195.80798.79
447046-4704696.74399.83
546397-4639795.40898.23
646599-4659995.82498.55
极限145738-4573894.05396.231.6697.2499.621.71
246097-4609794.79298.20
347730-4773098.150101.67
447326-4732697.319100.94
546635-4663595.89899.25
647266-4726697.195100.45
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(%)99.7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%
111.173854363853263849993854423853863853180.05
211.143851723853553852640.04
单位质量响应值RSD%判断
34495.7934583.840.19数据可信
供试品溶液-24041504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%
5min1104429-10442927.12928.4325.9027.1328.4325.90
2113700-11370029.53829.54
3116678-11667830.31130.31
470705-7070518.36818.37
5156389-15638940.62840.63
694737-9473724.61124.61
10min1211942-21194255.06066.0916.1555.2166.2516.16
2278981-27898172.47672.64
3276139-27613971.73771.91
4197846-19784651.39851.50
5302736-30273678.64778.87
6258791-25879167.23167.37
15min1281675-28167573.17682.869.4973.6383.399.52
2334863-33486386.99387.56
3308183-30818380.06280.63
4289054-28905475.09375.48
5349726-34972690.85491.52
6350269-35026990.99691.51
20min1326219-32621984.74886.686.6685.6187.676.68
2341739-34173988.78089.83
3313039-31303981.32482.34
4307100-30710079.78180.59
5349059-34905990.68191.85
6364884-36488494.79295.81
30min1346091-34609189.91089.374.3591.2490.844.41
2345620-34562089.78891.33
3337080-33708087.56989.03
4318767-31876782.81284.06
5355044-35504492.23693.91
6361441-36144193.89895.44
45min1358821-35882193.21790.363.9795.0592.324.01
2346269-34626989.95692.00
3340541-34054188.46890.42
4324712-32471284.35686.06
5354786-35478692.16994.35
6361740-36174093.97696.04
60min1365276-36527694.89491.283.9697.2593.743.98
2347592-34759290.30092.84
3345198-34519889.67892.12
4328715-32871585.39687.57
5356522-35652292.62095.32
6364786-36478694.76797.35
极限1383761-38376199.69699.591.18102.57102.561.13
2376400-37640097.784100.83
3380863-38086398.943101.88
4388158-388158100.839103.49
5388224-388224100.856104.07
6382658-38265899.410102.52
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%
112.444887448873488134880948855488450.07
212.414876548789487770.04
单位质量响应值RSD%判断
3926.453930.460.08数据可信
供试品溶液-240415041批-左氨氯地平-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min130789-3078963.34077.5522.2163.3477.5522.22
245715-4571594.04594.05
331027-3102763.82963.83
428490-2849058.61058.61
545443-4544393.48693.49
644710-4471091.97891.98
10min146637-4663795.94296.920.8496.2997.350.80
246773-4677396.22296.74
347647-4764798.02098.37
447464-4746497.64497.97
546986-4698696.66097.18
647166-4716697.03097.54
15min146245-4624595.13695.771.7296.0296.741.65
246437-4643795.53196.59
347300-4730097.30698.21
447457-4745797.62998.50
546624-4662495.91596.97
645252-4525293.09394.14
20min145560-4556093.72795.701.9195.1497.211.87
245242-4524293.07294.66
347351-4735197.41198.85
447043-4704396.77798.19
547053-4705396.79898.39
646878-4687896.43898.01
30min144930-4493092.43195.622.2594.3697.652.20
246187-4618795.01697.12
347954-4795498.652100.63
447261-4726197.22699.17
546483-4648395.62597.75
646059-4605994.75396.86
45min145845-4584594.31395.501.0996.7698.061.05
245974-4597494.57897.21
347186-4718697.07299.60
446781-4678196.23898.73
546319-4631995.28897.95
646417-4641795.49098.12
60min1-0.00079.6949.002.9782.7847.24
246043-4604394.72097.88
346526-4652695.71498.78
447124-4712496.94499.97
546305-4630595.25998.45
646423-4642395.50298.66
极限145405-4540593.40894.770.7596.3898.310.99
246078-4607894.79298.48
346397-4639795.44899.05
446112-4611294.86298.42
546181-4618195.00498.72
646236-4623695.11798.81
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(%)99.7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%
111.173859163858323855793861603858833858740.06
211.143851763847653849700.08
单位质量响应值RSD%判断
34545.5734557.450.03数据可信
供试品溶液-240415041批-阿齐沙坦-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min16183-61831.6061.0927.301.611.0927.56
24877-48771.2671.27
33367-33670.8740.87
43972-39721.0321.03
53496-34960.9080.91
63248-32480.8440.84
10min122288-222885.7884.8711.805.804.8811.81
218056-180564.6894.70
319910-199105.1715.18
415944-159444.1414.15
517272-172724.4864.49
619034-190344.9434.95
15min135339-353399.1788.427.719.228.457.73
231839-318398.2698.30
335044-350449.1019.13
428929-289297.5137.54
530631-306317.9557.98
632729-327298.5008.53
20min143609-4360911.32510.814.9211.4210.904.94
241227-4122710.70710.79
344281-4428111.50011.58
438691-3869110.04810.12
540538-4053810.52810.60
641497-4149710.77710.86
30min153443-5344313.87913.833.0814.0313.973.09
253262-5326213.83213.97
356353-5635314.63514.78
451932-5193213.48713.61
552270-5227013.57413.71
652222-5222213.56213.70
45min162439-6243916.21516.131.8416.4516.351.85
261951-6195116.08916.30
363781-6378116.56416.79
461332-6133215.92816.13
562748-6274816.29616.50
660513-6051315.71515.93
60min144328-4432811.51216.3314.5311.8316.6414.23
267092-6709217.42417.73
367329-6732917.48517.81
467031-6703117.40817.70
566587-6658717.29317.59
664934-6493416.86317.17
极限170023-7002318.18518.161.0818.5718.561.08
270756-7075618.37518.78
370062-7006218.19518.61
470167-7016718.22218.61
570012-7001218.18218.58
668494-6849417.78818.18
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