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%
111.694656546500465454640446544465120.14
211.734626546268462660.01
单位质量响应值RSD%判断
3978.793944.250.62数据可信
供试品溶液-24042903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%
5min140523-4052382.67081.761.8782.6781.761.87
239449-3944980.47980.48
340085-4008581.77781.78
441333-4133384.32384.32
539705-3970581.00181.00
639373-3937380.32480.32
10min146524-4652494.91391.602.4095.3792.052.40
244071-4407189.90890.36
345108-4510892.02492.48
445558-4555892.94293.41
544604-4460490.99691.45
643522-4352288.78889.23
15min147466-4746696.83592.672.8997.8293.642.88
244148-4414890.06691.01
346011-4601193.86694.83
445577-4557792.98193.97
545486-4548692.79593.75
643864-4386489.48690.43
20min146675-4667595.22192.293.4496.7593.763.42
243388-4338888.51589.96
344885-4488591.56993.06
447457-4745796.81698.32
544977-4497791.75793.23
644034-4403489.83391.27
30min147621-4762197.15193.043.0999.2095.033.07
244462-4446290.70692.64
345357-4535792.53294.53
446906-4690695.69297.73
545319-4531992.45494.44
643964-4396489.69091.63
45min146839-4683995.55592.403.1698.1594.903.14
244082-4408289.93192.37
345304-4530492.42494.93
447206-4720696.30498.87
544401-4440190.58293.08
643916-4391689.59292.03
60min145474-4547492.77191.543.3095.8994.563.26
242976-4297687.67590.62
344703-4470391.19894.22
447142-4714296.17499.28
545311-4531192.43895.44
643615-4361588.97891.91
极限148819-4881999.59598.283.38103.23101.813.34
245791-4579193.41796.85
349208-49208100.388103.92
450361-50361102.741106.38
547114-4711496.11699.63
647766-4776697.447100.87
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%
111.223971883969913964963968033965843968120.08
211.303950603949493950040.02
单位质量响应值RSD%判断
35366.4934956.110.83数据可信
供试品溶液-24042903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%
5min1135183-13518334.49932.867.8334.5032.867.83
2119833-11983330.58230.58
3141394-14139436.08436.08
4132199-13219933.73833.74
5114119-11411929.12429.12
6129892-12989233.14933.15
10min1299166-29916676.34875.311.2376.5475.501.24
2292099-29209974.54574.71
3300245-30024576.62476.82
4293697-29369774.95375.14
5292377-29237774.61674.78
6293083-29308374.79674.98
15min1338651-33865186.42583.802.8787.0484.402.85
2341090-34109087.04887.63
3322435-32243582.28782.91
4326157-32615783.23783.84
5324300-32430082.76383.34
6317466-31746681.01981.62
20min1348468-34846888.93085.403.7390.0386.473.70
2350732-35073289.50890.58
3321093-32109381.94483.03
4335210-33521085.54786.61
5327028-32702883.45984.49
6325374-32537483.03784.09
30min1350685-35068589.49687.133.3291.0988.673.29
2359402-35940291.72193.29
3329976-32997684.21185.75
4339239-33923986.57588.12
5334787-33478785.43986.94
6334307-33430785.31786.83
45min1354102-35410290.36888.623.0892.4690.653.06
2364111-36411192.92395.00
3334366-33436685.33287.34
4347804-34780488.76190.78
5339312-33931286.59488.57
6343899-34389987.76489.75
60min1350444-35044489.43588.862.6492.0291.382.62
2364871-36487193.11795.71
3337999-33799986.25988.74
4347551-34755188.69691.21
5344251-34425187.85490.31
6344101-34410187.81690.29
极限1378134-37813496.50199.001.7699.59102.011.71
2395725-395725100.991104.10
3390653-39065399.696102.66
4389719-38971999.458102.47
5381165-38116597.275100.22
6392112-392112100.069103.03
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%
111.694689946456465384660046434465850.41
211.734646346526464940.10
单位质量响应值RSD%判断
3985.033963.680.38数据可信
供试品溶液-24042903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%
5min143461-4346188.37684.812.9288.3884.812.92
242111-4211185.63185.63
341970-4197085.34585.34
440671-4067182.70382.70
542030-4203085.46785.47
640006-4000681.35181.35
10min148204-4820498.02194.462.3198.5194.942.31
246740-4674095.04495.52
345933-4593393.40393.88
445486-4548692.49492.95
546964-4696495.50095.97
645404-4540492.32792.78
15min148797-4879799.22795.781.93100.2696.771.93
246583-4658394.72595.73
346653-4665394.86795.86
446413-4641394.37995.35
547467-4746796.52397.53
646692-4669294.94795.91
20min148245-4824598.10594.842.0599.6996.362.05
247029-4702995.63297.16
346081-4608193.70495.22
445617-4561792.76194.26
546850-4685095.26896.81
646002-4600293.54495.04
30min147763-4776397.12494.541.7999.2696.601.80
246925-4692595.42097.48
345583-4558392.69194.73
445701-4570192.93194.94
546807-4680795.18097.25
646178-4617893.90195.91
45min148542-4854298.70995.242.05101.3897.822.05
247394-4739496.37498.97
346040-4604093.62196.18
446324-4632494.19896.73
546479-4647994.51397.11
646244-4624494.03696.57
60min147743-4774397.08493.422.48100.3096.532.46
245833-4583393.20096.33
344494-4449490.47793.55
445179-4517991.87094.92
546640-4664094.84197.97
645749-4574993.02996.09
极限149755-49755101.175100.191.01104.93103.811.02
249390-49390100.433104.08
349550-49550100.758104.34
448326-4832698.269101.83
549299-49299100.248103.90
649290-49290100.230103.80
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%
111.223964983969163967713967893966333967210.05
211.303976433978703977560.05
单位质量响应值RSD%判断
35358.3835199.650.32数据可信
供试品溶液-24042903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%
5min1121679-12167930.94831.3010.1530.9531.3010.15
2120151-12015130.56030.56
3147498-14749837.51537.52
4112969-11296928.73328.73
5121015-12101530.78030.78
6114998-11499829.24929.25
10min1292254-29225474.33374.150.9874.5174.320.99
2289147-28914773.54373.71
3295451-29545175.14775.35
4287975-28797573.24573.40
5293765-29376574.71874.89
6290594-29059473.91174.07
15min1338855-33885586.18682.143.2686.7782.733.23
2322476-32247682.02082.60
3312301-31230179.43280.06
4312008-31200879.35879.92
5321130-32113081.67882.26
6330955-33095584.17784.75
20min1344557-34455787.63683.223.5988.7084.263.55
2333562-33356284.84085.87
3315949-31594980.36081.43
4312961-31296179.60080.61
5325495-32549582.78883.83
6330697-33069784.11185.15
30min1351605-35160589.42984.823.5390.9886.323.50
2337934-33793485.95287.46
3322062-32206281.91583.43
4319424-31942481.24482.69
5332617-33261784.60086.10
6337285-33728585.78787.29
45min1355677-35567790.46586.903.6292.5188.873.58
2356874-35687490.76992.75
3330630-33063084.09486.06
4328935-32893583.66385.56
5334682-33468285.12587.09
6343082-34308287.26189.25
60min1352679-35267989.70286.023.0592.2588.483.03
2341709-34170986.91289.40
3327857-32785783.38985.82
4324814-32481482.61584.98
5339746-33974686.41388.86
6342457-34245787.10289.57
极限1385107-38510797.95097.480.97101.00100.421.01
2385341-38534198.010100.98
3383698-38369897.592100.49
4376204-37620495.68698.51
5382735-38273597.347100.27
6386577-38657798.324101.28
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