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%
111.914643346385464064638746440464100.06
211.994630146320463100.03
单位质量响应值RSD%判断
3896.733862.390.63数据可信
中间条件3月-供试品溶液-24051503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%
5min139063-3906381.37582.845.4481.3882.845.44
235873-3587374.73074.73
340150-4015083.64083.64
440240-4024083.82783.83
541223-4122385.87585.87
642056-4205687.61087.61
10min144767-4476793.25895.971.4993.7196.421.50
246134-4613496.10696.52
346256-4625696.36096.82
446033-4603395.89596.36
546749-4674997.38797.86
646466-4646696.79797.28
15min145093-4509393.93796.471.5594.9197.471.55
246358-4635896.57297.52
346456-4645696.77697.78
446122-4612296.08197.08
547290-4729098.51499.53
646543-4654396.95897.98
20min145436-4543694.65196.631.4996.1498.151.49
246579-4657997.03398.52
346300-4630096.45197.99
445963-4596395.74997.28
547499-4749998.949100.51
646525-4652596.92098.48
30min144679-4467993.07496.592.3795.0998.652.35
246536-4653696.94398.97
346616-4661697.11099.18
446077-4607795.98798.05
548093-48093100.186102.30
646192-4619296.22698.33
45min144640-4464092.99396.101.6995.5398.701.69
246212-4621296.26898.83
346652-4665297.18599.80
446163-4616396.16698.76
546832-4683297.560100.23
646298-4629896.44799.08
60min143589-4358990.80495.442.6393.8698.582.59
245698-4569895.19798.30
346276-4627696.40199.55
446349-4634996.55399.69
547135-4713598.191101.40
645843-4584395.49998.67
极限148872-48872101.809101.851.33105.37105.521.31
248597-48597101.236104.86
349486-49486103.088106.78
448065-48065100.128103.80
549804-49804103.751107.51
648532-48532101.101104.80
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%
111.353916403917343916153920333921763918400.07
211.363909933910583910260.02
单位质量响应值RSD%判断
34523.3534421.300.21数据可信
中间条件3月-供试品溶液-24051503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%
5min1105682-10568227.50926.306.9527.5126.306.95
293338-9333824.29624.30
395435-9543524.84124.84
4105478-10547827.45627.46
595880-9588024.95724.96
6110405-11040528.73828.74
10min1265827-26582769.19470.112.6169.3570.262.62
2272246-27224670.86571.00
3268627-26862769.92370.06
4272994-27299471.05971.21
5257985-25798567.15367.29
6278482-27848272.48872.65
15min1305311-30531179.47179.390.8280.0179.930.83
2307202-30720279.96480.49
3302698-30269878.79179.32
4302351-30235178.70179.25
5303917-30391779.10879.62
6308575-30857580.32180.88
20min1316619-31661982.41581.481.4683.3982.461.44
2318346-31834682.86483.84
3306467-30646779.77280.74
4309507-30950780.56481.55
5311990-31199081.21082.16
6315335-31533582.08183.09
30min1319622-31962283.19683.541.3784.6384.961.35
2327491-32749185.24586.68
3315739-31573982.18683.59
4318372-31837282.87184.30
5324846-32484684.55685.96
6319476-31947683.15884.62
45min1326925-32692585.09786.213.9287.0088.113.84
2357414-35741493.03494.94
3322551-32255183.95985.82
4326566-32656685.00486.90
5326421-32642184.96686.84
6327404-32740485.22287.15
60min1338704-33870488.16387.934.2490.5390.304.16
2366129-36612995.30297.73
3329126-32912685.67088.00
4332494-33249486.54788.91
5330494-33049486.02688.37
6329984-32998485.89488.29
极限1391693-391693101.956100.221.90104.82103.091.89
2395525-395525102.954105.91
3381799-38179999.381102.19
4375976-37597697.865100.71
5380710-38071099.097101.92
6384518-384518100.089102.97
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%
111.914633746355465084638446493464150.18
211.994649446382464380.18
单位质量响应值RSD%判断
3897.153873.060.44数据可信
中间条件3月-供试品溶液-24051503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%
5min136071-3607175.03477.2911.3275.0377.2911.32
240169-4016983.55983.56
339904-3990483.00883.01
430003-3000362.41262.41
535540-3554073.93073.93
641256-4125685.82085.82
10min146381-4638196.48193.088.8396.9093.518.83
246044-4604495.78096.24
345718-4571895.10295.56
436756-3675676.45976.81
546349-4634996.41596.83
647229-4722998.24598.72
15min146345-4634596.40693.487.8397.3694.427.84
245048-4504893.70894.70
345736-4573695.13996.13
437996-3799679.03979.81
546832-4683297.41998.37
647659-4765999.140100.16
20min146364-4636496.44695.153.5597.9396.623.62
246144-4614495.98897.51
345837-4583795.34996.87
442576-4257688.56689.78
546283-4628396.27797.76
647241-4724198.27099.84
30min145559-4555994.77195.521.7696.8097.511.72
244982-4498293.57195.62
345173-4517393.96896.02
446215-4621596.13697.84
546572-4657296.87898.90
647006-4700697.78199.90
45min145989-4598995.66696.162.0798.2298.682.06
245399-4539994.43897.01
345608-4560894.87397.44
446195-4619596.09498.33
546086-4608695.86798.43
648074-48074100.003102.67
60min146445-4644596.61495.701.7299.7098.761.71
244866-4486693.33096.42
345411-4541194.46397.56
445758-4575895.18597.96
546759-4675997.267100.36
646797-4679797.346100.56
极限149587-49587103.150101.641.43106.77105.231.46
248013-4801399.876103.49
348319-48319100.513104.13
448518-48518100.926104.23
548995-48995101.919105.55
649735-49735103.458107.22
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%
111.353913913913893918163916403916283915730.05
211.363903443906013904720.05
单位质量响应值RSD%判断
34499.8234372.540.27数据可信
中间条件3月-供试品溶液-24051503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%
5min1106782-10678227.82425.2120.6127.8225.2120.61
2119329-11932931.09431.09
398612-9861225.69525.70
460717-6071715.82115.82
591471-9147123.83523.83
6103613-10361326.99827.00
10min1284453-28445374.12066.2814.2774.2766.4214.28
2281738-28173873.41273.59
3259396-25939667.59167.73
4185211-18521148.26048.35
5250611-25061165.30265.43
6264699-26469968.97369.12
15min1302044-30204478.70477.503.2579.2778.013.32
2305592-30559279.62880.21
3294451-29445176.72577.24
4281650-28165073.39073.75
5293252-29325276.41376.91
6307496-30749680.12480.66
20min1307452-30745280.11379.422.1181.1280.362.17
2310996-31099681.03682.06
3301419-30141978.54179.49
4299385-29938578.01178.77
5296974-29697477.38278.30
6312486-31248681.42482.40
30min1309105-30910580.54381.481.8281.9982.861.75
2312419-31241981.40782.88
3305852-30585279.69681.08
4319026-31902683.12984.33
5309899-30989980.75082.10
6319972-31997283.37584.81
45min1319506-31950683.25484.511.9185.1586.341.87
2323276-32327684.23686.16
3321483-32148383.76985.59
4327507-32750785.33887.00
5318948-31894883.10884.91
6335293-33529387.36789.26
60min1327375-32737585.30486.141.2387.6688.441.26
2334667-33466787.20489.60
3328451-32845185.58487.87
4329841-32984185.94788.08
5326677-32667785.12287.38
6336482-33648287.67790.06
极限1378418-37841898.60499.560.75101.44102.340.70
2385627-385627100.483103.36
3382590-38259099.691102.46
4384739-384739100.251102.86
5381888-38188899.509102.24
6379326-37932698.841101.71
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%
111.914664946660467324664046686466730.08
211.994644246407464240.06
单位质量响应值RSD%判断
3918.813871.890.86数据可信
中间条件3月-供试品溶液-2024052421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%
5min139661-3966182.28787.633.5282.2987.633.52
242283-4228387.72787.73
343530-4353090.31590.31
443721-4372190.71190.71
541623-4162386.35886.36
642586-4258688.35688.36
10min147567-4756798.691103.693.6199.15104.183.61
250133-50133104.014104.50
351957-51957107.799108.30
451877-51877107.633108.14
548292-48292100.195100.67
650047-50047103.836104.33
15min147039-4703997.595103.874.1398.60104.934.12
248741-48741101.126102.19
352591-52591109.114110.21
452062-52062108.017109.12
549935-49935103.604104.64
649999-49999103.736104.80
20min146993-4699397.500103.643.8699.05105.283.85
249667-49667103.048104.67
351991-51991107.869109.58
452133-52133108.164109.87
549085-49085101.840103.45
649851-49851103.429105.07
30min144664-4466492.66799.784.8094.76101.994.77
247808-4780899.191101.39
350427-50427104.624106.93
450879-50879105.562107.87
546880-4688097.26599.44
647887-4788799.354101.57
45min145279-4527993.94399.574.3396.55102.344.32
247554-4755498.664101.41
350216-50216104.187107.07
450633-50633105.052107.94
546588-4658896.65999.38
647683-4768398.931101.70
60min145404-4540494.20399.354.1997.33102.674.19
247742-4774299.054102.35
350378-50378104.523107.99
450060-50060103.863107.34
546189-4618995.83299.09
647530-4753098.614101.93
极限145744-4574494.908101.434.0998.56105.314.08
247882-4788299.344103.19
351150-51150106.124110.17
450730-50730105.253109.30
548411-48411100.442104.23
649412-49412102.518106.39
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%
111.353928763929133929643926143930113928760.04
211.363909123909013909060.01
单位质量响应值RSD%判断
34614.6334410.740.42数据可信
中间条件3月-供试品溶液-2024052421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%
5min1130384-13038433.89927.8813.0733.9027.8813.07
2109120-10912028.37128.37
3105549-10554927.44227.44
488140-8814022.91622.92
599380-9938025.83825.84
6110781-11078128.80228.80
10min1300122-30012278.03074.566.7678.2274.726.76
2308688-30868880.25780.41
3295893-29589376.93077.08
4265485-26548569.02469.15
5260834-26083467.81567.96
6289683-28968375.31675.48
15min1312638-31263881.28484.333.1281.9184.903.10
2337104-33710487.64588.25
3333319-33331986.66187.24
4317200-31720082.47082.98
5329125-32912585.57086.09
6316759-31675982.35582.93
20min1318731-31873182.86885.852.8783.9486.892.86
2339526-33952688.27589.37
3342013-34201388.92189.98
4323228-32322884.03785.01
5333253-33325386.64487.64
6324463-32446384.35885.39
30min1317060-31706082.43485.252.7583.9786.762.70
2336950-33695087.60589.19
3332539-33253986.45888.01
4335581-33558187.24988.68
5328394-32839485.38086.86
6316728-31672882.34783.85
45min1339581-33958188.28988.773.1790.2890.763.13
2358468-35846893.19995.27
3339851-33985188.35990.39
4346597-34659790.11392.03
5338543-33854388.01989.97
6325499-32549984.62886.59
60min1341233-34123388.71889.783.1591.2092.263.11
2363083-36308394.39996.98
3344643-34464389.60592.13
4349695-34969590.91893.34
5343305-34330589.25791.70
6330023-33002385.80488.24
极限1378520-37852098.413100.081.14101.39103.061.11
2383444-38344499.693102.80
3389999-389999101.397104.42
4383291-38329199.653102.58
5389761-389761101.335104.27
6384482-38448299.963102.87
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%
111.914641846464464294642346403464270.05
211.994648146506464940.04
单位质量响应值RSD%判断
3898.153877.730.38数据可信
中间条件3月-供试品溶液-2024052421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%
5min140288-4028883.74585.484.0483.7585.484.04
242371-4237188.07588.07
341485-4148586.23386.23
441698-4169886.67686.68
542702-4270288.76388.76
638195-3819579.39479.39
10min146286-4628696.21396.662.1196.6897.142.11
247599-4759998.94299.43
347021-4702197.74198.22
446687-4668797.04697.53
546693-4669397.05997.55
644719-4471992.95693.40
15min147655-4765599.05997.692.52100.0698.702.52
247621-4762198.988100.03
347637-4763799.021100.04
447653-4765399.054100.08
546705-4670597.08498.12
644709-4470992.93593.89
20min148025-4802599.82898.142.77101.3899.702.76
248251-48251100.297101.89
347811-4781199.383100.96
447965-4796599.703101.27
546210-4621096.05597.63
645013-4501393.56795.04
30min148044-4804499.86797.802.01101.9799.902.01
247763-4776399.283101.43
347556-4755698.853100.98
446886-4688697.46099.59
546535-4653596.73198.84
645506-4550694.59296.59
45min147389-4738998.50697.532.29101.17100.172.28
246968-4696897.631100.33
347290-4729098.300100.97
447529-4752998.797101.46
547555-4755598.851101.49
644777-4477793.07695.60
60min147841-4784199.44597.412.68102.65100.602.66
247215-4721598.144101.38
347641-4764199.030102.25
447313-4731398.348101.56
546744-4674497.165100.36
644428-4442892.35195.39
极限148122-48122100.029100.781.04103.79104.501.07
248936-48936101.721105.51
348653-48653101.133104.90
449023-49023101.902105.66
548450-48450100.711104.44
647711-4771199.175102.72
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%
111.353913463908013909333910303910153910250.06
211.363922493921733922110.02
单位质量响应值RSD%判断
34451.5434525.620.16数据可信
中间条件3月-供试品溶液-2024052421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%
5min1109236-10923628.42029.483.4728.4229.483.47
2119497-11949731.09031.09
3114025-11402529.66629.67
4114673-11467329.83529.83
5108852-10885228.32028.32
6113480-11348029.52429.52
10min1276418-27641871.91770.622.8272.0770.782.82
2274423-27442371.39871.57
3273857-27385771.25071.42
4273706-27370671.21171.38
5255937-25593766.58866.75
6274216-27421671.34471.51
15min1302799-30279978.78077.871.8279.3478.421.82
2296094-29609477.03677.61
3301287-30128778.38778.95
4305223-30522379.41179.97
5290076-29007675.47076.00
6300218-30021878.10978.67
20min1310248-31024880.71879.582.1281.7180.572.11
2305273-30527379.42480.42
3310687-31068780.83281.83
4310823-31082380.86881.87
5294108-29410876.51977.47
6304179-30417979.13980.13
30min1326083-32608384.83881.482.5186.2882.912.48
2311547-31154781.05682.49
3312578-31257881.32482.77
4310018-31001880.65882.11
5302369-30236978.66880.04
6316371-31637182.31183.75
45min1334260-33426086.96683.532.1788.8885.422.15
2314192-31419281.74483.63
3320550-32055083.39985.30
4320985-32098583.51285.41
5316815-31681582.42784.24
6319613-31961383.15585.05
60min1337211-33721187.73384.412.0490.1386.762.02
2320232-32023283.31685.66
3324494-32449484.42586.79
4322885-32288584.00686.37
5318695-31869582.91685.18
6323210-32321084.09186.44
极限1375356-37535697.65898.151.06100.54100.971.06
2380151-38015198.905101.71
3378158-37815898.387101.22
4377978-37797898.340101.17
5370318-37031896.34799.07
6381554-38155499.270102.09
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