阿齐沙坦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%
1 10.982960052957372960602957792957632958690.06
2 10.962955362954732955040.02
单位质量响应值RSD%判断
26946.1726962.040.05数据可信
长期18月-供试品溶液-2023101221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%
5min1110096-11009636.65126.7931.6736.6526.7931.66
277317-7731725.73925.74
336404-3640412.11912.12
473651-7365124.51824.52
598693-9869332.85532.85
686698-8669828.86228.86
10min1268263-26826389.30577.3314.6789.5177.4814.70
2224473-22447374.72774.87
3173630-17363057.80157.87
4224530-22453074.74674.88
5261679-26167987.11387.30
6241225-24122580.30480.46
15min1296206-29620698.60791.458.4899.3192.038.53
2252963-25296384.21184.77
3238452-23845279.38079.77
4284632-28463294.75495.31
5290103-29010396.57597.24
6285938-28593895.18995.80
20min1298891-29889199.50194.126.65100.7595.216.72
2261680-26168087.11388.14
3255906-25590685.19186.02
4291230-29123096.95098.03
5294423-29442398.01399.22
6294299-29429997.97299.11
30min1299589-29958999.73396.074.53101.5397.684.61
2268339-26833989.33090.84
3276117-27611791.91993.22
4293586-29358697.73599.35
5297528-29752899.047100.79
6296329-29632998.648100.33
45min1300286-30028699.96596.903.52102.3299.043.63
2279299-27929992.97894.98
3276901-27690192.18093.99
4295434-29543498.350100.51
5296224-29622498.613100.91
6298306-29830699.306101.53
60min1300213-30021399.94196.992.96102.8599.673.09
2285311-28531194.98097.50
3277013-27701392.21794.54
4293593-29359397.737100.44
5295098-29509898.238101.08
6296805-29680598.806101.59
极限1306505-306505102.035101.481.07105.50104.700.98
2310246-310246103.281106.33
3304810-304810101.471104.31
4304223-304223101.276104.52
5301657-301657100.421103.81
6301672-301672100.426103.75
阿齐沙坦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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.127226972362720077210472044721570.22
215.117220372064721340.14
单位质量响应值RSD%判断
4772.294773.920.03数据可信
长期18月-供试品溶液-2023101221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%
5min153087-5308772.10973.7113.6572.1173.7113.66
247256-4725664.18964.19
343857-4385759.57259.57
460255-6025581.84681.85
560900-6090082.72282.72
660229-6022981.81081.81
10min163841-6384186.71789.444.7487.1289.844.77
263275-6327585.94886.30
362162-6216284.43684.77
469592-6959294.52894.98
567776-6777692.06292.52
668409-6840992.92193.38
15min165294-6529488.69093.134.4389.5794.044.47
266104-6610489.79090.62
366098-6609889.78290.58
471842-7184297.58498.56
571484-7148497.09898.07
670568-7056895.85496.82
20min166292-6629290.04693.834.0191.4295.264.05
266449-6644990.25991.59
366955-6695590.94692.25
471691-7169197.37998.90
571349-7134996.91598.43
671748-7174897.45798.96
30min166384-6638490.17195.434.3392.0597.384.34
266679-6667990.57192.41
370280-7028095.46397.27
472811-7281198.901100.96
572696-7269698.744100.79
672680-7268098.723100.77
45min167518-6751891.71194.763.1494.0997.233.18
266984-6698490.98693.32
369871-6987194.90797.24
470240-7024095.40898.02
572749-7274998.816101.41
671199-7119996.71199.30
60min167386-6738691.53295.673.7594.4298.673.79
267662-6766291.90794.75
369255-6925594.07196.93
473106-7310699.301102.44
572586-7258698.595101.74
672606-7260698.622101.75
极限164444-6444487.53695.634.8090.9399.164.76
268983-6898393.70197.05
370403-7040395.63099.01
473756-73756100.184103.88
572247-7224798.135101.83
672571-7257198.575102.25
阿齐沙坦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%
1 10.982947332944752941672950692945832946050.12
2 10.962968412964942966680.09
单位质量响应值RSD%判断
26831.0627068.250.63数据可信
长期18月-供试品溶液-2024010621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%
5min1134819-13481944.88938.6719.4044.8938.6719.40
273952-7395224.62324.62
3136064-13606445.30445.30
4116827-11682738.89938.90
5115711-11571138.52738.53
6119407-11940739.75839.76
10min1264776-26477688.16082.616.7988.4182.826.82
2221662-22166273.80573.94
3265688-26568888.46488.72
4239092-23909279.60879.82
5243870-24387081.19981.41
6253542-25354284.42084.64
15min1288313-28831395.99792.114.2096.7492.784.23
2265623-26562388.44288.99
3287845-28784595.84196.58
4260917-26091786.87587.53
5274295-27429591.32991.99
6282823-28282394.16994.86
20min1292957-29295797.54394.403.4998.8295.593.52
2275871-27587191.85492.89
3289827-28982796.50197.78
4267974-26797489.22590.37
5283247-28324794.31095.48
6291251-29125196.97598.19
30min1292272-29227297.31594.853.4899.1396.563.49
2280460-28046093.38294.93
3288047-28804795.90897.72
4266646-26664688.78390.42
5290030-29003096.56998.27
6291807-29180797.16098.91
45min1293840-29384097.83795.683.45100.1997.923.46
2280188-28018893.29295.36
3289051-28905196.24398.59
4271199-27119990.29992.43
5292129-29212997.26799.50
6297781-29778199.149101.44
60min1290433-29043396.70395.262.4499.6098.022.48
2279575-27957593.08795.67
3285266-28526694.98297.86
4276683-27668392.12594.76
5289449-28944996.37599.15
6295111-29511198.260101.10
极限1307452-307452102.369101.602.29105.81104.902.26
2299796-29979699.820102.92
3298265-29826599.311102.72
4307872-307872102.509105.65
5300658-300658100.107103.42
6316759-316759105.468108.86
阿齐沙坦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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.127188671452716417186371715717110.25
215.117225172312722820.06
单位质量响应值RSD%判断
4742.794783.720.61数据可信
长期18月-供试品溶液-2024010621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%
5min160410-6041082.22777.317.5582.2377.317.55
251860-5186070.59070.59
358170-5817079.17879.18
450952-5095269.35469.35
558804-5880480.04180.04
660591-6059182.47482.47
10min170851-7085196.43990.225.1496.9090.655.14
267144-6714491.39391.79
366560-6656090.59891.04
460474-6047482.31582.70
565222-6522288.77789.22
667437-6743791.79292.25
15min171805-7180597.73892.864.0098.7393.794.00
270063-7006395.36796.27
365719-6571989.45490.40
464817-6481788.22689.07
567233-6723391.51592.45
669669-6966994.83095.80
20min172729-7272998.99594.383.50100.5395.833.52
269227-6922794.22995.66
368603-6860393.37994.82
465509-6550989.16890.50
569026-6902693.95595.40
670954-7095496.57998.07
30min172616-7261698.84295.872.96100.9397.842.99
270788-7078896.35398.31
369807-6980795.01896.98
466761-6676190.87292.70
570488-7048895.94597.91
672142-7214298.196100.23
45min173309-7330999.78597.233.42102.4299.743.43
270765-7076596.32298.81
371578-7157897.42999.92
467522-6752291.90894.24
570813-7081396.38798.89
674620-74620101.569104.15
60min172549-7254998.75097.443.26101.94100.493.26
269369-6936994.42297.45
371523-7152397.354100.38
468614-6861493.39496.24
572471-7247198.644101.68
675009-75009102.099105.24
极限172919-7291999.25499.353.94102.99102.943.86
269027-6902793.95697.50
372805-7280599.099102.67
472605-7260598.827102.19
572581-7258198.794102.38
678008-78008106.181109.89
阿齐沙坦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%
1 10.982950772955532942092950922944522948770.19
2 10.962952292961112956700.22
单位质量响应值RSD%判断
26855.8326977.190.32数据可信
长期18月-供试品溶液-2024010721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%
5min1185953-18595361.99047.5520.6761.9947.5520.67
2101557-10155733.85633.86
3142037-14203747.35047.35
4156317-15631752.11152.11
5150403-15040350.13950.14
6119544-11954439.85239.85
10min1284593-28459394.87487.079.5195.2287.339.53
2256759-25675985.59585.78
3248788-24878882.93783.20
4284302-28430294.77795.07
5272615-27261590.88191.16
6219992-21999273.33873.56
15min1291992-29199297.34092.857.5298.2193.597.55
2276158-27615892.06292.73
3269676-26967689.90190.62
4302663-302663100.898101.71
5287569-28756995.86696.65
6242990-24299081.00581.63
20min1287362-28736295.79793.085.0197.2194.345.07
2282477-28247794.16895.34
3272303-27230390.77792.00
4292299-29229997.44398.82
5286652-28665295.56096.88
6254178-25417884.73485.81
30min1289789-28978996.60694.083.6998.5595.863.76
2286550-28655095.52697.22
3275026-27502691.68493.41
4290460-29046096.82998.75
5287153-28715395.72797.57
6264293-26429388.10689.66
45min1289812-28981296.61394.743.1699.0997.043.22
2291620-29162097.21699.45
3276546-27654692.19194.43
4290601-29060196.87699.33
5286793-28679395.60797.99
6269753-26975389.92691.97
60min1286839-28683995.62294.573.3398.6497.403.38
2290005-29000596.67899.45
3275632-27563291.88694.64
4294933-29493398.321101.31
5285122-28512295.05097.96
6269528-26952889.85192.39
极限1291951-29195197.32698.751.04100.88102.101.01
2300945-300945100.325103.63
3294639-29463998.223101.48
4297202-29720299.077102.62
5297509-29750999.179102.62
6295006-29500698.345101.38
阿齐沙坦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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.127184471768718637180971743718050.08
215.117196372224720940.26
单位质量响应值RSD%判断
4749.014771.280.34数据可信
长期18月-供试品溶液-2024010721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%
5min140170-4017054.71373.1915.7254.7173.1915.73
246637-4663763.52163.52
358414-5841479.56179.56
459933-5993381.63081.63
561288-6128883.47683.48
655962-5596276.22276.22
10min162273-6227384.81886.726.6685.1287.126.68
257032-5703277.67978.03
365840-6584089.67690.12
467859-6785992.42692.88
567676-6767692.17792.64
661326-6132683.52883.95
15min165448-6544889.14290.785.8289.9291.675.85
260290-6029082.11782.90
369549-6954994.72895.67
470045-7004595.40396.37
569790-6979095.05696.03
664774-6477488.22489.11
20min165872-6587289.71991.654.3890.9993.044.44
262395-6239584.98486.22
369134-6913494.16295.63
469412-6941294.54196.04
570303-7030395.75597.26
666605-6660590.71892.10
30min164776-6477688.22793.093.7990.0094.993.85
265780-6578089.59491.31
370194-7019495.60697.60
469715-6971594.95496.98
571333-7133397.15899.19
668283-6828393.00394.88
45min167696-6769692.20494.342.6894.4696.762.77
266786-6678690.96493.17
370818-7081896.45698.98
470028-7002895.38097.93
571547-7154797.449100.02
668721-6872193.60096.00
60min167894-6789492.47494.852.3795.2497.792.47
267759-6775992.29095.01
370269-7026995.70898.76
471352-7135297.183100.26
571468-7146897.341100.46
669071-6907194.07796.99
极限168299-6829993.02595.721.7096.3199.191.70
271618-7161897.546100.77
370347-7034795.81599.40
470436-7043695.93699.56
571283-7128397.089100.75
669694-6969494.92598.37
阿齐沙坦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%
1 10.982957332955572954592951472958412955470.10
2 10.962947362946532946940.02
单位质量响应值RSD%判断
26916.8526888.140.08数据可信
长期18月-供试品溶液-2024010921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%
5min1207237-20723769.12151.5517.5469.1251.5517.54
2128257-12825742.77942.78
3145134-14513448.40848.41
4147712-14771249.26849.27
5152651-15265150.91550.91
6146321-14632148.80448.80
10min1290448-29044896.87591.926.3397.2692.216.33
2267328-26732889.16489.40
3283387-28338794.52094.79
4287407-28740795.86196.13
5243975-24397581.37581.66
6281012-28101293.72894.00
15min1300943-300943100.37697.654.74101.3098.454.75
2283882-28388294.68595.42
3289669-28966996.61697.41
4310450-310450103.547104.35
5271750-27175090.63991.37
6299958-299958100.047100.84
20min1300642-300642100.27698.403.34101.7699.743.36
2289244-28924496.47497.73
3291519-29151997.23398.56
4305002-305002101.730103.11
5279900-27990093.35794.60
6303893-303893101.360102.71
30min1298378-29837899.52098.303.17101.56100.183.19
2286139-28613995.43897.23
3289737-28973796.63898.51
4309892-309892103.361105.31
5285772-28577295.31697.07
6298381-29838199.521101.43
45min1296619-29661998.93498.982.73101.52101.422.74
2292426-29242697.53599.86
3292465-29246597.54899.96
4309856-309856103.349105.87
5287222-28722295.79998.09
6302002-302002100.729103.19
60min1308706-308706102.96599.142.87106.10102.122.91
2289842-28984296.67399.54
3296220-29622098.801101.75
4304333-304333101.507104.60
5286115-28611595.43098.25
6298233-29823399.472102.50
极限1307402-307402102.530102.330.89106.24105.860.93
2309797-309797103.329106.73
3303707-303707101.298104.80
4309069-309069103.086106.75
5303247-303247101.144104.49
6307540-307540102.576106.15
阿齐沙坦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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.127170171730713087109971015713710.47
215.117155971858717080.30
单位质量响应值RSD%判断
4720.304745.730.38数据可信
长期18月-供试品溶液-2024010921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%
5min155528-5552876.06475.2013.5576.0675.2013.55
240149-4014954.99855.00
356481-5648177.37077.37
457568-5756878.85978.86
559341-5934181.28781.29
660316-6031682.62382.62
10min161946-6194684.85688.343.5285.2888.753.53
262764-6276485.97686.28
367933-6793393.05793.49
463391-6339186.83587.27
564616-6461688.51388.96
666268-6626890.77691.24
15min163736-6373687.30891.252.9288.2092.162.92
266219-6621990.70991.49
369460-6946095.14996.10
467676-6767692.70593.63
565595-6559589.85490.80
666997-6699791.77592.74
20min164304-6430488.08692.433.5989.4693.843.55
268745-6874594.16995.46
371091-7109197.38398.86
467061-6706191.86393.30
565504-6550489.73091.17
668128-6812893.32494.80
30min164676-6467688.59593.623.8190.4695.553.78
268481-6848193.80895.62
372525-7252599.347101.36
469304-6930494.93596.88
566974-6697491.74393.68
668119-6811993.31295.30
45min164919-6491988.92894.494.3891.2996.944.31
270540-7054096.62898.96
373611-73611100.835103.40
469805-6980595.62198.09
567349-6734992.25794.71
667637-6763792.65295.16
60min165716-6571690.02094.554.8492.8797.524.76
269909-6990995.76498.63
375028-75028102.776105.90
468883-6888394.35897.36
566331-6633190.86393.83
668281-6828193.53496.56
极限166015-6601590.43095.364.0693.7898.864.01
271096-7109697.390100.79
373898-73898101.228104.93
468264-6826493.51097.04
567768-6776892.83196.30
670626-7062696.746100.29
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