氨氯地平阿托伐他汀钙片项目信息
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2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.199567897602971349738497308970210.80
215.179707097094970820.02
单位质量响应值RSD%判断
6387.166399.600.14数据可信
供试品溶液-24080801批-氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min180768-8076881.89478.245.3381.8978.245.33
278293-7829379.38579.38
381969-8196983.11283.11
470775-7077571.76271.76
574734-7473475.77675.78
676455-7645577.52177.52
10min193756-9375695.06392.253.0795.2092.383.07
290076-9007691.33291.46
393778-9377895.08595.22
486269-8626987.47287.59
591369-9136992.64392.77
690622-9062291.88592.01
15min196782-9678298.13195.792.4498.4396.072.45
293186-9318694.48594.77
396910-9691098.26198.56
490951-9095192.21992.48
595267-9526796.59596.88
693716-9371695.02395.30
20min197806-9780699.17097.012.0799.6397.452.08
294105-9410595.41795.86
397645-9764599.00699.47
492985-9298594.28194.70
596599-9659997.94698.39
694892-9489296.21596.66
30min197944-9794499.30998.071.8499.9398.681.84
295318-9531896.64797.25
398518-9851899.891100.52
493978-9397895.28895.86
597932-9793299.29799.90
696640-9664097.98798.59
45min198400-9840099.77298.141.97100.5698.911.98
294967-9496796.29197.05
399061-99061100.442101.23
494403-9440395.71996.45
597768-9776899.13199.90
696162-9616297.50398.27
极限198419-9841999.79198.261.34100.7599.191.35
295478-9547896.80997.73
398176-9817699.545100.50
495739-9573997.07497.97
597520-9752098.88099.82
696097-9609797.43798.36
氨氯地平阿托伐他汀钙片项目信息
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100590-202005 对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.423576993553223556943551523549333557600.32
211.473544213545883545040.04
单位质量响应值RSD%判断
31152.3630907.060.56数据可信
供试品溶液-24080801批-阿托伐他汀钙-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1137855-13785536.69735.557.1436.7035.557.14
2138996-13899637.00137.00
3147411-14741139.24139.24
4122118-12211832.50832.51
5125328-12532833.36233.36
6129594-12959434.49834.50
10min1237005-23700563.09160.854.6863.1560.914.68
2231703-23170361.67961.74
3242459-24245964.54364.61
4212851-21285156.66156.72
5222173-22217359.14359.20
6225365-22536559.99260.05
15min1283831-28383175.55674.183.3775.7274.343.38
2278746-27874674.20274.37
3293079-29307978.01878.19
4265060-26506070.55970.71
5276690-27669073.65573.81
6274522-27452273.07873.24
20min1308852-30885282.21781.332.8682.5181.622.87
2304630-30463081.09381.38
3319216-31921684.97685.28
4292446-29244677.84978.12
5305832-30583281.41381.69
6302229-30222980.45480.73
30min1333192-33319288.69688.692.6389.1389.112.64
2335848-33584889.40389.83
3343989-34398991.57092.01
4317778-31777884.59384.99
5337373-33737389.80990.22
6330918-33091888.09188.50
45min1344153-34415391.61492.322.4792.1992.892.47
2350755-35075593.37193.94
3357134-35713495.06995.67
4332224-33222488.43888.98
5351273-35127393.50994.07
6345343-34534391.93192.49
极限1354116-35411694.26695.100.9795.0095.820.98
2360470-36047095.95796.69
3361461-36146196.22196.98
4353531-35353194.11094.79
5358823-35882395.51996.24
6355037-35503794.51195.22
氨氯地平阿托伐他汀钙片项目信息
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2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.199753197220972639718797243972890.15
215.179875498746987500.01
单位质量响应值RSD%判断
6404.816509.561.15数据可信
供试品溶液-24080801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%
5min146656-4665646.84243.327.1346.8443.327.13
246497-4649746.68246.68
339645-3964539.80339.80
439931-3993140.09040.09
543824-4382443.99944.00
642307-4230742.47642.48
10min169763-6976370.04170.623.4670.1270.693.46
271850-7185072.13772.21
365833-6583366.09666.16
472769-7276973.05973.13
570638-7063870.92070.99
671161-7116171.44571.52
15min179742-7974280.06082.965.4680.2583.155.45
283089-8308983.42083.62
377285-7728577.59377.77
490362-9036290.72290.91
581111-8111181.43581.63
684193-8419384.52984.72
20min183173-8317383.50587.666.3683.8387.996.34
286944-8694487.29187.63
381953-8195382.28082.59
497350-9735097.73898.08
585350-8535085.69086.02
689126-8912689.48189.81
30min185979-8597986.32290.576.5986.7991.046.58
289194-8919489.55090.03
386016-8601686.35986.80
4101841-101841102.247102.75
588008-8800888.35988.83
690198-9019890.55891.04
45min186631-8663186.97792.826.4187.5993.446.39
290939-9093991.30291.93
389075-8907589.43090.02
4103686-103686104.100104.77
591417-9141791.78292.40
692960-9296093.33193.96
极限193916-9391694.29198.044.7295.0598.824.71
297109-9710997.49698.28
395810-9581096.19296.93
4106578-106578107.003107.85
594736-9473695.11495.88
697754-9775498.14498.93
氨氯地平阿托伐他汀钙片项目信息
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100590-202005 对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.423549013545853548423545893546923547220.05
211.473619753619413619580.01
单位质量响应值RSD%判断
31061.4731556.931.12数据可信
供试品溶液-24080801批-阿托伐他汀钙-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%
5min1212382-21238256.03451.9610.2556.0351.9610.25
2215770-21577056.92856.93
3186003-18600349.07449.07
4162633-16263342.90942.91
5208943-20894355.12755.13
6195862-19586251.67651.68
10min1285605-28560575.35375.214.0075.4575.304.00
2295866-29586678.06078.16
3269310-26931071.05471.14
4273056-27305672.04272.11
5294582-29458277.72277.81
6292002-29200277.04177.13
15min1312826-31282682.53584.263.0882.7584.473.08
2324926-32492685.72785.95
3302132-30213279.71479.91
4325012-32501285.75085.94
5324958-32495885.73685.96
6326240-32624086.07486.29
20min1321301-32130184.77187.573.3485.1387.923.33
2335726-33572688.57788.94
3315479-31547983.23583.57
4344544-34454490.90391.24
5336255-33625588.71689.08
6338055-33805589.19189.55
30min1327384-32738486.37689.883.1886.8790.383.17
2342799-34279990.44390.96
3327516-32751686.41186.88
4353250-35325093.20093.69
5348135-34813591.85192.36
6344879-34487990.99291.50
45min1328404-32840486.64590.922.9187.2991.572.89
2344685-34468590.94191.61
3338435-33843589.29289.91
4354815-35481593.61394.25
5353947-35394793.38494.05
6347462-34746291.67392.33
极限1367979-36797997.08698.201.1797.8799.001.18
2377536-37753699.608100.43
3368632-36863297.25998.02
4368932-36893297.33898.14
5377087-37708799.489100.31
6373052-37305298.42599.24
氨氯地平阿托伐他汀钙片项目信息
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2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.199773197698976219760097635976570.06
215.179753797771976540.17
单位质量响应值RSD%判断
6429.036437.310.10数据可信
供试品溶液-24080802批-氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min177521-7752178.11679.693.8678.1279.693.86
280854-8085481.47481.47
383448-8344884.08884.09
480650-8065081.26981.27
576550-7655077.13777.14
675491-7549176.07076.07
10min190331-9033191.02491.182.2391.1591.312.23
291063-9106391.76191.90
392900-9290093.61393.75
492250-9225092.95893.09
587741-8774188.41488.54
688623-8862389.30389.43
15min193642-9364294.36094.161.5494.6494.451.55
293233-9323393.94894.24
394876-9487695.60495.90
494958-9495895.68695.98
591081-9108191.78092.06
692870-9287093.58293.86
20min194362-9436295.08695.121.6095.5295.561.61
293934-9393494.65495.10
395676-9567696.41096.87
496527-9652797.26797.72
592353-9235393.06193.49
693516-9351694.23394.66
30min194793-9479395.52095.851.4996.1296.451.50
294336-9433695.06095.66
396062-9606296.79997.41
497295-9729598.04198.65
593196-9319693.91194.49
695068-9506895.79796.39
45min194812-9481295.53995.741.3496.3096.501.35
294661-9466195.38796.15
395366-9536696.09796.87
497226-9722697.97298.75
593342-9334294.05894.80
694678-9467895.40496.15
极限194769-9476995.49695.921.2796.4196.841.28
294931-9493195.65996.58
396164-9616496.90297.84
496917-9691797.66098.60
593442-9344294.15995.06
694942-9494295.67096.58
氨氯地平阿托伐他汀钙片项目信息
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100590-202005 对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.423581203581343580793582793583353581890.04
211.473597833601233599530.07
单位质量响应值RSD%判断
31365.0631382.130.04数据可信
供试品溶液-24080802批-阿托伐他汀钙-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1156168-15616841.11642.906.1441.1242.906.14
2166922-16692243.94743.95
3180392-18039247.49347.49
4163190-16319042.96442.96
5158981-15898141.85641.86
6152060-15206040.03440.03
10min1258305-25830568.00667.653.9168.0767.723.91
2258198-25819867.97868.05
3272191-27219171.66271.74
4261207-26120768.77068.84
5244380-24438064.34064.41
6247393-24739365.13365.20
15min1306735-30673580.75779.613.4080.9479.803.40
2302546-30254679.65479.84
3315638-31563883.10183.30
4308515-30851581.22581.41
5288140-28814075.86176.04
6292749-29274977.07577.25
20min1331155-33115587.18686.093.2287.5086.413.22
2326496-32649685.95986.28
3339046-33904689.26489.60
4336076-33607688.48288.80
5313367-31336782.50382.81
6315904-31590483.17183.47
30min1352361-35236192.76992.142.8393.2392.602.83
2350925-35092592.39192.85
3359801-35980194.72895.21
4359950-35995094.76795.24
5335489-33548988.32788.77
6341251-34125189.84490.29
45min1361872-36187295.27394.612.4195.8995.222.42
2362812-36281295.52196.14
3365088-36508896.12096.76
4368982-36898297.14597.77
5347432-34743291.47192.06
6349971-34997192.14092.73
极限1365068-36506896.11595.842.2396.8996.612.24
2367295-36729596.70197.48
3371066-37106697.69498.50
4372241-37224198.00398.79
5352377-35237792.77393.51
6356096-35609693.75394.50
氨氯地平阿托伐他汀钙片项目信息
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2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.199900898646986109874598267986550.28
215.179823498260982470.02
单位质量响应值RSD%判断
6494.736476.400.20数据可信
供试品溶液-24080802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%
5min149350-4935049.32751.083.5449.3351.083.54
252258-5225852.23352.23
352460-5246052.43552.44
453170-5317053.14553.15
548743-4874348.72048.72
650635-5063550.61150.61
10min162906-6290662.87664.844.2162.9664.924.21
265552-6555265.52165.61
367155-6715567.12367.21
468161-6816168.12968.22
560773-6077360.74460.83
664651-6465164.62164.71
15min167292-6729267.26068.954.4367.4569.144.43
268952-6895268.92069.12
372106-7210672.07272.27
471880-7188071.84672.05
563982-6398263.95264.13
669667-6966769.63469.83
20min168752-6875268.72069.814.5769.0270.124.56
269889-6988969.85670.17
373359-7335973.32573.64
472665-7266572.63172.95
564438-6443864.40864.70
669972-6997269.93970.25
30min170573-7057370.54070.944.0970.9571.364.09
271293-7129371.26071.69
373924-7392473.88974.33
472387-7238772.35372.80
565522-6552265.49165.89
672127-7212772.09372.52
45min171675-7167571.64171.273.9872.1771.813.98
271565-7156571.53172.08
373317-7331773.28373.85
473883-7388373.84874.41
565900-6590065.86966.37
671458-7145871.42471.97
极限178563-7856378.52682.4310.3779.1883.1010.31
287645-8764587.60488.27
389173-8917389.13189.82
485912-8591285.87286.56
566735-6673566.70467.32
686801-8680186.76087.42
氨氯地平阿托伐他汀钙片项目信息
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100590-202005 对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.423608763606883603863608803591293603920.21
211.473626183626103626140.01
单位质量响应值RSD%判断
31557.9731614.120.13数据可信
供试品溶液-24080802批-阿托伐他汀钙-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%
5min1187432-18743249.01550.042.8449.0150.042.84
2194561-19456150.87950.88
3190147-19014749.72549.72
4200905-20090552.53852.54
5187092-18709248.92648.93
6188067-18806749.18149.18
10min1224338-22433858.66659.932.9658.7560.012.95
2229103-22910359.91260.00
3232198-23219860.72260.80
4240622-24062262.92563.01
5221306-22130657.87357.95
6227409-22740959.46959.55
15min1232670-23267060.84562.112.9761.0262.292.97
2236907-23690761.95362.14
3240728-24072862.95263.14
4248950-24895065.10265.29
5228405-22840559.73059.91
6237291-23729162.05462.23
20min1235678-23567861.63262.812.8861.9163.092.89
2239806-23980662.71163.00
3244185-24418563.85664.15
4250911-25091165.61565.92
5230842-23084260.36760.64
6239587-23958762.65462.94
30min1240382-24038262.86263.172.3563.2563.562.34
2241579-24157963.17563.57
3245453-24545364.18864.58
4248321-24832164.93865.35
5231692-23169260.58960.97
6241992-24199263.28363.67
45min1242582-24258263.43763.752.9463.9364.242.93
2242416-24241663.39463.89
3246211-24621164.38664.89
4255004-25500466.68667.20
5232820-23282060.88461.36
6243610-24361063.70664.20
极限1264752-26475269.23573.128.9469.8373.738.88
2297290-29729077.74478.35
3298154-29815477.97078.58
4292376-29237676.45977.09
5235212-23521261.51062.09
6289976-28997675.83176.43
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