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%
114.979455294074939399409093777940860.31
214.979379293733937620.05
单位质量响应值RSD%判断
6284.976263.330.25数据可信
供试品溶液-24072201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%
5min142309-4230943.71450.6011.4543.7150.6011.45
247077-4707748.64148.64
348616-4861650.23150.23
450670-5067052.35352.35
558903-5890360.85960.86
646245-4624547.78147.78
10min176615-7661579.16078.244.1079.2378.324.11
272805-7280575.22375.30
374186-7418676.65076.73
475933-7593378.45578.54
581328-8132884.02984.13
673480-7348075.92076.00
15min187508-8750890.41490.902.4690.6291.122.47
287221-8722190.11890.32
388179-8817991.10891.32
487039-8703989.93090.15
592105-9210595.16495.41
685833-8583388.68488.89
20min192529-9252995.60295.802.7095.9696.172.70
291923-9192394.97695.33
395638-9563898.81499.18
489996-8999692.98593.35
595798-9579898.98099.38
690451-9045193.45593.81
30min195774-9577498.95598.022.5199.4798.542.51
294900-9490098.05298.57
396571-9657199.778100.31
491459-9145994.49795.02
597753-97753101.000101.56
692751-9275195.83296.34
45min196829-96829100.04599.912.20100.72100.602.20
294390-9439097.52598.20
398688-98688101.966102.66
493798-9379896.91397.59
598400-98400101.668102.40
698084-98084101.342102.01
极限197482-97482100.720101.921.76101.57102.781.75
297535-97535100.774101.62
3101380-101380104.747105.61
496862-96862100.079100.92
598604-98604101.879102.78
699988-99988103.309104.15
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%
111.653605483607123607533602243601683604810.08
211.663600823596093598460.10
单位质量响应值RSD%判断
30942.5830861.580.19数据可信
供试品溶液-24072201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%
5min1150339-15033940.18544.4012.9340.1944.4012.92
2159235-15923542.56342.56
3153263-15326340.96740.97
4175309-17530946.85946.86
5205826-20582655.01755.02
6152696-15269640.81540.82
10min1256417-25641768.53967.527.2568.6167.607.25
2245782-24578265.69765.77
3232241-23224162.07762.15
4259656-25965669.40569.48
5283333-28333375.73475.83
6238306-23830663.69863.77
15min1302550-30255080.87178.655.3581.0578.845.35
2289756-28975677.45177.63
3278117-27811774.34074.51
4297226-29722679.44779.64
5319313-31931385.35185.57
6278463-27846374.43274.61
20min1321146-32114685.84183.174.4986.1683.494.50
2307805-30780582.27582.58
3300710-30071080.37980.67
4310718-31071883.05483.38
5332594-33259488.90189.26
6293954-29395478.57378.87
30min1333376-33337689.11086.304.0589.5786.754.06
2321689-32168985.98686.43
3310507-31050782.99783.43
4319689-31968985.45285.92
5342660-34266091.59292.10
6309186-30918682.64483.07
45min1340424-34042490.99489.493.1191.6090.093.12
2330654-33065488.38388.97
3319202-31920285.32285.89
4332239-33223988.80689.41
5350277-35027793.62894.29
6336071-33607189.83190.40
极限1364255-36425597.36496.361.2498.1297.111.25
2356047-35604795.17095.91
3354047-35404794.63695.35
4365048-36504897.57698.33
5361671-36167196.67397.49
6361899-36189996.73497.45
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%
114.979321593226932989307293029931680.13
214.979361093652936310.04
单位质量响应值RSD%判断
6223.656254.580.36数据可信
供试品溶液-24072202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%
5min133720-3372035.03641.2522.2935.0441.2522.30
249738-4973851.67951.68
333140-3314034.43334.43
446744-4674448.56848.57
546152-4615247.95347.95
628713-2871329.83329.83
10min164832-6483267.36267.6214.8067.4267.6814.81
272857-7285775.70075.79
350176-5017652.13452.19
475754-7575478.71078.79
568969-6896971.66071.74
657869-5786960.12760.18
15min180640-8064083.78680.6412.9583.9680.8212.95
282349-8234985.56285.77
361585-6158563.98864.13
489984-8998493.49593.71
580781-8078183.93384.13
670335-7033573.07973.23
20min187647-8764791.06787.249.4691.3887.559.48
286714-8671490.09790.45
373096-7309675.94876.20
494515-9451598.20398.57
585690-8569089.03389.37
676099-7609979.06879.34
30min190851-9085194.39691.806.4394.8692.266.45
288295-8829591.74092.25
385230-8523088.55688.93
497549-97549101.355101.89
587562-8756290.97991.47
680613-8061383.75884.16
45min192067-9206795.65993.385.6496.2894.005.66
289765-8976593.26793.93
389024-8902492.49893.02
497994-97994101.818102.52
587773-8777391.19891.84
682635-8263585.85986.40
极限192803-9280396.42495.605.6297.2096.375.63
292423-9242396.02996.84
391773-9177395.35496.03
4101030-101030104.972105.84
587920-8792091.35092.14
686124-8612489.48490.17
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%
111.653596343601623602303602593601333600840.08
211.663631563634263632910.06
单位质量响应值RSD%判断
30908.5031157.030.57数据可信
供试品溶液-24072202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%
5min1121598-12159832.36640.2423.1132.3740.2423.11
2190496-19049650.70550.71
3126953-12695333.79233.79
4153599-15359940.88440.88
5195997-19599752.16952.17
6118348-11834831.50131.50
10min1234668-23466862.46364.6413.9162.5264.7013.91
2270546-27054672.01272.10
3186908-18690849.75049.81
4246910-24691065.72165.79
5283458-28345875.44975.54
6234492-23449262.41662.47
15min1294146-29414678.29476.7111.4878.4576.8811.48
2304321-30432181.00381.21
3226824-22682460.37560.51
4296639-29663978.95879.14
5324290-32429086.31886.53
6282939-28293975.31175.47
20min1319886-31988685.14682.458.1685.4382.758.17
2315908-31590884.08784.43
3264703-26470370.45770.70
4315012-31501283.84884.16
5340402-34040290.60690.96
6302597-30259780.54480.83
30min1334404-33440489.01087.373.7389.4487.813.76
2325636-32563686.67687.16
3312206-31220683.10183.46
4325685-32568586.68987.14
5348510-34851092.76593.27
6323064-32306485.99186.41
45min1340566-34056690.65089.242.5591.2389.822.58
2330398-33039887.94488.57
3330517-33051787.97588.47
4329930-32993087.81988.41
5350475-35047593.28893.95
6329703-32970387.75988.32
极限1365038-36503897.16497.821.6497.8998.551.62
2366002-36600297.42098.19
3368609-36860998.11498.76
4359032-35903295.56596.31
5368920-36892098.19799.01
6377375-377375100.448101.15
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%
114.979304993115929709283293012929960.12
214.979390693885938960.02
单位质量响应值RSD%判断
6212.166272.280.69数据可信
供试品溶液-24072203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%
5min156686-5668658.86947.0627.5358.8747.0627.52
243947-4394745.64045.64
353581-5358155.64555.64
424628-2462825.57725.58
555112-5511257.23557.23
637938-3793839.39939.40
10min177115-7711580.08566.4126.7880.1866.4926.78
263575-6357566.02466.10
380311-8031183.40483.50
433552-3355234.84434.89
571647-7164774.40774.50
657506-5750659.72159.79
15min183829-8382987.05875.8225.4887.2976.0125.48
281287-8128784.41884.60
388493-8849391.90292.13
437180-3718038.61238.71
576718-7671879.67379.89
670537-7053773.25473.42
20min185049-8504988.32579.1624.0088.7079.4724.00
286293-8629389.61789.94
390694-9069494.18794.57
440452-4045242.01042.18
578229-7822981.24281.59
676625-7662579.57779.86
30min186073-8607389.38880.9122.7389.9181.3622.74
287534-8753490.90691.38
391922-9192295.46396.00
443174-4317444.83745.07
578851-7885181.88882.38
679897-7989782.97583.39
45min186353-8635389.67981.9621.6390.3582.5421.64
289474-8947492.92093.55
392337-9233795.89496.59
445665-4566547.42447.73
578955-7895581.99682.62
680749-8074983.85984.42
极限186902-8690290.24986.9410.0891.0787.6610.17
290968-9096894.47295.25
393113-9311396.70097.56
470232-7023272.93773.33
579357-7935782.41483.17
681718-8171884.86685.56
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%
111.653601343605653600503596983604363601770.10
211.663648263649713648980.03
单位质量响应值RSD%判断
30916.4831294.850.87数据可信
供试品溶液-24072203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%
5min1170755-17075545.34533.4729.5545.3533.4729.55
2120551-12055132.01332.01
3137670-13767036.55936.56
469762-6976218.52618.53
5156895-15689541.66441.66
6100554-10055426.70326.70
10min1232057-23205761.62447.4027.1661.7047.4527.16
2176054-17605446.75246.81
3212955-21295556.55256.61
498537-9853726.16726.20
5200878-20087853.34453.41
6150395-15039539.93839.98
15min1249772-24977266.32953.8924.7966.5154.0324.79
2222898-22289859.19259.32
3235308-23530862.48862.64
4110044-11004429.22329.30
5213247-21324756.62956.79
6186377-18637749.49449.60
20min1254686-25468667.63356.3023.6667.9256.5223.67
2237351-23735163.03063.26
3242836-24283664.48764.75
4117185-11718531.11931.24
5218993-21899358.15558.41
6200988-20098853.37453.57
30min1257929-25792968.49557.9622.3168.9058.2822.32
2244853-24485365.02265.36
3246884-24688465.56265.93
4124845-12484533.15333.33
5221009-22100958.69059.04
6214106-21410656.85757.14
45min1259680-25968068.96059.0321.0369.4859.4521.05
2248513-24851365.99466.44
3250815-25081566.60667.08
4132766-13276635.25735.49
5222590-22259059.11059.56
6219410-21941058.26658.64
极限1263339-26333969.93163.868.4270.5664.388.50
2257098-25709868.27468.83
3256009-25600967.98568.57
4220950-22095058.67558.96
5223867-22386759.44960.00
6221702-22170258.87459.35
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%
114.979296292840928249272792607927920.15
214.979262792509925680.10
单位质量响应值RSD%判断
6198.536183.570.18数据可信
供试品溶液-24072204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%
5min162609-6260965.55760.867.7865.5660.867.78
252382-5238254.84854.85
359681-5968162.49162.49
452842-5284255.33055.33
558837-5883761.60761.61
662381-6238165.31865.32
10min180300-8030084.08079.783.4284.1979.883.42
273460-7346076.91877.01
377186-7718680.82080.92
474862-7486278.38678.48
577431-7743181.07681.18
673903-7390377.38277.49
15min184130-8413088.09185.601.9188.3485.841.91
280156-8015683.93084.15
382347-8234786.22486.46
479931-7993183.69483.92
582205-8220586.07586.31
681754-8175485.60385.84
20min186264-8626490.32587.431.9990.7287.811.99
281843-8184385.69686.06
384394-8439488.36788.75
481986-8198685.84686.21
583001-8300186.90987.29
683530-8353087.46387.84
30min187531-8753191.65287.912.5292.2088.432.52
282904-8290486.80787.31
385420-8542089.44289.97
483386-8338687.31287.82
582134-8213486.00186.53
682343-8234386.22086.75
45min187351-8735191.46388.711.8492.1689.381.85
283208-8320887.12587.77
385549-8554989.57790.26
483798-8379887.74388.39
583560-8356087.49488.16
684886-8488688.88289.55
极限187882-8788292.01992.412.5592.8793.222.53
290237-9023794.48595.28
388976-8897693.16593.99
484586-8458688.56889.37
587132-8713291.23492.05
690690-9069094.96095.78
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%
111.653613963606693605943607633607303608300.09
211.663595203591123593160.09
单位质量响应值RSD%判断
30972.5330816.120.36数据可信
供试品溶液-24072204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%
5min1185890-18589049.70046.679.2349.7046.679.22
2160607-16060742.94142.94
3167475-16747544.77744.78
4154766-15476641.37941.38
5196210-19621052.46052.46
6182410-18241048.77048.77
10min1239394-23939464.00661.386.9264.0961.466.93
2220048-22004858.83358.90
3219763-21976358.75758.83
4218664-21866458.46358.53
5257813-25781368.93069.02
6221778-22177859.29659.38
15min1254085-25408567.93365.895.6468.1266.075.64
2236911-23691163.34263.51
3237332-23733263.45463.63
4236374-23637463.19863.36
5271276-27127672.53072.73
6242760-24276064.90565.09
20min1258677-25867769.16167.205.2769.4667.505.28
2242593-24259364.86165.14
3243653-24365365.14465.42
4241835-24183564.65864.93
5275227-27522773.58673.91
6246173-24617365.81866.11
30min1262181-26218170.09868.134.9670.5268.544.97
2246508-24650865.90866.29
3248149-24814966.34666.73
4247054-24705466.05466.43
5277555-27755574.20874.65
6247566-24756666.19066.59
45min1265190-26519070.90268.914.5671.4469.434.57
2248363-24836366.40466.90
3251682-25168267.29167.79
4251150-25115067.14967.64
5278405-27840574.43675.01
6251628-25162867.27667.78
极限1267986-26798671.65075.126.6572.3075.756.62
2288156-28815677.04377.65
3273783-27378373.20073.81
4255239-25523968.24268.84
5305784-30578481.75682.45
6294849-29484978.83279.45
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