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%
1 15.179350593576941769362293871937500.30
2 15.169344094352938960.69
单位质量响应值RSD%判断
6179.966193.670.16数据可信
加速6月-供试品溶液-2025021021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%
5min148214-4821450.51844.1013.4850.5244.1013.48
245119-4511947.27647.28
342277-4227744.29844.30
434586-3458636.23936.24
546480-4648048.70248.70
635874-3587437.58937.59
10min166153-6615369.31568.3311.3069.4068.4011.29
269597-6959772.92373.00
367510-6751070.73770.81
451475-5147553.93554.00
572650-7265076.12276.20
663890-6389066.94467.01
15min170301-7030173.66178.029.7173.8678.219.71
279063-7906382.84283.04
374968-7496878.55178.74
462228-6222865.20265.35
582216-8221686.14686.35
678013-7801381.74281.92
20min172670-7267076.14383.717.3176.4784.027.30
283158-8315887.13387.47
380714-8071484.57284.89
472887-7288776.37176.63
586740-8674090.88691.24
683157-8315787.13287.44
30min176966-7696680.64586.525.5681.0986.985.57
283529-8352987.52188.00
382049-8204985.97186.43
478142-7814281.87782.26
589209-8920993.47393.98
685544-8554489.63390.09
45min179907-7990783.72688.154.1584.3188.754.17
285136-8513689.20589.83
383055-8305587.02587.63
481660-8166085.56386.09
589959-8995994.25994.92
685048-8504889.11389.72
极限174926-7492678.50788.106.4579.2388.856.43
286433-8643390.56491.34
383287-8328787.26888.02
481698-8169885.60386.27
589786-8978694.07794.89
688375-8837592.59993.35
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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%
111.503572933574483561023566913567983568660.15
211.513568173572133570150.08
单位质量响应值RSD%判断
31031.8331017.810.04数据可信
加速6月-供试品溶液-2025021021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%
5min1223894-22389459.73552.9814.4759.7352.9814.47
2203561-20356154.31054.31
3209405-20940555.86955.87
4154595-15459541.24641.25
5226572-22657260.44960.45
6173532-17353246.29846.30
10min1281728-28172875.16572.7211.9075.2672.8111.90
2282140-28214075.27575.37
3285006-28500676.03976.13
4210339-21033956.11856.19
5304984-30498481.37081.47
6271282-27128272.37872.46
15min1301401-30140180.41481.129.1580.6481.339.15
2309097-30909782.46782.68
3312180-31218083.29083.51
4251638-25163867.13767.30
5333426-33342688.95889.19
6316502-31650284.44384.64
20min1305457-30545781.49684.886.6581.8585.226.66
2317795-31779584.78885.14
3323282-32328286.25286.61
4285077-28507776.05876.33
5346259-34625992.38292.77
6330922-33092288.29088.63
30min1310023-31002382.71487.095.2383.2187.585.24
2322535-32253586.05286.55
3329552-32955287.92488.43
4306818-30681881.85982.26
5351858-35185893.87694.41
6337774-33777490.11890.60
45min1310033-31003382.71787.644.8983.3588.274.89
2323462-32346286.30086.94
3329771-32977187.98388.63
4314680-31468083.95784.49
5352824-35282494.13394.83
6340112-34011290.74291.38
极限1310667-31066782.88688.344.9383.6689.124.94
2330319-33031988.12988.91
3330685-33068588.22789.02
4316611-31661184.47285.15
5354060-35406094.46395.32
6344322-34432291.86592.65
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%
1 15.179494794394945849508094532947070.31
2 15.169310593284931940.14
单位质量响应值RSD%判断
6243.056147.361.10数据可信
加速6月-供试品溶液-2025021121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%
5min133511-3351135.06744.9712.4835.0744.9712.47
248309-4830950.55250.55
344429-4442946.49246.49
441264-4126443.18043.18
547509-4750949.71549.72
642831-4283144.82044.82
10min153796-5379656.29465.908.3056.3565.978.31
269165-6916572.37772.46
365700-6570068.75168.83
461081-6108163.91763.99
564600-6460067.60067.68
663487-6348766.43566.51
15min164802-6480267.81174.275.0767.9674.455.08
275359-7535978.85979.06
373057-7305776.45076.64
469603-6960372.83573.01
571082-7108274.38374.58
671941-7194175.28275.47
20min172984-7298476.37378.523.2976.6478.823.30
279060-7906082.73183.07
376047-7604779.57879.90
472343-7234375.70276.00
575773-7577379.29279.61
673980-7398077.41577.73
30min177462-7746281.05981.363.3381.4581.803.33
282062-8206285.87386.35
377072-7707280.65181.10
474078-7407877.51877.94
578473-7847382.11782.57
677327-7732780.91881.36
45min177998-7799881.62081.643.1082.1582.223.10
282721-8272186.56287.18
377499-7749981.09881.68
475868-7586879.39179.95
577222-7722280.80881.40
676818-7681880.38580.96
极限181528-8152885.31483.802.9585.9884.522.94
284122-8412288.02888.79
379659-7965983.35884.08
477696-7769681.30481.99
578741-7874182.39883.12
678759-7875982.41683.13
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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%
111.503611453601363606163612143619043610030.19
211.513553363572153562760.38
单位质量响应值RSD%判断
31391.5730953.611.00数据可信
加速6月-供试品溶液-2025021121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%
5min1161375-16137542.85354.4611.9942.8554.4611.99
2229770-22977061.01561.01
3210608-21060855.92755.93
4199782-19978253.05253.05
5225974-22597460.00760.01
6203019-20301953.91153.91
10min1228472-22847260.67070.407.9160.7470.497.92
2288352-28835276.57176.67
3275839-27583973.24873.34
4256467-25646768.10468.19
5276279-27627973.36573.47
6265287-26528770.44670.54
15min1264779-26477970.31276.735.3370.4876.945.35
2309250-30925082.12182.35
3296091-29609178.62678.84
4280223-28022374.41374.61
5296522-29652278.74178.96
6286805-28680576.16076.37
20min1287771-28777176.41779.553.9476.7179.883.95
2318659-31865984.61984.99
3303227-30322780.52180.87
4287791-28779176.42276.75
5304277-30427780.80081.15
6295653-29565378.51078.84
30min1299780-29978079.60681.043.3980.0281.513.39
2323056-32305685.78786.29
3306449-30644981.37781.86
4293213-29321377.86278.32
5308622-30862281.95482.44
6299984-29998479.66080.13
45min1301998-30199880.19581.553.0180.7482.153.03
2322988-32298885.76986.42
3308226-30822681.84982.46
4295679-29567978.51779.10
5309622-30962282.21982.84
6303998-30399880.72681.32
极限1313946-31394683.36882.883.2384.0583.623.23
2328498-32849887.23288.03
3314111-31411183.41284.16
4299031-29903179.40780.12
5312616-31261683.01583.78
6304447-30444780.84581.58
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%
1 15.179573994859951249524295404952740.35
2 15.169544495554954990.09
单位质量响应值RSD%判断
6280.426299.410.22数据可信
加速6月-供试品溶液-2025021221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%
5min143000-4300044.31744.9413.5044.3244.9413.49
247558-4755849.01449.01
347430-4743048.88248.88
447537-4753748.99348.99
543738-4373845.07745.08
632340-3234033.33033.33
10min169104-6910471.22069.507.5271.2969.577.52
271698-7169873.89473.98
371305-7130573.48973.57
470114-7011472.26172.34
563071-6307165.00265.08
659300-5930061.11661.17
15min177822-7782280.20579.876.5180.4080.066.51
282590-8259085.11985.32
381128-8112883.61283.82
480830-8083083.30583.51
571591-7159173.78373.97
671035-7103573.21073.37
20min181954-8195484.46483.276.1184.7983.596.11
286764-8676489.42189.77
382930-8293085.47085.81
483539-8353986.09786.44
574364-7436476.64176.95
675208-7520877.51177.79
30min181797-8179784.30284.386.8184.7784.846.81
288689-8868991.40591.90
385761-8576188.38788.87
484301-8430186.88287.37
574237-7423776.51076.94
676453-7645378.79479.20
45min184326-8432686.90886.296.0487.5286.906.04
289275-8927592.00992.66
388321-8832191.02691.66
485108-8510887.71488.34
577792-7779280.17480.74
677550-7755079.92580.46
极限186678-8667889.33287.225.7490.0887.975.75
289885-8988592.63793.44
388264-8826490.96791.75
485661-8566188.28489.06
578424-7842480.82681.52
678864-7886481.27981.95
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100590-202406对照品来源中检院对照品使用方法直接使用
对照品含量(%)95.1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%
111.503630053654753656363642213644213645520.30
211.513640723648293644500.15
单位质量响应值RSD%判断
31700.1731663.770.09数据可信
加速6月-供试品溶液-2025021221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%
5min1193691-19369150.60552.2512.5150.6052.2512.51
2215783-21578356.37756.38
3221753-22175357.93657.94
4211900-21190055.36255.36
5203826-20382653.25353.25
6152997-15299739.97339.97
10min1278441-27844172.74772.865.6272.8372.945.63
2295295-29529577.15077.24
3292360-29236076.38476.48
4285597-28559774.61774.71
5266632-26663269.66269.75
6254830-25483066.57866.64
15min1307069-30706980.22780.284.9080.4380.484.91
2324431-32443184.76384.99
3319815-31981583.55783.78
4313462-31346281.89782.11
5290001-29000175.76775.97
6288744-28874475.43975.62
20min1317770-31777083.02282.814.8083.3683.154.81
2333988-33398887.26087.62
3330602-33060286.37586.74
4321613-32161384.02684.38
5297560-29756077.74278.07
6300198-30019878.43178.73
30min1322066-32206684.14584.144.8184.6284.624.81
2339327-33932788.65489.16
3336110-33611087.81488.32
4327373-32737385.53186.02
5303780-30378079.36779.83
6303619-30361979.32579.76
45min1323941-32394184.63584.704.7085.2585.324.71
2340692-34069289.01189.67
3338567-33856788.45689.11
4329632-32963286.12286.76
5306485-30648580.07480.67
6305887-30588779.91880.48
极限1331054-33105486.49385.334.7387.2586.094.74
2344134-34413489.91090.72
3339660-33966088.74189.54
4328727-32872785.88586.66
5308072-30807280.48981.22
6307966-30796680.46181.16
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