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%
115.239636396161963099656996339963480.16
215.209755597733976440.13
单位质量响应值RSD%判断
6326.206423.951.09数据可信
供试品溶液-24080101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%
5min192614-9261494.18091.504.3294.1891.504.32
292186-9218693.74593.75
390822-9082292.35892.36
484068-8406885.49085.49
593818-9381895.40595.40
686366-8636687.82787.83
10min198164-9816499.82496.934.3699.9897.084.36
296184-9618497.81197.97
397117-9711798.76098.91
487433-8743388.91289.05
598651-98651100.319100.48
694356-9435695.95296.10
15min1100951-100951102.65899.545.28102.9899.855.28
298207-9820799.868100.19
3101986-101986103.711104.03
487762-8776289.24689.54
599981-99981101.672102.00
698401-98401100.065100.37
20min1101857-101857103.580100.635.69104.07101.115.69
299373-99373101.054101.54
3103991-103991105.750106.24
488011-8801189.49989.94
5101069-101069102.778103.27
699421-99421101.102101.58
30min1102112-102112103.839101.215.89104.51101.865.88
299932-99932101.622102.28
3105002-105002106.778107.45
488117-8811789.60790.20
5101227-101227102.939103.61
6100762-100762102.466103.11
45min1101902-101902103.625101.236.20104.47102.056.18
299888-99888101.577102.40
3105354-105354107.136107.98
487528-8752889.00889.75
5101327-101327103.041103.88
6101274-101274102.987103.80
极限1101813-101813103.535101.085.97104.55102.075.96
299666-99666101.352102.34
3104731-104731106.502107.53
487787-8778789.27290.16
5101323-101323103.037104.05
6101075-101075102.784103.77
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%
111.68 3621753619873615423620563614933618510.09
211.693671583672513672040.02
单位质量响应值RSD%判断
30980.3931411.800.98数据可信
供试品溶液-24080101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%
5min1196903-19690352.13852.3215.3852.1452.3215.38
2202854-20285453.71453.71
3167358-16735844.31544.31
4244123-24412364.64164.64
5212507-21250756.27056.27
6161749-16174942.82942.83
10min1284510-28451075.33574.658.2675.4274.748.27
2280863-28086374.37074.46
3258184-25818468.36468.44
4319874-31987484.69984.81
5291004-29100477.05577.15
6257165-25716568.09568.17
15min1327027-32702786.59385.335.2686.8185.545.28
2317385-31738584.04084.25
3306068-30606881.04481.23
4351030-35103092.94993.20
5326607-32660786.48286.70
6305505-30550580.89481.08
20min1347713-34771392.07190.814.0492.4391.164.06
2338606-33860689.65990.01
3330934-33093487.62887.95
4366253-36625396.98097.38
5345989-34598991.61491.98
6328151-32815186.89187.21
30min1361011-36101195.59294.873.1096.1095.383.12
2352900-35290093.44493.95
3349730-34973092.60593.07
4377450-37745099.945100.51
5361643-36164395.75996.28
6347034-34703491.89192.36
45min1366054-36605496.92796.412.5097.6097.072.53
2358723-35872394.98695.64
3358793-35879395.00595.63
4380430-380430100.734101.47
5365551-36555196.79497.47
6354972-35497293.99394.61
极限1368246-36824697.50896.792.6398.3497.612.65
2359533-35953395.20196.02
3358362-35836294.89095.67
4382154-382154101.190102.09
5368377-36837797.54298.38
6356487-35648794.39495.17
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%
115.239651296512969579718596471967270.34
215.209836798467984170.08
单位质量响应值RSD%判断
6351.086474.801.37数据可信
供试品溶液-24080101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%
5min142915-4291543.38542.8911.5643.3842.8911.56
243541-4354144.01744.02
336031-3603136.42536.43
450847-5084751.40351.40
540251-4025140.69140.69
640960-4096041.40841.41
10min162236-6223662.91765.437.7662.9965.507.76
267667-6766768.40768.48
364286-6428664.98965.05
471386-7138672.16772.25
556672-5667257.29257.36
666056-6605666.77966.85
15min169854-6985470.61873.866.1570.8074.046.15
277469-7746978.31778.50
375784-7578476.61376.78
477139-7713977.98378.19
566312-6631267.03867.20
671812-7181272.59872.78
20min176557-7655777.39579.235.7577.6979.535.75
281374-8137482.26482.58
380522-8052281.40381.70
482130-8213083.02983.36
570080-7008070.84771.12
679567-7956780.43880.74
30min184245-8424585.16782.935.0785.5983.365.07
285612-8561286.54987.00
383356-8335684.26884.70
482236-8223683.13683.61
573893-7389374.70275.09
682841-8284183.74784.18
45min186035-8603586.97685.324.4387.5485.904.43
286379-8637987.32487.92
386740-8674087.68988.26
485976-8597686.91787.53
576969-7696977.81178.33
684289-8428985.21185.79
极限193458-9345894.48194.494.6695.1995.214.64
291107-9110792.10492.85
390520-9052091.51092.23
4101976-101976103.092103.85
590694-9069491.68692.33
693056-9305694.07494.79
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%
111.68 3627113626233624203644343625623629500.24
211.693705053707383706220.05
单位质量响应值RSD%判断
31074.4931704.191.42数据可信
供试品溶液-24080101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%
5min1184627-18462748.58948.658.7648.5948.668.76
2209434-20943455.11755.12
3159908-15990842.08342.08
4191971-19197150.52250.52
5184130-18413048.45848.46
6179195-17919547.15947.16
10min1242729-24272963.88068.948.1063.9669.028.10
2296753-29675378.09778.19
3269962-26996271.04771.12
4249323-24932365.61565.70
5242613-24261363.84963.93
6270387-27038771.15971.24
15min1265023-26502369.74776.499.2569.9376.689.24
2330005-33000586.84887.07
3309052-30905281.33481.52
4271488-27148871.44871.64
5266651-26665170.17570.36
6301552-30155279.36079.56
20min1289036-28903676.06780.548.7276.3780.868.71
2343747-34374790.46590.83
3327082-32708286.07986.40
4281186-28118674.00174.31
5279634-27963473.59273.90
6315510-31551083.03483.36
30min1320894-32089484.45184.518.1584.8884.968.14
2355507-35550793.56094.08
3340941-34094189.72790.19
4289710-28971076.24476.68
5292507-29250776.98077.41
6327105-32710586.08586.55
45min1332619-33261987.53686.777.5888.1187.367.58
2360132-36013294.77795.45
3349102-34910291.87492.49
4297749-29774978.36078.92
5302383-30238379.57980.13
6336207-33620788.48189.09
极限1369097-36909797.13697.201.9897.8597.942.02
2377998-37799899.479100.31
3374978-37497898.68499.45
4359767-35976794.68195.37
5361748-36174895.20295.89
6372394-37239498.00498.76
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%
115.239671597027970039725596946969890.20
215.209786897908978880.03
单位质量响应值RSD%判断
6368.296440.000.80数据可信
供试品溶液-24080102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%
5min188062-8806289.14288.361.4389.1488.361.43
287727-8772788.80388.80
389042-8904290.13490.13
486985-8698588.05288.05
585569-8556986.61986.62
686379-8637987.43987.44
10min196425-9642597.60896.491.6997.7696.631.69
295412-9541296.58396.73
397546-9754698.74398.89
495238-9523896.40696.55
592923-9292394.06394.21
694359-9435995.51795.66
15min198727-9872799.93899.351.91100.2599.661.90
297643-9764398.84199.15
3101282-101282102.525102.84
498609-9860999.819100.13
596105-9610597.28497.59
696534-9653497.71898.02
20min198959-98959100.17399.821.98100.65100.301.98
297954-9795499.15699.63
3101944-101944103.195103.68
499126-99126100.342100.82
596193-9619397.37397.84
697491-9749198.68799.15
30min199403-99403100.623100.191.70101.27100.831.70
298856-98856100.069100.71
3101498-101498102.743103.40
499649-99649100.872101.51
596545-9654597.72998.36
697879-9787999.08099.71
45min199724-99724100.947100.391.65101.76101.191.65
298788-98788100.000100.81
3101709-101709102.957103.79
499758-99758100.982101.79
596954-9695498.14498.93
698078-9807899.281100.08
极限199805-99805101.029100.281.84102.01101.261.83
298757-9875799.969100.94
3101797-101797103.046104.05
499743-99743100.967101.94
596598-9659897.78398.74
697716-9771698.91599.88
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%
111.68 3658063659913660753662813669373662180.12
211.693717333721893719610.09
单位质量响应值RSD%判断
31354.2831818.731.04数据可信
供试品溶液-24080102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%
5min1171938-17193844.96544.761.6744.9644.761.67
2174600-17460045.66145.66
3166489-16648943.54043.54
4169406-16940644.30344.30
5171650-17165044.89044.89
6172910-17291045.21945.22
10min1266772-26677269.76668.691.4069.8468.761.40
2267292-26729269.90269.98
3258626-25862667.63567.71
4260715-26071568.18268.26
5259737-25973767.92668.00
6262809-26280968.72968.80
15min1313603-31360382.01381.770.6182.2081.960.61
2315723-31572382.56782.76
3311728-31172881.52381.71
4312962-31296281.84582.03
5310282-31028281.14481.33
6311725-31172581.52281.71
20min1334582-33458287.49988.020.6187.8388.350.61
2338603-33860388.55188.88
3335375-33537587.70788.03
4339193-33919388.70589.03
5334520-33452087.48387.81
6337145-33714588.17088.50
30min1353130-35313092.35093.200.9092.8293.670.90
2358747-35874793.81994.30
3352466-35246692.17692.64
4360585-36058594.30094.77
5355774-35577493.04193.51
6357539-35753993.50393.98
45min1363649-36364995.10195.680.8195.7396.310.81
2367228-36722896.03796.67
3361089-36108994.43195.05
4369104-36910496.52797.16
5367466-36746696.09996.72
6366626-36662695.87996.51
极限1365904-36590495.69196.500.8996.4897.280.89
2369244-36924496.56497.36
3365581-36558195.60696.38
4373769-37376997.74798.54
5367690-36769096.15896.94
6371707-37170797.20898.00
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%
115.239849398324978319824798085981960.26
215.209813697881980080.19
单位质量响应值RSD%判断
6447.546447.890.01数据可信
供试品溶液-24080102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%
5min153073-5307353.35945.2814.3453.3645.2814.34
248438-4843848.69948.70
334426-3442634.61234.61
448328-4832848.58948.59
542701-4270142.93142.93
643240-4324043.47343.47
10min176561-7656176.97469.179.1377.0669.249.13
272436-7243672.82772.91
358444-5844458.75958.82
471201-7120171.58571.67
565564-6556465.91865.99
668579-6857968.94969.02
15min186771-8677187.23979.668.0087.4679.858.01
282967-8296783.41583.62
368867-6886769.23969.39
481813-8181382.25482.45
575297-7529775.70375.88
679680-7968080.11080.30
20min189623-8962390.10783.946.5390.4784.266.55
286428-8642886.89487.24
374479-7447974.88175.15
485812-8581286.27586.61
579762-7976280.19280.50
684811-8481185.26985.59
30min192946-9294693.44887.566.0393.9688.036.04
290535-9053591.02491.51
378889-7888979.31579.71
488608-8860889.08689.57
582742-8274283.18983.63
688846-8884689.32589.79
45min194594-9459495.10489.105.2995.7789.715.30
291271-9127191.76492.40
382317-8231782.76183.29
489888-8988890.37391.00
583741-8374184.19384.77
689918-8991890.40391.02
极限1103086-103086103.64297.003.74104.4797.753.75
295685-9568596.20196.99
394147-9414794.65595.32
493608-9360894.11394.89
594344-9434494.85395.57
697985-9798598.51499.28
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%
111.68 3705693701213687473691673684483694100.25
211.693712983709523711250.07
单位质量响应值RSD%判断
31627.5731747.220.27数据可信
供试品溶液-24080102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%
5min1220981-22098157.60452.7210.5957.6052.7210.59
2212956-21295655.51255.51
3163199-16319942.54142.54
4218738-21873857.01957.02
5197461-19746151.47351.47
6200187-20018752.18352.18
10min1285092-28509274.31672.116.6574.4172.206.66
2288265-28826575.14375.24
3243209-24320963.39863.47
4295180-29518076.94577.04
5271849-27184970.86470.95
6276284-27628472.02072.11
15min1311418-31141881.17880.636.1181.4080.846.11
2322691-32269184.11784.33
3278254-27825472.53372.71
4332190-33219086.59386.82
5299193-29919377.99178.20
6312066-31206681.34781.55
20min1326132-32613285.01484.295.7085.3784.635.71
2334884-33488487.29587.65
3293845-29384576.59776.89
4346424-34642490.30390.67
5311631-31163181.23481.57
6327146-32714685.27885.62
30min1334251-33425187.13087.044.7887.6387.524.79
2343894-34389489.64490.15
3310351-31035180.90081.33
4354890-35489092.51093.03
5321526-32152683.81384.28
6338435-33843588.22188.71
45min1335887-33588787.55688.444.0488.2089.074.06
2348632-34863290.87991.53
3321103-32110383.70384.26
4358089-35808993.34494.02
5327839-32783985.45986.07
6344167-34416789.71590.35
极限1370886-37088696.68098.131.3097.4798.911.30
2372061-37206196.98697.79
3374722-37472297.68098.38
4379942-37994299.04099.87
5377468-37746898.39699.15
6383678-383678100.014100.80
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