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%
115.089476694868950849495094947949230.13
215.049511795437952770.24
单位质量响应值RSD%判断
6294.636334.910.46数据可信
供试品溶液-24111101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%
5min161690-6169063.32962.212.2363.3362.212.22
259245-5924560.81960.82
361782-6178263.42463.42
460556-6055662.16562.17
561624-6162463.26263.26
658705-5870560.26560.27
10min182772-8277284.97284.071.9185.0884.181.91
282492-8249284.68484.79
383526-8352685.74685.85
479338-7933881.44681.55
582561-8256184.75584.86
680700-8070082.84582.94
15min189026-8902691.39291.031.4191.6491.281.41
288115-8811590.45790.70
390682-9068293.09293.34
487338-8733889.65989.90
589277-8927791.64991.90
687610-8761089.93890.18
20min191006-9100693.42493.411.3093.8293.811.30
291594-9159494.02894.42
393013-9301395.48595.89
489834-8983492.22192.61
590448-9044892.85293.25
690083-9008392.47792.87
30min192142-9214294.59194.272.0295.1594.822.02
291188-9118893.61194.16
394747-9474797.26597.83
489112-8911291.48092.02
592485-9248594.94395.50
691315-9131593.74294.28
45min193061-9306195.53495.881.5796.2596.591.57
292939-9293995.40996.11
394998-9499897.52298.25
492295-9229594.74895.44
595364-9536497.89898.61
691750-9175094.18894.89
极限193351-9335195.83296.432.5996.7097.302.57
289968-8996892.35993.22
394791-9479197.31098.20
492853-9285395.32096.17
596222-9622298.77999.65
696443-9644399.00699.86
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%
111.413555223557593560433550773541853553170.21
211.483588513596643592580.17
单位质量响应值RSD%判断
31140.8431294.250.35数据可信
供试品溶液-24111101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%
5min1264045-26404569.86565.494.8969.8765.494.89
2234384-23438462.01762.02
3245975-24597565.08465.08
4255372-25537267.57167.57
5251971-25197166.67166.67
6233356-23335661.74561.75
10min1325693-32569386.17782.582.7186.2982.692.71
2308850-30885081.72181.82
3311727-31172782.48282.59
4313865-31386583.04883.16
5312915-31291582.79682.91
6299566-29956679.26479.37
15min1342466-34246690.61587.162.4790.8887.412.47
2327511-32751186.65886.90
3329876-32987687.28487.53
4330733-33073387.51187.76
5328904-32890487.02787.28
6317039-31703983.88784.12
20min1347226-34722691.87588.792.3992.2989.182.40
2335218-33521888.69789.08
3336772-33677289.10989.50
4338277-33827789.50789.90
5333386-33338688.21388.61
6322470-32247085.32485.70
30min1351754-35175493.07389.752.3793.6490.292.37
2337485-33748589.29789.83
3339591-33959189.85590.39
4341919-34191990.47191.02
5337483-33748389.29789.84
6326979-32697986.51787.03
45min1353633-35363393.57090.592.3194.2991.282.31
2340063-34006389.97990.66
3340381-34038190.06490.75
4344233-34423391.08391.78
5346073-34607391.57092.26
6329848-32984887.27787.94
极限1362254-36225495.85192.981.8096.7393.821.80
2349630-34963092.51193.34
3345569-34556991.43692.28
4353422-35342293.51494.36
5352377-35237793.23894.08
6345219-34521991.34492.15
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%
115.089546495812954049601395375956140.30
215.049584996036959420.14
单位质量响应值RSD%判断
6340.456379.120.43数据可信
供试品溶液-24111102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%
5min167987-6798769.30063.2212.4169.3063.2212.41
252708-5270853.72653.73
367729-6772969.03769.04
453539-5353954.57354.57
560043-6004361.20261.20
670104-7010471.45771.46
10min187742-8774289.43686.824.5589.5586.924.56
279872-7987281.41481.50
387039-8703988.71988.83
480989-8098982.55382.64
585907-8590787.56687.67
689500-8950091.22891.35
15min192458-9245894.24393.193.0294.5193.443.03
286922-8692288.60088.83
392491-9249194.27794.54
489311-8931191.03591.26
593076-9307694.87395.12
694297-9429796.11896.39
20min194906-9490696.73895.483.4697.1695.883.47
287949-8794989.64790.02
394353-9435396.17596.59
492480-9248094.26594.65
594799-9479996.62997.04
697536-9753699.41999.85
30min196161-9616198.01897.362.0598.6097.932.07
292544-9254494.33194.85
395359-9535997.20097.78
494124-9412495.94196.48
597081-9708198.95599.52
697853-9785399.742100.34
45min195338-9533897.17997.221.7597.9297.951.77
292988-9298894.78395.46
395335-9533597.17697.92
494240-9424096.05996.76
596849-9684998.71999.45
697551-9755199.434100.20
极限197120-9712098.99598.591.6499.9099.471.66
294758-9475896.58797.42
398133-98133100.028100.93
494683-9468396.51197.37
597759-9775999.646100.54
697865-9786599.754100.68
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%
111.413588293598873582593600633581113590300.26
211.483599613606883603240.15
单位质量响应值RSD%判断
31466.2631387.110.18数据可信
供试品溶液-24111102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%
5min1267239-26723970.24065.799.5470.2465.799.54
2224547-22454759.01959.02
3268916-26891670.68070.68
4219467-21946757.68357.68
5246990-24699064.91764.92
6274628-27462872.18272.18
10min1320932-32093284.35283.862.0984.4783.962.10
2310900-31090081.71581.81
3320301-32030184.18684.30
4315203-31520382.84682.94
5316571-31657183.20683.31
6330356-33035686.82986.95
15min1335951-33595188.29988.331.8988.5688.581.90
2328262-32826286.27986.51
3334063-33406387.80388.06
4337951-33795188.82589.06
5333095-33309587.54987.80
6347188-34718891.25391.52
20min1339493-33949389.23090.011.8189.6490.401.81
2336336-33633688.40188.78
3338462-33846288.95989.36
4346683-34668391.12091.50
5340850-34085089.58789.98
6352852-35285292.74293.16
30min1343865-34386590.38091.121.7290.9391.671.72
2343071-34307190.17190.70
3340751-34075189.56190.11
4350551-35055192.13792.67
5345076-34507690.69891.24
6356789-35678993.77694.35
45min1343332-34333290.23991.361.5390.9492.061.52
2347105-34710591.23191.91
3342463-34246390.01190.71
4352352-35235292.61093.30
5344643-34464390.58491.28
6355598-35559893.46394.19
极限1346721-34672191.13092.540.9191.9893.390.91
2353422-35342292.89193.72
3352929-35292992.76293.61
4351190-35119092.30593.15
5351820-35182092.47093.31
6356387-35638793.67194.55
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