左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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2.5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%
117.944346743571436104339743400434890.23
217.934417344209441910.06
单位质量响应值RSD%判断
2424.142464.641.18数据可信
长期12月-供试品溶液-2023053121批-左氨氯地平-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%
5min141318-4131885.38581.026.1085.3881.026.10
235416-3541673.18873.19
337219-3721976.91476.91
441342-4134285.43485.43
540105-4010582.87882.88
639826-3982682.30182.30
10min146329-4632995.74091.816.3595.8891.946.35
239791-3979182.22982.35
342051-4205186.89987.03
446322-4632295.72595.87
545746-4574694.53594.67
646326-4632695.73495.87
15min146602-4660296.30493.884.5396.6194.174.53
242464-4246487.75388.01
343174-4317489.22089.49
447095-4709597.32397.62
546265-4626595.60895.90
646972-4697297.06997.37
20min146775-4677596.66294.553.3997.1294.993.40
243379-4337989.64490.05
344211-4421191.36391.78
446968-4696897.06097.52
546447-4644795.98496.44
646728-4672896.56497.02
30min146683-4668396.47195.482.9497.0996.082.95
243681-4368190.26890.82
345643-4564394.32294.90
447118-4711897.37098.00
546908-4690896.93697.55
647180-4718097.49998.12
45min146856-4685696.82994.802.8897.6195.562.87
244439-4443991.83492.54
345935-4593594.92695.66
446736-4673696.58197.37
544095-4409591.12391.90
647190-4719097.51998.30
60min146065-4606595.19496.621.5396.1497.541.54
246193-4619395.45996.32
346145-4614595.36096.25
447259-4725997.66298.61
547087-4708797.30698.23
647767-4776798.71299.66
极限146716-4671696.54097.142.1697.6498.222.12
246831-4683196.77797.79
348111-4811199.422100.47
445290-4529093.59394.70
547910-4791099.007100.10
647188-4718897.51598.62
左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%
110.723327383333883326463317203323313325650.19
210.743366143370823368480.10
单位质量响应值RSD%判断
31022.8531363.870.78数据可信
长期12月-供试品溶液-2023053121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%
5min1292525-29252577.46370.398.9177.4670.388.91
2232349-23234961.52861.53
3242028-24202864.09164.09
4281307-28130774.49274.49
5268348-26834871.06171.06
6278230-27823073.67773.68
10min1340114-34011490.06585.015.2190.1985.135.21
2296230-29623078.44478.55
3305637-30563780.93581.04
4329757-32975787.32287.45
5323603-32360385.69385.81
6330812-33081287.60287.72
15min1356470-35647094.39690.433.6294.6890.693.63
2324534-32453485.93986.17
3328710-32871087.04587.29
4348142-34814292.19192.46
5343218-34321890.88791.15
6347822-34782292.10692.37
20min1364724-36472496.58293.022.8597.0293.432.86
2339352-33935289.86390.24
3339793-33979389.98090.37
4355489-35548994.13694.56
5351871-35187193.17893.59
6356412-35641294.38194.80
30min1370986-37098698.24095.521.8498.8496.091.86
2354128-35412893.77694.30
3353274-35327493.55094.09
4362209-36220995.91696.50
5359683-35968395.24795.81
6364069-36406996.40896.99
45min1375210-37521099.35997.241.23100.1297.971.25
2366059-36605996.93597.62
3363145-36314596.16496.86
4366134-36613496.95597.70
5363432-36343296.24096.97
6369348-36934897.80698.55
60min1376014-37601499.57198.071.15100.5098.951.15
2374270-37427099.11099.95
3368076-36807697.46998.32
4367791-36779197.39498.30
5364821-36482196.60797.49
6371060-37106098.26099.16
极限1378299-378299100.17799.471.67101.27100.521.63
2384520-384520101.824102.83
3379009-379009100.365101.38
4366998-36699897.18498.25
5373739-37373998.969100.02
6371213-37121398.30099.37
左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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数5000
标示量(mg)2.5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%
117.944425244259442864422344264442570.06
217.934486444857448600.02
单位质量响应值RSD%判断
2466.952501.951.00数据可信
中间条件12月-供试品溶液-2023053121批-左氨氯地平-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%
5min141897-4189785.18378.839.5585.1878.849.55
238696-3869678.67578.68
340025-4002581.37781.38
440420-4042082.18082.18
531513-3151364.07164.07
640094-4009481.51881.52
10min146059-4605993.64591.623.5193.7991.753.51
244686-4468690.85490.99
344806-4480691.09891.23
446659-4665994.86595.00
542240-4224085.88185.99
645922-4592293.36793.50
15min146287-4628794.10992.542.4094.4192.832.41
245773-4577393.06493.35
345200-4520091.89992.19
446153-4615393.83794.13
543449-4344988.33988.59
646240-4624094.01394.30
20min147429-4742996.43193.342.3796.8993.782.37
245690-4569092.89593.33
345491-4549192.49192.93
446923-4692395.40295.85
544451-4445190.37690.77
645475-4547592.45892.91
30min146934-4693495.42492.006.2096.0492.596.19
246335-4633594.20794.80
345744-4574493.00593.60
447031-4703195.62296.23
539636-3963680.58681.13
645821-4582193.16293.76
45min147340-4734096.25093.431.7797.0294.181.78
244951-4495191.39392.14
345735-4573592.98793.74
446351-4635194.23995.01
545600-4560092.71293.39
645741-4574192.99993.76
60min147093-4709395.74893.212.0996.6894.112.08
246062-4606293.65294.55
344192-4419289.85090.75
446232-4623293.99794.92
545586-4558692.68493.52
645892-4589293.30694.22
极限147070-4707095.70193.871.5396.8094.931.53
245736-4573692.98994.05
345160-4516091.81892.87
446829-4682995.21196.29
546178-4617893.88794.88
646042-4604293.61194.68
左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%
110.723347903350143350523352353354423351070.08
210.743407863406433407140.03
单位质量响应值RSD%判断
31259.9831723.841.05数据可信
中间条件12月-供试品溶液-2023053121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%
5min1290971-29097176.32371.527.8176.3271.527.81
2268156-26815670.33870.34
3279409-27940973.29073.29
4283232-28323274.29374.29
5231954-23195460.84260.84
6282352-28235274.06274.06
10min1344945-34494590.48087.043.2190.6187.163.22
2334030-33403087.61787.73
3329148-32914886.33786.46
4334550-33455087.75487.88
5312826-31282682.05582.16
6335526-33552688.01088.13
15min1363613-36361395.37792.232.2595.6692.502.26
2354226-35422692.91593.18
3348385-34838591.38391.65
4351227-35122792.12892.40
5339420-33942089.03189.27
6352868-35286892.55992.83
20min1372130-37213097.61194.561.8598.0594.971.86
2362357-36235795.04895.47
3357543-35754393.78594.20
4359088-35908894.19094.61
5352069-35206992.34992.74
6359688-35968894.34894.77
30min1376791-37679198.83496.331.4999.4396.901.49
2369819-36981997.00597.58
3365473-36547395.86596.44
4366028-36602896.01196.59
5361284-36128494.76695.31
6364007-36400795.48096.06
45min1379274-37927499.48597.231.32100.2597.971.32
2372192-37219297.62798.37
3369941-36994197.03797.77
4367832-36783296.48497.22
5369943-36994397.03797.74
6364970-36497095.73396.47
60min1378601-37860199.30997.351.28100.2498.251.27
2372934-37293497.82298.72
3369712-36971296.97797.87
4366655-36665596.17597.08
5373039-37303997.85098.71
6365928-36592895.98496.88
极限1378525-37852599.28997.661.72100.3898.721.70
2375708-37570898.55099.61
3368570-36857096.67797.74
4366160-36616096.04597.11
5379635-37963599.580100.60
6365384-36538495.84296.90
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