阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.154603346110460444613546218461080.17
211.094597245893459320.13
单位质量响应值RSD%判断
4135.254141.750.12数据可信
供试品溶液-2024052421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%
5min139675-3967577.47784.284.9877.4884.284.98
243101-4310184.16884.17
343123-4312384.21184.21
442836-4283683.65083.65
543843-4384385.61785.62
646373-4637390.55790.56
10min146754-4675491.30193.722.8991.7394.202.87
249364-4936496.39896.87
348371-4837194.45994.93
448685-4868595.07295.54
548952-4895295.59496.07
645845-4584589.52690.03
15min148977-4897795.64295.263.6896.5896.253.64
250525-5052598.66599.67
349136-4913695.95396.95
448718-4871895.13796.13
549947-4994797.53798.54
645395-4539588.64789.65
20min142534-4253483.06092.066.4384.5393.586.34
249723-4972397.09998.65
348327-4832794.37395.90
448366-4836694.44995.97
544216-4421686.34587.89
649696-4969697.04698.54
30min149154-4915495.98895.571.2397.9297.601.22
250023-5002397.68599.78
348857-4885795.40897.46
448510-4851094.73096.78
548348-4834894.41496.44
648749-4874995.19797.23
45min146094-4609490.01295.292.9692.4897.842.93
249933-4993397.509100.14
348294-4829494.30996.89
449227-4922796.13198.70
549437-4943796.54199.09
649780-4978097.21099.77
60min148495-4849594.70193.925.6397.6697.015.42
242957-4295783.88687.06
348505-4850594.72197.82
448000-4800093.73496.84
550276-5027698.179101.27
650351-5035198.326101.43
极限148882-4888295.45797.081.4498.95100.691.43
250847-5084799.294102.94
349992-4999297.624101.25
449273-4927396.22099.85
550018-5001897.675101.31
649255-4925596.18599.83
阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.473936103941003935903939073942023938820.08
211.343939113940233939670.03
单位质量响应值RSD%判断
34340.1934741.360.83数据可信
供试品溶液-2024052421批-阿齐沙坦-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%
5min1103056-10305626.77328.807.9726.7728.807.96
2100988-10098826.23626.24
3115334-11533429.96229.96
4114972-11497229.86829.87
5124149-12414932.25332.25
6106649-10664927.70627.71
10min1292760-29276076.05676.123.4776.2076.283.47
2291344-29134475.68875.83
3279791-27979172.68772.85
4293968-29396876.37076.54
5310966-31096680.78580.96
6289274-28927475.15075.30
15min1316649-31664982.26283.794.5982.8384.364.58
2322526-32252683.78984.35
3304367-30436779.07179.64
4313462-31346281.43482.02
5346146-34614689.92590.55
6331924-33192486.23086.80
20min1326995-32699584.95084.614.2385.9885.664.22
2323320-32332083.99585.03
3306976-30697679.74980.76
4316848-31684882.31483.36
5347134-34713490.18191.31
6332851-33285186.47187.52
30min1347417-34741790.25587.164.4791.7688.684.45
2330847-33084785.95087.45
3315006-31500681.83583.29
4322927-32292783.89385.39
5353242-35324291.76893.40
6343685-34368589.28590.82
45min1346263-34626389.95589.504.6491.9691.514.59
2356938-35693892.72894.70
3322862-32286283.87685.78
4326658-32665884.86286.83
5355575-35557592.37494.51
6358884-35888493.23495.26
60min1348248-34824890.47191.225.1292.9793.725.06
2365219-36521994.88097.37
3331538-33153886.13088.50
4328259-32825985.27887.72
5368456-36845695.72198.37
6365151-36515194.86297.41
极限1373693-37369397.08198.861.44100.09101.871.48
2382497-38249799.368102.39
3379016-37901698.464101.32
4377292-37729298.016100.93
5389771-389771101.258104.44
6381060-38106098.995102.07
阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.154621646185461564602846170461510.16
211.094599845973459860.04
单位质量响应值RSD%判断
4139.104146.620.13数据可信
供试品溶液-2024052421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%
5min140797-4079779.58580.643.3179.5880.643.32
238949-3894975.98075.98
341570-4157081.09281.09
441963-4196381.85981.86
542997-4299783.87683.88
641739-4173981.42281.42
10min147716-4771693.08292.740.8693.5293.190.86
247544-4754492.74693.17
347796-4779693.23893.69
447307-4730792.28492.74
548011-4801193.65794.12
646869-4686991.42991.88
15min149665-4966596.88494.521.7997.8495.481.77
248975-4897595.53896.48
347797-4779793.24094.21
448590-4859094.78795.75
548481-4848194.57495.56
647209-4720992.09393.05
20min148320-4832094.26094.662.1595.7696.152.12
247830-4783093.30494.77
349895-4989597.33298.82
448924-4892495.43896.93
549198-4919895.97397.48
646980-4698091.64693.12
30min147164-4716492.00594.162.0894.0396.182.05
247757-4775793.16295.15
348246-4824694.11696.14
449939-4993997.41899.44
548877-4887795.34797.39
647644-4764492.94194.92
45min148817-4881795.23096.151.4497.7698.681.43
248764-4876495.12697.63
349135-4913595.85098.40
450366-5036698.251100.82
549959-4995997.457100.03
648687-4868794.97697.47
60min148475-4847594.56295.591.7097.6298.661.68
248379-4837994.37597.41
348938-4893895.46698.55
450172-5017297.873100.98
549863-4986397.270100.39
648188-4818894.00397.03
极限149223-4922396.02297.832.1199.61101.432.08
249339-4933996.24899.80
350437-5043798.390102.00
451610-51610100.678104.33
551103-5110399.689103.35
649184-4918495.94599.49
阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.473940483942683943093950553948793945120.11
211.343935213932583933900.05
单位质量响应值RSD%判断
34395.1234690.480.61数据可信
供试品溶液-2024052421批-阿齐沙坦-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%
5min1100549-10054926.12025.2019.4326.1225.2019.42
2105278-10527827.34827.35
381841-8184121.26021.26
4112141-11214129.13129.13
567002-6700217.40517.41
6115340-11534029.96229.96
10min1274109-27410971.20559.7422.3671.3559.8822.34
2196780-19678051.11751.27
3193202-19320250.18850.31
4262305-26230568.13968.30
5164448-16444842.71942.82
6288882-28888275.04375.21
15min1330164-33016485.76776.3114.8986.3176.7914.92
2268187-26818769.66770.10
3268597-26859769.77370.17
4318122-31812282.63883.18
5232645-23264560.43460.77
6344955-34495589.60990.19
20min1332760-33276086.44180.8510.8887.4681.7410.96
2289717-28971775.26076.08
3293231-29323176.17276.96
4331966-33196686.23587.23
5264857-26485768.80269.47
6354847-35484792.17893.26
30min1343104-34310489.12884.329.3490.6385.669.43
2314969-31496981.81983.06
3299514-29951477.80579.01
4344698-34469889.54291.02
5283168-28316873.55874.61
6362047-36204794.04995.64
45min1342938-34293889.08586.888.3691.0888.708.46
2325917-32591784.66386.36
3319647-31964783.03584.67
4347058-34705890.15592.13
5294504-29450476.50377.96
6376688-37668897.85299.97
60min1344085-34408589.38387.897.0391.8790.187.16
2336748-33674887.47789.64
3329338-32933885.55287.65
4347562-34756290.28692.76
5299973-29997377.92479.81
6372296-37229696.71199.37
极限1374172-37417297.19899.941.90100.18102.721.86
2377121-37712197.965100.62
3386378-386378100.369102.95
4388665-388665100.963103.94
5390592-390592101.464103.78
6391383-391383101.669104.87
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