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%
111.514583545709451554557145394455330.59
211.414554445577455600.06
单位质量响应值RSD%判断
3955.953992.990.66数据可信
供试品溶液-24022501批-左氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min146171-4617193.88696.602.2993.8996.602.29
247423-4742396.43296.43
347311-4731196.20496.20
449053-4905399.74699.75
548443-4844398.50698.51
646625-4662594.80994.81
10min149599-49599100.856100.442.83101.38100.982.81
250062-50062101.798102.33
348816-4881699.26499.80
448408-4840898.43598.99
551698-51698105.125105.67
647779-4777997.15697.68
15min147002-4700295.57698.653.0996.6699.743.08
248181-4818197.97399.07
348984-4898499.606100.69
448284-4828498.18299.28
551222-51222104.157105.29
647414-4741496.41397.48
20min148290-4829098.19598.232.8199.8199.872.79
247937-4793797.47799.12
349394-49394100.440102.08
448036-4803697.67899.32
550049-50049101.772103.48
646130-4613093.80295.40
30min147357-4735796.29796.884.5698.4699.074.51
246258-4625894.06396.25
347554-4755496.69898.90
447187-4718795.95298.14
551825-51825105.383107.66
645682-4568292.89195.01
45min146997-4699795.56596.773.5898.2699.503.55
247963-4796397.530100.24
348785-4878599.201101.94
446623-4662394.80597.53
549995-49995101.662104.52
645176-4517691.86394.50
60min147752-4775297.10196.703.02100.3399.963.00
247779-4777997.156100.41
348181-4818197.973101.26
446599-4659994.75698.01
549611-49611100.881104.31
645403-4540392.32495.47
极限146823-4682395.21294.223.3598.9898.033.31
247127-4712795.83099.62
346671-4667194.90398.73
444513-4451390.51494.29
548406-4840698.431102.42
644485-4448590.45794.12
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(%)99.7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%
111.604019144010004027974001094007054013050.27
211.624067824046654057240.37
单位质量响应值RSD%判断
34595.2634916.010.66数据可信
供试品溶液-24022501批-阿齐沙坦-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19691-96912.5022.3915.632.502.3915.68
29774-97742.5232.52
310313-103132.6632.66
49286-92862.3972.40
56407-64071.6541.65
610148-101482.6202.62
10min133103-331038.5477.966.858.567.976.88
230402-304027.8497.86
330441-304417.8597.87
433063-330638.5368.55
527406-274067.0767.08
630604-306047.9017.92
15min141614-4161410.74411.244.2310.8111.304.22
242909-4290911.07811.14
343507-4350711.23311.29
446225-4622511.93412.00
541805-4180510.79310.84
645142-4514211.65511.71
20min151704-5170413.34913.524.2513.4713.644.25
252117-5211713.45613.57
350433-5043313.02113.14
454951-5495114.18714.31
549928-4992812.89013.00
655168-5516814.24314.37
30min160103-6010315.51715.883.2915.7116.083.29
261977-6197716.00116.20
359008-5900815.23515.43
464122-6412216.55516.76
560407-6040715.59615.78
663508-6350816.39616.60
45min167931-6793117.53817.781.9117.8218.061.93
270396-7039618.17518.46
367213-6721317.35317.63
470378-7037818.17018.47
568240-6824017.61817.88
668930-6893017.79618.09
60min172261-7226118.65618.832.7819.0419.222.78
272640-7264018.75419.14
370259-7025918.13918.51
476042-7604219.63220.03
572022-7202218.59518.96
674435-7443519.21819.61
极限173544-7354418.98819.112.5219.4719.602.52
275810-7581019.57320.06
371734-7173418.52019.00
476208-7620819.67520.18
572136-7213618.62419.09
674631-7463119.26819.77
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%
111.514594145946459754531545803457960.61
211.414582546009459170.29
单位质量响应值RSD%判断
3978.804024.280.81数据可信
供试品溶液-24022502批-左氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min147594-4759496.12694.912.3796.1394.912.37
247914-4791496.77296.77
345352-4535291.59891.60
447101-4710195.13095.13
545924-4592492.75392.75
648063-4806397.07397.07
10min148710-4871098.38098.672.4798.9199.192.47
248905-4890598.77499.31
347940-4794096.82597.33
449531-49531100.038100.57
547298-4729895.52896.04
650728-50728102.456102.99
15min150485-50485101.965101.162.11103.05102.242.11
251013-51013103.031104.12
349987-49987100.959102.01
449392-4939299.757100.84
548427-4842797.80898.85
651224-51224103.457104.57
20min150833-50833102.668101.272.03104.31102.912.02
250330-50330101.652103.31
349939-49939100.862102.47
451068-51068103.142104.78
548228-4822897.40699.00
650456-50456101.906103.59
30min149443-4944399.860100.062.72102.08102.262.70
249820-49820100.622102.85
348900-4890098.763100.93
449648-49648100.274102.49
547667-4766796.27398.40
651777-51777104.574106.82
45min148731-4873198.42297.913.06101.19100.663.02
249515-49515100.006102.79
348625-4862598.208100.92
447076-4707695.08097.85
546476-4647693.86896.53
650427-50427101.848104.68
60min148877-4887798.71798.692.84102.04101.992.79
248887-4888798.737102.08
349412-4941299.798103.06
447188-4718895.30698.60
547687-4768796.31499.50
651120-51120103.247106.64
极限148604-4860498.16697.192.47102.03101.042.46
248499-4849997.954101.84
347372-4737295.67799.49
447636-4763696.211100.04
546609-4660994.13697.86
650012-50012101.009104.98
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(%)99.7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%
111.604055484025754035014054354072214048560.46
211.624044084049994047040.11
单位质量响应值RSD%判断
34901.3834828.230.15数据可信
供试品溶液-24022502批-阿齐沙坦-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min112319-123193.1703.3813.233.173.3813.22
211065-110652.8482.85
315764-157644.0574.06
414620-146203.7633.76
512143-121433.1253.13
612911-129113.3233.32
10min127768-277687.1477.679.807.167.699.81
225925-259256.6726.69
332227-322278.2948.32
433792-337928.6978.72
528675-286757.3807.40
630345-303457.8107.83
15min140913-4091310.53011.255.6510.5911.325.67
240794-4079410.49910.55
346130-4613011.87211.94
446347-4634711.92812.00
544798-4479811.52911.59
643340-4334011.15411.22
20min150910-5091013.10213.402.4513.2213.522.48
250872-5087213.09313.20
354004-5400413.89914.03
452484-5248413.50813.64
552880-5288013.61013.73
651212-5121213.18013.30
30min158916-5891615.16315.551.9115.3515.751.92
259937-5993715.42615.61
360219-6021915.49815.71
460612-6061215.59915.81
560359-6035915.53415.73
662442-6244216.07016.27
45min166277-6627717.05717.201.9517.3317.491.89
269189-6918917.80718.08
366949-6694917.23017.53
465942-6594216.97117.27
567133-6713317.27817.56
665523-6552316.86317.15
60min172711-7271118.71318.542.9019.0818.922.82
271105-7110518.30018.67
370915-7091518.25118.64
469185-6918517.80618.20
575219-7521919.35919.74
673000-7300018.78819.17
极限173192-7319218.83718.881.2819.3119.361.23
273615-7361518.94619.42
372873-7287318.75519.25
471955-7195518.51919.01
573821-7382118.99919.49
674713-7471319.22919.71
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%
111.514555845230452604591545418454760.62
211.414617746119461480.09
单位质量响应值RSD%判断
3951.004044.521.66数据可信
供试品溶液-24022801批-左氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min144420-4442089.80992.562.5389.8192.562.53
245697-4569792.39192.39
346332-4633293.67593.68
444421-4442189.81189.81
547187-4718795.40495.40
646613-4661394.24394.24
10min151191-51191103.49997.734.12104.0098.244.10
247902-4790296.84997.36
349356-4935699.789100.31
445358-4535891.70692.20
548958-4895898.98499.51
647264-4726495.55996.08
15min149204-4920499.48294.766.20100.5695.826.14
249528-49528100.137101.19
348509-4850998.07799.15
443917-4391788.79289.80
542641-4264186.21387.29
647416-4741695.86796.92
20min148195-4819597.44296.284.2999.0797.864.25
247255-4725595.54197.15
349569-49569100.220101.84
443790-4379088.53690.04
548938-4893898.944100.50
647963-4796396.97398.56
30min149442-4944299.96395.813.22102.1397.933.21
247396-4739695.82697.96
348111-4811197.27299.45
444962-4496290.90592.90
547881-4788196.80798.92
646546-4654694.10896.23
45min147632-4763296.30394.655.0899.0397.305.00
245991-4599192.98695.66
346747-4674794.51497.23
442740-4274086.41388.91
549812-49812100.711103.36
647952-4795296.95099.60
60min147069-4706995.16593.844.2798.4297.024.22
246235-4623593.47996.67
347286-4728695.60498.85
442817-4281786.56889.55
548745-4874598.554101.76
646339-4633993.68996.88
极限147975-4797596.99792.103.83100.7895.793.79
244744-4474490.46494.17
345769-4576992.53796.31
442801-4280186.53690.00
546551-4655194.11897.87
645465-4546591.92295.63
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(%)99.7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%
111.604043544029874044344028644040544037390.19
211.624100514097444098980.06
单位质量响应值RSD%判断
34805.0935275.220.95数据可信
供试品溶液-24022801批-阿齐沙坦-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114340-143403.6724.9013.373.674.9013.39
221503-215035.5075.51
320129-201295.1555.15
419310-193104.9454.95
520823-208235.3335.33
618682-186824.7844.78
10min133293-332938.5269.134.688.559.164.69
237289-372899.5499.58
336211-362119.2739.30
436736-367369.4089.44
536615-366159.3779.41
633857-338578.6708.70
15min144884-4488411.49411.984.1911.5612.054.20
249417-4941712.65512.74
348632-4863212.45412.53
446503-4650311.90911.99
544522-4452211.40211.48
646610-4661011.93612.01
20min152167-5216713.35913.721.9013.4913.871.92
254045-5404513.84013.99
355033-5503314.09314.24
453287-5328713.64613.79
552897-5289713.54613.69
654118-5411813.85914.00
30min161611-6161115.77815.621.5715.9815.841.54
260276-6027615.43615.67
362294-6229415.95316.18
461159-6115915.66215.88
559597-5959715.26215.48
661092-6109215.64515.86
45min166649-6664917.06817.691.8917.3618.001.89
269480-6948017.79318.11
369618-6961817.82818.14
469728-6972817.85718.17
568675-6867517.58717.89
670305-7030518.00418.31
60min173488-7348818.81918.402.3019.2118.812.24
271649-7164918.34918.76
372458-7245818.55618.97
469771-6977117.86818.28
570119-7011917.95718.36
673647-7364718.86019.27
极限174995-7499519.20518.841.7419.7019.351.68
272219-7221918.49519.01
373421-7342118.80219.32
474307-7430719.02919.54
571923-7192318.41918.92
674600-7460019.10419.61
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%
111.514551145320457604516045093453690.60
211.414624146416463280.27
单位质量响应值RSD%判断
3941.704060.302.10数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-24022501批-左氨氯地平-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%
5min139055-3905578.90593.118.5078.9093.118.50
247639-4763996.24896.25
347613-4761396.19596.20
450705-50705102.442102.44
546413-4641393.77193.77
645087-4508791.09291.09
10min147201-4720195.363101.724.0695.80102.234.08
253053-53053107.186107.72
350094-50094101.208101.74
451586-51586104.222104.79
551039-51039103.117103.64
649099-4909999.19799.70
15min148588-4858898.165100.844.6799.13101.934.66
251786-51786104.626105.76
347719-4771996.40997.51
452674-52674106.420107.57
551450-51450103.947105.04
647263-4726395.48896.55
20min148195-4819597.371101.344.4298.88102.984.43
252755-52755106.584108.30
348642-4864298.27499.91
452412-52412105.891107.63
551155-51155103.351105.02
647791-4779196.55598.14
30min147747-4774796.46698.983.4098.52101.193.42
249768-49768100.549102.85
347274-4727495.51097.69
450992-50992103.022105.35
550629-50629102.288104.53
647548-4754896.06498.19
45min147848-4784896.67098.503.9199.26101.263.90
250480-50480101.987104.85
346797-4679794.54697.26
450346-50346101.717104.62
550499-50499102.026104.84
646546-4654694.03996.70
60min146756-4675694.46498.094.0397.59101.404.03
250174-50174101.369104.80
346533-4653394.01397.25
450247-50247101.517104.98
550559-50559102.147105.53
647041-4704195.03998.22
极限148504-4850497.99598.162.92101.65102.002.94
250187-50187101.395105.39
347259-4725995.48099.24
450078-50078101.175105.20
548747-4874798.486102.43
646727-4672794.40598.11
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(%)99.7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%
111.604033864041794022944028614024384030320.20
211.624101974099354100660.05
单位质量响应值RSD%判断
34744.1435289.671.11数据可信
供试品溶液-24022501批-阿齐沙坦-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%
5min16290-62901.6121.9112.231.611.9112.35
26648-66481.7041.70
38844-88442.2662.27
47380-73801.8911.89
57850-78502.0122.01
67679-76791.9681.97
10min122547-225475.7785.715.765.795.725.76
223533-235336.0316.04
323270-232705.9635.98
420052-200525.1395.15
521578-215785.5305.54
622681-226815.8125.82
15min134055-340558.7278.474.078.778.514.08
233431-334318.5678.61
334972-349728.9629.01
431721-317218.1298.17
532581-325818.3498.39
631571-315718.0908.13
20min139949-3994910.23710.145.0910.3310.235.07
241564-4156410.65110.74
342230-4223010.82210.92
438460-384609.8569.94
537416-374169.5889.68
637789-377899.6849.77
30min143894-4389411.24811.522.3511.3911.672.35
244829-4482911.48811.64
346694-4669411.96612.12
445697-4569711.71011.85
544144-4414411.31211.45
644550-4455011.41711.56
45min150352-5035212.90313.132.0713.1113.342.10
252185-5218513.37313.59
352548-5254813.46613.69
451750-5175013.26213.47
550431-5043112.92413.13
650094-5009412.83713.04
60min153806-5380613.78813.712.2314.0713.992.22
255196-5519614.14514.43
354063-5406313.85414.15
453132-5313213.61613.89
553253-5325313.64713.92
651596-5159613.22213.50
极限155274-5527414.16514.233.3914.5214.593.37
257243-5724314.66915.04
357532-5753214.74315.12
456121-5612114.38214.74
552476-5247613.44813.80
654522-5452213.97214.32
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%
111.514624146635467034655746328464930.43
211.414700247093470480.14
单位质量响应值RSD%判断
4039.364123.401.46数据可信
供试品溶液-24022502批-左氨氯地平-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%
5min149493-4949398.01397.141.9898.0197.141.98
247307-4730793.68493.68
350049-5004999.11499.11
449505-4950598.03798.04
549329-4932997.68897.69
648634-4863496.31296.31
10min152609-52609104.18499.283.95104.7399.823.93
246626-4662692.33592.86
350496-5049699.999100.55
450410-5041099.829100.37
550959-50959100.916101.46
649698-4969898.41998.95
15min151837-51837102.65598.373.61103.7899.463.58
248549-4854996.14497.18
351431-51431101.851102.96
450035-5003599.086100.19
547135-4713593.34394.45
649051-4905197.13898.22
20min150941-50941100.88099.451.83102.57101.091.84
249594-4959498.21399.78
351563-51563102.112103.78
450196-5019699.405101.05
550016-5001699.049100.67
649010-4901097.05698.68
30min151608-51608102.20198.423.80104.46100.623.76
246874-4687492.82694.94
351110-51110101.215103.45
450924-50924100.847103.05
549611-4961198.247100.42
648077-4807795.20997.37
45min150743-50743100.48897.184.57103.3199.914.49
244920-4492088.95791.59
348849-4884996.73899.54
450074-5007499.164101.93
548785-4878596.61199.33
651049-51049101.094103.78
60min150951-50951100.90097.233.87104.28100.503.83
246147-4614791.38794.51
350684-50684100.372103.71
450359-5035999.728103.04
547871-4787194.80198.06
648569-4856996.18399.43
极限148983-4898397.00393.952.73100.9497.772.71
245997-4599791.09094.72
348835-4883596.710100.61
446720-4672092.52196.39
547801-4780194.66298.44
646313-4631391.71595.50
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(%)99.7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%
111.604107674097274109494115554105304107060.17
211.624162784181054171920.31
单位质量响应值RSD%判断
35405.6935902.930.99数据可信
供试品溶液-24022502批-阿齐沙坦-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%
5min16997-69971.7612.1222.341.762.1222.34
29150-91502.3032.30
37402-74021.8631.86
46258-62581.5751.58
59286-92862.3372.34
611357-113572.8582.86
10min118840-188404.7425.5010.194.755.5210.23
223434-234345.8985.91
322303-223035.6135.62
419396-193964.8824.89
523006-230065.7905.80
624235-242356.0996.12
15min131949-319498.0418.354.078.088.394.11
235213-352138.8628.91
332530-325308.1878.23
431817-318178.0088.04
533222-332228.3618.41
634263-342638.6238.67
20min137227-372279.36910.035.929.4510.125.92
244095-4409511.09811.19
338244-382449.6259.71
439422-394229.92210.00
539998-3999810.06710.16
640243-4024310.12810.23
30min153762-5376213.53111.917.5213.6612.057.39
248146-4814612.11712.27
343512-4351210.95111.09
447376-4737611.92412.06
545797-4579711.52611.67
645268-4526811.39311.55
45min151868-5186813.05413.003.3413.2613.213.32
251370-5137012.92913.15
349322-4932212.41312.61
453350-5335013.42713.63
550314-5031412.66312.87
653797-5379713.54013.76
60min155696-5569614.01813.772.4614.3014.052.45
256319-5631914.17414.47
353936-5393613.57513.84
455505-5550513.96914.25
552768-5276813.28113.56
654010-5401013.59313.89
极限155041-5504113.85313.962.4714.2114.322.38
257091-5709114.36914.74
357245-5724514.40714.75
454694-5469413.76514.12
554815-5481513.79614.15
653946-5394613.57713.95
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