阿齐沙坦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(%)99.75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%
111.202876092878442879042876932872392876580.10
211.232859082858462858770.02
单位质量响应值RSD%判断
25683.7525456.540.63数据可信
供试品溶液-555886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%
5min12723-27230.9561.0414.810.961.0414.74
23732-37321.3101.31
32831-28310.9940.99
43135-31351.1011.10
52471-24710.8680.87
62819-28190.9900.99
10min117273-172736.0656.4410.186.076.4410.19
219733-197336.9286.94
316409-164095.7615.77
418560-185606.5166.52
521195-211957.4427.45
616799-167995.8985.90
15min129171-2917110.24210.895.9810.2810.945.98
232386-3238611.37111.42
329733-2973310.43910.48
431400-3140011.02511.07
533856-3385611.88711.93
629593-2959310.39010.43
20min136144-3614412.69013.323.5812.7913.423.59
238735-3873513.60013.71
337046-3704613.00713.10
438285-3828513.44213.55
539966-3996614.03214.14
637379-3737913.12413.22
30min143461-4346115.25915.601.9615.4315.771.99
245078-4507815.82716.01
343877-4387715.40515.57
444745-4474515.71015.89
545652-4565216.02816.22
643721-4372115.35015.52
45min147852-4785216.80117.183.6017.0517.453.59
252453-5245318.41618.69
348115-4811516.89317.15
448259-4825916.94417.21
548937-4893717.18217.46
648026-4802616.86217.12
60min150205-5020517.62717.761.6217.9718.111.65
250954-5095417.89018.26
350118-5011817.59617.94
450427-5042717.70518.06
552032-5203218.26818.64
649746-4974617.46617.81
极限151324-5132418.02018.050.8018.4618.510.84
251924-5192418.23118.70
351103-5110317.94218.39
451511-5151118.08618.54
551793-5179318.18518.66
650860-5086017.85718.30
阿齐沙坦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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.867058570670706547055970513705960.10
214.876999770124700600.13
单位质量响应值RSD%判断
4750.744711.500.59数据可信
供试品溶液-555886批-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%
5min134688-3468847.53669.0220.5547.5469.0220.55
242903-4290358.79458.79
361299-6129984.00484.00
460790-6079083.30783.31
552675-5267572.18672.19
649828-4982868.28468.28
10min168022-6802293.21790.928.3593.4891.308.30
270743-7074396.94697.27
365684-6568490.01390.48
466809-6680991.55592.02
570919-7091997.18797.59
655882-5588276.58176.96
15min172040-7204098.72493.597.9899.5194.487.93
271075-7107597.40198.27
368050-6805093.25694.22
470099-7009996.06497.04
570970-7097097.25798.20
657526-5752678.83479.64
20min171812-7181298.41193.887.1699.7495.297.13
270855-7085597.10098.51
368048-6804893.25394.74
470929-7092997.20198.71
570540-7054096.66898.15
658833-5883380.62581.87
30min171115-7111597.45693.176.2399.3395.106.22
269957-6995795.86997.81
367380-6738092.33794.34
470286-7028696.32098.37
569438-6943895.15897.18
659729-5972981.85383.54
45min170185-7018596.18193.576.0798.6096.026.04
273352-73352100.522103.00
367112-6711291.97094.49
469489-6948995.22897.81
568577-6857793.97896.52
660971-6097183.55585.70
60min169541-6954195.29992.504.6798.2595.474.70
268802-6880294.28697.32
366826-6682691.57894.61
469492-6949295.23298.34
568938-6893894.47397.54
661402-6140284.14586.75
极限169604-6960495.38594.351.2098.8797.831.26
268462-6846293.82097.38
367970-6797093.14696.68
470083-7008396.04299.68
568735-6873594.19497.79
668241-6824193.51796.59
阿齐沙坦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(%)99.75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%
111.202858082863922855282863222861272860350.13
211.232850852847452849150.09
单位质量响应值RSD%判断
25538.8425370.880.47数据可信
供试品溶液-555886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%
5min15696-56962.0094.00161.972.014.00161.86
22666-26660.9400.94
348765-4876517.19917.20
44328-43281.5261.53
53587-35871.2651.27
62997-29971.0571.06
10min122894-228948.0746.5113.228.096.5413.04
216995-169955.9946.00
316668-166685.8795.97
419746-197466.9646.97
516910-169105.9645.97
617611-176116.2116.22
15min134136-3413612.03910.706.4512.1010.766.44
229181-2918110.29210.33
329582-2958210.43310.56
430709-3070910.83110.88
528966-2896610.21610.26
629472-2947210.39410.43
20min139649-3964913.98413.023.9314.1113.143.97
236089-3608912.72812.82
336554-3655412.89213.08
437302-3730213.15613.26
535600-3560012.55612.65
636323-3632312.81112.91
30min145242-4524215.95615.362.2016.1615.552.30
243547-4354715.35815.52
343870-4387015.47215.73
443371-4337115.29615.48
542548-4254815.00615.17
642779-4277915.08815.26
45min148305-4830517.03716.751.0917.3317.021.25
247279-4727916.67516.93
347879-4787916.88617.23
447311-4731116.68616.95
546882-4688216.53516.78
647231-4723116.65816.91
60min150617-5061717.85217.491.3318.2417.861.40
250018-5001817.64117.99
349613-4961317.49817.94
449145-4914517.33317.69
548759-4875917.19717.54
649390-4939017.41917.76
极限151109-5110918.02518.032.7218.5118.502.57
250618-5061817.85218.29
350291-5029117.73718.27
450359-5035917.76118.22
553893-5389319.00719.44
650476-5047617.80218.24
阿齐沙坦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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.867027470281701387022670278702390.09
214.877003169932699820.11
单位质量响应值RSD%判断
4726.724706.250.31数据可信
供试品溶液-555886批-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%
5min157076-5707678.45949.6953.2278.4649.6853.22
235467-3546748.75448.75
3-0.0000.00
441189-4118956.62056.62
538356-3835652.72552.73
644779-4477961.55561.55
10min166075-6607590.82992.202.2591.2692.482.20
267922-6792293.36893.64
367822-6782293.23093.23
468537-6853794.21394.53
564495-6449588.65788.95
667599-6759992.92493.27
15min170963-7096397.54896.731.1598.4997.511.29
270601-7060197.05197.84
368852-6885294.64695.16
470554-7055496.98697.82
570163-7016396.44897.23
671054-7105497.67398.53
20min170861-7086197.40896.761.3298.8998.091.44
270664-7066497.13798.47
368798-6879894.57295.62
471206-7120697.88299.26
569786-6978695.93097.25
671043-7104397.65899.06
30min170258-7025896.57995.770.7798.6097.630.84
269998-6999896.22298.09
369271-6927195.22296.79
470160-7016096.44498.36
569032-6903294.89496.75
669292-6929295.25197.19
45min168852-6885294.64694.741.0397.2197.131.06
268506-6850694.17196.57
368659-6865994.38196.48
470252-7025296.57199.03
568249-6824993.81796.20
668994-6899494.84197.31
60min168937-6893794.76394.110.9697.8597.031.02
269046-6904694.91397.84
368073-6807393.57596.20
468974-6897494.81497.81
567399-6739992.64995.55
668332-6833293.93196.93
极限168275-6827593.85393.550.4697.4796.990.56
267734-6773493.10996.56
367764-6776493.15196.29
468534-6853494.20997.73
567981-6798193.44996.87
668027-6802793.51297.03
阿齐沙坦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(%)99.75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%
111.202884552886452888882886012884352886050.07
211.232884972877312881140.19
单位质量响应值RSD%判断
25768.3025655.740.31数据可信
供试品溶液-555886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%
5min13282-32821.1461.7823.641.151.7823.50
25928-59282.0702.07
35683-56831.9841.98
44626-46261.6151.62
54458-44581.5571.56
66615-66152.3102.31
10min110286-102863.5915.2015.913.605.2115.90
215769-157695.5065.52
316159-161595.6425.65
416027-160275.5965.60
514478-144785.0555.06
616624-166245.8045.82
15min120907-209077.3008.627.817.338.667.84
225817-258179.0149.06
325267-252678.8228.86
425419-254198.8758.92
524505-245058.5568.59
626137-261379.1269.17
20min128084-280849.80610.714.319.8710.804.37
231501-3150110.99911.09
331389-3138910.96011.05
431043-3104310.83910.93
530595-3059510.68210.77
631501-3150110.99911.09
30min134881-3488112.17912.762.4612.3012.912.53
237186-3718612.98413.14
336740-3674012.82812.98
436744-3674412.82912.98
536323-3632312.68212.83
637398-3739813.05813.21
45min139841-3984113.91114.181.1814.1014.401.25
241104-4110414.35214.58
340403-4040314.10714.33
440678-4067814.20314.42
540535-4053514.15314.37
641114-4111414.35514.58
60min142021-4202114.67214.821.0614.9415.121.11
242893-4289314.97615.28
342267-4226714.75815.06
442258-4225814.75515.05
542173-4217314.72515.02
643142-4314215.06315.37
极限142905-4290514.98115.110.8015.3315.490.86
243418-4341815.16015.55
343150-4315015.06615.45
443171-4317115.07315.46
543114-4311415.05415.43
643891-4389115.32515.72
阿齐沙坦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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.867109771193712187102471171711410.12
214.877102870865709460.17
单位质量响应值RSD%判断
4787.424771.080.25数据可信
供试品溶液-555886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%
5min136505-3650549.52279.5822.4549.5279.5822.45
251845-5184570.33270.33
370183-7018395.20995.21
460611-6061182.22482.22
560399-6039981.93681.94
672443-7244398.27598.27
10min163755-6375586.48996.585.2786.7697.025.34
272341-7234198.13698.53
373447-7344799.637100.17
471861-7186197.48597.94
571801-7180197.40497.86
673962-73962100.335100.88
15min169256-6925693.95197.822.3094.7198.802.39
272781-7278198.73399.67
373384-7338499.551100.63
471191-7119196.57697.57
572341-7234198.13699.13
673699-7369999.979101.08
20min169575-6957594.38497.511.7695.6699.031.85
272773-7277398.722100.21
372894-7289498.886100.52
471304-7130496.73098.26
572261-7226198.02899.57
672466-7246698.30699.96
30min169460-6946094.22897.201.7596.0399.261.84
272457-7245798.294100.33
372636-7263698.536100.72
471066-7106696.40798.48
571607-7160797.14199.23
672659-7265998.568100.77
45min169663-6966394.50396.841.4296.8399.441.51
272500-7250098.352100.93
371781-7178197.377100.11
470971-7097196.27898.89
571249-7124996.65599.28
672138-7213897.861100.61
60min169375-6937594.11396.351.5996.9699.491.67
271977-7197797.642100.77
371659-7165997.211100.48
470311-7031195.38298.53
570547-7054795.70398.87
672270-7227098.040101.34
极限168901-6890193.47095.851.5396.8499.531.63
271400-7140096.860100.53
371454-7145496.933100.75
470149-7014995.16398.84
570284-7028495.34699.04
671740-7174097.321101.16
阿齐沙坦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(%)99.75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%
111.202886062882642883492883952887732884770.08
211.232883192886332884760.08
单位质量响应值RSD%判断
25756.8825687.980.19数据可信
供试品溶液-555886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%
5min16024-60242.1021.8015.622.101.8015.61
25914-59142.0642.06
33903-39031.3621.36
44588-45881.6011.60
55241-52411.8291.83
65257-52571.8351.83
10min115735-157355.4925.4113.025.505.4213.05
216447-164475.7405.75
312714-127144.4374.44
413817-138174.8224.83
518443-184436.4376.45
615852-158525.5335.54
15min125558-255588.9208.653.158.968.683.16
225571-255718.9258.97
324069-240698.4008.43
424104-241048.4138.45
524031-240318.3878.43
625310-253108.8348.87
20min131147-3114710.87110.671.8510.9610.761.85
231148-3114810.87110.96
330209-3020910.54310.62
430313-3031310.58010.66
529759-2975910.38610.48
630823-3082310.75810.85
30min136484-3648412.73312.660.8812.8912.810.91
236802-3680212.84413.00
336156-3615612.61912.76
436103-3610312.60012.74
535913-3591312.53412.68
636216-3621612.64012.79
45min140022-4002213.96814.010.6314.1914.220.63
240526-4052614.14414.37
340352-4035214.08314.29
439965-3996513.94814.16
540027-4002713.97014.19
639877-3987713.91814.14
60min142131-4213114.70414.700.5915.0014.990.58
242363-4236314.78515.09
342351-4235114.78115.07
441881-4188114.61714.91
542156-4215614.71315.01
641749-4174914.57114.87
极限142465-4246514.82114.860.7815.2015.230.78
243139-4313915.05615.44
342385-4238514.79315.16
442715-4271514.90815.28
542497-4249714.83215.21
642185-4218514.72315.10
阿齐沙坦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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.867121371010710657098371038710620.13
214.877107871054710660.03
单位质量响应值RSD%判断
4782.104779.150.05数据可信
供试品溶液-555886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%
5min161750-6175083.74482.1817.1183.7482.1817.11
270534-7053495.65795.66
343882-4388259.51259.51
453835-5383573.01073.01
570994-7099496.28196.28
662581-6258184.87184.87
10min173728-7372899.98997.253.19100.4597.703.24
271681-7168197.21397.74
367326-6732691.30691.64
471807-7180797.38497.79
573165-7316599.22599.76
672542-7254298.38098.85
15min173654-7365499.88898.391.47100.9199.391.52
272013-7201397.66398.73
370667-7066795.83796.68
472957-7295798.94399.89
573121-7312199.166100.25
672893-7289398.85699.87
20min173502-7350299.68298.181.69101.2699.731.72
271616-7161697.12598.74
370313-7031395.35796.73
473259-7325999.353100.85
572575-7257598.425100.06
673116-7311699.159100.73
30min173025-7302599.03597.641.49101.1699.731.51
271146-7114696.48798.64
370307-7030795.34997.25
472902-7290298.869100.92
572146-7214697.843100.03
672458-7245898.266100.38
45min172465-7246598.27697.031.34100.9699.661.37
270839-7083996.07198.76
370027-7002794.97097.40
472434-7243498.234100.83
571874-7187497.474100.20
671657-7165797.18099.84
60min172383-7238398.16596.871.18101.39100.041.21
270604-7060495.75298.98
370248-7024895.26998.23
472040-7204097.700100.84
571834-7183497.420100.69
671464-7146496.918100.12
极限171363-7136396.78195.631.50100.5599.341.53
270253-7025395.27699.03
368639-6863993.08796.57
471594-7159497.095100.78
570749-7074995.94999.76
670501-7050195.61299.35
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