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%
111.202882272908782908592904532888402898510.43
211.2032894382877312885840.42
单位质量响应值RSD%判断
25879.5525759.530.33数据可信
供试品溶液-546074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%
5min14831-48311.6801.4419.631.681.4419.68
25082-50821.7671.77
34570-45701.5891.59
43883-38831.3501.35
53024-30241.0511.05
63474-34741.2081.21
10min120475-204757.1196.645.837.136.645.84
220328-203287.0687.08
319089-190896.6376.65
418438-184386.4116.42
518455-184556.4176.42
617712-177126.1596.17
15min130869-3086910.73310.452.3310.7810.502.34
230903-3090310.74510.79
329941-2994110.41110.46
429135-2913510.13010.17
529763-2976310.34910.39
629725-2972510.33510.38
20min135834-3583412.46012.382.2312.5712.482.22
236511-3651112.69512.80
336198-3619812.58612.69
435160-3516012.22512.32
535554-3555412.36212.46
634302-3430211.92712.03
30min141138-4113814.30414.421.8314.4814.591.84
241994-4199414.60114.78
342558-4255814.79814.97
440775-4077514.17814.34
541797-4179714.53314.70
640623-4062314.12514.29
45min145314-4531415.75615.901.4316.0116.151.44
246399-4639916.13316.39
346574-4657416.19416.45
445608-4560815.85816.10
545551-4555115.83816.09
644865-4486515.60015.84
60min147253-4725316.43016.641.1316.7716.981.13
248220-4822016.76617.12
348509-4850916.86717.21
447793-4779316.61816.95
548119-4811916.73117.07
647189-4718916.40816.74
极限148591-4859116.89516.921.0517.3317.351.06
248963-4896317.02517.47
349483-4948317.20517.64
448147-4814716.74117.17
548584-4858416.89317.32
648155-4815516.74417.16
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%
114.867169471381707807163871198713380.52
214.877136470622709930.74
单位质量响应值RSD%判断
4800.674774.240.40数据可信
供试品溶液-546074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%
5min168413-6841392.64972.5519.8192.6572.5419.81
253390-5339072.30472.30
354919-5491974.37574.37
461238-6123882.93282.93
540968-4096855.48155.48
642481-4248157.53057.53
10min170364-7036495.29195.733.1695.8196.143.20
272587-7258798.30298.70
370043-7004394.85695.27
473921-73921100.108100.57
569565-6956594.20994.52
667670-6767091.64391.96
15min170497-7049795.47196.531.6496.5297.461.67
272247-7224797.84198.79
370503-7050395.47996.42
473188-7318899.116100.13
570864-7086495.96896.80
670353-7035395.27696.10
20min169580-6958094.22996.072.0195.8097.542.02
272051-7205197.57699.07
370607-7060795.62097.09
473111-7311199.011100.58
570850-7085095.94997.31
669458-6945894.06495.42
30min168990-6899093.43095.351.5595.5397.351.54
271345-7134596.62098.65
370193-7019395.06097.06
471828-7182897.27499.39
570610-7061095.62497.52
669460-6946094.06795.95
45min167753-6775391.75594.301.9894.3796.831.97
270918-7091896.04198.61
369693-6969394.38296.91
471351-7135196.62899.29
569586-6958694.23796.67
668488-6848892.75195.15
60min168034-6803492.13694.161.6195.2697.221.61
270431-7043195.38298.49
369259-6925993.79596.85
471012-7101296.16999.36
569813-6981394.54597.50
668626-6862692.93795.86
极限168023-6802392.12193.280.9795.7696.861.00
269533-6953394.16697.80
368784-6878493.15196.73
469782-6978294.50398.23
568699-6869993.03696.51
668452-6845292.70296.14
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%
111.202876882863242901202896672899982887590.59
211.2032866112867682866900.04
单位质量响应值RSD%判断
25782.0525590.470.53数据可信
供试品溶液-546074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%
5min12975-29751.0401.3633.831.041.3633.77
23585-35851.2531.25
34854-48541.6971.70
43610-36101.2621.26
52315-23150.8090.81
65936-59362.0752.07
10min115072-150725.2686.0913.415.276.1013.44
218657-186576.5216.53
317422-174226.0896.10
418971-189716.6316.64
514254-142544.9824.99
620216-202167.0667.08
15min126563-265639.2849.845.299.329.885.34
229799-2979910.41510.46
329015-2901510.14110.18
428522-285229.96910.01
526071-260719.1129.14
628943-2894310.11610.17
20min132908-3290811.50212.003.8011.5912.103.82
235180-3518012.29612.40
336285-3628512.68212.78
434241-3424111.96812.07
532947-3294711.51511.60
634419-3441912.03012.14
30min140031-4003113.99114.101.3814.1414.261.43
240965-4096514.31814.49
340802-4080214.26114.43
440573-4057314.18114.35
539464-3946413.79313.94
640228-4022814.06014.23
45min144392-4439215.51515.731.7015.7415.971.72
246387-4638716.21316.46
345231-4523115.80916.06
445010-4501015.73115.98
544317-4431715.48915.71
644701-4470115.62315.88
60min147043-4704316.44216.341.3816.7616.661.40
247656-4765616.65617.00
346915-4691516.39716.73
446410-4641016.22116.55
545745-4574515.98816.30
646665-4666516.31016.65
极限147808-4780816.70916.760.7617.1217.180.80
248631-4863116.99717.43
347989-4798916.77317.20
447820-4782016.71417.14
547551-4755116.62017.02
647911-4791116.74517.17
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%
114.867106071226716217186371667714870.47
214.877078771141709640.36
单位质量响应值RSD%判断
4810.704772.290.57数据可信
供试品溶液-546074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%
5min171069-7106996.16678.5825.4596.1778.5825.45
258527-5852779.19579.19
341383-4138355.99756.00
468680-6868092.93392.93
538515-3851552.11652.12
670280-7028095.09895.10
10min174014-74014100.15197.214.37100.6897.644.46
274264-74264100.489100.93
367885-6788591.85792.17
473621-7362199.619100.14
567725-6772591.64191.93
673519-7351999.481100.01
15min173997-73997100.12897.992.35101.2298.972.41
273862-7386299.945100.94
369510-6951094.05694.88
473257-7325799.126100.20
572274-7227497.79698.59
671608-7160896.89597.98
20min173970-73970100.09197.411.72101.7498.931.77
272847-7284798.571100.12
371084-7108496.18697.53
471999-7199997.42499.04
571350-7135096.54697.89
670669-7066995.62497.24
30min173548-7354899.52096.482.27101.7298.552.33
272196-7219697.69199.79
368758-6875893.03894.92
471730-7173097.06099.22
570871-7087195.89897.78
670724-7072495.69997.85
45min171690-7169097.00695.841.9899.7698.442.02
272801-7280198.509101.15
368797-6879793.09195.49
471120-7112096.23598.94
570702-7070295.66998.08
669851-6985194.51797.20
60min171813-7181397.17294.532.33100.4797.662.37
271980-7198097.398100.59
368192-6819292.27395.18
469312-6931293.78897.02
568837-6883793.14596.09
669014-6901493.38596.59
极限171157-7115796.28594.391.85100.1298.051.90
271156-7115696.283100.02
367778-6777891.71295.14
469448-6944893.97297.73
569809-6980994.46197.92
669199-6919993.63597.36
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%
111.202910552893002909932907642924332909090.39
211.2032934892894952914920.97
单位质量响应值RSD%判断
25974.0226019.100.13数据可信
供试品溶液-546074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%
5min161243-6124321.1498.44105.1621.158.44105.17
22028-20280.7000.70
336437-3643712.58312.58
42234-22340.7710.77
52346-23460.8100.81
642426-4242614.65114.65
10min113247-132474.5754.2611.694.694.3111.11
212808-128084.4234.43
310008-100083.4563.53
413710-137104.7354.74
513098-130984.5234.53
611137-111373.8463.93
15min122880-228807.9017.586.998.047.666.77
222470-224707.7607.79
319124-191246.6046.69
422779-227797.8667.90
523201-232018.0128.04
621329-213297.3667.47
20min128259-282599.7599.503.969.959.623.85
228447-284479.8249.90
325519-255198.8138.94
427894-278949.6339.71
527938-279389.6489.72
627057-270579.3449.49
30min133353-3335311.51811.532.3911.7611.702.20
234396-3439611.87812.00
332046-3204611.06711.24
433941-3394111.72111.85
533479-3347911.56111.69
633198-3319811.46411.66
45min137982-3798213.11613.193.0513.4213.423.09
238144-3814413.17213.36
336829-3682912.71812.95
437926-3792613.09713.29
537905-3790513.09013.28
640354-4035413.93614.19
60min139587-3958713.67113.953.7314.0514.263.76
240018-4001813.82014.08
339438-3943813.61913.93
440058-4005813.83314.10
539875-3987513.77014.03
643434-4343414.99915.34
极限140726-4072614.06414.170.8414.5214.550.83
241386-4138614.29214.63
340688-4068814.05114.43
441069-4106914.18314.53
540806-4080614.09214.43
641473-4147314.32214.74
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%
114.867202371839723517233272421721930.35
214.877292572016724700.89
单位质量响应值RSD%判断
4858.214873.570.23数据可信
供试品溶液-546074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%
5min1-0.00041.31111.200.0041.30111.20
251461-5146168.56868.57
3-0.0000.00
469327-6932792.37392.37
565214-6521486.89386.89
6-0.0000.00
10min169936-6993693.18496.523.2693.1896.753.41
271809-7180995.68096.06
369588-6958892.72192.72
475029-7502999.970100.48
573665-7366598.15398.64
674630-7463099.43999.44
15min174829-7482999.70499.781.55100.22100.551.55
273242-7324297.58998.50
374161-7416198.81499.33
475910-75910101.144102.21
574750-7475099.599100.63
676445-76445101.857102.41
20min174845-7484599.72599.360.73100.80100.680.60
273756-7375698.27499.73
374601-7460199.400100.46
474304-7430499.004100.63
574539-7453999.318100.90
675384-75384100.443101.56
30min172741-7274196.92298.081.6398.5599.951.57
271858-7185895.74597.75
374082-7408298.709100.32
474247-7424798.928101.11
573464-7346497.885100.02
675251-75251100.266101.94
45min172679-7267996.83997.981.5299.00100.401.45
272648-7264896.79899.33
373488-7348897.917100.08
473971-7397198.561101.29
572879-7287997.10699.78
675544-75544100.657102.89
60min172607-7260796.74397.171.2199.45100.131.09
271812-7181295.68498.75
373266-7326697.621100.33
472962-7296297.216100.49
572517-7251796.62399.84
674415-7441599.152101.94
极限172778-7277896.97196.811.19100.21100.311.07
271733-7173395.57999.18
372457-7245796.54399.79
472589-7258996.719100.54
572144-7214496.12699.88
674250-7425098.932102.28
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%
111.202926052919192938262925212932362928210.25
211.2032913332917022915180.09
单位质量响应值RSD%判断
26144.7326021.420.34数据可信
供试品溶液-546074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%
5min134230-3423011.7827.2797.4211.787.2797.44
22838-28380.9770.98
343514-4351414.97714.98
42684-26840.9240.92
52127-21270.7320.73
641311-4131114.21914.22
10min110935-109353.7644.0018.563.834.0417.37
213437-134374.6254.63
39573-95733.2953.38
413650-136504.6984.70
513356-133564.5974.60
68766-87663.0173.10
15min120853-208537.1777.189.897.267.249.35
222179-221797.6347.66
318948-189486.5226.62
422673-226737.8047.84
522671-226717.8037.83
617812-178126.1316.23
20min126951-269519.2769.477.529.409.577.41
228736-287369.8919.96
330249-3024910.41110.55
427636-276369.5129.59
527441-274419.4459.52
624040-240408.2748.40
30min132899-3289911.32411.454.5111.5011.604.22
233576-3357611.55711.69
332117-3211711.05411.25
434161-3416111.75811.89
535499-3549912.21812.34
631299-3129910.77310.95
45min136547-3654712.57912.782.0012.8213.001.85
237828-3782813.02013.21
337500-3750012.90713.16
437657-3765712.96113.15
537367-3736712.86113.05
635928-3592812.36612.60
60min140088-4008813.79813.611.9614.1113.901.87
239945-3994513.74914.01
339416-3941613.56713.90
440400-4040013.90514.17
539189-3918913.48813.75
638252-3825213.16613.47
极限139830-3983013.70913.941.7114.1014.301.56
241334-4133414.22714.57
340623-4062313.98214.39
441048-4104814.12814.47
540566-4056613.96214.30
639548-3954813.61213.99
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%
114.867246971949729337219572993725080.63
214.877245372340723960.12
单位质量响应值RSD%判断
4879.414868.590.16数据可信
供试品溶液-546074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%
5min1-0.00047.66109.650.0047.66109.65
271078-7107894.54894.55
3-0.0000.00
474502-7450299.10399.10
569394-6939492.30892.31
6-0.0000.00
10min174068-7406898.52694.836.6798.5395.096.85
272808-7280896.85097.37
369238-6923892.10192.10
475765-75765100.783101.33
573210-7321097.38497.90
662629-6262983.30983.31
15min175716-75716100.71899.113.04101.2799.912.95
272018-7201895.79996.86
376121-76121101.256101.77
477424-77424102.990104.10
571992-7199295.76496.82
673792-7379298.15898.62
20min175217-75217100.05498.552.93101.1699.892.84
271424-7142495.00996.60
375853-75853100.900101.97
476715-76715102.047103.73
571936-7193695.69097.28
673368-7336897.59498.60
30min174671-7467199.32898.362.88100.99100.252.77
271076-7107694.54696.67
375683-75683100.674102.31
476530-76530101.801104.05
571905-7190595.64897.77
673808-7380898.18099.73
45min173659-7365997.98297.573.11100.20100.012.95
270430-7043093.68696.33
376169-76169101.320103.51
475369-75369100.256103.07
571048-7104894.50897.16
673436-7343697.68599.78
60min171939-7193995.69495.843.0898.4598.822.97
269768-6976892.80695.97
374627-7462799.269102.03
474585-7458599.213102.59
569562-6956292.53295.71
671809-7180995.52198.16
极限172341-7234196.22895.992.6799.5299.502.58
269929-6992993.02096.70
374496-7449699.095102.40
474295-7429598.828102.75
570465-7046593.73397.42
671434-7143495.02298.19
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