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(%)99.70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%
110.712846952847452850832846202846872847660.07
210.742825492826152825820.02
单位质量响应值RSD%判断
26588.8026311.170.75数据可信
供试品溶液-2024010721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%
5min15965-59652.0241.8620.192.021.8620.04
24682-46821.5881.59
36485-64852.2002.20
46822-68222.3142.31
54747-47471.6101.61
64112-41121.3951.40
10min117023-170235.7755.794.285.795.804.30
216551-165515.6155.62
317832-178326.0506.06
418061-180616.1276.14
516350-163505.5475.56
616519-165195.6045.61
15min122690-226907.6987.743.607.747.783.58
222367-223677.5887.63
323578-235787.9998.04
423984-239848.1378.18
522402-224027.6007.64
621806-218067.3987.44
20min127136-271369.2069.112.449.299.192.47
226512-265128.9949.08
327355-273559.2809.37
427688-276889.3939.49
526403-264038.9579.04
625965-259658.8098.89
30min131692-3169210.75210.731.6410.8910.871.66
231402-3140210.65310.79
331903-3190310.82310.97
432407-3240710.99411.14
531439-3143910.66610.80
630880-3088010.47610.61
45min135457-3545712.02912.261.5912.2312.461.60
235943-3594312.19412.39
336396-3639612.34712.55
437130-3713012.59612.80
536076-3607612.23912.43
635827-3582712.15412.34
60min138727-3872713.13813.271.3113.4013.541.30
238723-3872313.13713.40
339126-3912613.27413.54
439380-3938013.36013.64
540019-4001913.57713.84
638798-3879813.16213.42
极限141850-4185014.19814.411.6114.5314.751.62
242004-4200414.25014.58
343300-4330014.69015.03
443303-4330314.69115.04
542551-4255114.43614.77
641891-4189114.21214.54
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%
114.726970769811699626982869766698150.14
214.836953869202693700.35
单位质量响应值RSD%判断
4742.874677.680.98数据可信
供试品溶液-2024010721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%
5min160884-6088483.80788.516.8083.8188.516.80
265866-6586690.66590.66
369860-6986096.16396.16
468153-6815393.81393.81
558635-5863580.71180.71
662425-6242585.92885.93
10min169173-6917395.21797.712.3995.6898.202.37
271113-7111397.88798.39
371036-7103697.78198.32
472063-7206399.19599.72
573451-73451101.106101.55
669051-6905195.04995.53
15min168307-6830794.02597.192.7895.0298.222.77
271288-7128898.12899.18
370814-7081497.47698.55
472100-7210099.246100.32
572928-72928100.386101.40
668199-6819993.87694.88
20min168693-6869394.55696.442.2096.0798.012.19
269816-6981696.10297.69
370169-7016996.58898.21
470985-7098597.71199.33
572448-7244899.725101.29
668242-6824293.93695.46
30min167527-6752792.95195.562.4894.9997.672.46
270171-7017196.59198.72
369243-6924395.31397.47
469974-6997496.32098.49
572036-7203699.158101.28
667575-6757593.01795.07
45min166373-6637391.36394.442.8393.9297.082.81
268020-6802093.63096.29
368392-6839294.14296.83
470081-7008196.46799.17
571631-7163198.601101.27
667146-6714692.42794.99
60min166597-6659791.67194.362.5394.7497.532.51
269321-6932195.42198.60
368443-6844394.21297.42
469285-6928595.37198.61
571057-7105797.810101.03
666618-6661891.70094.78
极限166164-6616491.07593.413.0194.6597.102.98
267898-6789893.46297.18
368431-6843194.19697.93
469176-6917695.22198.99
570566-7056697.135100.90
664930-6493089.37792.97
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(%)99.70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%
110.712761672760362758852757462758982759460.06
210.742744622742982743800.05
单位质量响应值RSD%判断
25765.2725547.490.61数据可信
供试品溶液-2024010721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%
5min15799-57992.0282.1017.242.032.1017.27
25531-55311.9341.93
36091-60912.1302.13
48004-80042.7992.80
55313-53131.8581.86
65236-52361.8311.83
10min116600-166005.8066.023.955.826.043.91
216999-169995.9455.96
318468-184686.4596.47
416985-169855.9405.96
516771-167715.8665.88
617458-174586.1066.12
15min122992-229928.0418.053.098.088.093.08
222707-227077.9427.99
324085-240858.4248.47
422197-221977.7637.81
522503-225037.8707.91
623606-236068.2568.30
20min126929-269299.4189.442.439.519.532.42
227399-273999.5839.67
327147-271479.4949.59
426048-260489.1109.20
526518-265189.2759.36
627904-279049.7599.85
30min132129-3212911.23711.292.2111.3811.432.23
231586-3158611.04711.19
333333-3333311.65811.81
432720-3272011.44411.59
531438-3143810.99511.13
632436-3243611.34411.49
45min136685-3668512.83012.582.9513.0312.782.91
234663-3466312.12312.33
336031-3603112.60212.81
435284-3528412.34012.55
535468-3546812.40512.60
637598-3759813.15013.36
60min138596-3859613.49913.742.2513.7714.022.22
240563-4056314.18714.46
339462-3946213.80214.08
439291-3929113.74214.02
538064-3806413.31313.58
639784-3978413.91414.19
极限142079-4207914.71715.092.7915.0715.442.74
243489-4348915.21015.56
343155-4315515.09315.45
445111-4511115.77716.13
541708-4170814.58714.93
643288-4328815.14015.50
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%
114.726857968566685356842968510685240.09
214.836851168246683780.28
单位质量响应值RSD%判断
4655.164610.790.68数据可信
供试品溶液-2024010721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%
5min156189-5618978.63392.748.8878.6392.748.88
268791-6879196.26996.27
373799-73799103.277103.28
466237-6623792.69592.69
564247-6424789.91089.91
668341-6834195.63995.64
10min170137-7013798.15299.852.3698.59100.372.39
271360-7136099.864100.40
374488-74488104.241104.82
469852-6985297.75398.27
571642-71642100.258100.76
670623-7062398.83299.36
15min171894-71894100.61199.311.75101.59100.381.73
269984-6998497.93899.03
372450-72450101.389102.54
469411-6941197.13698.19
571805-71805100.487101.54
670251-7025198.31299.39
20min170880-7088099.19299.101.20100.73100.721.20
271435-7143599.969101.60
371406-7140699.928101.64
469157-6915796.78198.38
571107-7110799.510101.12
670897-7089799.216100.84
30min171154-7115499.57698.991.18101.67101.171.17
270041-7004198.018100.21
371716-71716100.362102.63
470707-7070798.950101.09
571307-7130799.790101.96
669508-6950897.27299.45
45min171087-7108799.48297.291.53102.13100.021.46
269036-6903696.61299.35
368785-6878596.26099.09
468155-6815595.37998.06
570052-7005298.033100.76
670026-7002697.997100.72
60min169335-6933597.03097.511.31100.23100.771.28
271209-7120999.653102.92
369970-6997097.919101.28
469861-6986197.766100.98
569136-6913696.751100.02
668563-6856395.95099.21
极限169303-6930396.98597.270.71100.72101.070.72
270035-7003598.010101.83
370183-7018398.217102.12
469385-6938597.100100.86
569083-6908396.677100.48
669031-6903196.605100.40
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(%)99.70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%
110.712807642809142808882808092808972808540.03
210.742791932791212791570.02
单位质量响应值RSD%判断
26223.5325992.270.63数据可信
供试品溶液-2024010921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%
5min16114-61142.1012.8214.662.102.8214.70
28209-82092.8212.82
38708-87082.9932.99
48736-87363.0033.00
59649-96493.3163.32
67746-77462.6622.66
10min119122-191226.5727.044.686.587.064.72
221157-211577.2727.29
321338-213387.3347.35
420655-206557.0997.12
521168-211687.2757.29
619462-194626.6896.70
15min126693-266939.1749.342.739.229.392.76
227754-277549.5399.60
327811-278119.5599.62
427583-275839.4809.54
527232-272329.3609.42
625913-259138.9068.96
20min131152-3115210.70710.814.2310.8110.924.19
233648-3364811.56511.67
331929-3192910.97411.08
431420-3142010.79910.91
531010-3101010.65810.77
629588-2958810.16910.27
30min137324-3732412.82812.682.9012.9912.852.88
237555-3755512.90713.08
336944-3694412.69712.87
438255-3825513.14813.32
535724-3572412.27812.45
635537-3553712.21412.37
45min142074-4207414.46114.152.7314.6914.392.71
241912-4191214.40514.65
342085-4208514.46414.71
441417-4141714.23514.48
540117-4011713.78814.03
639461-3946113.56313.79
60min145173-4517315.52615.053.2015.8415.373.17
244274-4427415.21715.54
344680-4468015.35615.68
444330-4433015.23615.56
542840-4284014.72415.04
641415-4141514.23414.54
极限148197-4819716.56516.062.9816.9616.462.95
247463-4746316.31316.72
347402-4740216.29216.70
447392-4739216.28816.69
545086-4508615.49615.89
644885-4488515.42715.81
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%
114.726923969056689546901769101690730.16
214.836902668915689700.12
单位质量响应值RSD%判断
4692.464650.710.64数据可信
供试品溶液-2024010921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%
5min162029-6202986.08893.864.9586.0993.864.95
269118-6911895.92795.93
370359-7035997.64997.65
467472-6747293.64293.64
571015-7101598.55998.56
665777-6577791.29091.29
10min171228-7122898.85598.292.4599.3398.822.45
271162-7116298.76399.30
371928-7192899.827100.37
468464-6846495.01995.54
573055-73055101.391101.94
669105-6910595.90996.42
15min171062-7106298.62598.171.8799.6599.241.87
270265-7026597.51998.60
371449-7144999.162100.26
469543-6954396.51697.56
572810-72810101.051102.16
669287-6928796.16197.20
20min169690-6969096.72097.022.3498.3098.632.34
270994-7099498.530100.15
370745-7074598.18599.83
468363-6836394.87996.46
571926-7192699.824101.50
667699-6769993.95795.53
30min169273-6927396.14296.631.2098.2598.781.22
269747-6974796.80098.97
370171-7017197.38899.58
468451-6845195.00197.11
570847-7084798.326100.55
669242-6924296.09998.19
45min168422-6842294.96195.832.0997.6198.522.08
269090-6909095.88898.60
370431-7043197.749100.48
467181-6718193.23895.88
570990-7099098.525101.30
668175-6817594.61897.25
60min168764-6876495.43594.692.1798.6197.912.16
268338-6833894.84498.09
368828-6882895.52498.80
466311-6631192.03195.19
570348-7034897.634100.95
666779-6677992.68095.84
极限169376-6937696.28595.111.8899.9998.861.87
268620-6862095.23599.00
368999-6899995.76199.57
466528-6652892.33296.00
570067-7006797.244101.11
667577-6757793.78897.46
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(%)99.70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%
110.712785092786832787622786002784312785970.05
210.742777152778562777860.04
单位质量响应值RSD%判断
26012.7925864.620.41数据可信
供试品溶液-2024010921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%
5min16120-61202.1172.3518.032.122.3517.92
28475-84752.9322.93
37449-74492.5772.58
45508-55081.9051.91
57566-75662.6172.62
65568-55681.9261.93
10min118664-186646.4576.523.576.476.543.58
219006-190066.5756.59
319604-196046.7826.80
417965-179656.2156.23
519578-195786.7736.79
618283-182836.3256.34
15min125556-255568.8418.863.008.898.913.01
225929-259298.9709.02
326734-267349.2489.30
424876-248768.6058.65
525983-259838.9889.04
624657-246578.5308.58
20min130202-3020210.44810.322.2610.5410.422.27
230253-3025310.46610.57
330621-3062110.59310.70
429216-2921610.10710.20
529857-2985710.32910.43
628855-288559.98210.08
30min135954-3595412.43812.142.3412.5912.292.34
235726-3572612.35912.52
335675-3567512.34112.50
434314-3431411.87012.02
534823-3482312.04612.21
633998-3399811.76111.91
45min140226-4022613.91613.782.2714.1414.002.26
240675-4067514.07114.30
340882-4088214.14214.37
438732-3873213.39913.61
538998-3899813.49113.72
639407-3940713.63213.85
60min142800-4280014.80614.722.3715.1115.022.38
244257-4425715.31015.62
342973-4297314.86615.18
441837-4183714.47314.76
542031-4203114.54014.84
641480-4148014.34914.64
极限146204-4620415.98415.652.1016.3716.042.11
245883-4588315.87216.27
346172-4617215.97216.36
444292-4429215.32215.69
544818-4481815.50415.89
644140-4414015.27015.64
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%
114.726884868869686976877768916688210.13
214.836881868664687410.16
单位质量响应值RSD%判断
4675.344635.270.61数据可信
供试品溶液-2024010921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%
5min156333-5633378.45682.4210.9778.4682.4210.96
249456-4945668.87868.88
360995-6099584.94984.95
462424-6242486.93986.94
568664-6866495.63095.63
657202-5720279.66679.67
10min171304-7130499.30696.224.5099.7496.684.51
263032-6303287.78688.17
369114-6911496.25696.73
470075-7007597.59598.08
571391-7139199.42899.96
669624-6962496.96797.41
15min170282-7028297.88397.092.2598.8798.082.30
266777-6677793.00293.87
370253-7025397.84398.85
470771-7077198.56499.59
570998-7099898.88099.96
669201-6920196.37897.36
20min170127-7012797.66796.701.2999.2098.231.33
268497-6849795.39796.78
368806-6880695.82797.38
470129-7012997.67099.24
570442-7044298.10699.74
668581-6858195.51497.03
30min170324-7032497.94296.001.69100.0298.071.70
268325-6832595.15897.07
367674-6767494.25196.33
469730-6973097.11499.23
569800-6980097.21299.39
667731-6773194.33096.38
45min168968-6896896.05395.661.0098.6798.261.02
267865-6786594.51796.96
368078-6807894.81497.42
468389-6838995.24797.90
569247-6924796.44299.16
669579-6957996.90499.48
60min168733-6873395.72695.371.3898.8898.501.37
268530-6853095.44398.41
366875-6687593.13896.27
469063-6906396.18599.37
569596-6959696.928100.18
668057-6805794.78497.89
极限168421-6842195.29194.241.0898.9797.901.12
266628-6662892.79496.30
367242-6724293.64997.30
468135-6813594.89398.61
568306-6830695.13198.92
667254-6725493.66697.30
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