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%
110.302843082845342842332841332842982843010.06
210.332843642844792844220.03
单位质量响应值RSD%判断
27602.0427533.590.18数据可信
供试品溶液-20220124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%
5min13009-30090.9794.8792.670.984.8692.69
222988-229887.4827.48
336569-3656911.90311.90
42961-29610.9640.96
54180-41801.3611.36
620000-200006.5106.51
10min114529-145294.7293.6627.064.733.6826.60
29072-90722.9532.99
311518-115183.7493.82
415131-151314.9254.93
59450-94503.0763.08
67734-77342.5172.55
15min122080-220807.1876.569.257.226.619.17
219175-191756.2416.30
320637-206376.7176.80
422512-225127.3277.36
518373-183735.9806.00
618221-182215.9315.98
20min125928-259288.4398.134.758.518.224.78
224177-241777.8697.96
325399-253998.2678.39
426614-266148.6638.74
523494-234947.6477.70
624330-243307.9198.00
30min131650-3165010.3029.953.3610.4210.083.38
230363-303639.88310.02
330663-306639.98010.15
431727-3172710.32710.45
529076-290769.4649.56
629893-298939.7309.86
45min135192-3519211.45511.312.1511.6311.492.23
234691-3469111.29211.48
334951-3495111.37611.60
435606-3560611.58911.77
533422-3342210.87811.03
634562-3456211.25011.43
60min137730-3773012.28112.152.0212.5212.402.09
237793-3779312.30112.56
337282-3728212.13512.42
437775-3777512.29512.54
535837-3583711.66511.88
637519-3751912.21212.46
极限141263-4126313.43113.471.4613.7413.781.55
241722-4172213.58013.90
341699-4169913.57313.93
442173-4217313.72714.04
540504-4050413.18413.46
640947-4094713.32813.64
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%
114.937140171652715717133171513714940.19
214.987150771766716360.26
单位质量响应值RSD%判断
4788.614782.110.10数据可信
供试品溶液-20220124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%
5min123143-2314331.35513.85161.7731.3613.85161.77
2-0.0000.00
3-0.0000.00
438193-3819351.74651.75
5-0.0000.00
6-0.0000.00
10min164877-6487787.89884.1819.9888.0784.2620.01
265109-6510988.21288.21
369319-6931993.91693.92
470222-7022295.14095.43
537215-3721550.42050.42
666065-6606589.50889.51
15min168036-6803692.17892.198.6992.8492.748.76
270049-7004994.90595.40
371255-7125596.53997.06
470694-7069495.77996.60
556299-5629976.27676.56
671950-7195097.48197.98
20min167582-6758291.56395.052.9892.7496.112.97
270127-7012795.01196.03
371310-7131096.61497.67
470007-7000794.84896.20
568461-6846192.75493.46
673466-7346699.535100.57
30min167902-6790291.99795.072.3193.6896.662.31
270108-7010894.98596.53
370858-7085896.00197.60
470306-7030695.25497.13
569162-6916293.70494.92
672705-7270598.504100.10
45min167408-6740891.32794.332.0993.5296.452.06
269642-6964294.35496.43
370529-7052995.55697.68
469345-6934593.95296.36
569094-6909493.61295.35
671740-7174097.19699.34
60min167466-6746691.40694.082.1894.1196.722.20
269947-6994794.76797.36
369996-6999694.83497.49
469639-6963994.35097.28
567971-6797192.09094.35
671609-7160997.01999.70
极限166781-6678190.47893.832.1293.6996.992.13
269352-6935293.96197.08
370077-7007794.94398.13
469838-6983894.62098.07
568491-6849192.79595.57
670981-7098196.16899.39
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%
110.302842882843472844492844302844762843980.03
210.332838502837452837980.03
单位质量响应值RSD%判断
27611.4627473.180.36数据可信
供试品溶液-20220124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%
5min118344-183445.9768.4951.905.988.4951.87
217650-176505.7505.75
344948-4494814.64414.64
434417-3441711.21311.21
532651-3265110.63710.64
68343-83432.7182.72
10min112144-121443.9563.3620.933.993.4120.85
211090-110903.6133.64
310064-100643.2793.36
49671-96713.1513.21
512407-124074.0424.10
66507-65072.1202.14
15min121280-212806.9336.458.156.996.528.27
220022-200226.5236.58
320026-200266.5246.62
419269-192696.2786.36
521251-212516.9237.00
616917-169175.5115.54
20min125634-256348.3518.044.378.458.144.55
224987-249878.1418.23
324586-245868.0108.15
424359-243597.9368.05
525679-256798.3668.49
622759-227597.4157.47
30min131634-3163410.3069.872.8710.4510.022.99
229968-299689.7639.90
330582-305829.96310.14
429740-297409.6899.85
530765-3076510.02310.19
629169-291699.5039.60
45min136355-3635511.84411.362.4012.0411.562.41
234901-3490111.37011.56
334370-3437011.19711.43
434414-3441411.21211.42
535098-3509811.43511.66
634000-3400011.07711.23
60min138510-3851012.54612.092.0512.8112.352.09
236928-3692812.03112.28
336867-3686712.01112.31
436603-3660311.92512.20
537290-3729012.14912.43
636375-3637511.85112.06
极限142164-4216413.73713.401.4214.0713.731.47
241142-4114213.40413.72
340953-4095313.34213.71
440843-4084313.30613.65
541220-4122013.42913.78
640426-4042613.17013.45
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%
114.937177771202714997171571641715670.32
214.987121571546713800.33
单位质量响应值RSD%判断
4793.504765.020.43数据可信
供试品溶液-20220124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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min163718-6371886.43987.427.5886.4487.427.58
260407-6040781.94781.95
368964-6896493.55593.56
464520-6452087.52787.53
570926-7092696.21796.22
658122-5812278.84778.85
15min171036-7103696.36695.432.2396.8595.922.25
269606-6960694.42694.88
370660-7066095.85696.38
468248-6824892.58493.07
572859-7285998.83999.37
669664-6966494.50594.94
20min170639-7063995.82895.471.3996.8496.491.39
270296-7029695.36296.34
369962-6996294.90995.96
468789-6878993.31894.32
571669-7166997.22598.31
670904-7090496.18797.15
30min170252-7025295.30394.912.1196.8596.462.10
268142-6814292.44093.95
370875-7087596.14897.73
468105-6810592.39093.91
570993-7099396.30897.93
671401-7140196.86198.36
45min170945-7094596.24395.081.5998.3297.151.58
269540-6954094.33796.36
369237-6923793.92696.04
468603-6860393.06695.10
571368-7136896.81798.98
670822-7082296.07698.11
60min170724-7072495.94394.451.6798.5697.061.67
268936-6893693.51796.06
369069-6906993.69896.33
467959-6795992.19294.74
570936-7093696.23198.93
670138-7013895.14897.72
极限170376-7037695.47194.011.6298.6297.141.62
268211-6821192.53495.60
369100-6910093.74096.90
467798-6779891.97495.04
570435-7043595.55198.78
669876-6987694.79397.89
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%
110.302839602839602840242839362838912839540.02
210.332842402842472842440.01
单位质量响应值RSD%判断
27568.3527516.360.14数据可信
供试品溶液-20220126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%
5min119437-194376.3325.4369.306.335.4369.28
24448-44481.4491.45
313575-135754.4234.42
430549-305499.9539.95
528391-283919.2499.25
63614-36141.1771.18
10min19728-97283.1693.6716.793.203.7016.32
210562-105623.4413.45
311535-115353.7583.78
49749-97493.1763.23
511136-111363.6283.68
614813-148134.8264.83
15min120085-200856.5436.797.496.606.847.34
219932-199326.4946.52
320306-203066.6156.66
419667-196676.4076.48
521134-211346.8856.96
623844-238447.7687.80
20min125029-250298.1548.313.118.248.403.16
224547-245477.9978.06
325459-254598.2948.38
425158-251588.1968.30
526111-261118.5078.62
626733-267338.7098.79
30min130498-304989.93610.072.1910.0710.202.26
230064-300649.7959.90
330701-3070110.00210.13
430788-3078810.03010.18
531790-3179010.35710.51
631659-3165910.31410.44
45min135265-3526511.48911.512.2511.6811.702.34
234235-3423511.15311.32
334790-3479011.33411.52
435555-3555511.58311.79
536582-3658211.91812.13
635532-3553211.57611.76
60min137448-3744812.20012.341.8112.4512.601.88
237305-3730512.15412.38
337371-3737112.17512.42
437768-3776812.30412.58
538984-3898412.70112.98
638465-3846512.53112.78
极限141661-4166113.57313.621.2313.8913.941.31
240868-4086813.31413.61
342118-4211813.72214.04
441805-4180513.62013.96
542333-4233313.79214.14
641969-4196913.67313.99
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%
114.937123871647714727138971561714610.23
214.987159671547715720.05
单位质量响应值RSD%判断
4786.404777.840.13数据可信
供试品溶液-20220126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%
5min1-0.0006.12244.950.006.12244.95
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
627102-2710236.74436.74
10min169156-6915693.75985.5612.0393.7685.6012.03
249457-4945767.05267.05
359768-5976881.03181.03
468268-6826892.55592.56
568291-6829192.58692.59
663724-6372486.39586.60
15min171679-7167997.18096.682.3497.7097.182.41
268358-6835892.67793.05
371598-7159897.07097.52
472435-7243598.20598.72
570675-7067595.81896.33
673102-7310299.10999.79
20min170761-7076195.93595.972.5197.0097.022.47
269415-6941594.11095.00
372482-7248298.26899.26
473381-7338199.487100.55
569568-6956894.31895.36
669121-6912193.71294.95
30min170686-7068695.83395.832.3397.4397.412.29
269387-6938794.07295.48
372243-7224397.94499.48
473040-7304099.025100.64
569819-6981994.65896.23
668923-6892393.44395.20
45min171020-7102096.28695.532.6498.4197.642.58
269158-6915893.76295.69
371451-7145196.87198.95
473178-7317899.212101.37
570077-7007795.00897.10
667869-6786992.01494.29
60min170397-7039795.44295.412.0798.1098.052.02
269761-6976194.57997.03
371774-7177497.30899.93
472391-7239198.145100.86
569205-6920593.82596.45
668699-6869993.13995.93
极限170720-7072095.87995.082.8499.0798.252.77
268609-6860993.01796.00
372650-7265098.496101.65
472137-7213797.801101.06
568734-6873493.18796.33
667934-6793492.10295.41
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%
110.302838132838002837722839742838442838410.03
210.332883302882522882910.02
单位质量响应值RSD%判断
27557.3827908.130.90数据可信
供试品溶液-20220126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%
5min1-0.0001.5675.030.001.5674.98
29950-99503.2193.22
37036-70362.2772.28
42714-27140.8780.88
56493-64932.1012.10
62806-28060.9080.91
10min18366-83662.7073.6127.092.713.6226.94
27109-71092.3002.32
311117-111173.5973.61
414351-143514.6434.65
511540-115403.7343.75
614501-145014.6924.70
15min118629-186296.0286.699.306.046.729.35
218153-181535.8745.90
320647-206476.6816.71
422342-223427.2297.26
521486-214866.9526.98
622793-227937.3757.41
20min124573-245737.9518.375.388.008.435.42
223914-239147.7387.80
325665-256658.3048.37
427211-272118.8058.88
526558-265588.5938.66
627227-272278.8108.88
30min130840-308409.97910.222.8710.0710.342.93
230232-302329.7829.89
331510-3151010.19610.31
432108-3210810.38910.51
532431-3243110.49410.61
632435-3243510.49510.62
45min135058-3505811.34411.613.2411.4911.783.29
234422-3442211.13811.30
335055-3505511.34311.52
436590-3659011.83912.02
537180-3718012.03012.21
636920-3692011.94612.13
60min137401-3740112.10212.564.3112.3112.804.32
237252-3725212.05312.28
337696-3769612.19712.43
439284-3928412.71112.95
541426-4142613.40413.65
639919-3991912.91613.16
极限141667-4166713.48213.571.1313.7613.871.20
241442-4144213.40913.70
341509-4150913.43113.73
442172-4217213.64513.96
542187-4218713.65013.97
642640-4264013.79714.11
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%
114.937155071709714457149771540715480.14
214.987256372560725620.01
单位质量响应值RSD%判断
4792.234843.930.76数据可信
供试品溶液-20220126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%
5min1-0.00013.53170.170.0013.53170.18
2-0.0000.00
3-0.0000.00
418968-1896825.52525.52
5-0.0000.00
641349-4134955.64355.64
10min140188-4018854.08081.8819.5154.0881.9519.58
270636-7063695.05495.05
358685-5868578.97178.97
466044-6604488.87489.02
557027-5702776.74076.74
672483-7248397.53997.85
15min171541-7154196.27197.362.6496.5797.892.70
274965-74965100.879101.41
370130-7013094.37394.81
470567-7056794.96195.60
573089-7308998.35498.78
673794-7379499.303100.15
20min173207-7320798.51397.341.5699.3598.411.57
273110-7311098.38399.47
370828-7082895.31296.27
470946-7094695.47196.63
572891-7289198.08899.06
673033-7303398.27999.68
30min173833-7383399.35697.272.47100.7498.882.41
274181-7418199.824101.46
371446-7144696.14497.64
469291-6929193.24494.94
572189-7218997.14398.66
672755-7275597.90599.85
45min172937-7293798.15096.472.01100.0898.621.99
272997-7299798.231100.42
370229-7022994.50696.53
469610-6961093.67395.88
571927-7192796.79198.85
672432-7243297.47099.96
60min172644-7264497.75697.122.87100.2499.802.81
272893-7289398.091100.83
369483-6948393.50296.05
470053-7005394.26997.00
575060-75060101.007103.60
672884-7288498.079101.11
极限172614-7261497.71595.222.51100.7498.452.45
272695-7269597.824101.10
369290-6929093.24296.31
468341-6834191.96595.22
570308-7030894.61297.77
671324-7132495.97999.56
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