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%
112.284923349102491114918549167491600.12
212.294901849053490360.06
单位质量响应值RSD%判断
4003.263989.910.24数据可信
供试品溶液-24050701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%
5min145098-4509891.19595.844.9191.1995.844.91
249209-4920999.50899.51
349187-4918799.46399.46
449116-4911699.32099.32
543925-4392588.82388.82
647836-4783696.73196.73
10min147892-4789296.84599.922.2697.35100.452.27
250798-50798102.721103.27
350303-50303101.720102.27
449857-49857100.818101.37
549190-4919099.46999.96
648435-4843597.94398.48
15min148117-4811797.30099.011.2498.34100.101.25
249346-4934699.785100.91
349582-49582100.262101.38
449326-4932699.744100.86
549106-4910699.300100.35
648310-4831097.69098.77
20min147706-4770696.46998.491.5798.05100.131.59
249048-4904899.182100.86
349169-4916999.427101.10
449789-49789100.681102.35
548168-4816897.40399.00
648355-4835597.78199.41
30min147680-4768096.41698.521.4998.54100.711.50
249458-49458100.011102.24
349225-4922599.540101.77
449227-4922799.544101.77
548729-4872998.537100.68
648019-4801997.10299.27
45min146334-4633493.69497.262.5796.3599.992.55
248710-4871098.499101.28
349120-4912099.328102.11
449563-49563100.224103.00
547438-4743895.92798.61
647412-4741295.87498.58
60min146421-4642193.87097.942.4097.05101.212.37
248359-4835997.789101.12
349304-4930499.700103.03
449733-49733100.567103.90
548719-4871998.517101.74
648060-4806097.184100.42
极限147053-4705395.14897.201.4698.85101.011.47
248739-4873998.557102.43
348779-4877998.638102.52
448326-4832697.722101.62
548051-4805197.166100.93
647448-4744895.94799.73
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%
110.843820983816773819203817283817893818420.05
210.963809043812943810990.08
单位质量响应值RSD%判断
35225.2834771.810.92数据可信
供试品溶液-24050701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%
5min1-0.0000.12155.180.000.12155.26
2-0.0000.00
3-0.0000.00
41514-15140.3880.39
51378-13780.3530.35
6-0.0000.00
10min15755-57551.4761.8817.961.481.8817.89
27320-73201.8771.88
37370-73701.8901.89
49154-91542.3472.35
58424-84242.1602.16
66030-60301.5461.55
15min113761-137613.5284.0513.913.544.0613.87
215872-158724.0694.08
315562-155623.9904.00
418598-185984.7684.78
517945-179454.6014.61
613066-130663.3503.36
20min121258-212585.4505.929.065.485.959.07
222996-229965.8965.93
322670-226705.8125.85
426061-260616.6826.72
524875-248756.3786.42
620587-205875.2785.31
30min131078-310787.9688.384.598.038.454.63
232494-324948.3318.40
332227-322278.2638.33
434734-347348.9068.98
534229-342298.7768.85
631336-313368.0348.09
45min138646-386469.90910.373.3910.0110.483.44
239764-3976410.19510.31
340601-4060110.41010.52
442721-4272110.95311.08
540954-4095410.50010.62
639972-3997210.24910.35
60min143944-4394411.26711.783.0811.4211.953.14
244877-4487711.50611.67
345674-4567411.71011.88
447399-4739912.15312.34
547560-4756012.19412.38
646144-4614411.83111.99
极限148362-4836212.40012.531.0812.6212.771.15
248459-4845912.42512.66
348894-4889412.53612.77
448963-4896312.55412.81
549827-4982712.77513.03
648689-4868912.48412.71
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%
112.284911349085492444917849230491700.15
212.294918349226492040.07
单位质量响应值RSD%判断
4004.074003.580.01数据可信
供试品溶液-24050701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%
5min145407-4540791.65371.2837.9891.6571.2837.98
215697-1569731.68431.68
323029-2302946.48446.48
445324-4532491.48691.49
547989-4798996.86596.87
634441-3444169.51969.52
10min146703-4670394.26995.305.4394.7895.705.50
242311-4231185.40485.58
348891-4889198.68698.94
447977-4797796.84197.35
549280-4928099.471100.01
648133-4813397.15697.54
15min147434-4743495.74596.932.1796.7897.862.22
246499-4649993.85894.51
349206-4920699.322100.13
447599-4759996.07897.12
549046-4904698.999100.09
648347-4834797.58898.51
20min146838-4683894.54296.051.6896.1197.511.66
246909-4690994.68595.86
348855-4885598.61399.97
447043-4704394.95696.54
548004-4800496.89598.54
647854-4785496.59398.06
30min146991-4699194.85196.761.7396.9498.761.70
247229-4722995.33197.03
349286-4928699.483101.39
447828-4782896.54098.65
547907-4790796.70098.88
648384-4838497.66299.67
45min145381-4538191.60195.172.8994.2297.712.88
245670-4567092.18494.41
348250-4825097.39299.85
446998-4699894.86597.51
548397-4839797.689100.40
648210-4821097.31199.86
60min146466-4646693.79194.432.1896.9297.502.14
245956-4595692.76195.50
348314-4831497.521100.52
445517-4551791.87595.05
547031-4703194.93198.19
647420-4742095.71798.80
极限146084-4608493.02094.101.6196.6797.691.62
245754-4575492.35495.61
347451-4745195.77999.32
446091-4609193.03496.72
546879-4687994.62598.41
647464-4746495.80599.43
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%
110.843816773813753814163811943816703814660.06
210.963825723825343825530.01
单位质量响应值RSD%判断
35190.5934904.470.58数据可信
供试品溶液-24050701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%
5min13620-36200.9271.2151.270.931.2151.00
23813-38130.9760.98
33700-37000.9470.95
49548-95482.4452.44
54552-45521.1651.17
63056-30560.7820.78
10min19373-93732.4002.3122.442.402.3222.61
27763-77631.9881.99
39305-93052.3822.39
411151-111512.8552.87
510895-108952.7892.80
65744-57441.4711.47
15min117054-170544.3664.1913.854.384.2113.85
216434-164344.2084.22
316998-169984.3524.37
416743-167434.2874.32
518910-189104.8414.86
612100-121003.0983.11
20min123330-233305.9736.359.556.026.399.36
224014-240146.1486.19
323751-237516.0816.12
423249-232495.9526.01
524937-249376.3856.43
629456-294567.5427.57
30min132421-324218.3018.275.738.388.355.68
233395-333958.5508.62
333146-331468.4868.56
432715-327158.3768.46
533590-335908.6008.68
628645-286457.3347.41
45min139528-3952810.12010.223.5310.2410.353.56
239970-3997010.23310.35
340404-4040410.34510.47
440709-4070910.42310.56
541575-4157510.64410.78
637436-374369.5859.70
60min145536-4553611.65811.442.4711.8411.622.50
245080-4508011.54211.72
345337-4533711.60811.79
444398-4439811.36711.56
545113-4511311.55011.74
642563-4256310.89711.06
极限148114-4811412.31912.181.2612.5612.421.30
247596-4759612.18612.43
347937-4793712.27312.52
447720-4772012.21812.47
547660-4766012.20212.46
646424-4642411.88612.11
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%
112.284919949132492254920749220491970.08
212.294915549161491580.01
单位质量响应值RSD%判断
4006.273999.840.12数据可信
供试品溶液-24050702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%
5min146144-4614493.15980.3834.2493.1680.3834.24
212115-1211524.45924.46
345247-4524791.34891.35
443566-4356687.95487.95
547257-4725795.40695.41
644552-4455289.94589.94
10min148136-4813697.18191.8319.1597.7092.2819.22
227862-2786256.25056.39
350750-50750102.458102.97
448403-4840397.72098.21
549953-49953100.849101.38
647808-4780896.51897.02
15min148365-4836597.64397.534.6498.7098.494.83
244043-4404388.91789.37
350380-50380101.711102.79
448542-4854298.00099.03
549835-49835100.611101.70
648698-4869898.31599.35
20min147393-4739395.68197.113.5497.2898.603.71
245527-4552791.91392.86
349338-4933899.607101.25
447549-4754995.99597.57
550434-50434101.820103.47
648353-4835397.61999.20
30min147802-4780296.50698.162.4998.64100.202.62
247510-4751095.91797.37
349957-49957100.857103.05
448035-4803596.97799.09
550350-50350101.650103.87
648083-4808397.07499.20
45min146910-4691094.70599.303.6097.37101.883.65
247986-4798696.87898.86
351756-51756104.489107.24
449410-4941099.753102.40
550558-50558102.070104.85
648506-4850697.928100.59
60min147950-4795096.80599.042.14100.00102.172.19
248790-4879098.501101.02
350457-50457101.866105.20
448005-4800596.916100.12
550106-50106101.158104.50
649025-4902598.975102.18
极限147712-4771296.32598.222.24100.06101.902.17
249239-4923999.407102.48
350313-50313101.576105.48
447724-4772496.349100.09
549159-4915999.246103.15
647752-4775296.405100.16
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%
110.843822243819563819873818043817943819530.05
210.963818623820203819410.03
单位质量响应值RSD%判断
35235.5234848.630.79数据可信
供试品溶液-24050702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%
5min14765-47651.2201.329.111.221.329.11
24630-46301.1861.19
35632-56321.4421.44
45803-58031.4861.49
55000-50001.2801.28
65093-50931.3041.30
10min18215-82152.1042.6019.652.112.6019.65
29404-94042.4082.41
313437-134373.4413.45
411640-116402.9812.99
58704-87042.2292.24
69473-94732.4262.43
15min124727-247276.3324.7621.976.354.7821.85
215918-159184.0764.10
321820-218205.5875.61
418819-188194.8194.84
513820-138203.5393.56
616317-163174.1784.20
20min121441-214415.4906.0311.105.546.0811.10
223293-232935.9656.01
327598-275987.0677.13
425082-250826.4236.47
520254-202545.1865.23
623561-235616.0336.08
30min131122-311227.9698.395.868.058.475.90
232945-329458.4368.51
335629-356299.1249.22
433866-338668.6728.76
530260-302607.7497.82
632818-328188.4048.48
45min139296-3929610.06310.634.4910.1910.764.51
241092-4109210.52210.65
343910-4391011.24411.39
443266-4326611.07911.21
539694-3969410.16410.28
641904-4190410.73010.85
60min146022-4602211.78511.912.3511.9712.102.42
246801-4680111.98412.17
347693-4769312.21312.42
447097-4709712.06012.26
544572-4457211.41411.58
646839-4683911.99412.18
极限148337-4833712.37812.532.2212.6312.792.32
249354-4935412.63812.89
350405-5040512.90713.19
449524-4952412.68212.95
547261-4726112.10212.33
648724-4872412.47712.73
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%
112.284911849212493984938649401493030.27
212.294918949179491840.02
单位质量响应值RSD%判断
4014.904001.950.23数据可信
供试品溶液-24050702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%
5min121286-2128642.91678.1331.2342.9278.1331.23
245570-4557091.87791.88
347013-4701394.78694.79
448323-4832397.42897.43
525290-2529050.98950.99
645022-4502290.77290.77
10min144922-4492290.57096.723.8790.8197.153.97
249095-4909598.98499.49
349328-4932899.45499.98
449925-49925100.657101.20
547209-4720995.18195.46
647355-4735595.47695.98
15min148077-4807796.93298.691.4097.6799.661.50
249767-49767100.339101.40
349163-4916399.121100.20
449629-49629100.061101.16
548668-4866898.12398.94
648395-4839597.57398.61
20min147830-4783096.43497.271.3197.7198.791.41
248884-4888498.559100.18
348542-4854297.86999.50
448977-4897798.746100.40
547614-4761495.99897.36
647627-4762796.02497.60
30min146880-4688094.51896.641.7596.3398.701.83
249345-4934599.488101.65
347723-4772396.21898.39
448346-4834697.47499.68
547659-4765996.08997.98
647640-4764096.05098.16
45min147290-4729095.34597.751.8797.69100.341.98
249484-4948499.768102.49
348845-4884598.480101.19
449428-4942899.655102.40
547807-4780796.38798.81
648037-4803796.85199.49
60min147463-4746395.69498.232.1998.56101.372.23
249339-4933999.476102.75
348028-4802896.833100.09
450396-50396101.607104.91
548987-4898798.766101.73
648118-4811897.014100.20
极限147288-4728895.34197.291.9698.74100.972.01
249264-4926499.325103.15
348513-4851397.811101.60
449187-4918799.169103.03
548261-4826197.302100.81
647007-4700794.77498.50
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%
110.843828053827713828133823883827963827150.05
210.963830153828233829190.04
单位质量响应值RSD%判断
35305.8134937.860.75数据可信
供试品溶液-24050702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%
5min16244-62441.5951.408.681.601.408.82
25764-57641.4731.47
35338-53381.3641.36
45003-50031.2781.28
55405-54051.3811.38
65025-50251.2841.28
10min111813-118133.0182.749.293.032.759.39
211972-119723.0593.07
310688-106882.7312.74
410008-100082.5572.56
510562-105622.6982.71
69421-94212.4072.41
15min120046-200465.1224.768.785.154.788.75
220738-207385.2985.32
317808-178084.5504.57
418167-181674.6414.66
518750-187504.7904.81
616184-161844.1354.16
20min126154-261546.6826.365.876.746.415.90
226731-267316.8296.88
324349-243496.2216.27
424622-246226.2916.34
524924-249246.3686.42
622589-225895.7715.81
30min134589-345898.8378.593.588.938.683.61
235361-353619.0349.13
332890-328908.4038.49
433633-336338.5938.67
533200-332008.4828.57
632024-320248.1828.26
45min142567-4256710.87510.682.1211.0210.812.16
243042-4304210.99711.14
341596-4159610.62710.76
441747-4174710.66610.80
541096-4109610.50010.63
640686-4068610.39510.52
60min146928-4692811.99012.257.4712.1912.447.39
255075-5507514.07114.27
345657-4565711.66511.85
447617-4761712.16612.35
546984-4698412.00412.19
645517-4551711.62911.81
极限149263-4926312.58612.541.8412.8512.801.88
249833-4983312.73213.01
348877-4887712.48812.74
449610-4961012.67512.93
549499-4949912.64612.90
647355-4735512.09912.34
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