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)10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%
111.514606446013459994607746218460740.19
211.414636646411463880.07
单位质量响应值RSD%判断
4002.954065.561.10数据可信
供试品溶液-24022501批-左氨氯地平-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%
5min146732-4673223.40523.943.0623.4123.943.06
250633-5063325.35925.36
347508-4750823.79423.79
447171-4717123.62523.63
547902-4790223.99123.99
646807-4680723.44323.44
10min148662-4866224.37224.133.9824.5024.263.97
251136-5113625.61125.75
347715-4771523.89824.03
445593-4559322.83522.97
549062-4906224.57224.71
646877-4687723.47823.61
15min149908-4990824.99624.223.9025.2624.493.89
250434-5043425.26025.54
348149-4814924.11524.38
445632-4563222.85523.11
549308-4930824.69624.97
646739-4673923.40923.67
20min148322-4832224.20223.713.4024.6124.113.41
249440-4944024.76225.19
347062-4706223.57123.97
445037-4503722.55722.94
548103-4810324.09224.50
646083-4608323.08023.47
30min147391-4739123.73623.393.6424.2723.923.63
249403-4940324.74325.30
345696-4569622.88723.42
444962-4496222.51923.03
547502-4750223.79124.33
645289-4528922.68323.20
45min146178-4617823.12823.213.7423.8023.873.73
249097-4909724.59025.29
345778-4577822.92823.58
443949-4394922.01222.65
547309-4730923.69424.37
645729-4572922.90323.55
60min145996-4599623.03722.863.0623.8423.663.07
247704-4770423.89224.73
344170-4417022.12222.91
444088-4408822.08122.84
546510-4651023.29424.10
645444-4544422.76023.53
极限146095-4609523.08622.963.8424.0123.883.82
248484-4848424.28325.25
345444-4544422.76023.67
443372-4337221.72322.60
546890-4689023.48524.42
644829-4482922.45223.35
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)10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%
111.64015554020734021904026184024804021830.11
211.624058194054244056220.07
单位质量响应值RSD%判断
34670.9534907.230.49数据可信
供试品溶液-24022501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%
5min18381-83814.3235.4114.684.325.4114.67
213054-130546.7346.73
39650-96504.9784.98
410582-105825.4595.46
510792-107925.5675.57
610444-104445.3885.39
10min133887-3388717.48118.283.6217.5018.313.62
234178-3417817.63117.67
335016-3501618.06318.09
436112-3611218.62918.66
536308-3630818.73018.76
637116-3711619.14719.18
15min150197-5019725.89425.864.5726.0226.004.55
245570-4557023.50823.64
350983-5098326.30026.43
451214-5121426.41926.55
551708-5170826.67426.81
651161-5116126.39226.53
20min158097-5809729.97029.844.4630.2330.114.44
252643-5264327.15627.42
359364-5936430.62330.90
458926-5892630.39730.68
558942-5894230.40630.69
659045-5904530.45930.74
30min170104-7010436.16434.864.0836.6035.304.06
262261-6226132.11832.53
367364-6736434.75035.19
468647-6864735.41235.86
568135-6813535.14835.60
668897-6889735.54135.99
45min172888-7288837.60038.042.3638.2338.672.37
270744-7074436.49437.09
375668-7566839.03439.67
473882-7388238.11338.76
574376-7437638.36739.01
674869-7486938.62239.27
60min176279-7627939.34939.604.3840.1940.454.33
271139-7113936.69837.50
376380-7638039.40140.26
481533-8153342.05942.92
577657-7765740.06040.92
677615-7761540.03840.90
极限179248-7924840.88140.952.8241.9442.012.82
275139-7513938.76139.76
381568-8156842.07743.15
479530-7953041.02642.12
580629-8062941.59342.68
680132-8013241.33742.42
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)10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%
111.514652746597466584633346619465470.28
211.414696546869469170.15
单位质量响应值RSD%判断
4044.054111.921.18数据可信
供试品溶液-24022502批-左氨氯地平-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%
5min147087-4708723.33122.932.0623.3322.932.07
246364-4636422.97222.97
347157-4715723.36523.37
445574-4557422.58122.58
546777-4677723.17723.18
644751-4475122.17322.17
10min150149-5014924.84824.032.9024.9824.162.89
249340-4934024.44724.57
349141-4914124.34824.48
446500-4650023.04023.17
548718-4871824.13924.27
647101-4710123.33823.46
15min149668-4966824.60923.962.6524.8824.222.65
248072-4807223.81924.08
349669-4966924.61024.88
446923-4692323.24923.50
548920-4892024.23924.50
646851-4685123.21423.47
20min149400-4940024.47723.652.9624.8824.042.94
248200-4820023.88224.28
348896-4889624.22724.63
446187-4618722.88523.27
547745-4774523.65724.05
645942-4594222.76323.15
30min149682-4968224.61623.403.0325.1623.923.00
247277-4727723.42523.95
346069-4606922.82623.36
446714-4671423.14623.66
547848-4784823.70824.24
645750-4575022.66823.18
45min148746-4874624.15323.622.8224.8324.282.79
247181-4718123.37724.04
347275-4727523.42424.09
446768-4676823.17323.81
549814-4981424.68225.34
646238-4623822.91023.54
60min150856-5085625.19823.484.1226.0124.264.06
246423-4642323.00223.79
347631-4763123.60024.39
446774-4677423.17623.94
547611-4761123.59024.39
645031-4503122.31223.07
极限148062-4806223.81423.043.1024.7623.963.08
246674-4667423.12624.04
346978-4697823.27724.20
444881-4488122.23823.13
547784-4778423.67624.60
644652-4465222.12423.01
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)10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%
111.64069844067104061524056144063674063650.13
211.624087524092494090000.09
单位质量响应值RSD%判断
35031.4735197.930.34数据可信
供试品溶液-24022502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%
5min113594-135946.9477.397.386.957.397.38
215531-155317.9377.94
314683-146837.5047.50
413834-138347.0707.07
515830-158308.0908.09
613247-132476.7706.77
10min134365-3436517.56317.792.0817.6017.832.09
235898-3589818.34618.39
334345-3434517.55317.59
433975-3397517.36417.40
534953-3495317.86317.91
635358-3535818.07018.11
15min146686-4668623.86024.171.2924.0024.311.28
247413-4741324.23124.38
347830-4783024.44524.58
446873-4687323.95524.09
546805-4680523.92124.06
648163-4816324.61524.75
20min153803-5380327.49728.144.5927.7728.414.55
259957-5995730.64230.92
355326-5532628.27628.55
454050-5405027.62327.89
552932-5293227.05227.33
654273-5427327.73728.01
30min162250-6225031.81431.960.7432.2432.390.74
262777-6277732.08332.53
362962-6296232.17832.61
463039-6303932.21732.64
561885-6188531.62832.05
662313-6231331.84632.28
45min168869-6886935.19736.121.6535.8036.731.64
271810-7181036.70037.33
369952-6995235.75036.36
471248-7124836.41337.01
571821-7182136.70637.31
670395-7039535.97736.58
60min176466-7646639.08037.822.1639.8738.632.11
273872-7387237.75438.59
374442-7444238.04538.85
474652-7465238.15238.96
571998-7199836.79637.60
672580-7258037.09437.90
极限174797-7479738.22738.761.4939.2439.781.46
276146-7614638.91639.96
376292-7629238.99140.01
477713-7771339.71740.73
575276-7527638.47139.48
674787-7478738.22139.23
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)10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%
111.514675846662469254681446727467770.22
211.414689646855468760.07
单位质量响应值RSD%判断
4064.034108.330.77数据可信
供试品溶液-24022801批-左氨氯地平-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%
5min144499-4449922.00322.543.2122.0022.543.20
247066-4706623.27323.27
346173-4617322.83122.83
443676-4367621.59621.60
544806-4480622.15522.16
647229-4722923.35323.35
10min145982-4598222.73723.324.1222.8623.454.12
249501-4950124.47724.61
348512-4851223.98824.11
444308-4430821.90922.03
546345-4634522.91623.04
648327-4832723.89624.03
15min144420-4442021.96423.074.6122.2123.334.60
249130-4913024.29324.56
348131-4813123.79924.06
444082-4408221.79722.04
545931-4593122.71122.96
648271-4827123.86824.13
20min144197-4419721.85422.915.4222.2223.295.40
249118-4911824.28724.69
348096-4809623.78224.17
442564-4256421.04621.41
546340-4634022.91423.29
647705-4770523.58823.98
30min145483-4548322.49023.005.6422.9823.515.61
248789-4878924.12424.66
348723-4872324.09224.62
441887-4188720.71221.19
546360-4636022.92323.43
647862-4786223.66624.19
45min143155-4315521.33922.314.7821.9622.954.75
247425-4742523.45024.12
346947-4694723.21423.87
442036-4203620.78521.38
546185-4618522.83723.47
644976-4497622.23922.90
60min144528-4452822.01822.154.4722.7522.914.46
245764-4576422.62923.43
346470-4647022.97823.77
441609-4160920.57421.28
543491-4349121.50522.26
646873-4687323.17723.96
极限143512-4351221.51522.393.8622.3723.273.88
247548-4754823.51124.44
345764-4576422.62923.54
443291-4329121.40622.23
544702-4470222.10422.98
646852-4685223.16724.08
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)10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%
111.64088724086754084564089374082234086330.08
211.624108014107784107900.01
单位质量响应值RSD%判断
35226.9835351.980.26数据可信
供试品溶液-24022801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%
5min119892-1989210.1169.328.0210.129.328.05
217897-178979.1019.10
318813-188139.5679.57
416150-161508.2138.21
517350-173508.8238.82
619819-1981910.07910.08
10min137265-3726518.95118.362.5319.0118.412.54
235957-3595718.28618.34
335919-3591918.26618.32
434610-3461017.60117.65
536047-3604718.33118.38
636822-3682218.72518.78
15min147319-4731924.06423.781.0824.2323.931.09
247446-4744624.12824.28
346204-4620423.49723.65
446422-4642223.60723.75
546583-4658323.68923.84
646590-4659023.69323.85
20min154875-5487527.90627.291.5228.2027.581.51
253710-5371027.31427.60
352784-5278426.84327.13
453341-5334127.12627.40
554333-5433327.63027.91
652956-5295626.93027.22
30min165079-6507933.09531.862.3033.5532.302.29
262866-6286631.97032.41
362160-6216031.61132.05
461223-6122331.13431.56
563263-6326332.17232.61
661343-6134331.19531.64
45min169196-6919635.18934.793.0435.8235.402.99
268027-6802734.59435.21
369446-6944635.31635.93
468539-6853934.85535.45
570659-7065935.93336.55
664586-6458632.84433.46
60min174620-7462037.94736.472.2838.7837.282.25
269627-6962735.40836.22
371691-7169136.45837.26
471540-7154036.38137.17
571782-7178236.50437.32
671061-7106136.13736.93
极限176208-7620838.75538.232.0339.8039.241.98
275058-7505838.17039.17
373523-7352337.38938.40
477646-7764639.48640.48
574702-7470237.98939.01
673971-7397137.61738.61
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)10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%
111.514662546748466634672246553466620.17
211.414682147014469180.30
单位质量响应值RSD%判断
4054.044112.011.01数据可信
供试品溶液-24022501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%
5min146490-4649023.00624.405.5423.0124.405.53
248195-4819523.85023.85
349804-4980424.64624.65
454339-5433926.89026.89
549313-4931324.40324.40
647735-4773523.62223.62
10min147468-4746823.49024.973.4623.6225.113.47
249633-4963324.56124.69
351800-5180025.63425.77
452354-5235425.90826.06
550728-5072825.10325.24
650790-5079025.13425.27
15min147163-4716323.33924.643.7123.6024.913.71
249325-4932524.40924.68
351670-5167025.56925.85
451685-5168525.57725.87
550576-5057625.02825.30
648320-4832023.91224.18
20min147127-4712723.32124.604.0723.7125.024.06
248764-4876424.13124.54
351921-5192125.69426.11
451821-5182125.64426.08
550603-5060325.04125.46
648077-4807723.79124.19
30min144990-4499022.26424.034.8022.7824.584.78
247839-4783923.67424.21
351233-5123325.35325.92
450292-5029224.88725.47
549880-4988024.68425.24
647169-4716923.34223.88
45min145865-4586522.69724.254.2923.3424.934.28
248711-4871124.10524.78
350979-5097925.22725.93
451372-5137225.42226.14
549562-4956224.52625.22
647485-4748523.49824.16
60min145031-4503122.28423.684.7323.0524.494.71
246064-4606422.79523.60
350831-5083125.15426.00
449811-4981124.64925.51
548584-4858424.04224.87
646758-4675823.13923.93
极限145507-4550722.52023.964.2323.4124.904.22
248750-4875024.12425.06
350496-5049624.98825.97
450648-5064825.06426.06
548395-4839523.94924.91
646675-4667523.09724.02
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)10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%
111.64082954091274087094094714090234089250.11
211.624105304102074103680.06
单位质量响应值RSD%判断
35252.1635315.660.13数据可信
供试品溶液-24022501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%
5min19219-92194.6894.6613.304.694.6613.29
28790-87904.4714.47
38135-81354.1384.14
411524-115245.8615.86
58861-88614.5074.51
68421-84214.2834.28
10min125664-2566413.05313.275.1813.0813.305.18
227360-2736013.91613.94
323783-2378312.09612.12
427439-2743913.95613.99
525874-2587413.16013.19
626420-2642013.43813.46
15min136150-3615018.38718.093.3118.4918.193.31
237403-3740319.02419.13
334143-3414317.36617.46
435232-3523217.92018.03
535870-3587018.24418.34
634584-3458417.59017.69
20min142049-4204921.38721.131.4921.5921.331.49
242411-4241121.57121.78
341071-4107120.88921.08
440744-4074420.72320.93
541614-4161421.16621.37
641378-4137821.04621.24
30min146589-4658923.69624.082.1224.0224.402.09
248661-4866124.75025.08
347537-4753724.17824.48
445802-4580223.29623.62
547802-4780224.31324.63
647651-4765124.23624.55
45min153677-5367727.30127.121.9527.7527.571.93
254799-5479927.87228.34
353294-5329427.10627.54
451626-5162626.25826.71
552959-5295926.93627.39
653549-5354927.23627.68
60min155493-5549328.22528.101.8728.8328.701.83
255154-5515428.05228.67
356498-5649828.73629.32
453507-5350727.21527.81
554827-5482727.88628.49
655948-5594828.45629.06
极限158372-5837229.68929.402.5330.4530.162.49
260214-6021430.62631.40
358015-5801529.50730.25
455913-5591328.43829.19
556960-5696028.97129.73
657354-5735429.17129.93
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)10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%
111.514602545989457964593545925459340.19
211.414689847021469600.19
单位质量响应值RSD%判断
3990.794115.692.18数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-24022502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%
5min150409-5040925.13323.8310.4025.1323.8310.41
238037-3803718.96518.96
349865-4986524.86224.86
451747-5174725.80025.80
549004-4900424.43324.43
647720-4772023.79323.79
10min151161-5116125.50825.361.5425.6525.501.54
250888-5088825.37225.48
350584-5058425.22125.36
452216-5221626.03426.18
550367-5036725.11225.25
649970-4997024.91425.05
15min150416-5041625.13725.371.4325.4225.641.44
250640-5064025.24825.49
349967-4996724.91325.19
452086-5208625.96926.26
551090-5109025.47325.75
651047-5104725.45125.72
20min149909-4990924.88425.382.6825.3025.792.66
251336-5133625.59525.98
351052-5105225.45425.87
453342-5334226.59627.03
549750-4975024.80525.22
650001-5000124.93025.34
30min149364-4936424.61225.122.2525.1725.672.24
249734-4973424.79725.33
349192-4919224.52725.08
452093-5209325.97326.55
550972-5097225.41425.97
650900-5090025.37825.93
45min151090-5109025.47324.843.7326.1725.543.63
251495-5149525.67526.34
349750-4975024.80525.50
451316-5131625.58626.31
546922-4692223.39524.09
648355-4835524.10924.80
60min150024-5002424.94124.882.9225.7825.722.88
249987-4998724.92325.73
348912-4891224.38725.22
452638-5263826.24527.11
549300-4930024.58025.41
648595-4859524.22925.05
极限149834-4983424.84724.481.9125.8225.441.85
250029-5002924.94425.89
349019-4901924.44025.41
449483-4948324.67225.68
548702-4870224.28225.24
647465-4746523.66524.63
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)10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%
111.64019984021434017154016374021814019350.07
211.624090454091654091050.03
单位质量响应值RSD%判断
34649.5735206.971.13数据可信
供试品溶液-24022502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%
5min18998-89984.6233.6723.754.623.6723.73
24727-47272.4292.43
37539-75393.8743.87
47555-75553.8823.88
58579-85794.4084.41
65486-54862.8192.82
10min124519-2451912.59912.465.3212.6212.485.33
223681-2368112.16812.18
324857-2485712.77212.79
426367-2636713.54813.57
523430-2343012.03912.06
622701-2270111.66411.68
15min134264-3426417.60617.602.0317.7017.682.07
233829-3382917.38217.46
334921-3492117.94318.04
435087-3508718.02918.13
534139-3413917.54217.63
633220-3322017.06917.15
20min139651-3965120.37420.753.5920.5720.943.58
240461-4046120.79020.97
342110-4211021.63721.83
442131-4213121.64821.85
539208-3920820.14620.34
638793-3879319.93320.11
30min145910-4591023.59024.412.9023.9024.712.88
245960-4596023.61623.91
347397-4739724.35424.67
449303-4930325.33325.65
548599-4859924.97225.27
647809-4780924.56624.85
45min153326-5332627.40026.992.9927.8427.432.96
253504-5350427.49227.92
353569-5356927.52527.97
453661-5366127.57328.03
550036-5003625.71026.15
651057-5105726.23526.66
60min155675-5567528.60728.882.4829.2029.472.48
255229-5522928.37828.96
356583-5658329.07429.67
458845-5884530.23630.85
555697-5569728.61929.20
655181-5518128.35428.92
极限156781-5678129.17629.252.2529.9230.002.24
257565-5756529.57930.31
358757-5875730.19130.95
457353-5735329.47030.25
556009-5600928.77929.52
655084-5508428.30429.03
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