美阿沙坦钾氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号24AD032对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6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0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.934850347924480694795047989480870.50
213.774681546636467260.28
单位质量响应值RSD%判断
3452.053393.321.22数据可信
供试品溶液-25090301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%
5min149093-4909392.70991.339.9592.7191.339.95
254936-54936103.743103.74
352097-5209798.38298.38
444374-4437483.79783.80
547769-4776990.20990.21
641903-4190379.13179.13
10min149215-4921592.93992.559.4193.9793.579.42
255387-55387104.595105.75
352543-5254399.224100.32
445538-4553885.99686.93
548763-4876392.08693.09
642608-4260880.46381.34
15min148921-4892192.38490.979.7894.4593.029.78
254787-54787103.462105.78
351965-5196598.133100.33
444352-4435283.75685.64
546823-4682388.42290.45
642186-4218679.66681.44
20min147440-4744089.58789.089.7392.6892.149.73
253729-53729101.464104.93
350783-5078395.90099.19
443808-4380882.72985.55
546158-4615887.16690.17
641113-4111377.63980.30
30min146137-4613787.12787.189.1391.2191.239.16
252151-5215198.484103.08
349704-4970493.86398.21
443641-4364182.41386.15
544910-4491084.81088.79
640462-4046276.41079.93
45min144531-4453184.09485.598.7689.1590.618.80
251005-5100596.320102.01
348513-4851391.61497.01
443739-4373982.59887.25
544544-4454484.11989.04
639619-3961974.81879.19
60min144294-4429483.64684.209.0189.6390.169.03
250307-5030795.002101.76
348169-4816990.96497.38
442435-4243580.13685.71
542998-4299881.19987.05
639310-3931074.23479.44
极限144282-4428283.62483.078.7990.5489.978.82
248761-4876192.08299.89
347515-4751589.72997.15
442634-4263480.51286.97
542755-4275580.74087.50
637992-3799271.74577.77
美阿沙坦钾氨氯地平片项目信息
介质体积(ml)1000取样体积(ml)10补液体积(ml)10
对照品批号D211-4R701-2402002对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数500
标示量(mg)40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%
110.833006163017253014393015373015483013730.15
210.853025803022883024340.07
单位质量响应值RSD%判断
27827.6127874.100.12数据可信
供试品溶液-25090301批-美阿沙坦-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%
5min13243-32431.1590.9315.721.160.9315.55
22116-21160.7560.76
32925-29251.0451.04
42550-25500.9110.91
52341-23410.8360.84
62474-24740.8840.88
10min14387-43871.5671.448.131.581.448.21
23569-35691.2751.28
34281-42811.5291.54
44234-42341.5131.52
53783-37831.3521.36
63857-38571.3781.39
15min15424-54241.9381.778.131.971.808.17
24430-44301.5831.60
35203-52031.8591.88
45035-50351.7991.82
54516-45161.6131.64
65198-51981.8571.88
20min15647-56472.0171.985.682.062.025.73
25575-55751.9922.03
35604-56042.0022.05
46006-60062.1462.19
55078-50781.8141.85
65328-53281.9031.94
30min16324-63242.2592.268.682.332.328.48
25686-56862.0312.09
37251-72512.5902.65
46607-66072.3602.42
55972-59722.1342.19
66130-61302.1902.25
45min17466-74662.6672.728.792.762.818.61
26691-66912.3902.47
38153-81532.9133.00
48611-86113.0763.16
57376-73762.6352.71
67450-74502.6622.74
60min18824-88243.1523.127.113.273.237.11
27960-79602.8442.94
39202-92023.2883.41
49620-96203.4373.55
58216-82162.9353.04
68526-85263.0463.15
极限110096-100963.6073.406.523.753.546.52
28808-88083.1473.28
39771-97713.4913.64
410258-102583.6653.82
58876-88763.1713.30
69280-92803.3153.45
美阿沙坦钾氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号24AD032对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6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0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.934602244940458434608446124458031.08
213.774533644306448211.63
单位质量响应值RSD%判断
3288.083254.970.72数据可信
供试品溶液-25090901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%
5min143398-4339885.73788.493.5885.7488.493.58
244174-4417487.27087.27
345906-4590690.69290.69
447181-4718193.21093.21
545146-4514689.19089.19
642935-4293584.82284.82
10min144882-4488288.66991.333.9789.6292.313.96
245872-4587290.62491.59
347470-4747093.78194.79
449185-4918597.17098.21
545821-4582190.52491.51
644137-4413787.19788.14
15min144810-4481088.52690.484.2090.4692.484.19
245055-4505589.01090.99
347146-4714693.14195.19
449048-4904896.89999.01
544851-4485188.60790.60
643878-4387886.68588.60
20min143328-4332885.59888.694.0688.5291.694.06
244819-4481988.54491.51
346269-4626991.40994.49
447791-4779194.41697.61
543992-4399286.91089.89
643148-4314885.24388.12
30min143262-4326285.46888.124.0789.3492.114.06
244630-4463088.17192.12
346254-4625491.37995.48
447233-4723393.31397.55
543698-4369886.32990.28
642562-4256284.08587.91
45min142954-4295484.86087.264.1989.6892.224.18
243918-4391886.76491.69
345451-4545189.79394.91
447197-4719793.24298.52
543321-4332185.58590.49
642159-4215983.28988.04
60min141673-4167382.32985.344.1388.0991.284.11
243025-4302585.00090.89
343721-4372186.37592.49
446486-4648691.83798.15
542487-4248783.93789.79
641798-4179882.57688.26
极限142629-4262984.21885.754.2490.9092.634.20
243169-4316985.28492.12
343755-4375586.44293.52
446871-4687192.59899.93
542244-4224483.45790.25
641747-4174782.47589.07
美阿沙坦钾氨氯地平片项目信息
介质体积(ml)1000取样体积(ml)10补液体积(ml)10
对照品批号D211-4R701-2402002对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数500
标示量(mg)40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%
110.833008863003643003323001292998233003070.13
210.852960942960132960540.02
单位质量响应值RSD%判断
27729.1827286.081.14数据可信
供试品溶液-25090901批-美阿沙坦-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%
5min15237-52371.8941.911.611.891.901.66
25235-52351.8941.89
35300-53001.9171.92
45382-53821.9471.95
55316-53161.9231.92
65137-51371.8581.86
10min17092-70922.5652.641.942.582.661.97
27300-73002.6412.66
37279-72792.6332.65
47520-75202.7202.74
57367-73672.6652.68
67242-72422.6202.64
15min18216-82162.9723.023.493.023.073.48
28403-84033.0403.09
38316-83163.0083.05
48916-89163.2253.27
58204-82042.9683.01
68099-80992.9302.97
20min18954-89543.2393.282.093.313.362.06
29069-90693.2813.36
39278-92783.3563.43
49291-92913.3613.44
59090-90903.2883.36
68799-87993.1833.26
30min110160-101603.6753.782.253.783.892.25
210760-107603.8924.00
310543-105433.8143.92
410635-106353.8473.96
510345-103453.7423.85
610246-102463.7063.81
45min111106-111064.0174.182.994.164.332.94
211921-119214.3124.46
311262-112624.0744.22
411971-119714.3304.48
511578-115784.1884.33
611516-115164.1664.31
60min112666-126664.5824.553.094.774.743.06
212420-124204.4934.68
312177-121774.4054.59
413276-132764.8025.00
512306-123064.4524.64
612582-125824.5514.74
极限113537-135374.8974.984.205.135.224.11
214162-141625.1235.36
313192-131924.7725.00
414750-147505.3365.58
513558-135584.9045.14
613427-134274.8575.09
美阿沙坦钾氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号24AD032对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6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0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.934579445764457724559145584457010.23
213.774418544306442460.20
单位质量响应值RSD%判断
3280.763213.221.48数据可信
供试品溶液-25102101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%
5min149166-4916697.87496.663.9197.8796.663.91
246747-4674793.05993.06
347206-4720693.97293.97
451779-51779103.076103.08
547254-4725494.06894.07
649189-4918997.92097.92
10min149947-4994799.42997.834.71100.5298.904.70
246788-4678893.14094.17
347175-4717593.91194.95
452941-52941105.389106.53
547962-4796295.47796.52
650045-5004599.624100.71
15min148403-4840396.35595.284.2498.5597.454.23
247124-4712493.80995.88
346255-4625592.07994.17
451240-51240102.003104.32
545589-4558990.75392.86
648580-4858096.70898.90
20min148938-4893897.42094.673.08100.6897.893.11
246661-4666192.88896.00
346316-4631692.20195.31
449644-4964498.826102.28
546125-4612591.82194.93
647665-4766594.88698.16
30min146323-4632392.21590.673.2096.5694.943.23
244747-4474789.07793.22
344507-4450788.60092.73
447883-4788395.32099.87
543908-4390887.40791.54
645918-4591891.40895.73
45min145411-4541190.39989.063.3895.7794.343.40
243485-4348586.56591.70
343397-4339786.39091.51
447151-4715193.86399.47
543595-4359586.78491.89
645382-4538290.34195.68
60min144268-4426888.12487.973.2094.5094.243.23
243003-4300385.60691.70
343052-4305285.70391.78
446695-4669592.95599.60
543373-4337386.34292.41
644764-4476489.11195.45
极限145121-4512189.82286.522.4397.1893.762.36
242361-4236184.32891.37
342590-4259084.78391.82
443012-4301285.62393.31
543420-4342086.43693.47
644258-4425888.10495.44
美阿沙坦钾氨氯地平片项目信息
介质体积(ml)1000取样体积(ml)10补液体积(ml)10
对照品批号D211-4R701-2402002对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数500
标示量(mg)40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%
110.832997182992452988992986792979982989080.22
210.852958762963942961350.13
单位质量响应值RSD%判断
27600.0027293.550.79数据可信
供试品溶液-25102101批-美阿沙坦-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%
5min12592-25920.9400.9826.390.940.9826.11
22115-21150.7670.77
32114-21140.7660.77
43569-35691.2941.29
52216-22160.8030.80
63626-36261.3151.31
10min14135-41351.4991.5319.371.511.5419.44
23555-35551.2891.30
33568-35681.2941.30
45369-53691.9461.96
53585-35851.3001.31
65082-50821.8421.86
15min15047-50471.8301.8817.221.851.9017.29
24350-43501.5771.60
34813-48131.7451.77
46573-65732.3832.42
54371-43711.5851.61
65915-59152.1442.18
20min16187-61872.2432.1412.072.292.1812.22
25056-50561.8331.87
35282-52821.9151.95
46847-68472.4822.54
55516-55162.0002.04
66454-64542.3402.39
30min16895-68952.5002.4811.602.562.5411.73
25810-58102.1062.16
36381-63812.3132.37
47865-78652.8512.93
56423-64232.3292.39
67640-76402.7702.85
45min18051-80512.9192.8811.293.012.9711.37
26711-67112.4332.51
37381-73812.6762.76
49185-91853.3303.44
57602-76022.7562.84
68651-86513.1363.24
60min19043-90433.2783.269.973.403.3810.14
27842-78422.8432.94
38411-84113.0493.16
410358-103583.7553.90
58727-87273.1643.27
69642-96423.4963.63
极限19979-99793.6183.564.803.773.725.01
28942-89423.2423.37
39828-98283.5633.70
49895-98953.5873.77
59958-99583.6103.75
610358-103583.7553.93
美阿沙坦钾氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号24AD032对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6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0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.934370343687437024378043715437170.09
213.774385643819438380.06
单位质量响应值RSD%判断
3138.333183.591.02数据可信
供试品溶液-25102102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%
5min149875-49875101.98297.164.96101.9897.164.96
249391-49391100.992100.99
343484-4348488.91488.91
446664-4666495.41695.42
546987-4698796.07796.08
648693-4869399.56599.57
10min150304-50304102.85997.316.20103.9998.396.18
249173-49173100.546101.67
342391-4239186.67987.67
446776-4677695.64596.71
546976-4697696.05497.12
649929-49929102.092103.20
15min149583-49583101.38596.584.94103.6698.744.95
249317-49317100.841103.08
343661-4366189.27691.23
445950-4595093.95696.08
546260-4626094.59096.72
648628-4862899.432101.67
20min148396-4839698.95894.434.74102.3697.664.76
247679-4767997.492100.85
342887-4288787.69390.64
444697-4469791.39494.56
545462-4546292.95896.14
647976-4797698.099101.44
30min147438-4743896.99991.844.44101.5096.124.46
246084-4608494.23098.67
342132-4213286.14990.07
443788-4378889.53693.72
543792-4379289.54493.76
646260-4626094.59099.03
45min147025-4702596.15490.614.81101.7395.924.81
245640-4564093.32298.81
341434-4143484.72289.60
443002-4300287.92893.11
543071-4307188.06993.28
645713-4571393.47298.96
60min146216-4621694.50089.484.52101.1595.794.55
245017-4501792.04998.58
341014-4101483.86389.68
442650-4265087.20993.36
542580-4258087.06593.26
645076-4507692.16998.69
极限145536-4553693.11088.314.29100.8195.614.33
244003-4400389.97597.52
340599-4059983.01589.76
442281-4228186.45493.58
542063-4206386.00893.17
644642-4464291.28298.83
美阿沙坦钾氨氯地平片项目信息
介质体积(ml)1000取样体积(ml)10补液体积(ml)10
对照品批号D211-4R701-2402002对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数500
标示量(mg)40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%
110.832923342925012921492920172922432922490.07
210.852964202964772964480.02
单位质量响应值RSD%判断
26985.1327322.400.88数据可信
供试品溶液-25102102批-美阿沙坦-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%
5min13544-35441.2991.0726.451.301.0826.39
22290-22900.8390.84
31983-19830.7270.73
43269-32691.1981.20
53954-39541.4491.45
62537-25370.9300.93
10min14938-49381.8101.6218.411.821.6318.48
23586-35861.3141.32
33381-33811.2391.25
44935-49351.8081.82
55406-54061.9812.00
64259-42591.5611.57
15min15996-59962.1971.9913.952.232.0214.05
25230-52301.9171.94
34233-42331.5511.57
45768-57682.1142.14
56349-63492.3272.36
65073-50731.8591.88
20min16759-67592.4772.2212.802.532.2712.99
25194-51941.9031.94
35044-50441.8481.88
46389-63892.3412.39
56847-68472.5092.57
66153-61532.2552.30
30min17665-76652.8092.5611.312.892.6411.45
26031-60312.2102.27
36183-61832.2662.32
47347-73472.6922.77
57964-79642.9183.00
66810-68102.4952.56
45min19019-90193.3053.029.193.413.119.37
27364-73642.6992.78
37323-73232.6832.76
48513-85133.1203.22
58990-89903.2943.41
68168-81682.9933.08
60min19854-98543.6113.436.383.753.566.55
28670-86703.1773.29
38715-87153.1943.30
49574-95743.5083.64
510120-101203.7083.85
69210-92103.3753.50
极限110694-106943.9193.795.014.093.945.29
29762-97623.5773.72
39790-97903.5883.72
410409-104093.8143.98
511090-110904.0644.25
610248-102483.7553.91
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