缬沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.972449342447292451612445272444852447670.12
213.942455712455542455620.01
单位质量响应值RSD%判断
17520.9017615.640.39数据可信
供试品溶液-25031801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%
5min147938-4793817.68917.643.5317.6917.643.52
247940-4794017.68917.69
345714-4571416.86816.87
446156-4615617.03117.03
548886-4888618.03918.04
650228-5022818.53418.53
10min197909-9790936.12835.772.5036.1635.802.49
299875-9987536.85336.88
393550-9355034.51934.55
495020-9502035.06235.09
596355-9635535.55435.58
698959-9895936.51536.55
15min1134303-13430349.55748.672.2649.6548.762.26
2130565-13056548.17748.27
3129238-12923847.68847.77
4129073-12907347.62747.71
5131652-13165248.57948.67
6136522-13652250.37650.47
20min1161382-16138259.54958.151.7659.7258.321.75
2157274-15727458.03358.20
3154589-15458957.04257.21
4155512-15551257.38357.55
5156251-15625157.65557.83
6160507-16050759.22659.40
30min1198014-19801473.06672.071.0573.3472.341.06
2195073-19507371.98072.25
3193250-19325071.30871.57
4194807-19480771.88272.14
5193237-19323771.30371.57
6197511-19751172.88073.15
45min1232641-23264185.84384.021.2086.2484.401.20
2225969-22596983.38183.77
3226160-22616083.45183.83
4227247-22724783.85284.23
5225310-22531083.13883.52
6228800-22880084.42584.82
60min1249107-24910791.91989.921.4692.4590.451.46
2239071-23907188.21588.74
3240688-24068888.81289.33
4244012-24401290.03990.56
5243884-24388489.99190.52
6245395-24539590.54991.09
90min1260440-26044096.10093.091.7896.7993.771.77
2249131-24913191.92792.60
3248078-24807891.53992.21
4253876-25387693.67894.35
5250552-25055292.45293.13
6251678-25167892.86793.55
120min1259086-25908695.60193.611.1596.4594.441.15
2250899-25089992.58093.41
3251966-25196692.97493.79
4252214-25221493.06593.89
5254045-25404593.74194.57
6253876-25387693.67894.52
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1265793-26579398.07697.651.0699.0898.641.06
2260360-26036096.07197.05
3263070-26307097.07198.04
4265771-26577198.06799.05
5264347-26434797.54298.53
6268559-26855999.096100.09
缬沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数100
标示量(mg)160供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.329633747963927296379699637998963705096372070.03
216.389714497972905897217780.11
单位质量响应值RSD%判断
590515.13593515.140.36数据可信
供试品溶液-25031801批-缬沙坦-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%
5min14189870-418987039.45238.972.1539.4538.972.16
24150008-415000839.07639.08
33987303-398730337.54437.54
44083839-408383938.45338.45
54197501-419750139.52439.52
64224401-422440139.77739.78
10min16130484-613048457.72557.512.5957.7957.582.59
26381822-638182260.09160.16
35906723-590672355.61855.68
46025797-602579756.73956.80
56070493-607049357.16057.23
66132550-613255057.74457.81
15min17249900-724990068.26567.913.7668.4368.073.75
27097270-709727066.82866.99
36962595-696259565.56065.72
47105400-710540066.90467.06
57123818-712381867.07867.24
67732306-773230672.80772.97
20min17900141-790014174.38873.491.1374.6673.761.14
27781945-778194573.27573.55
37649601-764960172.02972.29
47794784-779478473.39673.67
57830856-783085673.73574.01
67870345-787034574.10774.39
30min18761905-876190582.50281.621.1682.9082.021.16
28615737-861573781.12681.52
38522838-852283880.25180.64
48662150-866215081.56381.96
58647448-864744881.42481.82
68798299-879829982.84583.25
45min19430631-943063188.79987.581.0789.3488.111.07
29242394-924239487.02687.56
39153730-915373086.19186.71
49318509-931850987.74388.27
59279551-927955187.37687.91
69379965-937996588.32288.87
60min19711979-971197991.44890.251.2192.1390.931.21
29491261-949126189.37090.05
39409849-940984988.60389.27
49595944-959594490.35591.03
59686810-968681091.21191.89
69615528-961552890.54091.23
90min19927698-992769893.47991.821.1794.3292.651.17
29679022-967902291.13891.97
39595636-959563690.35291.16
49805951-980595192.33393.16
59726211-972621191.58292.41
69776780-977678092.05892.90
120min19946062-994606293.65291.931.1494.6592.911.14
29700224-970022491.33792.32
39614458-961445890.53091.49
49803418-980341892.30993.29
59738567-973856791.69892.68
69774021-977402192.03293.03
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限110074540-1007454094.86294.600.7396.0195.740.74
29964299-996429993.82494.96
39952296-995229693.71194.82
410116132-1011613295.25396.39
510052578-1005257894.65595.79
610119577-1011957795.28696.44
缬沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.972466632464332462772462412460162463260.10
213.942481532478242479880.10
单位质量响应值RSD%判断
17632.5017789.670.63数据可信
供试品溶液-25031802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%
5min126995-269959.88110.315.349.8810.315.34
229253-2925310.70710.71
327509-2750910.06910.07
427326-2732610.00210.00
527183-271839.9509.95
630743-3074311.25311.25
10min166035-6603524.17024.822.9424.1924.842.93
269570-6957025.46425.48
366941-6694124.50224.52
466351-6635124.28624.30
566985-6698524.51824.53
670964-7096425.97425.99
15min199160-9916036.29536.662.2336.3536.722.23
2101593-10159337.18537.25
398808-9880836.16636.22
498947-9894736.21736.27
598364-9836436.00336.06
6104064-10406438.09038.15
20min1126622-12662246.34646.281.6646.4646.401.66
2129239-12923947.30447.43
3125323-12532345.87145.99
4124792-12479245.67745.79
5124058-12405845.40845.53
6128536-12853647.04747.17
30min1164957-16495760.37861.211.1660.5761.411.16
2170118-17011862.26762.47
3165920-16592060.73060.92
4167161-16716161.18561.38
5166415-16641560.91161.10
6168869-16886961.81062.01
45min1210131-21013176.91276.131.0177.2176.431.01
2209090-20909076.53176.84
3204547-20454774.86975.16
4207378-20737875.90576.20
5207123-20712375.81176.11
6209692-20969276.75277.06
60min1237296-23729686.85585.031.5687.2885.461.56
2235705-23570586.27386.71
3228250-22825083.54483.96
4230623-23062384.41384.84
5229210-22921083.89684.32
6232764-23276485.19785.63
90min1262328-26232896.01893.361.9196.5993.931.90
2258743-25874394.70695.28
3253508-25350892.78993.35
4248783-24878391.06091.62
5255089-25508993.36893.93
6251929-25192992.21192.79
120min1273762-273762100.20396.002.24100.9396.722.23
2263110-26311096.30497.04
3258552-25855294.63695.35
4259507-25950794.98595.70
5260084-26008495.19695.91
6258698-25869894.68995.42
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1276424-276424101.17797.922.63102.0798.802.62
2273163-27316399.984100.88
3269449-26944998.62499.50
4266127-26612797.40898.28
5262796-26279696.18997.06
6257131-25713194.11595.00
缬沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数100
标示量(mg)160供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.329447208944601194450219449276944045994455950.04
216.389462346947953894709420.13
单位质量响应值RSD%判断
578774.20578201.590.07数据可信
供试品溶液-25031802批-缬沙坦-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%
5min12886366-288636627.81328.172.7027.8128.172.70
22980686-298068628.72228.72
32877372-287737227.72727.73
42867145-286714527.62827.63
52869366-286936627.65027.65
63058003-305800329.46729.47
10min14762243-476224345.89046.381.8245.9446.421.82
24884302-488430247.06647.11
34745800-474580045.73145.78
44754789-475478945.81845.86
54771771-477177145.98146.03
64957079-495707947.76747.82
15min15953932-595393257.37357.371.1957.5057.491.19
26020410-602041058.01358.14
35890460-589046056.76156.88
45901394-590139456.86756.99
55897989-589798956.83456.96
66055719-605571958.35458.48
20min16784465-678446565.37665.160.9965.5965.380.99
26844866-684486665.95866.18
36685796-668579664.42564.64
46723949-672394964.79365.01
56705651-670565164.61664.83
66829174-682917465.80766.03
30min17881421-788142175.94675.660.8176.2775.980.81
27924925-792492576.36576.70
37756527-775652774.74375.07
47807341-780734175.23275.56
57837433-783743375.52275.85
67900386-790038676.12976.46
45min18847730-884773085.25884.250.9185.7184.700.91
28828166-882816685.06985.53
38655209-865520983.40383.85
48697588-869758883.81184.26
58682760-868276083.66884.12
68748190-874819084.29984.76
60min19349808-934980890.09688.631.0390.6989.221.03
29278691-927869189.41190.01
39111082-911108287.79588.38
49145012-914501288.12288.71
59142739-914273988.10088.69
69158909-915890988.25688.86
90min19810704-981070494.53792.691.2195.2893.441.20
29715680-971568093.62194.37
39545122-954512291.97892.71
49548473-954847392.01092.75
59559282-955928292.11492.85
69538019-953801991.90992.66
120min19992630-999263096.29093.841.4597.1994.741.44
29819078-981907894.61895.52
39661168-966116893.09693.98
49658038-965803893.06693.96
59667589-966758993.15894.05
69633043-963304392.82593.73
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限110104383-1010438397.36795.011.4698.4396.061.45
29960138-996013895.97797.04
39791694-979169494.35495.40
49794405-979440594.38095.43
59782277-978227794.26395.31
69725141-972514193.71394.77
缬沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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2000
标示量(mg)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.972475072472602475102472772465742472260.16
213.942502152503882503020.05
单位质量响应值RSD%判断
17696.9217955.671.03数据可信
供试品溶液-25031806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%
5min151940-5194018.88919.121.8118.8919.121.82
253473-5347319.44619.45
352224-5222418.99218.99
452148-5214818.96518.96
554022-5402219.64619.65
651640-5164018.78018.78
10min196309-9630935.02434.931.9135.0634.961.90
297036-9703635.28935.32
396296-9629635.02035.05
495801-9580134.84034.87
598144-9814435.69235.72
692714-9271433.71733.75
15min1133570-13357048.57548.301.7848.6648.391.78
2132089-13208948.03748.13
3131961-13196147.99048.08
4133161-13316148.42648.52
5136645-13664549.69349.79
6129468-12946847.08347.17
20min1164148-16414859.69559.291.4159.8759.461.41
2162061-16206158.93659.11
3160511-16051158.37358.54
4164640-16464059.87460.04
5166126-16612660.41560.59
6160716-16071658.44758.61
30min1204975-20497574.54374.251.8774.8174.521.86
2199366-19936672.50372.77
3201413-20141373.24773.51
4210234-21023476.45576.73
5205919-20591974.88675.16
6203145-20314573.87774.14
45min1242729-24272988.27387.931.3888.6788.321.38
2237858-23785886.50186.89
3237615-23761586.41386.80
4245842-24584289.40589.80
5243488-24348888.54988.95
6243219-24321988.45188.84
60min1262019-26201995.28893.911.7095.8394.451.70
2256170-25617093.16193.70
3250710-25071091.17591.71
4262648-26264895.51796.06
5259505-25950594.37494.92
6258382-25838293.96594.50
90min1274680-27468099.89298.291.19100.5998.991.19
2268713-26871397.72298.41
3265715-26571596.63297.32
4273062-27306299.304100.01
5269418-26941897.97998.68
6270069-27006998.21598.91
120min1277517-277517100.92498.771.43101.7999.631.42
2271961-27196198.90499.76
3266042-26604296.75197.60
4273622-27362299.508100.38
5269569-26956998.03498.90
6270806-27080698.48399.34
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1278304-278304101.21099.901.07102.25100.921.06
2273777-27377799.564100.58
3273369-27336999.416100.42
4278186-278186101.167102.20
5271042-27104298.56999.60
6273536-27353699.476100.49
缬沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数100
标示量(mg)160供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.329476056948378494786039469746946414494744670.09
216.389597823959570495967640.02
单位质量响应值RSD%判断
580543.32585883.030.65数据可信
供试品溶液-25031806批-缬沙坦-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%
5min14091005-409100539.10339.111.9039.1039.111.89
24133627-413362739.51039.51
34107127-410712739.25739.26
44157974-415797439.74339.74
54119884-411988439.37939.38
63940805-394080537.66737.67
10min16036361-603636157.69757.371.3157.7657.431.31
25976710-597671057.12757.19
36011482-601148257.45957.52
46036262-603626257.69657.76
56090297-609029758.21358.28
65861650-586165056.02756.09
15min17156985-715698568.40868.011.0968.5768.161.09
27058494-705849467.46767.63
37098866-709886667.85368.01
47162425-716242568.46068.62
57211246-721124668.92769.09
67001019-700101966.91767.07
20min17929873-792987375.79675.311.0676.0775.581.07
27778099-777809974.34574.62
37852549-785254975.05775.33
47971049-797104976.18976.47
57950392-795039275.99276.27
67790564-779056474.46474.73
30min18847046-884704684.56284.141.1184.9684.541.10
28671104-867110482.88083.28
38761122-876112283.74184.14
48936805-893680585.42085.82
58862352-886235284.70885.11
68736556-873655683.50683.90
45min19606533-960653391.82290.771.0492.3691.301.04
29346989-934698989.34189.88
39427579-942757990.11190.65
49589377-958937791.65892.20
59521209-952120991.00691.55
69484786-948478690.65891.19
60min19850346-985034694.15293.230.8294.8593.930.82
29659704-965970492.33093.01
39679352-967935292.51893.21
49841456-984145694.06794.77
59755502-975550293.24593.94
69739972-973997293.09793.78
90min110034292-1003429295.91094.780.7296.7695.630.72
29838338-983833894.03794.88
39899027-989902794.61795.46
49965088-996508895.24996.10
59881759-988175994.45295.30
69880525-988052594.44095.28
120min110053927-1005392796.09894.750.8697.1195.760.86
29864028-986402894.28395.28
39836030-983603094.01595.02
49979865-997986595.39096.40
59859189-985918994.23795.25
69885000-988500094.48395.48
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限110068527-1006852796.23795.130.7997.4196.290.79
29893814-989381494.56795.72
39960988-996098895.21096.37
410013187-1001318795.70896.88
59916666-991666694.78695.95
69860684-986068494.25195.40
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