沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.42 2910602912382909402912112913432911580.06
228.942927662919012923340.21
单位质量响应值RSD%判断
10244.8310101.381.00数据可信
供试品溶液-2024032721批-缬沙坦钠-pH2.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min163808-6380810.34715.6029.9210.3515.6029.91
2105137-10513717.04817.05
3115785-11578518.77518.77
4111074-11107418.01118.01
556413-564139.1489.15
6124856-12485620.24620.25
10min1164946-16494626.74633.2517.9226.7733.2917.93
2200849-20084932.56832.61
3231564-23156437.54937.59
4235704-23570438.22038.26
5157458-15745825.53225.55
6239840-23984038.89138.94
15min1237193-23719338.46144.9213.5438.5445.0313.56
2266169-26616943.16043.27
3303337-30333749.18749.31
4312668-31266850.70050.82
5230785-23078537.42237.50
6311991-31199150.59050.72
20min1281078-28107845.57850.776.9045.7550.986.93
2302027-30202748.97449.18
3329434-32943453.41953.65
4334543-33454354.24754.48
5300864-30086448.78648.95
6330654-33065453.61653.86
30min1314661-31466151.02353.032.2651.2953.352.32
2325562-32556252.79153.11
3329749-32974953.47053.82
4335762-33576254.44554.80
5324417-32441752.60552.87
6332157-33215753.86054.22
45min1318490-31849051.64453.381.9852.0353.822.03
2332754-33275453.95754.39
3330733-33073353.62954.10
4336620-33662054.58455.06
5324855-32485552.67653.06
6331828-33182853.80754.29
60min1320145-32014551.91253.251.6652.4153.811.73
2328964-32896453.34253.89
3329966-32996653.50554.10
4335830-33583054.45655.06
5324456-32445652.61153.11
6331011-33101153.67454.28
极限1326715-32671552.97853.881.5753.5954.561.61
2334983-33498354.31854.99
3330300-33030053.55954.27
4341304-34130455.34356.06
5328919-32891953.33553.95
6331514-33151453.75654.48
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.42 5029355032855023785028635030335028990.07
228.945054035057435055730.05
单位质量响应值RSD%判断
17695.2517469.700.91数据可信
供试品溶液-2024032721批-沙库巴曲-pH2.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1109696-10969610.89316.5130.2810.8916.5130.29
2182337-18233718.10718.11
3200538-20053819.91419.91
4192265-19226519.09319.09
596497-964979.5839.58
6216189-21618921.46921.47
10min1283143-28314328.11735.1718.1828.1435.2118.19
2346748-34674834.43434.47
3401869-40186939.90739.95
4407705-40770540.48740.53
5271393-27139326.95126.97
6414363-41436341.14841.20
15min1407614-40761440.47847.5113.7840.5647.6313.81
2459182-45918245.59945.72
3525726-52572652.20752.34
4540598-54059853.68453.82
5397902-39790239.51339.59
6539733-53973353.59853.74
20min1483299-48329947.99453.747.1448.1753.967.18
2521550-52155051.79252.01
3571416-57141656.74456.99
4578923-57892357.49057.74
5520059-52005951.64451.81
6571696-57169656.77257.03
30min1542154-54215453.83856.142.4354.1256.482.49
2562387-56238755.84856.18
3571664-57166456.76957.14
4581109-58110957.70758.09
5560446-56044655.65555.94
6574280-57428057.02957.41
45min1548624-54862454.48156.512.1354.8856.972.20
2574124-57412457.01357.47
3574233-57423357.02457.53
4582333-58233357.82858.34
5561077-56107755.71756.12
6573676-57367656.96957.48
60min1551119-55111954.72956.361.8755.2556.951.93
2567504-56750456.35656.94
3572810-57281056.88357.51
4581286-58128657.72458.36
5560487-56048755.65956.19
6572189-57218956.82157.46
极限1565058-56505856.11357.181.7056.7657.901.73
2580761-58076157.67258.38
3573127-57312756.91457.67
4592702-59270258.85859.62
5569814-56981456.58557.24
6573545-57354556.95657.72
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.42 2965392966592966882965042964972965770.04
228.943022163015843019000.15
单位质量响应值RSD%判断
10435.5010431.930.03数据可信
供试品溶液-2024032721批-缬沙坦钠-pH2.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1111946-11194617.69813.7034.2117.7013.7034.20
289868-8986814.20814.21
3125818-12581819.89119.89
469828-6982811.03911.04
578992-7899212.48812.49
643456-434566.8706.87
10min1224868-22486835.55030.6113.5435.5930.6413.56
2198704-19870431.41431.45
3216193-21619334.17934.22
4195141-19514130.85130.88
5170228-17022826.91226.94
6156546-15654624.74924.76
15min1284851-28485145.03342.157.2945.1542.257.31
2275034-27503443.48143.58
3273449-27344943.23143.35
4281994-28199444.58244.67
5239763-23976337.90537.99
6244726-24472638.69038.76
20min1319581-31958150.52448.176.5150.7448.376.52
2319352-31935250.48850.69
3303072-30307247.91448.13
4323384-32338451.12551.32
5274443-27444343.38843.56
6288452-28845245.60345.76
30min1324114-32411451.24150.543.4051.5750.843.41
2331700-33170052.44052.75
3316643-31664350.06050.38
4329693-32969352.12352.43
5303418-30341847.96948.24
6312606-31260649.42149.68
45min1323814-32381451.19350.612.8951.6451.022.91
2328920-32892052.00052.43
3318473-31847350.34950.78
4329360-32936052.07052.49
5305314-30531448.26848.64
6314899-31489949.78450.15
60min1323274-32327451.10850.632.7351.6751.162.75
2329089-32908952.02752.57
3318470-31847050.34850.89
4329260-32926052.05452.59
5307020-30702048.53849.02
6314446-31444649.71250.19
极限1331036-33103652.33551.601.6853.0152.241.72
2331183-33118352.35853.02
3325422-32542251.44752.11
4329328-32932852.06552.72
5316794-31679450.08350.67
6324560-32456051.31151.90
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.42 5108105110075111625109335113195110460.04
228.945162515159445160980.05
单位质量响应值RSD%判断
17981.9117833.380.59数据可信
供试品溶液-2024032721批-沙库巴曲-pH2.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1193864-19386418.90214.5934.7218.9014.5934.72
2154646-15464615.07815.08
3219027-21902721.35521.35
4119937-11993711.69411.69
5135850-13585013.24513.25
674609-746097.2747.27
10min1388428-38842837.87132.6213.6737.9132.6613.69
2343111-34311133.45333.49
3374652-37465236.52836.58
4337743-33774332.93032.96
5294133-29413328.67828.71
6269526-26952626.27826.29
15min1491286-49128647.90044.927.3148.0345.037.33
2475436-47543646.35446.46
3473217-47321746.13846.27
4487821-48782147.56247.66
5414579-41457940.42140.51
6422081-42208141.15241.23
20min1551636-55163653.78451.346.6054.0251.546.60
2552094-55209453.82954.04
3523986-52398651.08851.32
4560054-56005454.60554.81
5474079-47407946.22246.41
6497269-49726948.48348.65
30min1559280-55928054.52953.853.4954.8854.173.51
2573634-57363455.92956.26
3546887-54688753.32153.67
4570910-57091055.66355.99
5524204-52420451.10951.39
6538789-53878952.53152.81
45min1559049-55904954.50753.942.9654.9854.382.99
2568873-56887355.46455.92
3550403-55040353.66454.13
4570383-57038355.61256.06
5527772-52777251.45751.86
6542689-54268952.91253.30
60min1558281-55828154.43253.962.8655.0354.522.88
2569263-56926355.50256.08
3550615-55061553.68454.27
4570832-57083255.65556.23
5530707-53070751.74352.26
6541221-54122152.76853.28
极限1573327-57332755.89955.231.4856.6155.911.52
2573713-57371355.93656.64
3565851-56585155.17055.87
4571491-57149155.72056.42
5552073-55207353.82654.46
6562392-56239254.83355.46
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.42 2920972922932915852913662913982917480.15
228.943014343008833011580.13
单位质量响应值RSD%判断
10265.5910406.290.97数据可信
供试品溶液-2024032821批-缬沙坦钠-pH2.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min183776-8377613.37012.9523.1313.3712.9523.14
262383-623839.9569.96
364626-6462610.31410.31
469811-6981111.14211.14
5107147-10714717.10017.10
699175-9917515.82815.83
10min1209756-20975633.47732.9812.7333.5133.0012.74
2164035-16403526.18026.20
3188844-18884430.13930.16
4213522-21352234.07834.10
5231148-23114836.89136.93
6232422-23242237.09437.13
15min1293048-29304846.77044.166.3946.8744.266.39
2243628-24362838.88238.96
3275384-27538443.95144.04
4288733-28873346.08146.18
5275567-27556743.98044.10
6283812-28381245.29645.41
20min1326776-32677652.15349.883.9652.3650.083.95
2298564-29856447.65047.82
3317432-31743250.66150.85
4313311-31331150.00450.21
5296879-29687947.38147.60
6322266-32226651.43351.65
30min1327458-32745852.26150.982.5652.5951.302.53
2327280-32728052.23352.51
3320347-32034751.12751.43
4316427-31642750.50150.81
5305389-30538948.73949.06
6319836-31983651.04551.38
45min1327107-32710752.20551.122.3952.6551.552.36
2328611-32861152.44652.83
3319049-31904950.91951.33
4319349-31934950.96751.39
5307077-30707749.00949.44
6320745-32074551.19051.64
60min1326643-32664352.13151.451.2652.6951.991.24
2327888-32788852.33052.84
3319289-31928950.95851.48
4320943-32094351.22251.76
5317738-31773850.71051.25
6321816-32181651.36151.92
极限1326055-32605552.03851.661.8152.7152.321.78
2329771-32977152.63153.25
3317757-31775750.71351.35
4327602-32760252.28452.94
5315196-31519650.30550.96
6325851-32585152.00552.68
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.42 5034405031945028715036055032185032660.06
228.945141235145555143390.06
单位质量响应值RSD%判断
17708.1617772.600.26数据可信
供试品溶液-2024032821批-沙库巴曲-pH2.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1143767-14376714.14913.6423.9114.1513.6423.91
2104546-10454610.28910.29
3110419-11041910.86710.87
4118196-11819611.63211.63
5184399-18439918.14818.15
6170063-17006316.73716.74
10min1361957-36195735.62335.0712.8335.6535.1012.85
2281965-28196527.75027.77
3325753-32575332.06032.08
4368439-36843936.26136.29
5398720-39872039.24139.28
6401156-40115639.48039.52
15min1506269-50626949.82546.996.4549.9447.106.46
2419767-41976741.31241.40
3476193-47619346.86546.96
4498199-49819949.03149.14
5475101-47510146.75846.89
6489162-48916248.14248.27
20min1565018-56501855.60753.074.1055.8353.284.10
2514915-51491550.67650.85
3549196-54919654.05054.25
4539647-53964753.11053.33
5510864-51086450.27850.51
6555885-55588554.70854.94
30min1565877-56587755.69254.252.7056.0454.582.67
2564914-56491455.59755.89
3554389-55438954.56154.88
4545205-54520553.65753.99
5525628-52562851.73152.07
6551083-55108354.23654.59
45min1565022-56502255.60854.382.5556.0854.832.51
2567404-56740455.84256.25
3551902-55190254.31654.76
4549922-54992254.12254.57
5527984-52798451.96252.42
6552854-55285454.41054.88
60min1564826-56482655.58854.731.4356.1855.301.40
2566377-56637755.74156.28
3551766-55176654.30354.86
4552952-55295254.42054.99
5546074-54607453.74354.32
6554747-55474754.59655.19
极限1563557-56355755.46355.081.8956.1855.781.86
2570915-57091556.18856.85
3549778-54977854.10754.79
4566805-56680555.78356.48
5543733-54373353.51254.21
6563249-56324955.43356.15
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.42 2978352973872977652974772980542977040.10
228.942917362909422913390.20
单位质量响应值RSD%判断
10475.1610067.002.81数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-2024032821批-缬沙坦钠-pH2.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min179677-7967712.80117.2414.9412.8017.2414.94
2118772-11877219.08219.08
3108660-10866017.45717.46
4113983-11398318.31318.31
598890-9889015.88815.89
6123814-12381419.89219.89
10min1156142-15614225.08634.8013.9625.1134.8413.96
2218655-21865535.12935.17
3232611-23261137.37237.41
4235079-23507937.76837.81
5232042-23204237.28037.32
6225144-22514436.17236.22
15min1206615-20661533.19544.4113.1233.2844.5313.12
2279778-27977844.95045.07
3292623-29262347.01347.14
4309684-30968449.75449.88
5275571-27557144.27444.39
6294299-29429947.28247.41
20min1240691-24069138.67048.6110.7338.8348.8210.74
2306965-30696549.31749.54
3321325-32132551.62551.85
4330650-33065053.12353.36
5297415-29741547.78348.00
6318238-31823851.12951.36
30min1275292-27529244.22950.546.4844.4750.866.52
2319607-31960751.34851.68
3327697-32769752.64852.99
4330574-33057453.11053.46
5311254-31125450.00650.33
6322878-32287851.87452.22
45min1278884-27888444.80650.665.9845.1551.106.02
2320004-32000451.41251.86
3327425-32742552.60553.06
4329768-32976852.98153.45
5312678-31267850.23550.67
6323186-32318651.92352.38
60min1280315-28031545.03650.625.5745.4851.175.61
2319309-31930951.30151.86
3326880-32688052.51753.09
4325521-32552152.29952.89
5315437-31543750.67951.22
6323015-32301551.89652.47
极限1313151-31315150.31152.241.8750.8552.901.96
2326506-32650652.45753.13
3329885-32988553.00053.69
4328359-32835952.75553.46
5325536-32553652.30152.96
6327512-32751252.61953.31
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.42 5103375099675107295103935113055105460.10
228.945030405020725025560.14
单位质量响应值RSD%判断
17964.3217365.452.40数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-2024032821批-沙库巴曲-pH2.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1135672-13567213.41318.2315.2913.4118.2315.29
2204579-20457920.22620.23
3186569-18656918.44518.45
4196362-19636219.41319.41
5169804-16980416.78816.79
6213158-21315821.07421.07
10min1267532-26753226.45036.9014.1626.4836.9414.16
2376799-37679937.25237.30
3401383-40138339.68339.72
4405507-40550740.09140.13
5400138-40013839.56039.60
6387922-38792238.35238.40
15min1354342-35434235.03247.0913.3335.1247.2213.33
2482003-48200347.65347.78
3504477-50447749.87550.00
4535253-53525352.91853.05
5474540-47454046.91647.04
6507402-50740250.16550.30
20min1412537-41253740.78651.5310.9940.9551.7611.00
2528603-52860352.26152.49
3554671-55467154.83855.08
4571745-57174556.52656.78
5511380-51138050.55850.79
6548553-54855354.23354.48
30min1472624-47262446.72653.596.7046.9853.936.73
2550627-55062754.43854.79
3565694-56569455.92856.29
4571435-57143556.49556.87
5535126-53512652.90553.25
6556619-55661955.03055.39
45min1478046-47804647.26253.696.2347.6254.156.28
2551124-55112454.48754.96
3564766-56476655.83656.32
4569997-56999756.35356.85
5537294-53729453.12053.58
6557124-55712455.08055.57
60min1480480-48048047.50353.655.8247.9754.235.87
2550236-55023654.39954.99
3563778-56377855.73856.35
4563151-56315155.67656.30
5541802-54180253.56654.14
6556479-55647955.01755.63
极限1540368-54036853.42455.581.9554.0056.282.04
2565499-56549955.90856.62
3570041-57004156.35757.09
4567699-56769956.12656.88
5563195-56319555.68156.38
6566456-56645656.00356.73
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.42 2932482934762935312934762935162934490.04
228.942982362988062985210.14
单位质量响应值RSD%判断
10325.4410315.170.08数据可信
供试品溶液-2024032921批-缬沙坦钠-pH2.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1113913-11391318.20714.8429.3118.2114.8429.32
2104282-10428216.66816.67
357556-575569.1999.20
458654-586549.3759.37
5114992-11499218.37918.38
6107769-10776917.22517.22
10min1242564-24256438.76933.1020.0238.8133.1320.03
2231844-23184437.05637.09
3144279-14427923.06023.08
4164945-16494526.36326.38
5230452-23045236.83436.87
6228290-22829036.48836.53
15min1279934-27993444.74242.7014.8544.8742.8114.87
2301299-30129948.15748.28
3200970-20097032.12132.19
4239242-23924238.23938.32
5279351-27935144.64944.77
6302171-30217148.29748.42
20min1295907-29590747.29547.1711.7947.5247.3711.80
2325518-32551852.02852.25
3231634-23163437.02337.17
4287927-28792746.02046.18
5303566-30356648.52048.74
6326205-32620552.13852.36
30min1302108-30210848.28749.179.0648.6249.479.08
2327695-32769552.37652.72
3253985-25398540.59540.82
4319004-31900450.98751.25
5316301-31630150.55550.88
6326626-32662652.20552.55
45min1307423-30742349.13649.828.0549.5750.238.07
2326625-32662552.20552.66
3262841-26284142.01042.33
4320232-32023251.18351.56
5327248-32724852.30552.75
6325739-32573952.06452.52
60min1321109-32110951.32350.357.5951.8750.887.64
2326040-32604052.11252.69
3266792-26679242.64243.05
4320105-32010551.16351.66
5329792-32979252.71153.27
6326436-32643652.17552.75
极限1322438-32243851.53652.191.4752.2052.831.49
2326958-32695852.25852.95
3321565-32156551.39651.90
4333586-33358653.31853.93
5330647-33064752.84853.52
6324083-32408351.79952.49
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.42 5067985066165065305065795064925066030.03
228.945123515133435128470.14
单位质量响应值RSD%判断
17825.5817721.040.42数据可信
供试品溶液-2024032921批-沙库巴曲-pH2.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1199002-19900219.54915.8330.4019.5515.8330.41
2181372-18137217.81717.82
397937-979379.6219.62
499287-992879.7539.75
5201055-20105519.75119.75
6188410-18841018.50818.51
10min1422431-42243141.49735.3620.3541.5435.4020.36
2405877-40587739.87139.91
3249089-24908924.46924.49
4285457-28545728.04228.06
5399734-39973439.26839.31
6397205-39720539.01939.06
15min1486031-48603147.74545.5015.0747.8845.6115.09
2522999-52299951.37751.50
3346504-34650434.03934.11
4414723-41472340.74040.82
5482812-48281247.42947.56
6525688-52568851.64151.77
20min1512019-51201950.29850.1912.0050.5450.4012.02
2565363-56536355.53855.78
3399674-39967439.26239.41
4497705-49770548.89249.07
5524301-52430151.50551.74
6566400-56640055.64055.88
30min1521199-52119951.20052.249.2951.5552.579.31
2567165-56716555.71556.08
3437044-43704442.93343.17
4552237-55223754.24954.53
5546678-54667853.70354.05
6566487-56648755.64956.02
45min1530991-53099152.16252.928.2852.6353.378.31
2565011-56501155.50455.99
3451916-45191644.39444.73
4554008-55400854.42354.83
5566071-56607155.60856.08
6564423-56442355.44655.94
60min1553534-55353454.37653.537.7454.9654.097.78
2564819-56481955.48556.10
3459968-45996845.18545.62
4554781-55478154.49955.02
5570933-57093356.08656.68
6565441-56544155.54656.16
极限1559351-55935154.94855.681.3355.6556.361.34
2566863-56686355.68656.42
3560619-56061955.07255.61
4577447-57744756.72557.37
5574216-57421656.40857.13
6562411-56241155.24855.98
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.42 2997962998432997182997142991962996530.09
228.942989882986582988230.08
单位质量响应值RSD%判断
10543.7410325.601.48数据可信
供试品溶液-2024032921批-缬沙坦钠-pH2.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min172187-7218711.41314.6930.0711.4114.6930.10
284644-8464413.38213.38
383457-8345713.19413.19
462385-623859.8639.86
5128121-12812120.25620.26
6126729-12672920.03620.04
10min1186207-18620729.43929.4014.4229.4629.4414.43
2190638-19063830.13930.17
3155204-15520424.53724.57
4154751-15475124.46624.49
5217662-21766234.41234.46
6211382-21138233.41933.46
15min1270941-27094142.83539.1413.2542.9339.2413.25
2270662-27066242.79142.89
3199865-19986531.59831.68
4211450-21145033.43033.51
5269058-26905842.53742.66
6263476-26347641.65541.77
20min1328890-32889051.99745.2713.6052.1845.4513.59
2320782-32078250.71550.91
3225995-22599535.72935.88
4257143-25714340.65440.80
5294542-29454246.56646.78
6290583-29058345.94046.15
30min1335125-33512552.98247.8610.6553.2848.1410.64
2324381-32438151.28451.59
3246326-24632638.94339.18
4286767-28676745.33745.58
5317609-31760950.21350.53
6306028-30602848.38248.70
45min1334822-33482252.93449.066.3953.3549.456.42
2328531-32853151.94052.36
3286609-28660945.31245.63
4288795-28879545.65846.00
5312268-31226849.36949.80
6310743-31074349.12849.55
60min1334466-33446652.87849.295.8353.4249.795.87
2328054-32805451.86452.40
3289656-28965645.79446.21
4292485-29248546.24146.68
5311761-31176149.28949.83
6314030-31403049.64750.18
极限1335287-33528753.00851.192.4653.6651.802.52
2330376-33037652.23252.88
3313059-31305949.49450.02
4320786-32078650.71551.26
5319638-31963850.53451.18
6323581-32358151.15751.80
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.85对照品水分(%)5.54对照品稀释倍数500
标示量(mg)50供试品稀释倍数1系数0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.42 5135965137375139535140705137195138150.04
228.945120455116805118620.06
单位质量响应值RSD%判断
18079.3517687.011.56数据可信
供试品溶液-2024032921批-沙库巴曲-pH2.0(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1124331-12433112.14015.7730.8312.1415.7730.82
2146874-14687414.34114.34
3145598-14559814.21714.22
4106500-10650010.39910.40
5224528-22452821.92321.92
6221038-22103821.58321.58
10min1323493-32349331.58731.4814.5331.6131.5114.54
2331257-33125732.34532.38
3267017-26701726.07226.10
4268854-26885426.25226.27
5377440-37744036.85436.90
6366203-36620335.75735.80
15min1469928-46992845.88541.9513.2945.9842.0613.29
2470333-47033345.92446.03
3343038-34303833.49533.58
4371509-37150936.27536.36
5467798-46779845.67745.81
6455468-45546844.47344.60
20min1570884-57088455.74248.3914.0455.9448.5914.02
2557425-55742554.42854.63
3387658-38765837.85238.02
4443647-44364743.31943.48
5513790-51379050.16850.40
6500027-50002748.82449.05
30min1579966-57996656.62951.1311.1856.9551.4411.18
2567143-56714355.37755.70
3422148-42214841.22041.47
4493285-49328548.16648.42
5552193-55219353.91754.26
6527418-52741851.49851.83
45min1579826-57982656.61652.386.4657.0652.806.49
2568209-56820955.48155.93
3494104-49410448.24548.59
4500423-50042348.86249.23
5540738-54073852.79953.26
6535467-53546752.28452.73
60min1579827-57982756.61652.546.1857.1953.086.21
2567889-56788955.45056.02
3498151-49815148.64149.09
4502154-50215449.03149.51
5540325-54032552.75953.34
6540030-54003052.73053.30
极限1581188-58118856.74954.862.3957.4555.522.46
2572409-57240955.89156.59
3542671-54267152.98853.54
4556751-55675154.36254.95
5557357-55735754.42255.12
6560746-56074654.75355.44
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