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%
128.532991502970052986842988082979752983240.29
228.432909452911912910680.06
单位质量响应值RSD%判断
10456.5010238.061.50数据可信
供试品溶液-2024032721批-沙库巴曲-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min193191-9319114.85820.4117.0914.8620.4117.09
2138766-13876622.12422.12
3157746-15774625.15025.15
4122775-12277519.57419.57
5119114-11911418.99118.99
6136564-13656421.77321.77
10min1213526-21352634.04338.789.1934.0838.839.19
2256446-25644640.88640.94
3262862-26286241.90941.96
4245849-24584939.19639.24
5217746-21774634.71634.76
6263167-26316741.95842.01
15min1301729-30172948.10649.023.6448.2149.163.65
2314520-31452050.14550.28
3315829-31582950.35450.50
4306313-30631348.83648.97
5288517-28851745.99946.12
6318041-31804150.70650.85
20min1336760-33676053.69153.371.5953.9153.611.59
2330185-33018552.64252.89
3330864-33086452.75153.01
4342159-34215954.55154.79
5329469-32946952.52852.75
6339084-33908454.06154.32
30min1332302-33230252.98053.601.6853.3153.961.67
2329933-32993352.60252.97
3333109-33310953.10953.49
4345138-34513855.02655.39
5336789-33678953.69554.03
6340011-34001154.20954.58
45min1333352-33335253.14753.481.4853.6053.961.49
2330594-33059452.70853.19
3335938-33593853.56054.06
4342895-34289554.66955.15
5330532-33053252.69853.16
6339364-33936454.10654.60
60min1332076-33207652.94453.111.9353.5153.711.92
2327141-32714152.15752.76
3326146-32614651.99852.61
4342034-34203454.53255.14
5332037-33203752.93853.51
6339453-33945354.12054.74
极限1332250-33225052.97253.222.4353.6653.942.42
2327882-32788252.27552.99
3329920-32992052.60053.33
4333950-33395053.24353.97
5329179-32917952.48253.17
6349726-34972655.75856.49
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%
128.535155255127325144955148715140355143320.21
228.435039735041515040620.03
单位质量响应值RSD%判断
18027.7617729.931.18数据可信
供试品溶液-2024032721批-缬沙坦钠-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1158317-15831715.46121.2917.2515.4621.2917.25
2234364-23436422.88822.89
3268986-26898626.26926.27
4209412-20941220.45120.45
5201620-20162019.69019.69
6235067-23506722.95722.96
10min1366683-36668335.81140.658.8235.8440.708.83
2440487-44048743.01843.07
3445866-44586643.54443.60
4420142-42014241.03141.08
5374944-37494436.61736.66
6449323-44932343.88143.93
15min1521955-52195550.97551.723.7151.0951.863.72
2540771-54077152.81252.96
3542558-54255852.98753.14
4528582-52858251.62251.76
5494890-49489048.33148.46
6548760-54876053.59253.74
20min1580419-58041956.68456.281.3056.9156.531.30
2571114-57111455.77656.04
3570235-57023555.69055.96
4581285-58128556.76957.02
5567941-56794155.46655.70
6586499-58649957.27857.55
30min1573107-57310755.97056.491.3056.3256.871.30
2571197-57119755.78456.17
3573825-57382556.04056.44
4587441-58744157.37057.75
5576910-57691056.34256.70
6588135-58813557.43857.83
45min1575874-57587456.24056.421.1256.7256.921.12
2571708-57170855.83456.35
3574707-57470756.12656.65
4585730-58573057.20357.71
5572270-57227055.88856.37
6585754-58575457.20557.73
60min1574018-57401856.05956.121.6756.6656.751.66
2567156-56715655.38956.02
3561727-56172754.85955.50
4585320-58532057.16357.80
5574148-57414856.07256.68
6585711-58571157.20157.85
极限1572549-57254955.91656.161.7656.6456.921.75
2568207-56820755.49256.25
3569107-56910755.58056.35
4576647-57664756.31657.08
5569306-56930655.59956.33
6594663-59466358.07558.85
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%
128.532942462939952939322937122920772935920.30
228.432921862924762923310.08
单位质量响应值RSD%判断
10290.6410282.480.06数据可信
供试品溶液-2024032721批-沙库巴曲-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min185813-8581313.76118.3023.9813.7618.3023.98
2142940-14294022.92122.92
382613-8261313.24813.25
4102172-10217216.38416.38
5130093-13009320.86120.86
6140959-14095922.60422.60
10min1192258-19225830.83034.7013.1330.8634.7413.15
2250347-25034740.14540.20
3175812-17581228.19328.22
4212941-21294134.14634.18
5228206-22820636.59436.64
6238768-23876838.28838.34
15min1283344-28334445.43645.277.7145.5445.387.72
2293668-29366847.09147.23
3244581-24458139.22039.31
4270748-27074843.41643.53
5301159-30115948.29348.42
6300260-30026048.14948.28
20min1343303-34330355.05151.115.8555.2551.335.85
2311819-31181950.00250.25
3293371-29337147.04447.22
4305531-30553148.99449.20
5334179-33417953.58853.82
6324207-32420751.98952.23
30min1328989-32898952.75552.651.4253.0852.981.41
2321839-32183951.60951.96
3328178-32817852.62552.91
4328740-32874052.71653.03
5336112-33611253.89854.25
6326222-32622252.31252.67
45min1326486-32648652.35453.241.9052.7953.691.87
2324873-32487352.09552.57
3335442-33544253.79054.19
4338666-33866654.30754.74
5338669-33866954.30854.78
6327982-32798252.59453.07
60min1332618-33261853.33753.041.5053.8953.601.45
2323606-32360651.89252.48
3335399-33539953.78354.30
4330724-33072453.03453.59
5335832-33583253.85354.45
6326309-32630952.32652.92
极限1331712-33171253.19253.181.5353.8753.861.50
2322317-32231751.68652.39
3334873-33487353.69954.34
4330293-33029352.96553.64
5334070-33407053.57054.28
6336421-33642153.94754.65
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%
128.535084945083975078635084325058105077990.23
228.435059735065725062720.09
单位质量响应值RSD%判断
17798.7717807.670.04数据可信
供试品溶液-2024032721批-缬沙坦钠-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1143618-14361814.08418.9224.9214.0818.9224.93
2241869-24186923.72023.72
3136977-13697713.43313.43
4172056-17205616.87316.87
5222401-22240121.81121.81
6240792-24079223.61423.61
10min1332715-33271532.62936.3313.3032.6636.3713.31
2430944-43094442.26242.31
3300441-30044129.46429.49
4357324-35732435.04235.08
5391896-39189638.43338.48
6409351-40935140.14540.20
15min1488519-48851947.90947.608.0348.0147.738.05
2506289-50628949.65149.80
3418624-41862441.05441.15
4462443-46244345.35145.47
5518444-51844450.84350.98
6518055-51805550.80550.95
20min1577206-57720656.60653.555.4856.8253.785.49
2536963-53696352.65952.92
3501668-50166849.19849.38
4525924-52592451.57751.79
5575964-57596456.48456.73
6558385-55838554.76055.01
30min1567719-56771955.67655.481.3856.0155.831.37
2555342-55534254.46254.84
3565578-56557855.46655.76
4564452-56445255.35555.69
5579030-57903056.78557.16
6562406-56240655.15555.53
45min1564159-56415955.32756.081.8055.7956.551.75
2559833-55983354.90255.40
3585105-58510557.38157.80
4575874-57587456.47556.93
5581012-58101256.97957.48
6564922-56492255.40155.90
60min1575794-57579456.46856.001.5457.0556.591.50
2557930-55793054.71655.33
3578740-57874056.75657.30
4570405-57040555.93956.52
5579671-57967156.84857.47
6563456-56345655.25855.88
极限1573671-57367156.25956.131.4756.9756.851.44
2556462-55646254.57255.31
3578685-57868556.75157.42
4570570-57057055.95556.66
5576305-57630556.51857.27
6578452-57845256.72857.47
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%
128.532922152940532929972931812920612929010.28
228.432957372933592945480.58
单位质量响应值RSD%判断
10266.4210360.460.65数据可信
供试品溶液-2024032821批-沙库巴曲-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1149628-14962823.93218.3020.7723.9318.3020.76
2124138-12413819.85519.85
386519-8651913.83813.84
4108003-10800317.27417.27
591601-9160114.65114.65
6126522-12652220.23620.24
10min1267066-26706642.71534.5212.7542.7734.5612.76
2206579-20657933.04133.08
3196346-19634631.40431.43
4220092-22009235.20235.24
5189909-18990930.37430.41
6214915-21491534.37434.42
15min1313153-31315350.08644.527.2750.2344.647.28
2264180-26418042.25342.37
3281138-28113844.96645.07
4285394-28539445.64645.76
5255474-25547440.86140.96
6270947-27094743.33643.46
20min1314887-31488750.36449.525.4250.6249.745.39
2280408-28040844.84945.06
3329222-32922252.65652.86
4309355-30935549.47949.70
5319968-31996851.17651.37
6303968-30396848.61748.83
30min1330174-33017452.80952.571.0053.1852.890.99
2329570-32957052.71253.02
3333454-33345453.33353.65
4327018-32701852.30452.63
5328022-32802252.46452.77
6323777-32377751.78552.11
45min1323189-32318951.69152.701.4352.1853.141.39
2324926-32492651.96952.40
3335878-33587853.72154.16
4331821-33182153.07253.52
5330947-33094752.93253.35
6330263-33026352.82353.26
60min1317843-31784350.83653.012.7651.4453.572.70
2325611-32561152.07952.62
3344184-34418455.04955.60
4336318-33631853.79154.35
5334593-33459353.51554.05
6330200-33020052.81353.37
极限1321601-32160151.43752.521.2852.1553.191.24
2326482-32648252.21852.88
3333653-33365353.36554.04
4327220-32722052.33653.02
5330298-33029852.82853.49
6330802-33080252.90953.58
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%
128.535041005070525057015065575039635054750.28
228.435085575050495068030.49
单位质量响应值RSD%判断
17717.3217826.350.44数据可信
供试品溶液-2024032821批-缬沙坦钠-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1256572-25657225.20619.1021.5725.2119.1021.57
2211924-21192420.82020.82
3145514-14551414.29614.30
4183583-18358318.03618.04
5153516-15351615.08215.08
6215313-21531321.15321.15
10min1459812-45981245.17336.4212.9145.2336.4612.92
2355416-35541634.91734.96
3337133-33713333.12133.15
4378265-37826537.16237.20
5325076-32507631.93731.97
6368644-36864436.21736.26
15min1541337-54133753.18346.967.5853.3447.097.59
2454432-45443244.64544.77
3478965-47896547.05547.16
4491755-49175548.31248.43
5438202-43820243.05043.15
6463550-46355045.54145.67
20min1554106-55410654.43752.645.6054.7152.875.57
2480698-48069847.22547.45
3559368-55936854.95455.16
4548148-54814853.85254.08
5550704-55070454.10354.30
6522086-52208651.29151.52
30min1562832-56283255.29455.301.1755.6955.641.15
2557557-55755754.77655.10
3574723-57472356.46356.79
4559549-55954954.97255.32
5564942-56494255.50255.82
6557430-55743054.76455.11
45min1557804-55780454.80055.801.3755.3256.271.34
2560266-56026655.04255.49
3578941-57894156.87757.33
4571307-57130756.12756.60
5570240-57024056.02256.47
6569452-56945255.94556.41
60min1550752-55075254.10855.992.1654.7556.582.11
2561592-56159255.17355.74
3584811-58481157.45458.04
4579049-57904956.88857.48
5573662-57366256.35856.93
6569482-56948255.94856.54
极限1555840-55584054.60855.671.2455.3756.391.20
2563182-56318255.32956.02
3575399-57539956.52957.24
4564524-56452455.46156.18
5569300-56930055.93056.62
6571952-57195256.19056.90
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0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.532914942901502907222914402917122911040.23
228.433016253034533025390.43
单位质量响应值RSD%判断
10203.4310641.542.98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-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1156473-15647324.77518.5321.1124.7818.5321.11
2136235-13623521.57121.57
3110553-11055317.50417.50
493705-9370514.83714.84
5110671-11067117.52317.52
694687-9468714.99214.99
10min1230618-23061836.51535.804.3536.5735.844.36
2241905-24190538.30238.35
3225255-22525535.66635.70
4222179-22217935.17935.21
5212213-21221333.60133.64
6224268-22426835.50935.54
15min1281260-28126044.53344.903.5644.6745.023.55
2285724-28572445.24045.37
3274293-27429343.43043.55
4274656-27465643.48843.60
5283843-28384344.94245.06
6301799-30179947.78547.90
20min1313344-31334449.61349.304.8049.8549.524.78
2307078-30707848.62148.85
3292968-29296846.38746.60
4298061-29806147.19347.40
5327960-32796051.92752.14
6328677-32867752.04152.26
30min1335258-33525853.08351.722.3953.4352.062.39
2323375-32337551.20251.54
3315591-31559149.96950.29
4321272-32127250.86951.18
5331075-33107552.42152.75
6333491-33349152.80353.14
45min1332713-33271352.68052.821.5153.1453.271.51
2334043-33404352.89153.35
3326790-32679051.74252.17
4335623-33562353.14153.57
5330720-33072052.36552.81
6341706-34170654.10454.56
60min1333580-33358052.81752.591.0953.4053.161.08
2332170-33217052.59453.17
3326854-32685451.75252.30
4337867-33786753.49654.04
5330589-33058952.34452.91
6331946-33194652.55953.13
极限1331496-33149652.48752.610.4353.1953.290.42
2333068-33306852.73653.43
3332571-33257152.65853.32
4332584-33258452.66053.32
5329918-32991852.23852.92
6333986-33398652.88253.57
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%
128.535030025016775022345035295039615028810.19
228.435163655183315173480.27
单位质量响应值RSD%判断
17626.3918197.262.26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-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1267986-26798626.12819.3821.7526.1319.3821.76
2230649-23064922.48822.49
3189692-18969218.49518.49
4156545-15654515.26315.26
5188551-18855118.38418.38
6159218-15921815.52415.52
10min1395255-39525538.53737.824.2638.6037.874.27
2414132-41413240.37840.43
3388385-38838537.86737.91
4379522-37952237.00337.04
5364571-36457135.54535.59
6385724-38572437.60837.64
15min1483485-48348547.13947.543.7347.2847.663.72
2487813-48781347.56147.70
3475127-47512746.32546.45
4468843-46884345.71245.83
5488908-48890847.66847.79
6521121-52112150.80950.93
20min1537131-53713152.37052.214.9552.6252.444.93
2526308-52630851.31551.56
3508853-50885349.61349.84
4507499-50749949.48149.70
5565709-56570955.15655.38
6567381-56738155.31955.55
30min1577666-57766656.32254.892.4156.6955.242.41
2555073-55507354.11954.48
3547148-54714853.34653.68
4550899-55089953.71254.04
5571567-57156755.72756.08
6575798-57579856.14056.49
45min1574862-57486256.04956.141.3656.5456.621.35
2572277-57227755.79756.28
3569122-56912255.48955.95
4576308-57630856.19056.64
5571473-57147355.71856.19
6590842-59084257.60758.09
60min1575124-57512456.07455.840.7256.6956.440.71
2573664-57366455.93256.54
3566038-56603855.18855.77
4578004-57800456.35556.93
5570721-57072155.64556.24
6572809-57280955.84856.46
极限1572616-57261655.83055.910.5456.5756.630.54
2576754-57675456.23356.96
3575533-57553356.11456.82
4570581-57058155.63156.33
5569401-56940155.51656.24
6575845-57584556.14456.88
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%
128.532930812948432943892940552926832938100.31
228.433020163011063015610.22
单位质量响应值RSD%判断
10298.2810607.142.09数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-2024032921批-沙库巴曲-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1127043-12704320.05320.1017.7420.0520.1017.74
296497-9649715.23115.23
3151793-15179323.95923.96
4144634-14463422.82922.83
5139905-13990522.08322.08
6104028-10402816.42016.42
10min1236128-23612837.27136.387.4837.3236.427.48
2216357-21635734.15034.18
3222125-22212535.06135.11
4228470-22847036.06236.11
5262261-26226141.39641.44
6217439-21743934.32134.36
15min1291760-29176046.05245.385.3646.1845.515.33
2303004-30300447.82747.94
3265169-26516941.85541.99
4271699-27169942.88543.02
5298439-29843947.10647.25
6295140-29514046.58546.70
20min1307259-30725948.49848.965.4448.7349.195.42
2330447-33044752.15852.37
3286931-28693145.29045.51
4295145-29514546.58646.81
5318065-31806550.20450.45
6323421-32342151.04951.27
30min1329762-32976252.05051.382.6852.3951.712.67
2331925-33192552.39252.72
3315226-31522649.75650.08
4314094-31409449.57749.91
5327642-32764251.71652.07
6334361-33436152.77653.11
45min1330811-33081152.21652.010.9952.6752.460.98
2330370-33037052.14652.59
3327271-32727151.65752.09
4325179-32517951.32751.77
5328926-32892651.91852.39
6334579-33457952.81153.26
60min1330238-33023852.12552.190.8352.6952.760.83
2329944-32994452.07952.64
3331592-33159252.33952.89
4325941-32594151.44752.00
5332393-33239352.46553.05
6333874-33387452.69953.26
极限1330653-33065352.19152.170.9952.8852.860.97
2328181-32818151.80152.48
3336404-33640453.09953.77
4327036-32703651.62052.29
5330056-33005652.09752.80
6330944-33094452.23752.92
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%
128.535059895083315070975068065053275067100.23
228.435178425168075173240.15
单位质量响应值RSD%判断
17760.6018196.411.72数据可信
供试品溶液-2024032921批-缬沙坦钠-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1216886-21688621.06621.0918.2321.0721.0918.22
2162948-16294815.82715.83
3260624-26062425.31425.31
4247063-24706323.99724.00
5238522-23852223.16723.17
6176555-17655517.14817.15
10min1405271-40527139.36338.437.1739.4138.477.18
2372538-37253836.18436.22
3378583-37858336.77136.83
4396286-39628638.49038.54
5446978-44697843.41443.47
6374108-37410836.33636.37
15min1503086-50308648.86348.045.3249.0048.175.30
2521817-52181750.68350.80
3453767-45376744.07344.21
4470908-47090845.73845.88
5509447-50944749.48149.63
6508658-50865849.40549.52
20min1528145-52814551.29751.805.4151.5452.045.38
2570442-57044255.40555.63
3493064-49306447.89048.13
4510545-51054549.58849.83
5540310-54031052.47952.74
6557118-55711854.11154.34
30min1567309-56730955.10154.392.6455.4654.742.62
2572260-57226055.58255.93
3540881-54088152.53452.88
4543245-54324552.76453.11
5560925-56092554.48154.86
6575317-57531755.87956.23
45min1569715-56971555.33555.220.9655.8155.700.96
2570966-57096655.45655.93
3563428-56342854.72455.18
4564332-56433254.81255.28
5565101-56510154.88755.38
6577777-57777756.11856.59
60min1569041-56904155.26955.390.7455.8755.990.74
2569120-56912055.27755.88
3572156-57215655.57256.15
4564855-56485554.86355.45
5569229-56922955.28855.91
6577505-57750556.09156.69
极限1569688-56968855.33255.310.7756.0656.030.75
2566482-56648255.02155.74
3577236-57723656.06556.77
4565888-56588854.96355.67
5566306-56630655.00455.74
6571105-57110555.47056.19
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%
128.532963682970532968992981712968182970620.23
228.433041653036483039060.13
单位质量响应值RSD%判断
10412.2710689.621.86数据可信
供试品溶液-2024032921批-沙库巴曲-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1133695-13369520.90519.1614.2420.9119.1614.24
2121410-12141018.98418.98
3100237-10023715.67415.67
4106451-10645116.64516.65
5125958-12595819.69519.70
6147629-14762923.08423.08
10min1246719-24671938.57836.199.3038.6236.239.29
2240412-24041237.59237.63
3241843-24184337.81637.85
4195529-19552930.57430.61
5249415-24941539.00039.04
6214698-21469833.57133.62
15min1322412-32241250.41444.958.1250.5545.088.11
2289021-28902145.19345.32
3295638-29563846.22746.35
4258637-25863740.44240.55
5294968-29496846.12346.25
6264223-26422341.31541.44
20min1334288-33428852.27149.004.5552.5249.224.55
2303806-30380647.50547.73
3319072-31907249.89250.11
4317191-31719149.59849.79
5313371-31337149.00049.23
6292430-29243045.72645.94
30min1334581-33458152.31751.141.7252.6851.471.72
2318205-31820549.75650.09
3330815-33081551.72852.06
4328198-32819851.31951.62
5325711-32571150.93051.27
6324739-32473950.77851.10
45min1333228-33322852.10551.800.9452.5852.240.93
2329577-32957751.53451.98
3335837-33583752.51352.96
4332508-33250851.99352.41
5327790-32779051.25551.71
6328703-32870351.39851.83
60min1331230-33123051.79351.700.8552.3952.260.87
2330797-33079751.72552.28
3335197-33519752.41352.98
4326610-32661051.07051.60
5329260-32926051.48552.05
6330853-33085351.73452.28
极限1331660-33166051.86051.661.0152.5752.341.02
2330755-33075551.71952.39
3334901-33490152.36753.05
4324918-32491850.80651.45
5328878-32887851.42552.11
6331218-33121851.79152.45
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%
128.535124395128745135275153825126975133840.24
228.435231955221875226910.14
单位质量响应值RSD%判断
17994.5318385.191.52数据可信
供试品溶液-2024032921批-缬沙坦钠-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1228929-22892921.97620.0614.6021.9820.0614.60
2206831-20683119.85519.85
3170180-17018016.33716.34
4180242-18024217.30217.30
5215178-21517820.65620.66
6252346-25234624.22424.22
10min1425053-42505340.80338.199.5640.8538.249.54
2413215-41321539.66739.71
3416085-41608539.94239.98
4334897-33489732.14932.19
5430076-43007641.28541.33
6367645-36764535.29235.35
15min1555185-55518553.29547.428.4653.4347.558.46
2497972-49797247.80347.94
3508486-50848648.81248.94
4440590-44059042.29542.40
5508787-50878748.84148.98
6452910-45291043.47743.61
20min1577196-57719655.40851.814.6455.6752.044.64
2523587-52358750.26250.50
3550847-55084752.87953.11
4543765-54376552.19952.40
5539578-53957851.79752.04
6503246-50324648.30948.54
30min1577383-57738355.42654.121.8255.8154.471.82
2547855-54785552.59252.94
3570867-57086754.80155.15
4566415-56641554.37354.69
5559855-55985553.74454.10
6560241-56024153.78154.12
45min1574853-57485355.18354.760.8955.6955.230.90
2567943-56794354.52054.99
3578406-57840655.52456.00
4567985-56798554.52454.96
5565057-56505754.24354.72
6568549-56854954.57855.03
60min1571584-57158454.87054.760.8955.5055.350.90
2570075-57007554.72555.31
3578429-57842955.52756.12
4562908-56290854.03754.60
5568169-56816954.54255.14
6571671-57167154.87855.45
极限1572231-57223154.93254.771.0255.6855.481.03
2572016-57201654.91155.62
3577581-57758155.44556.16
4560493-56049353.80554.49
5567983-56798354.52455.25
6572915-57291554.99755.70
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