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%
128.53 1185308118486611827241183826118157911836610.13
228.43 1184563118498211847720.03
单位质量响应值RSD%判断
41488.2941673.300.32数据可信
供试品溶液-2024032121批-沙库巴曲-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1193768-1937687.68711.4030.987.6911.4030.97
2365160-36516014.48614.49
3246059-2460599.7619.76
4196625-1966257.8007.80
5405701-40570116.09416.09
6316668-31666812.56212.56
10min1546411-54641121.67626.2615.9621.6926.2915.98
2834965-83496533.12333.16
3671848-67184826.65226.67
4554472-55447221.99622.01
5686275-68627527.22527.26
6678406-67840626.91326.94
15min1826771-82677132.79837.3813.2232.8637.4613.22
21186925-118692547.08647.19
3903366-90336635.83735.92
4918337-91833736.43136.50
5903753-90375335.85235.95
6914576-91457636.28136.37
20min11014743-101474340.25543.999.9240.3944.159.94
21326604-132660452.62752.84
31075410-107541042.66242.82
41087128-108712843.12743.27
51064512-106451242.22942.41
61084417-108441743.01943.19
30min11157855-115785545.93248.814.6046.1649.074.64
21328400-132840052.69853.03
31213716-121371648.14848.40
41238407-123840749.12849.37
51204356-120435647.77748.05
61239263-123926349.16249.43
45min11193997-119399747.36650.643.7047.7051.013.72
21325432-132543252.58053.02
31261106-126110650.02850.39
41313109-131310952.09152.44
51270395-127039550.39750.77
61294679-129467951.36051.73
60min11217469-121746948.29751.203.0948.7351.693.12
21323934-132393452.52153.08
31281008-128100850.81851.29
41321547-132154752.42652.89
51289324-128932451.14851.64
61311039-131103952.00952.50
极限11314073-131407352.13052.750.8252.6753.350.82
21319776-131977652.35653.03
31334644-133464452.94653.53
41335668-133566852.98653.57
51331310-133131052.81353.42
61343207-134320753.28553.89
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%
128.53 2023407202192120226682023478201887320220690.10
228.43 2028921202590320274120.11
单位质量响应值RSD%判断
70875.1871312.420.44数据可信
供试品溶液-2024032121批-缬沙坦钠-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1320512-3205127.87111.8832.087.8711.8832.08
2618691-61869115.19415.19
3412820-41282010.13810.14
4324919-3249197.9807.98
5690012-69001216.94616.95
6536709-53670913.18113.18
10min1926635-92663522.75727.6015.9922.7727.6216.00
21416500-141650034.78734.82
31143130-114313028.07428.10
4939488-93948823.07223.09
51164639-116463928.60228.64
61152461-115246128.30328.33
15min11409368-140936834.61239.3613.1234.6839.4513.11
22016122-201612249.51349.62
31536102-153610237.72437.81
41562435-156243538.37138.44
51537446-153744637.75737.86
61555787-155578738.20838.30
20min11720431-172043142.25146.2810.0842.4046.4610.09
22260523-226052355.51555.74
31829347-182934744.92645.09
41844739-184473945.30445.46
51808766-180876644.42144.61
61844139-184413945.28945.47
30min11966873-196687348.30451.414.7448.5451.694.78
22265192-226519255.63055.97
32064965-206496550.71350.98
42114732-211473251.93552.19
52046009-204600950.24750.53
62103481-210348151.65851.94
45min12030313-203031349.86253.353.7750.2153.753.80
22260627-226062755.51855.99
32144429-214442952.66453.05
42233866-223386654.86155.23
52164808-216480853.16553.56
62201017-220101754.05454.45
60min12071018-207101850.86153.893.1251.3254.413.15
22256882-225688255.42656.02
32173177-217317753.37053.87
42247310-224731055.19155.68
52192865-219286553.85454.37
62225990-222599054.66755.18
极限12239854-223985455.00855.700.8055.5856.330.81
22256044-225604455.40556.12
32269378-226937855.73356.35
42277996-227799655.94456.56
52273838-227383855.84256.48
62291624-229162456.27956.91
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%
128.53 1196967119691311983511197803119380311967670.15
228.43 1211956121366212128090.10
单位质量响应值RSD%判断
41947.6742659.481.19数据可信
供试品溶液-2024032121批-沙库巴曲-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1343006-34300613.37611.0820.4713.3811.0820.48
2221736-2217368.6478.65
3335208-33520813.07113.07
4304256-30425611.86411.86
5204225-2042257.9647.96
6297011-29701111.58211.58
10min1655463-65546325.56024.267.1925.5924.297.20
2589259-58925922.97823.00
3620995-62099524.21624.24
4600103-60010323.40123.43
5574503-57450322.40322.42
6693189-69318927.03127.06
15min1912534-91253435.58434.687.8235.6734.767.81
2872756-87275634.03334.10
3866808-86680833.80133.88
4846054-84605432.99233.07
5821138-82113832.02032.09
61016953-101695339.65639.74
20min11113142-111314243.40742.248.3643.5742.398.36
21076072-107607241.96242.11
31040439-104043940.57240.73
41029748-102974840.15540.31
5991748-99174838.67338.81
61247502-124750248.64648.82
30min11303592-130359250.83448.365.3051.1048.615.31
21257171-125717149.02349.26
31218267-121826747.50647.75
41164282-116428245.40145.64
51175237-117523745.82846.05
61322589-132258951.57451.86
45min11328799-132879951.81750.223.2652.1950.583.28
21300173-130017350.70051.05
31306807-130680750.95951.31
41228151-122815147.89248.23
51242969-124296948.47048.80
61320162-132016251.48051.88
60min11328839-132883951.81850.642.3252.3151.102.35
21307119-130711950.97151.43
31313287-131328751.21251.68
41253889-125388948.89549.34
51268708-126870849.47349.91
61319259-131925951.44551.96
极限11329168-132916851.83151.760.5952.4452.340.56
21324071-132407151.63252.21
31337245-133724552.14652.73
41321759-132175951.54252.10
51334610-133461052.04352.59
61316981-131698151.35651.98
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0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.53 2041618203989720383822040291203470220389780.14
228.43 2049673205144920505610.07
单位质量响应值RSD%判断
71467.8672126.660.65数据可信
供试品溶液-2024032121批-缬沙坦钠-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1583690-58369014.19411.6721.3914.1911.6621.38
2369373-3693738.9828.98
3569193-56919313.84213.84
4515697-51569712.54112.54
5338786-3387868.2398.24
6501831-50183112.20412.20
10min11115085-111508527.11725.687.3127.1525.717.31
2996626-99662624.23624.26
31055067-105506725.65725.69
41019252-101925224.78624.81
5973384-97338423.67123.69
61176557-117655728.61228.64
15min11550639-155063937.70936.738.0537.8036.828.04
21480253-148025335.99736.07
31473170-147317035.82535.91
41436931-143693134.94435.03
51388994-138899433.77833.85
61733438-173343842.15442.24
20min11895535-189553546.09644.828.4946.2744.988.49
21829075-182907544.48044.63
31770508-177050843.05643.22
41752335-175233542.61442.77
51683569-168356940.94141.09
62126695-212669551.71751.90
30min12216385-221638553.89951.315.3654.1851.585.37
22143400-214340052.12452.38
32071275-207127550.37050.63
41980636-198063648.16648.42
51996082-199608248.54148.78
62252312-225231254.77255.07
45min12260190-226019054.96453.273.2955.3653.653.31
22209862-220986253.74054.11
32219148-221914853.96654.34
42092840-209284050.89451.26
52109756-210975651.30651.65
62252031-225203154.76555.19
60min12272730-227273055.26953.762.4655.7954.252.49
22218498-221849853.95054.44
32233657-223365754.31954.81
42134076-213407651.89752.37
52155794-215579452.42552.88
62248945-224894554.69055.23
极限12267482-226748255.14155.040.5955.7855.650.57
22255752-225575254.85655.46
32280655-228065555.46156.08
42254339-225433954.82255.41
52274799-227479955.31955.89
62245887-224588754.61655.28
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%
128.53 1187144118739111888521186735118542711871100.11
228.43 1202958120109412020260.11
单位质量响应值RSD%判断
41609.1842280.201.14数据可信
供试品溶液-2024032221批-沙库巴曲-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1202969-2029697.9829.9817.707.989.9717.71
2259194-25919410.19410.19
3202440-2024407.9627.96
4318871-31887112.54112.54
5276719-27671910.88310.88
6261694-26169410.29210.29
10min1540177-54017721.24425.7710.0521.2625.8010.06
2628650-62865024.72424.75
3702382-70238227.62427.64
4727650-72765028.61728.65
5667921-66792126.26826.29
6665242-66524226.16326.19
15min1841888-84188833.11037.889.3733.1837.969.37
2880705-88070534.63734.71
31062890-106289041.80241.88
41052597-105259741.39741.49
5994241-99424139.10239.18
6946058-94605837.20737.29
20min11070420-107042042.09846.387.8542.2446.557.85
21091170-109117042.91443.07
31272492-127249250.04550.22
41282135-128213550.42450.61
51224336-122433648.15148.32
61135705-113570544.66644.83
30min11210650-121065047.61350.714.0547.8550.984.07
21271194-127119449.99450.24
31328297-132829752.24052.52
41333941-133394152.46252.76
51337711-133771152.61052.89
61254121-125412149.32349.59
45min11252381-125238149.25451.662.5449.5952.042.57
21298201-129820151.05651.42
31326030-132603052.15152.55
41332302-133230252.39752.81
51339481-133948152.68053.07
61333398-133339852.44052.81
60min11281788-128178850.41151.901.5550.8652.391.57
21313882-131388251.67352.15
31322901-132290152.02852.54
41328526-132852652.24952.78
51332018-133201852.38652.90
61338600-133860052.64553.13
极限11326293-132629352.16152.280.4652.7252.880.44
21335920-133592052.54053.13
31321025-132102551.95452.58
41325543-132554352.13252.78
51330668-133066852.33352.96
61335863-133586352.53753.14
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%
128.53 2029120203071920344452027763202586520295820.17
228.43 2043692204150320425980.08
单位质量响应值RSD%判断
71138.5271846.570.71数据可信
供试品溶液-2024032221批-缬沙坦钠-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1337635-3376358.24610.3918.448.2510.3918.41
2431659-43165910.54210.54
3336118-3361188.2098.21
4540285-54028513.19513.19
5465040-46504011.35711.36
6440962-44096210.76910.77
10min1913558-91355822.31127.1810.2122.3327.2110.22
21067430-106743026.06926.09
31192840-119284029.13129.15
41237339-123733930.21830.25
51135491-113549127.73127.76
61131986-113198627.64527.67
15min11431346-143134634.95640.029.5235.0240.109.52
21494659-149465936.50236.58
31815431-181543144.33644.42
41791318-179131843.74743.84
51688170-168817041.22841.32
61610667-161066739.33639.42
20min11821033-182103344.47349.067.8544.6249.237.85
21860830-186083045.44545.61
32169077-216907752.97353.15
42181057-218105753.26653.46
52086416-208641650.95451.13
61933807-193380747.22747.40
30min12055549-205554950.20153.654.1450.4453.944.16
22164341-216434152.85753.12
32263931-226393155.29055.59
42275451-227545155.57155.88
52278880-227888055.65555.95
62143491-214349152.34852.63
45min12132740-213274052.08654.652.5952.4455.052.62
22208299-220829953.93154.31
32260288-226028855.20155.62
42272204-227220455.49255.93
52282511-228251155.74356.16
62270896-227089655.46055.85
60min12180216-218021653.24554.921.6353.7255.441.66
22237785-223778554.65155.15
32255852-225585255.09255.64
42266090-226609055.34255.90
52272054-227205455.48856.03
62279607-227960755.67256.19
极限12261856-226185655.23955.380.5055.8356.030.48
22279021-227902155.65856.28
32250869-225086954.97155.64
42262859-226285955.26355.95
52271182-227118255.46756.13
62280425-228042555.69256.33
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%
128.53 1188357118663011860931186312118578311866350.09
228.43 1206126120448112053040.10
单位质量响应值RSD%判断
41592.5342395.501.36数据可信
供试品溶液-2024032221批-沙库巴曲-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1385928-38592815.16113.9418.4015.1613.9418.40
2256028-25602810.05810.06
3296878-29687811.66211.66
4368039-36803914.45814.46
5429381-42938116.86816.87
6393521-39352115.45915.46
10min1722759-72275928.39228.189.4328.4328.229.43
2638094-63809425.06625.09
3707867-70786727.80727.83
4735676-73567628.90028.93
5833802-83380232.75532.79
6666642-66664226.18826.22
15min1988356-98835638.82639.799.4438.9239.889.44
2957077-95707737.59737.68
3904812-90481235.54435.63
41093319-109331942.94943.05
51161518-116151845.62845.74
6972043-97204338.18538.28
20min11242507-124250748.81047.968.2648.9948.148.27
21203715-120371547.28647.45
31033892-103389240.61540.78
41297583-129758350.97351.17
51316480-131648051.71651.93
61230517-123051748.33948.52
30min11352885-135288553.14651.735.5853.4452.025.58
21347762-134776252.94553.21
31167643-116764345.86946.13
41355179-135517953.23653.54
51336713-133671352.51152.84
61341112-134111252.68352.97
45min11352167-135216753.11852.272.4953.5352.682.52
21338636-133863652.58652.97
31264797-126479749.68550.04
41353007-135300753.15153.57
51333987-133398752.40352.85
61341186-134118652.68653.09
60min11354271-135427153.20052.581.0053.7353.101.03
21335963-133596352.48152.98
31316900-131690051.73252.20
41350298-135029853.04453.59
51333476-133347652.38352.94
61340071-134007152.64253.16
极限11345324-134532452.84952.660.5353.4953.290.51
21337086-133708652.52553.14
31342744-134274452.74753.33
41348373-134837352.96953.63
51328517-132851752.18952.86
61340942-134094252.67753.31
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%
128.53 2022514202305520216662021573202186020221340.04
228.43 2043856204167920427680.08
单位质量响应值RSD%判断
70877.4671852.550.97数据可信
供试品溶液-2024032221批-缬沙坦钠-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1655115-65511516.02814.7119.1216.0314.7119.11
2426655-42665510.43910.44
3499375-49937512.21812.22
4625017-62501715.29215.29
5731800-73180017.90417.90
6669580-66958016.38216.38
10min11228081-122808130.04629.829.6130.0829.859.61
21082190-108219026.47726.50
31198791-119879129.33029.36
41250307-125030730.59030.62
51420918-142091834.76434.80
61132046-113204627.69727.73
15min11683719-168371941.19442.209.5641.3042.309.56
21628249-162824939.83739.92
31537252-153725237.61137.70
41864802-186480245.62545.73
51980075-198007548.44548.56
61655124-165512440.49540.59
20min12119426-211942651.85450.908.3952.0551.108.39
22044646-204464650.02550.20
31759007-175900743.03643.21
42218046-221804654.26754.47
52244362-224436254.91155.14
62097616-209761651.32151.51
30min12304434-230443456.38154.905.6456.6955.205.64
22294874-229487456.14756.43
31986719-198671948.60748.88
42309274-230927456.49956.82
52281071-228107155.80956.16
62286658-228665855.94656.25
45min12305042-230504256.39555.472.6556.8355.902.67
22281089-228108955.80956.22
32147745-214774552.54752.93
42307091-230709156.44656.90
52277447-227744755.72056.19
62285595-228559555.92056.35
60min12302191-230219156.32655.781.0156.8956.331.05
22275584-227558455.67556.21
32240049-224004954.80555.30
42302237-230223756.32756.90
52276481-227648155.69756.29
62282696-228269655.84956.40
极限12296197-229619756.17955.940.5556.8656.620.53
22281565-228156555.82156.48
32286874-228687455.95156.57
42301041-230104156.29857.00
52265708-226570855.43356.15
62288121-228812155.98256.66
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%
128.53 1202028120149312005801200485120014112009450.07
228.43 1217242121706812171550.02
单位质量响应值RSD%判断
42094.1142812.351.20数据可信
供试品溶液-2024032321批-沙库巴曲-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1323066-32306612.55411.1129.8412.5511.1129.84
2147667-1476675.7385.74
3211667-2116678.2258.22
4336078-33607813.05913.06
5346908-34690813.48013.48
6350244-35024413.61013.61
10min1645156-64515625.06925.6111.2825.1025.6311.28
2608627-60862723.65023.66
3558657-55865721.70821.73
4677211-67721126.31526.34
5689292-68929226.78426.81
6775419-77541930.13130.16
15min1844078-84407832.79937.859.6932.8837.939.68
2995438-99543838.68038.75
3913677-91367735.50335.57
4944022-94402236.68236.77
51036474-103647440.27540.36
61110819-111081943.16443.26
20min1988586-98858638.41444.2410.3138.5744.4010.30
21149568-114956844.66944.82
31044773-104477340.59740.74
41107900-110790043.05043.22
51240821-124082148.21548.39
61299661-129966150.50250.69
30min11143706-114370644.44248.735.0144.6848.995.02
21295186-129518650.32850.58
31232479-123247947.89148.13
41242804-124280448.29248.56
51302897-130289750.62750.91
61307147-130714750.79351.10
45min11245562-124556248.40050.061.7748.7450.441.80
21301883-130188350.58850.95
31287178-128717850.01750.36
41285599-128559949.95550.33
51302533-130253350.61351.01
61307721-130772150.81551.23
60min11300200-130020050.52350.370.5250.9750.850.53
21301141-130114150.55951.03
31290692-129069250.15350.61
41285348-128534849.94650.43
51298810-129881050.46950.98
61301250-130125050.56351.09
极限11325877-132587751.52050.451.1652.0851.051.12
21299669-129966950.50251.09
31291140-129114050.17150.74
41280949-128094949.77550.37
51295364-129536450.33550.96
61296834-129683450.39251.04
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%
128.53 2043351204295920419402043801204371320431530.04
228.43 2064646206636820655070.06
单位质量响应值RSD%判断
71614.2072652.371.02数据可信
供试品溶液-2024032321批-缬沙坦钠-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1549829-54982913.30911.7130.9513.3111.7130.96
2241006-2410065.8345.83
3353654-3536548.5608.56
4571086-57108613.82413.82
5590500-59050014.29314.29
6597359-59735914.45914.46
10min11096124-109612426.53227.1411.4526.5627.1611.47
21033265-103326525.01125.02
3948661-94866122.96322.98
41152811-115281127.90527.94
51173304-117330428.40128.43
61322280-132228032.00732.04
15min11434713-143471334.72840.159.7734.8240.249.76
21691382-169138240.94141.01
31556139-155613937.66737.74
41609417-160941738.95739.05
51766314-176631442.75542.85
61894246-189424645.85245.95
20min11681233-168123340.69546.9510.3940.8647.1210.39
21957140-195714047.37447.53
31779368-177936843.07143.22
41887339-188733945.68445.86
52115759-211575951.21351.40
62216058-221605853.64153.85
30min11945444-194544447.09151.765.1247.3552.045.12
22206888-220688853.41953.68
32101741-210174150.87451.12
42119883-211988351.31351.59
52223447-222344753.82054.12
62232711-223271154.04454.37
45min12120105-212010551.31953.181.8651.6853.571.89
22217231-221723153.67054.05
32194807-219480753.12753.49
42193336-219333653.09153.49
52223709-222370953.82654.25
62232122-223212254.03054.47
60min12214270-221427053.59853.520.5054.0754.040.53
22219080-221908053.71454.22
32201075-220107553.27953.76
42194344-219434453.11653.63
52217026-221702653.66554.21
62221613-222161353.77654.34
极限12263125-226312554.78053.651.1555.3754.281.12
22219444-221944453.72354.35
32203654-220365453.34153.94
42187086-218708652.94053.57
52211842-221184253.53954.20
62213817-221381753.58754.27
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%
128.53 1178263117886511784661179218117813611785900.04
228.43 1199870119722211985460.16
单位质量响应值RSD%判断
41310.5542157.791.44数据可信
供试品溶液-2024032321批-沙库巴曲-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1317910-31791012.5669.8323.8312.579.8323.84
2314388-31438812.42712.43
3249513-2495139.8639.86
4237744-2377449.3989.40
5202901-2029018.0208.02
6169715-1697156.7096.71
10min1740463-74046329.26924.1819.8629.3024.2019.87
2754171-75417129.81129.84
3643777-64377725.44725.47
4551373-55137321.79521.82
5526698-52669820.82020.84
6453537-45353717.92817.94
15min11074309-107430942.46636.7614.7542.5636.8414.76
21074503-107450342.47342.57
3962920-96292038.06338.14
4855268-85526833.80733.88
5893554-89355435.32135.38
6719595-71959528.44428.50
20min11275239-127523950.40846.0610.2350.6046.2210.26
21268964-126896450.16050.35
31192412-119241247.13447.30
41142147-114214745.14745.29
51163318-116331845.98446.13
6948716-94871637.50137.62
30min11306428-130642851.64150.964.1251.9451.224.15
21319291-131929152.14952.45
31309827-130982751.77552.04
41303060-130306051.50851.75
51315151-131515151.98652.23
61181604-118160446.70746.91
45min11304369-130436951.56051.601.5451.9751.971.59
21319141-131914152.14452.56
31312782-131278251.89252.27
41305517-130551751.60551.96
51323091-132309152.30052.66
61267394-126739450.09850.40
60min11304183-130418351.55251.580.8052.0852.060.86
21314505-131450551.96052.49
31304974-130497451.58452.08
41305601-130560151.60852.08
51313721-131372151.92952.41
61285862-128586250.82851.24
极限11299783-129978351.37851.500.3452.0252.110.36
21307728-130772851.69252.34
31301254-130125451.43652.05
41297775-129777551.29951.89
51308844-130884451.73652.33
61302497-130249751.48652.01
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%
128.53 2011952201266520126482013828201248520127160.04
228.43 2047581204610420468420.06
单位质量响应值RSD%判断
70547.3571995.851.44数据可信
供试品溶液-2024032321批-缬沙坦钠-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1541288-54128813.26110.2724.9413.2610.2724.93
2534676-53467613.09913.10
3420937-42093710.31310.31
4399392-3993929.7859.78
5338340-3383408.2898.29
6279900-2799006.8576.86
10min11260794-126079430.88925.4620.2030.9225.4820.22
21284881-128488131.47931.51
31097054-109705426.87726.90
4934212-93421222.88822.91
5892844-89284421.87421.89
6765306-76530618.75018.76
15min11830513-183051344.84738.7914.8344.9438.8714.84
21830891-183089144.85644.96
31637397-163739740.11640.20
41455889-145588935.66935.74
51523764-152376437.33237.40
61222016-122201629.93930.00
20min12174991-217499153.28648.6810.3053.4848.8410.32
22165066-216506653.04353.24
32034454-203445449.84350.02
41947040-194704047.70247.85
51984206-198420648.61248.76
61615079-161507939.56939.69
30min12228147-222814754.58953.864.1954.9054.144.22
22251985-225198555.17355.49
32234590-223459054.74755.03
42221191-222119154.41854.68
52243479-224347954.96455.22
62012217-201221749.29949.51
45min12227790-222779054.58054.541.7055.0254.931.75
22252810-225281055.19355.63
32244620-224462054.99255.40
42225660-222566054.52854.91
52252550-225255055.18755.57
62153034-215303452.74853.07
60min12225556-222555654.52554.500.9055.0855.020.96
22242080-224208054.93055.49
32228814-222881454.60555.13
42224449-222444954.49855.00
52240038-224003854.88055.38
62186662-218666253.57254.01
极限12219002-221900254.36554.490.3555.0455.120.37
22232264-223226454.69055.37
32222290-222229054.44555.09
42214279-221427954.24954.87
52234193-223419354.73755.36
62223098-222309854.46555.02
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