沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源自制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125
标示量(mg)200供试品稀释倍数1系数0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.005512625528585529545516065505225518400.20
228.075555985557025556500.02
单位质量响应值RSD%判断
19708.5719795.150.31数据可信
供试品溶液-24111402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%
5min1243174-24317419.94018.216.8819.9418.216.88
2230657-23065718.91318.91
3222836-22283618.27218.27
4197194-19719416.16916.17
5221831-22183118.19018.19
6216856-21685617.78217.78
10min1407087-40708733.38034.035.5533.4134.065.54
2383983-38398331.48631.52
3434662-43466235.64135.67
4394623-39462332.35832.39
5430478-43047835.29835.33
6439028-43902835.99936.03
15min1516293-51629342.33542.776.6442.4242.856.63
2472303-47230338.72838.81
3534531-53453143.83043.92
4495998-49599840.67140.75
5570331-57033146.76646.85
6539892-53989244.27044.36
20min1573294-57329447.00947.226.3147.1747.386.30
2525627-52562743.10043.25
3570259-57025946.76046.92
4559829-55982945.90546.05
5635551-63555152.11452.28
6590403-59040348.41248.58
30min1621222-62122250.93950.733.9151.1850.973.91
2580217-58021747.57647.80
3603396-60339649.47749.72
4624481-62448151.20651.43
5649524-64952453.25953.51
6633543-63354351.94952.19
45min1634241-63424152.00652.022.8252.3352.342.83
2603683-60368349.50149.80
3627850-62785051.48251.81
4637221-63722152.25152.56
5649182-64918253.23153.57
6654045-65404553.63053.96
60min1641980-64198052.64152.552.3753.0552.962.38
2615134-61513450.44050.82
3638270-63827052.33752.75
4640276-64027652.50152.90
5648626-64862653.18653.62
6661221-66122154.21954.64
极限1641939-64193952.63853.071.6853.1353.571.69
2640702-64070252.53653.00
3640905-64090552.55353.05
4643884-64388452.79753.28
5647236-64723653.07253.59
6668878-66887854.84655.36
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源自制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125
标示量(mg)200供试品稀释倍数1系数0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.009552229565859566389549529535859553960.14
228.079611769610549611150.01
单位质量响应值RSD%判断
34121.2934239.940.25数据可信
供试品溶液-24111402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%
5min1419944-41994418.80017.107.4018.8017.107.40
2397260-39726017.78417.78
3385327-38532717.25017.25
4334816-33481614.98914.99
5381737-38173717.08917.09
6373019-37301916.69916.70
10min1699703-69970331.32431.975.7531.3632.005.75
2659313-65931329.51629.55
3750377-75037733.59233.62
4677685-67768530.33830.36
5741279-74127933.18533.21
6756981-75698133.88833.92
15min1887229-88722939.71940.166.7639.8040.246.76
2811206-81120636.31536.39
3921829-92182941.26841.35
4851839-85183938.13438.21
5982240-98224043.97244.06
6928430-92843041.56341.65
20min1985529-98552944.11944.376.4444.2744.526.42
2903718-90371840.45740.60
3981225-98122543.92744.08
4962298-96229843.07943.22
51095984-109598449.06449.22
61017847-101784745.56645.72
30min11068494-106849447.83347.693.9848.0647.913.98
2999051-99905144.72544.93
31038146-103814646.47546.70
41074969-107496948.12348.33
51121208-112120850.19350.43
61089858-108985848.79049.02
45min11091719-109171948.87348.922.8849.1849.232.88
21039307-103930746.52746.81
31081265-108126548.40548.71
41097825-109782549.14649.44
51120622-112062250.16750.49
61126457-112645750.42850.74
60min11107614-110761449.58549.482.3949.9749.872.40
21059847-105984747.44647.81
31100690-110069049.27549.66
41104102-110410249.42749.80
51120744-112074450.17350.58
61139226-113922651.00051.39
极限11108968-110896849.64550.081.6850.1150.541.68
21108053-110805349.60450.04
31107446-110744649.57750.04
41112635-111263549.80950.26
51118654-111865450.07950.57
61155818-115581851.74352.22
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源自制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125
标示量(mg)200供试品稀释倍数1系数0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.005526685524615528075526615522495525690.04
228.075587425587255587340.01
单位质量响应值RSD%判断
19734.6119905.020.61数据可信
供试品溶液-24111402批-缬沙坦钠-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1375899-37589930.71823.1832.4630.7223.1832.47
2178112-17811214.55514.55
3177608-17760814.51414.51
4364307-36430729.77029.77
5257035-25703521.00421.00
6348884-34888428.51028.51
10min1405741-40574133.15627.6322.8733.2127.6722.89
2233120-23312019.05019.07
3247998-24799820.26620.29
4395781-39578132.34232.39
5358712-35871229.31329.35
6387250-38725031.64531.69
15min1483288-48328839.49336.6714.1739.6036.7514.20
2354341-35434128.95629.01
3381209-38120931.15231.21
4496829-49682940.60040.70
5481395-48139539.33839.42
6495229-49522940.46940.57
20min1520246-52024642.51343.276.7242.6943.426.76
2505391-50539141.29941.40
3485445-48544539.66939.78
4564964-56496446.16846.34
5522497-52249742.69742.85
6578589-57858947.28147.45
30min1540828-54082844.19547.475.3844.4447.685.37
2608128-60812849.69549.87
3542089-54208944.29844.47
4600603-60060349.08049.33
5588834-58883448.11848.34
6604679-60467949.41349.66
45min1544655-54465544.50847.975.3044.8248.275.28
2613227-61322750.11250.37
3550863-55086345.01545.27
4606284-60628449.54449.87
5596050-59605048.70849.01
6611169-61116949.94350.27
60min1544811-54481144.52148.496.2944.9148.876.26
2617512-61751250.46250.80
3550201-55020144.96145.29
4606715-60671549.57949.99
5605156-60515649.45249.83
6636067-63606751.97852.39
极限1594152-59415248.55349.611.3149.0250.061.32
2609089-60908949.77350.20
3605340-60534049.46749.87
4608485-60848549.72450.22
5606448-60644849.55850.02
6618713-61871350.56051.06
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源自制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125
标示量(mg)200供试品稀释倍数1系数0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.009560409561219561029560779559559560590.01
228.079661279663459662360.02
单位质量响应值RSD%判断
34144.9634422.370.58数据可信
供试品溶液-24111402批-沙库巴曲-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1546408-54640824.38819.0931.7524.3919.0931.75
2267537-26753711.94111.94
3266570-26657011.89811.90
4546243-54624324.38124.38
5403135-40313517.99317.99
6536278-53627823.93623.94
10min1677092-67709230.22125.3323.2030.2625.3623.21
2382231-38223117.06017.08
3418746-41874618.69018.71
4661681-66168129.53329.57
5612829-61282927.35227.38
6652563-65256329.12629.17
15min1829200-82920037.01034.4514.3937.1034.5214.42
2605243-60524327.01427.06
3656026-65602629.28129.33
4855053-85505338.16438.25
5831887-83188737.13037.21
6853507-85350738.09538.18
20min1896206-89620640.00140.946.9440.1541.086.96
2876889-87688939.13839.23
3839484-83948437.46937.57
4975257-97525743.52943.68
5906223-90622340.44840.59
61010014-101001445.08045.23
30min1931031-93103141.55545.216.1841.7745.416.16
21065032-106503247.53647.69
3939554-93955441.93542.10
41044680-104468046.62746.85
51023964-102396445.70345.91
61073056-107305647.89448.12
45min1936932-93693241.81845.616.0942.1145.896.07
21071641-107164147.83148.07
3951179-95117942.45442.69
41051729-105172946.94247.25
51039777-103977746.40946.69
61080448-108044848.22448.53
60min1934398-93439841.70545.856.8442.0646.206.82
21075794-107579448.01648.33
3947631-94763142.29642.60
41052277-105227746.96647.35
51046620-104662046.71447.07
61106784-110678449.39949.79
极限11027601-102760145.86547.392.0146.2947.822.02
21070854-107085447.79648.19
31057316-105731647.19147.56
41060232-106023247.32247.78
51061175-106117547.36447.80
61093411-109341148.80249.27
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DSMF-4022-230920对照品来源自制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125
标示量(mg)200供试品稀释倍数1系数0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.005544195550315536925534505532185539620.14
228.075574175574155574160.01
单位质量响应值RSD%判断
19784.3619858.070.27数据可信
供试品溶液-24111402批-缬沙坦钠-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%
5min1112472-1124729.19010.4615.759.1910.4615.75
2137347-13734711.22311.22
3125400-12540010.24710.25
4103811-1038118.4828.48
5161316-16131613.18113.18
6127743-12774310.43810.44
10min1249192-24919220.36220.693.1420.3820.713.15
2254054-25405420.75920.78
3259547-25954721.20821.22
4245627-24562720.07020.08
5265257-26525721.67421.70
6245782-24578220.08320.10
15min1362443-36244329.61529.294.4629.6629.344.46
2359484-35948429.37429.43
3358694-35869429.30929.36
4328890-32889026.87426.92
5377246-37724630.82530.88
6363866-36386629.73229.78
20min1450030-45003036.77234.845.6936.8734.945.68
2410096-41009633.50933.61
3433439-43343935.41735.52
4386804-38680431.60631.70
5429639-42963935.10635.22
6448361-44836136.63636.74
30min1530935-53093543.38339.527.3943.5439.687.37
2457038-45703837.34537.50
3476989-47698938.97539.14
4443466-44346636.23636.38
5470057-47005738.40938.58
6523545-52354542.77942.94
45min1567836-56783646.39842.187.2546.6342.417.24
2485165-48516539.64339.86
3508293-50829341.53341.76
4480083-48008339.22839.43
5498673-49867340.74740.98
6557445-55744545.54945.78
60min1588058-58805848.05143.827.2448.3644.127.21
2501622-50162240.98841.27
3527754-52775443.12343.42
4502066-50206641.02441.30
5516945-51694542.24042.54
6581270-58127047.49647.80
极限1617792-61779250.48049.252.8350.8749.622.83
2608325-60832549.70750.06
3598739-59873948.92349.29
4583365-58336547.66748.01
5584181-58418147.73448.10
6623991-62399150.98751.37
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源自制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125
标示量(mg)200供试品稀释倍数1系数0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.009606089611219592469581569577599593780.16
228.079616939622329619620.04
单位质量响应值RSD%判断
34263.5034270.110.02数据可信
供试品溶液-24111402批-沙库巴曲-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%
5min1137346-1373466.1337.4018.056.137.4018.04
2177452-1774527.9247.92
3164540-1645407.3477.35
4130797-1307975.8415.84
5213490-2134909.5339.53
6170430-1704307.6107.61
10min1330753-33075314.77015.054.4614.7815.064.48
2335469-33546914.98014.99
3348964-34896415.58315.60
4325311-32531114.52714.54
5360325-36032516.09016.11
6320781-32078114.32414.34
15min1495758-49575822.13821.925.1822.1721.965.18
2491998-49199821.97022.01
3495462-49546222.12522.16
4446291-44629119.92919.96
5525406-52540623.46223.50
6490531-49053121.90421.94
20min1631503-63150328.19926.785.9228.2726.855.92
2576035-57603525.72225.80
3615217-61521727.47227.55
4538306-53830624.03824.10
5614801-61480127.45427.54
6621859-62185927.76927.84
30min1773727-77372734.55031.497.4934.6731.607.47
2660748-66074829.50529.62
3703366-70336631.40831.53
4639647-63964728.56328.67
5694723-69472331.02231.15
6758404-75840433.86633.99
45min1868011-86801138.76134.937.5738.9435.107.56
2730158-73015832.60532.77
3777277-77727734.70934.88
4719367-71936732.12332.28
5761364-76136433.99834.18
6837357-83735737.39237.57
60min1927767-92776741.42937.337.6541.6737.567.64
2775705-77570534.63934.86
3827314-82731436.94337.17
4776535-77653534.67634.88
5809380-80938036.14236.38
6899738-89973840.17740.42
极限11008585-100858545.03843.473.1345.3543.763.14
2978888-97888843.71243.99
3965316-96531643.10643.40
4936051-93605141.79942.06
5945253-94525342.21042.51
61006799-100679944.95845.26
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源自制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125
标示量(mg)200供试品稀释倍数1系数0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.005566685564905562655568705549805562550.14
228.075647575643115645340.06
单位质量响应值RSD%判断
19866.2520111.650.87数据可信
供试品溶液-24111402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%
5min1214516-21451617.38216.0210.4017.3816.0210.40
2183995-18399514.90914.91
3227570-22757018.44018.44
4196670-19667015.93615.94
5193097-19309715.64615.65
6170689-17068913.83113.83
10min1342100-34210027.72029.966.7327.7529.986.73
2371833-37183330.12930.15
3390237-39023731.62031.65
4396140-39614032.09832.12
5381182-38118230.88630.91
6336914-33691427.29927.32
15min1432594-43259435.05240.657.8935.1340.737.88
2520044-52004442.13842.21
3519628-51962842.10442.19
4540568-54056843.80143.88
5519455-51945542.09042.17
6478021-47802138.73338.80
20min1496375-49637540.22046.917.9040.3547.067.89
2615994-61599449.91350.06
3580451-58045147.03347.19
4620970-62097050.31650.47
5595518-59551848.25448.40
6564385-56438545.73145.86
30min1541588-54158843.88450.477.0944.0850.707.09
2667551-66755154.09054.32
3626786-62678650.78751.02
4651374-65137452.77953.02
5637378-63737851.64551.87
6612927-61292749.66449.87
45min1578844-57884446.90251.544.7747.1851.854.76
2669101-66910154.21654.53
3637902-63790251.68852.00
4649003-64900352.58752.91
5641123-64112351.94952.26
6640829-64082951.92552.22
60min1606954-60695449.18052.163.1949.5352.553.21
2668829-66882954.19454.60
3642205-64220552.03652.44
4649255-64925552.60853.02
5642026-64202652.02252.42
6653210-65321052.92853.31
极限1645569-64556952.30953.122.4052.7453.602.38
2668414-66841454.16054.66
3648434-64843452.54153.03
4647166-64716652.43852.94
5642477-64247752.05952.55
6681480-68148055.21955.69
沙库巴曲缬沙坦钠片项目信息
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DSMF-4022-230920对照品来源自制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125
标示量(mg)200供试品稀释倍数1系数0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.009632369613609612209614429591019612720.16
228.079763229746999755100.12
单位质量响应值RSD%判断
34331.1434752.760.87数据可信
供试品溶液-24111402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%
5min1362491-36249116.05814.7810.8916.0614.7810.90
2309109-30910913.69413.69
3387423-38742317.16317.16
4331251-33125114.67514.67
5325360-32536014.41414.41
6286698-28669812.70112.70
10min1582337-58233725.79827.956.9225.8227.976.93
2635262-63526228.14228.17
3668210-66821029.60229.63
4675644-67564429.93129.96
5650529-65052928.81928.84
6572909-57290925.38025.40
15min1737732-73773232.68238.078.0832.7538.148.07
2892075-89207539.51939.59
3892513-89251339.53939.62
4925730-92573041.01041.08
5890497-89049739.44939.52
6817510-81751036.21636.28
20min1849723-84972337.64343.998.0337.7744.128.02
21058363-105836346.88647.02
3996102-99610244.12844.27
41066039-106603947.22647.37
51022199-102219945.28445.42
6965535-96553542.77442.90
30min1926138-92613841.02847.347.2841.2247.557.27
21147901-114790150.85251.07
31076619-107661947.69547.91
41118605-111860549.55549.78
51094362-109436248.48148.69
61048558-104855846.45146.65
45min1991224-99122443.91248.394.9144.1748.674.92
21150510-115051050.96851.27
31096528-109652848.57748.87
41118168-111816849.53549.84
51100288-110028848.74349.04
61096583-109658348.57948.85
60min11039084-103908446.03248.933.2946.3649.293.30
21149302-114930250.91451.30
31103809-110380948.89949.28
41116614-111661449.46649.85
51101221-110122148.78449.16
61116388-111638849.45649.81
极限11111119-111111949.22350.012.3949.6350.462.36
21151781-115178151.02451.49
31117211-111721149.49349.95
41114612-111461249.37849.85
51106353-110635349.01249.47
61172881-117288151.95952.39
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