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0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.271147083114615211474711147429114617411468620.06
228.321152461115277311526170.02
单位质量响应值RSD%判断
40568.1640699.750.23数据可信
加速3月-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%
5min1204887-2048878.16610.1822.418.1710.1822.42
2326624-32662413.01913.02
3285230-28523011.36911.37
4273592-27359210.90510.90
5271957-27195710.84010.84
6170212-1702126.7846.78
10min1599484-59948423.89424.3910.2723.9124.4110.29
2683758-68375827.25327.28
3679586-67958627.08727.11
4587091-58709123.40123.42
5605707-60570724.14324.16
6516159-51615920.57320.58
15min1878385-87838535.01135.738.4035.0635.798.41
2984231-98423139.23039.30
3994476-99447639.63839.70
4844728-84472833.67033.73
5864216-86421634.44634.50
6812903-81290332.40132.45
20min11049826-104982641.84443.677.8641.9643.797.86
21187594-118759447.33647.47
31216458-121645848.48648.62
41003846-100384640.01240.12
51074807-107480742.84042.96
61040824-104082441.48641.59
30min11180983-118098347.07249.064.6247.2549.254.63
21282521-128252151.11951.33
31304275-130427551.98652.20
41156918-115691846.11346.29
51237620-123762049.33049.52
61223037-122303748.74848.92
45min11258163-125816350.14850.872.9350.4151.142.94
21298478-129847851.75552.05
31303952-130395251.97352.27
41216079-121607948.47148.73
51316769-131676952.48452.75
61264617-126461750.40650.66
60min11291922-129192251.49451.382.1251.8451.742.13
21295596-129559651.64052.02
31301536-130153651.87752.26
41240230-124023049.43449.77
51322225-132222552.70253.06
61282626-128262651.12351.46
极限11296596-129659651.68052.060.8352.1152.500.80
21294816-129481651.60952.08
31299114-129911451.78152.25
41309570-130957052.19752.62
51318144-131814452.53952.98
61318662-131866252.56052.98
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.271994030199307519942871992226199130319929840.07
228.321998538199891819987280.02
单位质量响应值RSD%判断
70498.2070576.550.08数据可信
加速3月-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%
5min1345021-3450217.4859.4723.427.489.4723.41
2562869-56286912.21012.21
3489093-48909310.61010.61
4470127-47012710.19810.20
5467042-46704210.13210.13
6284666-2846666.1756.18
10min11034335-103433522.43822.9110.4022.4522.9210.41
21181418-118141825.62825.65
31173903-117390325.46525.48
41013424-101342421.98422.00
51045846-104584622.68722.70
6887920-88792019.26219.27
15min11520288-152028832.98033.648.4733.0333.708.48
21704357-170435736.97337.04
31720641-172064137.32637.39
41460171-146017131.67531.73
51494598-149459832.42232.48
61404306-140430630.46430.51
20min11815289-181528939.37941.147.9539.4841.257.95
22057787-205778744.63944.76
32107386-210738645.71545.84
41735478-173547837.64837.75
51862114-186211440.39540.50
61800435-180043539.05739.15
30min12042938-204293844.31746.254.7444.4946.434.75
22222024-222202448.20248.40
32263371-226337149.09949.30
42000902-200090243.40543.57
52145168-214516846.53546.71
62117502-211750245.93546.09
45min12177325-217732547.23347.943.0547.4848.203.06
22252351-225235148.86049.14
32260518-226051849.03749.32
42101977-210197745.59845.84
52280886-228088649.47949.73
62186888-218688847.44047.67
60min12237350-223735048.53548.432.2348.8648.772.24
22247594-224759448.75749.12
32257153-225715348.96449.33
42143537-214353746.50046.82
52290920-229092049.69750.03
62218647-221864748.12948.44
极限12249342-224934248.79549.150.8249.2049.560.79
22246077-224607748.72449.17
32253687-225368748.88949.33
42271072-227107249.26649.66
52285956-228595649.58950.01
62287186-228718649.61650.01
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.271155774115432111545791153777115287811542660.10
228.321151726115271911522220.07
单位质量响应值RSD%判断
40830.0740685.810.26数据可信
加速3月-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%
5min1216892-2168928.61910.3321.998.6210.3321.97
2335028-33502813.31313.31
3318318-31831812.64912.65
4263850-26385010.48510.48
5190904-1909047.5867.59
6234510-2345109.3199.32
10min1544654-54465421.64323.608.5021.6623.628.51
2689959-68995927.41727.44
3601681-60168123.90923.93
4579229-57922923.01723.03
5572249-57224922.74022.75
6575830-57583022.88222.90
15min1834246-83424633.15134.545.2133.2034.595.21
2930828-93082836.98837.06
3849464-84946433.75533.82
4839530-83953033.36133.42
5923330-92333036.69136.74
6837187-83718733.26733.32
20min11049985-104998541.72342.655.6241.8342.765.61
21099482-109948243.69043.82
31040226-104022641.33641.45
41036815-103681541.20041.31
51184890-118489047.08447.20
61028098-102809840.85440.96
30min11263691-126369150.21648.624.7950.3948.804.77
21248222-124822249.60149.80
31150559-115055945.72045.91
41193226-119322647.41547.60
51305405-130540551.87352.06
61179579-117957946.87347.05
45min11294108-129410851.42450.333.5451.6850.603.54
21304714-130471451.84652.13
31203116-120311647.80848.07
41271546-127154650.52850.79
51306150-130615051.90352.18
61219663-121966348.46648.72
60min11294286-129428651.43150.922.1251.7851.272.12
21301961-130196151.73652.11
31249811-124981149.66450.01
41290551-129055151.28351.63
51306650-130665051.92352.29
61244674-124467449.46049.80
极限11294199-129419951.42851.950.6851.8652.380.66
21300137-130013751.66452.12
31313516-131351652.19552.62
41318284-131828452.38552.81
51307603-130760351.96052.41
61310030-131003052.05752.48
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.272003291200139920009492000430199927820010690.08
228.321999815200175820007860.07
单位质量响应值RSD%判断
70784.1970649.220.14数据可信
加速3月-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%
5min1369098-3690987.9879.6122.877.999.6122.87
2577310-57731012.49212.49
3548315-54831511.86411.86
4452037-4520379.7819.78
5320941-3209416.9456.94
6397863-3978638.6098.61
10min1937128-93712820.27822.148.6620.2922.168.66
21192020-119202025.79325.81
31036098-103609822.41922.44
4997049-99704921.57421.59
5986361-98636121.34321.35
6990475-99047521.43221.45
15min11442220-144222031.20732.495.3231.2532.545.32
21608278-160827834.80034.86
31467901-146790131.76231.82
41449199-144919931.35831.41
51599761-159976134.61634.66
61442662-144266231.21631.27
20min11816359-181635939.30240.175.7239.4040.285.71
21902478-190247841.16641.29
31799505-179950538.93839.05
41794142-179414238.82238.93
52053020-205302044.42344.53
61773590-177359038.37738.48
30min12185565-218556547.29145.804.8947.4645.984.88
22162572-216257246.79446.98
31988505-198850543.02743.20
42064436-206443644.67044.84
52261781-226178148.94049.12
62037166-203716644.08044.25
45min12241801-224180148.50847.433.6948.7547.683.69
22263403-226340348.97549.24
32078919-207891944.98445.23
42197688-219768847.55347.80
52262560-226256048.95749.22
62106513-210651345.58145.82
60min12243368-224336848.54247.992.2548.8748.322.25
22258750-225875048.87549.22
32160812-216081246.75647.08
42229068-222906848.23248.56
52264578-226457849.00149.34
62150486-215048646.53246.85
极限12244304-224430448.56249.060.6648.9749.460.64
22255945-225594548.81449.25
32276914-227691449.26849.67
42285665-228566549.45749.86
52268155-226815549.07849.50
62271555-227155549.15249.54
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0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.271149931114955911510201149782115027411501130.05
228.321154160115404911541040.01
单位质量响应值RSD%判断
40683.1640752.260.12数据可信
加速3月-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%
5min1358256-35825614.25012.1923.3514.2512.1923.35
2398080-39808015.83415.83
3272270-27227010.83010.83
4210498-2104988.3738.37
5345232-34523213.73213.73
6254998-25499810.14310.14
10min1740504-74050429.45527.5010.2029.4827.5210.21
2739592-73959229.41829.44
3624611-62461124.84524.86
4587151-58715123.35523.37
5760579-76057930.25330.28
6696163-69616327.69127.71
15min11048719-104871941.71439.549.8041.7939.619.81
21050410-105041041.78141.86
3891088-89108835.44435.50
4849923-84992333.80733.86
51079691-107969142.94643.02
61044621-104462141.55141.61
20min11254229-125422949.88947.688.3450.0347.818.35
21255211-125521149.92850.07
31135808-113580845.17845.30
41023376-102337640.70640.82
51284483-128448351.09251.24
61238797-123879749.27549.41
30min11313027-131302752.22751.193.8952.4551.403.90
21313303-131330352.23852.47
31187076-118707647.21847.41
41286696-128669651.18051.36
51313736-131373652.25652.49
61307688-130768852.01552.23
45min11312753-131275352.21751.622.2952.5351.922.30
21311388-131138852.16252.48
31237551-123755149.22549.50
41307603-130760352.01252.27
51311555-131155552.16952.49
61305607-130560751.93252.23
60min11309470-130947052.08651.821.0452.4952.201.06
21309345-130934552.08152.48
31275493-127549350.73451.09
41309038-130903852.06952.42
51308129-130812952.03352.44
61305062-130506251.91152.30
极限11305371-130537151.92352.000.3952.4152.470.37
21307633-130763352.01352.50
31304402-130440251.88452.32
41317251-131725152.39552.83
51306616-130661651.97252.46
61303176-130317651.83652.31
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.271997496199650619982021996784199684019971660.04
228.322005504200582720056660.02
单位质量响应值RSD%判断
70646.1370821.540.18数据可信
加速3月-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%
5min1618176-61817613.37311.3524.2713.3711.3524.26
2686515-68651514.85114.85
3462875-46287510.01310.01
4353514-3535147.6477.65
5592432-59243212.81612.82
6433443-4334439.3779.38
10min11282056-128205627.73425.8610.3227.7625.8810.32
21279463-127946327.67827.70
31078063-107806323.32123.34
41013160-101316021.91721.93
51315193-131519328.45128.47
61204475-120447526.05626.07
15min11818312-181831239.33537.249.9339.4037.309.93
21820178-182017839.37539.45
31541149-154114933.33933.39
41468247-146824731.76231.81
51870408-187040840.46240.53
61810370-181037039.16339.22
20min12175559-217555947.06344.918.4647.2045.048.47
22174817-217481747.04747.18
31964300-196430042.49342.60
41768972-176897238.26838.37
52227346-222734648.18448.32
62145949-214594946.42346.55
30min12278245-227824549.28548.244.0249.5048.444.03
22276687-227668749.25149.47
32051989-205198944.39044.57
42226288-222628848.16148.33
52278506-227850649.29049.51
62267833-226783349.05949.26
45min12277235-227723549.26348.652.4149.5648.932.42
22274830-227483049.21149.51
32139277-213927746.27846.53
42263353-226335348.96349.21
52274515-227451549.20449.50
62264114-226411448.97949.26
60min12268336-226833649.07048.831.1049.4549.191.12
22271174-227117449.13249.51
32207359-220735947.75148.08
42264756-226475648.99349.32
52269395-226939549.09349.47
62263613-226361348.96849.33
极限12263491-226349148.96549.070.3949.4249.510.36
22268805-226880549.08049.54
32262777-226277748.95049.36
42285027-228502749.43149.84
52266849-226684949.03849.50
62261856-226185648.93049.38
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0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.271150928115116511509231151259115149611511540.03
228.321151743115239911520710.05
单位质量响应值RSD%判断
40719.9940680.470.07数据可信
加速3月-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%
5min1272175-27217510.83110.6915.0410.8310.6915.03
2270945-27094510.78210.78
3239710-2397109.5399.54
4311753-31175312.40612.41
5309944-30994412.33412.33
6207477-2074778.2568.26
10min1632305-63230525.16225.249.9225.1825.269.92
2580027-58002723.08123.10
3695731-69573127.68627.70
4705959-70595928.09328.11
5645682-64568225.69425.71
6546041-54604121.72921.74
15min1828910-82891032.98536.2711.7633.0536.3411.76
2817722-81772232.54032.60
31028145-102814540.91340.98
41009564-100956440.17440.24
5986922-98692239.27339.34
6797947-79794731.75331.80
20min1966152-96615238.44643.0711.8138.5643.1911.80
2972469-97246938.69838.81
31144933-114493345.56145.69
41229571-122957148.92949.06
51213474-121347448.28848.42
6967183-96718338.48738.59
30min11104068-110406843.93547.518.8044.1147.708.81
21092379-109237943.46943.64
31247427-124742749.63949.85
41314915-131491552.32552.54
51299766-129976651.72251.93
61104488-110448843.95144.12
45min11235266-123526649.15549.505.3249.4149.775.34
21173251-117325146.68846.94
31282841-128284151.04951.34
41312995-131299552.24952.55
51300609-130060951.75652.05
61158736-115873646.11046.35
60min11265829-126582950.37250.323.5550.7150.683.59
21235122-123512249.15049.48
31285737-128573751.16451.54
41309971-130997152.12852.52
51299677-129967751.71952.10
61190667-119066747.38147.70
极限11283743-128374351.08451.700.8451.5052.140.84
21312717-131271752.23752.64
31289741-128974151.32351.78
41307476-130747652.02952.51
51300954-130095451.76952.24
61301174-130117451.77852.17
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0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.272001145200171520013922001028200115620012870.02
228.322001528200151420015210.01
单位质量响应值RSD%判断
70791.9070675.180.12数据可信
加速3月-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%
5min1464623-46462310.0519.9015.7010.059.9015.72
2461971-4619719.9949.99
3405658-4056588.7768.78
4534265-53426511.55811.56
5530474-53047411.47611.48
6348726-3487267.5447.54
10min11091142-109114223.60423.6610.2323.6223.6810.22
2998617-99861721.60321.62
31203466-120346626.03426.05
41220578-122057826.40526.42
51114000-111400024.09924.12
6935783-93578320.24420.26
15min11431334-143133430.96434.0911.9631.0234.1511.96
21412548-141254830.55730.61
31780361-178036138.51438.57
41747975-174797537.81437.88
51708801-170880136.96637.03
61374229-137422929.72829.77
20min11669270-166927036.11140.5112.0136.2240.6212.01
21680226-168022636.34836.45
31983042-198304242.89943.02
42130248-213024846.08346.21
52104911-210491145.53545.66
61668066-166806636.08536.18
30min11907709-190770941.26944.669.0241.4444.849.03
21883236-188323640.74040.90
32161681-216168146.76346.96
42280290-228029049.32949.53
52250037-225003748.67548.87
61904724-190472441.20541.36
45min12136296-213629646.21446.565.4746.4546.815.50
22027335-202733543.85744.09
32219878-221987848.02248.29
42276684-227668449.25149.54
52252814-225281448.73549.01
61999972-199997243.26543.49
60min12187531-218753147.32247.353.6747.6447.683.71
22135483-213548346.19646.50
32224737-222473748.12748.48
42272366-227236649.15849.53
52253099-225309948.74149.10
62058712-205871244.53644.83
极限12227245-222724548.18248.770.8548.5749.180.84
22278062-227806249.28149.66
32237782-223778248.40948.84
42268681-226868149.07849.53
52257234-225723448.83049.27
62257230-225723048.83049.20
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0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.271153212115317811528251151565115132111524200.08
228.321148696114853011486130.02
单位质量响应值RSD%判断
40764.7740558.370.36数据可信
加速3月-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%
5min1419752-41975216.71911.7125.3516.7211.7125.35
2237544-2375449.4629.46
3334133-33413313.30913.31
4214866-2148668.5588.56
5293881-29388111.70611.71
6264004-26400410.51610.52
10min1877876-87787634.96725.6619.5734.9925.6819.57
2559622-55962222.29122.31
3688993-68899327.44427.47
4534487-53448721.28921.30
5609741-60974124.28724.31
6594471-59447123.67923.70
15min11196576-119657647.66137.1816.5247.7537.2516.53
2786520-78652031.32831.38
31030630-103063041.05241.12
4814539-81453932.44432.49
5887474-88747435.34935.41
6885508-88550835.27135.33
20min11311572-131157252.24242.9012.3252.4143.0212.34
2930398-93039837.05937.16
31130657-113065745.03645.17
4994330-99433039.60639.71
51045202-104520241.63241.75
61049702-104970241.81141.93
30min11309979-130997952.17847.586.7852.4347.776.81
21073083-107308342.74242.91
31232280-123228049.08449.29
41152676-115267645.91346.08
51172336-117233646.69646.88
61226136-122613648.83949.02
45min11310586-131058652.20350.243.9952.5450.514.02
21171550-117155046.66546.90
31279401-127940150.96051.25
41278244-127824450.91451.16
51236514-123651449.25249.52
61291575-129157551.44551.71
60min11310654-131065452.20551.172.0152.6351.532.04
21235960-123596049.23049.55
31281387-128138751.04051.42
41297421-129742151.67852.01
51290914-129091451.41951.77
61291929-129192951.45951.81
极限11303777-130377751.93151.700.8052.4452.140.79
21298077-129807751.70452.10
31282757-128275751.09451.56
41308320-130832052.11252.53
51306634-130663452.04552.48
61288580-128858051.32651.76
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0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.272001827200167120012801999495199913020006810.07
228.321994591199474019946660.01
单位质量响应值RSD%判断
70770.4670433.120.34数据可信
加速3月-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%
5min1726776-72677615.75210.9326.2315.7510.9326.23
2402429-4024298.7228.72
3576188-57618812.48812.49
4364048-3640487.8907.89
5505843-50584310.96310.96
6451566-4515669.7879.79
10min11520476-152047632.95424.1119.8332.9824.1219.84
2963734-96373420.88720.90
31191573-119157325.82525.85
4919701-91970119.93319.95
51052605-105260522.81322.83
61025369-102536922.22322.24
15min12074474-207447444.96135.0316.6645.0435.0816.66
21358314-135831429.43929.49
31786996-178699638.73038.79
41408594-140859430.52930.58
51536359-153635933.29833.35
61531940-153194033.20233.26
20min12274292-227429249.29140.4112.4549.4540.5212.47
21606621-160662134.82134.92
31957324-195732442.42242.55
41719819-171981937.27437.37
51809980-180998039.22839.34
61818161-181816139.40639.51
30min12272038-227203849.24344.836.9049.4845.016.93
21854851-185485140.20140.36
32135669-213566946.28746.49
41994224-199422443.22143.38
52028988-202898843.97544.15
62124087-212408746.03646.21
45min12273082-227308249.26547.354.1049.5947.604.13
22026258-202625843.91644.14
32215430-221543048.01648.29
42212262-221226247.94748.18
52138637-213863746.35146.60
62241292-224129248.57648.83
60min12275188-227518849.31148.242.1049.7148.582.15
22138004-213800446.33846.63
32219397-221939748.10248.46
42246377-224637748.68649.00
52233259-223325948.40248.73
62241862-224186248.58948.92
极限12262787-226278749.04248.810.7849.5349.230.78
22251956-225195648.80749.18
32225923-222592348.24348.68
42268415-226841549.16449.56
52266738-226673849.12849.54
62236064-223606448.46348.88
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.271150733115131711509201151275115092411510340.03
228.321147769114805611479120.02
单位质量响应值RSD%判断
40715.7440533.620.32数据可信
加速3月-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%
5min1247472-2474729.86610.4417.539.8710.4417.54
2268990-26899010.72410.72
3343025-34302513.67613.68
4263462-26346210.50410.50
5244482-2444829.7479.75
6203764-2037648.1248.12
10min1563207-56320722.45422.785.7522.4722.805.75
2584184-58418423.29023.31
3625301-62530124.92924.95
4573903-57390322.88022.90
5526759-52675921.00121.02
6555292-55529222.13822.15
15min1809174-80917432.26033.176.6032.3133.226.60
2814849-81484932.48632.54
3855891-85589134.12234.19
4918050-91805036.60036.66
5753390-75339030.03630.09
6840356-84035633.50333.55
20min1968523-96852338.61340.799.2438.7240.919.23
2971181-97118138.71938.83
31062148-106214842.34542.47
41172610-117261046.74946.87
5905593-90559336.10436.21
61059241-105924142.22942.34
30min11095897-109589743.69146.227.3943.8646.407.38
21099137-109913743.82044.00
31161761-116176146.31746.51
41298945-129894551.78651.98
51081921-108192143.13443.30
61218242-121824248.56848.75
45min11169863-116986346.64048.814.1146.8849.064.11
21190675-119067547.46947.72
31208880-120888048.19548.46
41300461-130046151.84652.13
51205384-120538448.05648.29
61270357-127035750.64650.90
60min11213814-121381448.39250.142.4948.7150.472.50
21236034-123603449.27849.61
31248461-124846149.77350.12
41299391-129939151.80452.17
51265349-126534950.44650.76
61282380-128238051.12551.47
极限11276077-127607750.87451.620.8051.2852.040.80
21290634-129063451.45451.86
31298138-129813851.75452.19
41297988-129798851.74852.20
51304986-130498652.02752.42
61300287-130028751.83952.27
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0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.271998251199884619975051999110199883719985100.04
228.321992857199349219931740.03
单位质量响应值RSD%判断
70693.6770380.440.32数据可信
加速3月-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%
5min1423712-4237129.1929.7118.179.199.7218.19
2461244-46124410.00610.01
3591230-59123012.82612.83
4449952-4499529.7619.76
5416602-4166029.0379.04
6344083-3440837.4647.46
10min1971584-97158421.07721.355.8821.0921.375.90
21006734-100673421.83921.86
31079422-107942223.41623.44
4988735-98873521.44921.47
5906728-90672819.67019.68
6953095-95309520.67620.69
15min11397829-139782930.32331.186.7330.3731.236.73
21406074-140607430.50230.56
31478953-147895332.08332.14
41590275-159027534.49834.55
51299773-129977328.19628.24
61449895-144989531.45331.50
20min11674182-167418236.31838.399.3936.4238.499.37
21676998-167699836.37936.48
31838470-183847039.88240.00
42032061-203206144.08244.19
51563385-156338533.91534.01
61832366-183236639.75039.85
30min11892195-189219541.04843.507.5641.2143.677.55
21899435-189943541.20541.37
32010652-201065243.61743.80
42252741-225274148.86949.05
51868322-186832240.53040.68
62108312-210831245.73645.90
45min12021136-202113643.84545.954.2444.0746.184.25
22060384-206038444.69644.93
32092170-209217045.38645.64
42257154-225715448.96549.23
52080588-208058845.13545.35
62196385-219638547.64747.89
60min12099062-209906245.53547.202.5545.8447.512.56
22138946-213894646.40046.71
32159267-215926746.84147.17
42253679-225367948.88949.24
52186878-218687847.44047.73
62215859-221585948.06948.39
极限12214149-221414948.03248.730.7948.4149.120.80
22239228-223922848.57648.96
32251603-225160348.84449.25
42252178-225217848.85749.28
52263905-226390549.11149.48
62256743-225674348.95649.36
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