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%
128.275760625767085767555763535750325761820.13
228.325628035695665661840.85
单位质量响应值RSD%判断
20381.3919992.371.37数据可信
加速3月-供试品溶液-2024032421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%
5min1208851-20885116.75816.0716.8816.7616.0716.87
2146160-14616011.72811.73
3192002-19200215.40615.41
4239313-23931319.20219.20
5185383-18538314.87514.87
6230219-23021918.47218.47
10min1422402-42240233.89332.249.8733.9232.279.87
2339958-33995827.27727.30
3375653-37565330.14230.17
4428957-42895734.41934.45
5395788-39578831.75731.78
6448206-44820635.96335.99
15min1527709-52770942.34242.185.4642.4342.265.48
2478801-47880138.41838.48
3512971-51297141.16041.24
4553700-55370044.42844.52
5524211-52421142.06242.14
6556746-55674644.67244.76
20min1583407-58340746.81147.872.9246.9748.022.93
2572003-57200345.89646.03
3600303-60030348.16748.31
4620270-62027049.76949.93
5594569-59456947.70747.85
6608959-60895948.86249.03
30min1624834-62483450.13551.992.3350.3752.222.34
2647217-64721751.93152.14
3643632-64363251.64451.87
4662800-66280053.18253.43
5642725-64272551.57151.80
6666335-66633553.46553.71
45min1652495-65249552.35552.681.0452.6753.001.05
2661329-66132953.06453.36
3654330-65433052.50252.81
4660590-66059053.00453.34
5646052-64605251.83852.15
6664308-66430853.30353.64
60min1660374-66037452.98752.631.2053.3953.041.19
2659015-65901552.87853.26
3654733-65473352.53452.93
4661242-66124253.05753.48
5640682-64068251.40751.81
6659643-65964352.92853.35
极限1658500-65850052.83752.690.8553.3353.180.84
2663704-66370453.25453.72
3652150-65215052.32752.81
4660510-66051052.99853.51
5648545-64854552.03852.52
6656393-65639352.66853.18
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%
128.2710025559988201000736100113799992710006350.14
228.329775729876979826340.73
单位质量响应值RSD%判断
35395.6534697.531.41数据可信
加速3月-供试品溶液-2024032421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%
5min1358562-35856215.65714.9917.8115.6614.9917.79
2244485-24448510.67510.68
3328537-32853714.34614.35
4413179-41317918.04218.04
5317802-31780213.87713.88
6397371-39737117.35117.35
10min1729896-72989631.87130.249.9431.9030.279.94
2584634-58463425.52825.55
3648628-64862828.32228.35
4738105-73810532.22932.26
5681374-68137429.75229.78
6773088-77308833.75733.79
15min1908911-90891139.68839.735.9639.7739.805.97
2823882-82388235.97536.04
3885020-88502038.64538.72
4957223-95722341.79741.88
5907370-90737039.62039.69
6976464-97646442.63742.72
20min11006715-100671543.95845.043.0044.1045.183.01
2988257-98825743.15243.27
31037280-103728045.29345.43
41073415-107341546.87147.02
51029977-102997744.97445.11
61053780-105378046.01346.17
30min11079511-107951147.13748.962.4247.3649.182.42
21117548-111754848.79848.99
31113066-111306648.60248.81
41147302-114730250.09750.33
51115117-111511748.69248.91
61154825-115482550.42650.66
45min11126856-112685649.20449.651.0249.5049.941.02
21141277-114127749.83450.11
31134750-113475049.54949.84
41145664-114566450.02650.34
51121506-112150648.97149.27
61151899-115189950.29850.61
60min11143767-114376749.94349.621.1450.3250.001.15
21140393-114039349.79550.15
31134884-113488449.55549.93
41146389-114638950.05750.46
51111137-111113748.51848.89
61141599-114159949.84850.25
极限11142457-114245749.88649.720.7750.3550.190.76
21148124-114812450.13350.57
31133322-113332249.48749.94
41145521-114552150.01950.50
51124508-112450849.10249.56
61138614-113861449.71850.20
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%
128.275691085745755754925752505759935740840.50
228.325714335755015734670.51
单位质量响应值RSD%判断
20307.1820249.540.21数据可信
加速3月-供试品溶液-2024032421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%
5min1171124-17112413.66715.387.0413.6715.387.03
2192080-19208015.34115.34
3189367-18936715.12415.12
4199469-19946915.93115.93
5212479-21247916.97016.97
6190916-19091615.24815.25
10min1389850-38985031.13730.624.3831.1630.654.37
2375990-37599030.03030.06
3360227-36022728.77128.80
4410239-41023932.76532.79
5386956-38695630.90630.93
6377170-37717030.12430.15
15min1501309-50130940.03939.615.3740.1139.685.36
2477166-47716638.11138.19
3461707-46170736.87636.95
4525004-52500441.93142.01
5483071-48307138.58238.66
6527184-52718442.10542.18
20min1563762-56376245.02744.826.4045.1744.966.38
2541591-54159143.25643.40
3518078-51807841.37841.51
4605872-60587248.39048.54
5536664-53666442.86343.01
6600969-60096947.99948.14
30min1623102-62310249.76649.543.6849.9849.753.68
2632267-63226750.49850.71
3596650-59665047.65447.86
4650233-65023351.93352.16
5590041-59004147.12647.34
6629128-62912850.24850.47
45min1654313-65431352.25951.741.0952.5652.041.10
2649315-64931551.86052.16
3645278-64527851.53751.82
4655588-65558852.36152.68
5636325-63632550.82251.12
6645741-64574151.57451.88
60min1658929-65892952.62852.460.9353.0152.850.91
2654373-65437352.26452.65
3667863-66786353.34153.71
4652740-65274052.13352.54
5650997-65099751.99452.37
6656407-65640752.42652.82
极限1663072-66307252.95952.971.5153.4353.441.49
2655924-65592452.38852.86
3681374-68137454.42054.88
4653431-65343152.18952.68
5659462-65946252.67053.14
6665903-66590353.18553.67
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%
128.279904499965349994719984039988049967320.37
228.329905429982089943750.55
单位质量响应值RSD%判断
35257.5935112.110.30数据可信
加速3月-供试品溶液-2024032421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%
5min1292196-29219612.70714.347.2312.7114.347.22
2328138-32813814.27114.27
3324257-32425714.10214.10
4341969-34196914.87214.87
5364902-36490215.86915.87
6326766-32676614.21114.21
10min1673308-67330829.28228.744.3429.3028.774.34
2644107-64410728.01228.04
3623069-62306927.09727.12
4706492-70649230.72530.75
5668117-66811729.05629.08
6650506-65050628.29028.31
15min1865215-86521537.62837.205.5037.7037.285.49
2821153-82115335.71235.78
3795431-79543134.59334.66
4905653-90565339.38639.46
5833553-83355336.25136.33
6911762-91176239.65239.72
20min1972157-97215742.27942.156.6142.4142.286.61
2934188-93418840.62740.76
3893173-89317338.84438.97
41048009-104800945.57745.72
5925081-92508140.23140.37
61042316-104231645.33045.47
30min11076209-107620946.80446.613.8247.0146.823.82
21094071-109407147.58147.78
31028622-102862244.73444.93
41125769-112576948.95949.18
51018700-101870044.30344.51
61087727-108772747.30547.52
45min11128421-112842149.07448.681.0649.3648.961.07
21118438-111843848.64048.92
31118639-111863948.64948.91
41134545-113454549.34149.64
51099933-109993347.83548.11
61116275-111627548.54648.84
60min11136628-113662849.43149.400.8249.7949.770.80
21132854-113285449.26749.63
31153506-115350650.16550.51
41130869-113086949.18149.56
51126643-112664348.99749.35
61135625-113562549.38849.76
极限11147523-114752349.90549.931.3050.3550.371.27
21136007-113600749.40449.84
31173588-117358851.03951.47
41131373-113137349.20349.67
51146974-114697449.88150.32
61152825-115282550.13650.59
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%
128.275711965743275743445758185745715740510.30
228.325701705744245722970.53
单位质量响应值RSD%判断
20306.0120208.230.35数据可信
加速3月-供试品溶液-2024032521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%
5min1182159-18215914.56414.9814.3814.5614.9814.39
2148873-14887311.90311.90
3209727-20972716.76816.77
4164146-16414613.12413.12
5202673-20267316.20416.20
6216388-21638817.30117.30
10min1383212-38321230.63931.094.7930.6631.114.79
2376681-37668130.11730.14
3373866-37386629.89229.92
4377402-37740230.17430.20
5421443-42144333.69533.72
6400405-40040532.01332.04
15min1534160-53416042.70742.713.7042.7842.793.69
2527805-52780542.19942.27
3499294-49929439.92040.00
4552196-55219644.15044.22
5539119-53911943.10443.19
6552718-55271844.19144.27
20min1581838-58183846.51947.913.8546.6748.063.83
2631530-63153050.49250.63
3569643-56964345.54445.69
4614005-61400549.09149.24
5588776-58877647.07447.23
6609376-60937648.72148.88
30min1649126-64912651.89952.473.4652.1252.703.45
2689678-68967855.14255.37
3624363-62436349.91950.14
4654675-65467552.34352.57
5646786-64678651.71251.95
6673226-67322653.82654.06
45min1665062-66506253.17352.690.7353.4853.000.73
2662639-66263952.98053.30
3652259-65225952.15052.45
4658296-65829652.63252.95
5654971-65497152.36752.69
6660705-66070552.82553.15
60min1666524-66652453.29052.631.0053.6953.041.00
2662062-66206252.93453.34
3647901-64790151.80152.19
4659011-65901152.69053.09
5653967-65396752.28652.69
6660424-66042452.80353.22
极限1665575-66557553.21452.610.8853.7053.100.88
2662573-66257352.97453.47
3650586-65058652.01652.49
4659294-65929452.71253.20
5652331-65233152.15652.65
6657749-65774952.58953.09
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%
128.279901949957379960219961449960319948250.27
228.329885239991949938580.76
单位质量响应值RSD%判断
35190.1335093.860.20数据可信
加速3月-供试品溶液-2024032521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%
5min1311174-31117413.54913.9414.9413.5513.9414.93
2251509-25150910.95110.95
3360869-36086915.71315.71
4279249-27924912.15912.16
5347397-34739715.12615.13
6370788-37078816.14516.14
10min1662738-66273828.85729.174.7728.8829.194.78
2648509-64850928.23828.26
3642180-64218027.96227.99
4650973-65097328.34528.37
5725546-72554631.59231.62
6689202-68920230.01030.04
15min1923609-92360940.21640.183.6140.2940.263.60
2910969-91096939.66639.73
3864574-86457437.64637.72
4953944-95394441.53741.60
5929687-92968740.48140.56
6954347-95434741.55541.63
20min11007333-100733343.86245.063.7044.0045.203.69
21087198-108719847.33947.47
3982096-98209642.76342.90
41058782-105878246.10246.24
51021844-102184444.49444.64
61052398-105239845.82445.97
30min11122084-112208448.85849.423.5349.0749.633.51
21196323-119632352.09152.30
31078378-107837846.95547.16
41132866-113286649.32849.54
51120014-112001448.76848.99
61159925-115992550.50650.73
45min11152586-115258650.18649.720.7050.4850.020.71
21144699-114469949.84350.14
31130752-113075249.23649.52
41141199-114119949.69149.99
51135075-113507549.42449.72
61146925-114692549.94050.25
60min11153804-115380450.23949.640.9850.6250.020.98
21148960-114896050.02850.41
31123214-112321448.90749.27
41136933-113693349.50549.88
51133752-113375249.36649.75
61143898-114389849.80850.20
极限11154844-115484450.28549.620.8950.7450.080.88
21145971-114597149.89850.36
31128278-112827849.12849.58
41138647-113864749.57950.04
51129507-112950749.18149.65
61139691-113969149.62550.10
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%
128.275698365749225748345747455775455743760.49
228.325810975850445830700.48
单位质量响应值RSD%判断
20317.5120588.630.94数据可信
加速3月-供试品溶液-2024032521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%
5min1203334-20333416.10215.578.8516.1015.578.85
2185401-18540114.68214.68
3189524-18952415.00815.01
4172318-17231813.64613.65
5219821-21982117.40817.41
6209318-20931816.57616.58
10min1385454-38545430.52430.914.6430.5530.944.64
2418421-41842133.13533.16
3386774-38677430.62830.65
4382124-38212430.26030.28
5403042-40304231.91731.95
6366233-36623329.00229.03
15min1493163-49316339.05340.595.1839.1340.675.17
2542607-54260742.96943.05
3494660-49466039.17239.25
4533686-53368642.26242.34
5532020-53202042.13042.21
6479523-47952337.97338.05
20min1546255-54625543.25845.235.6343.4045.385.63
2618823-61882349.00449.16
3549325-54932543.50143.64
4598867-59886747.42447.57
5574381-57438145.48545.64
6539255-53925542.70342.84
30min1602165-60216547.68549.613.7547.9049.833.74
2646807-64680751.22051.45
3601737-60173747.65147.87
4657280-65728052.05052.27
5615802-61580248.76548.99
6635284-63528450.30850.52
45min1653516-65351651.75251.881.0152.0552.181.01
2655794-65579451.93252.25
3649929-64992951.46851.76
4666808-66680852.80453.11
5648093-64809351.32251.63
6656731-65673152.00652.30
60min1652255-65225551.65252.230.8252.0352.620.82
2658230-65823052.12552.53
3663140-66314052.51452.89
4667818-66781852.88453.28
5658713-65871352.16352.56
6657064-65706452.03352.41
极限1655693-65569351.92452.310.9552.3952.790.94
2654704-65470451.84652.34
3667484-66748452.85853.32
4666707-66670752.79653.28
5664510-66451052.62253.10
6654434-65443451.82452.29
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%
128.279894789962059963209967009987169954840.36
228.321009788101505610124220.37
单位质量响应值RSD%判断
35213.4435749.361.07数据可信
加速3月-供试品溶液-2024032521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%
5min1349313-34931315.06514.549.1915.0714.549.19
2316606-31660613.65513.65
3324756-32475614.00614.01
4294254-29425412.69112.69
5378438-37843816.32116.32
6360114-36011415.53115.53
10min1666171-66617128.73129.024.7128.7629.054.70
2721764-72176431.12831.15
3665692-66569228.71028.73
4658899-65889928.41728.44
5695026-69502629.97530.00
6629981-62998127.17027.20
15min1852841-85284136.78238.165.3036.8538.235.29
2936562-93656240.39240.47
3853508-85350836.81036.88
4923532-92353239.83039.90
5918325-91832539.60639.68
6824340-82434035.55235.62
20min1944162-94416240.72042.595.5340.8542.725.52
21069974-106997446.14646.29
3951660-95166041.04341.18
41032413-103241344.52644.66
5992381-99238142.80042.94
6933947-93394740.28040.41
30min11037722-103772244.75546.683.8444.9646.893.83
21120069-112006948.30748.53
31039320-103932044.82445.03
41135010-113501048.95149.16
51064318-106431845.90246.12
61098009-109800947.35547.55
45min11131404-113140448.79548.871.0949.0749.161.09
21134731-113473148.93949.24
31122429-112242948.40848.68
41153477-115347749.74750.04
51118871-111887148.25548.55
61138168-113816849.08749.36
60min11129768-112976848.72549.240.8349.0849.610.83
21136006-113600648.99449.37
31146042-114604249.42749.78
41157399-115739949.91750.29
51141381-114138149.22649.60
61140237-114023749.17649.53
极限11136269-113626949.00549.371.1049.4449.811.09
21130208-113020848.74449.21
31156643-115664349.88450.32
41156907-115690749.89550.35
51153999-115399949.77050.22
61133655-113365548.89349.33
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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%
128.275690395737125743715742415730985728920.39
228.325698185714385706280.21
单位质量响应值RSD%判断
20265.0220149.290.41数据可信
加速3月-供试品溶液-2024032621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%
5min1188647-18864715.12015.307.7315.1215.307.73
2200681-20068116.08516.08
3169545-16954513.58913.59
4178309-17830914.29214.29
5207401-20740116.62316.62
6200959-20095916.10716.11
10min1362642-36264229.06632.087.1829.0932.107.18
2442968-44296835.50435.53
3380387-38038730.48830.51
4417118-41711833.43233.46
5409234-40923432.80032.83
6389107-38910731.18731.21
15min1481632-48163238.60341.804.4338.6841.884.43
2548727-54872743.98144.07
3535751-53575142.94143.01
4530208-53020842.49642.58
5516787-51678741.42141.50
6515944-51594441.35341.43
20min1576122-57612246.17647.653.2446.3147.803.23
2612643-61264349.10449.26
3619550-61955049.65749.80
4591847-59184747.43747.59
5571221-57122145.78445.94
6595379-59537947.72047.87
30min1643124-64312451.54751.851.4051.7652.081.40
2652670-65267052.31252.55
3659801-65980152.88353.11
4650552-65055252.14252.37
5640043-64004351.30051.53
6635318-63531850.92151.15
45min1649729-64972952.07653.081.5652.3853.401.55
2651620-65162052.22852.56
3661792-66179253.04353.36
4663782-66378253.20253.52
5675833-67583354.16854.48
6671028-67102853.78354.10
60min1648324-64832451.96352.721.6452.3553.131.63
2650269-65026952.11952.53
3651737-65173752.23752.64
4654962-65496252.49652.90
5675778-67577854.16454.57
6665811-66581153.36553.77
极限1656560-65656052.62452.931.4153.1053.421.40
2654994-65499452.49853.00
3656486-65648652.61853.11
4650844-65084452.16552.66
5675021-67502154.10354.60
6668453-66845353.57754.07
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%
128.279872459953769958759950979940319935250.36
228.329869559926659898100.41
单位质量响应值RSD%判断
35144.1534950.920.39数据可信
加速3月-供试品溶液-2024032621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%
5min1322471-32247114.07914.288.1514.0814.288.15
2344240-34424015.03015.03
3289294-28929412.63112.63
4303411-30341113.24713.25
5356821-35682115.57915.58
6346150-34615015.11315.11
10min1623741-62374127.23330.097.3327.2630.127.33
2763711-76371133.34433.37
3654246-65424628.56428.59
4719500-71950031.41331.44
5706546-70654630.84830.87
6667388-66738829.13829.16
15min1829389-82938936.21139.314.6136.2839.384.60
2950153-95015341.48441.56
3926937-92693740.47040.54
4913778-91377839.89639.97
5892743-89274338.97739.05
6889556-88955638.83838.91
20min1992219-99221943.32044.833.1843.4544.963.17
21053434-105343445.99346.14
31069207-106920746.68246.82
41023741-102374144.69744.84
5987658-98765843.12143.26
61033935-103393545.14245.28
30min11109055-110905548.42148.801.4948.6249.021.49
21129751-112975149.32549.55
31139649-113964949.75749.97
41126562-112656249.18649.40
51105204-110520448.25348.47
61096732-109673247.88348.10
45min11124486-112448649.09550.021.6249.3850.321.61
21128038-112803849.25049.56
31139236-113923649.73950.04
41149793-114979350.20050.50
51170477-117047751.10351.40
61162528-116252850.75651.05
60min11121479-112147948.96449.701.7849.3350.081.77
21121448-112144848.96249.35
31127647-112764749.23349.61
41134568-113456849.53549.92
51171642-117164251.15451.53
61153802-115380250.37550.75
极限11136424-113642449.61649.921.4550.0650.381.44
21132965-113296549.46549.94
31135666-113566649.58350.04
41127841-112784149.24249.71
51170733-117073351.11451.58
61156022-115602250.47250.93
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%
128.275764945767545767535784155766255770080.14
228.325754145777215765680.29
单位质量响应值RSD%判断
20410.6120359.040.18数据可信
加速3月-供试品溶液-2024032621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%
5min1160687-16068712.76716.4124.1112.7716.4124.12
2164517-16451713.07113.07
3279800-27980022.23022.23
4254977-25497720.25820.26
5178369-17836914.17214.17
6201155-20115515.98215.98
10min1351003-35100327.88831.139.3527.9131.169.36
2365445-36544529.03529.06
3453719-45371936.04936.09
4411821-41182132.72032.75
5383604-38360430.47830.50
6385495-38549530.62830.65
15min1488574-48857438.81840.064.4038.8940.144.42
2490421-49042138.96539.03
3547876-54787643.53043.63
4504022-50402240.04540.13
5493911-49391139.24239.32
6500685-50068539.78039.86
20min1564170-56417044.82444.632.0244.9644.782.03
2562399-56239944.68344.82
3580576-58057646.12846.30
4562628-56262844.70244.86
5547362-54736243.48943.63
6553437-55343743.97144.12
30min1613711-61371148.76050.163.2548.9750.383.26
2630867-63086750.12350.33
3660099-66009952.44652.69
4650274-65027451.66551.89
5607333-60733348.25348.47
6625982-62598249.73549.95
45min1661740-66174052.57651.991.6852.8652.301.68
2643019-64301951.08951.38
3660517-66051752.47952.81
4658231-65823152.29752.61
5638287-63828750.71351.01
6664752-66475252.81553.12
60min1668926-66892653.14752.201.3453.5252.591.33
2648219-64821951.50251.88
3657448-65744852.23552.66
4652325-65232551.82852.23
5648980-64898051.56251.94
6665908-66590852.90753.30
极限1659922-65992252.43251.950.9952.9052.420.99
2652335-65233551.82952.29
3660585-66058552.48452.99
4650445-65044551.67952.17
5643587-64358751.13451.60
6655931-65593152.11552.59
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%
128.2710012631002279999669999552100030510006140.12
228.3299857810000119992940.11
单位质量响应值RSD%判断
35394.9135285.810.22数据可信
加速3月-供试品溶液-2024032621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%
5min1274410-27441011.88115.3724.7211.8815.3724.73
2279295-27929512.09312.09
3483185-48318520.92120.92
4441049-44104919.09719.10
5306485-30648513.27013.27
6346033-34603314.98314.98
10min1604498-60449826.17429.229.4826.1929.259.49
2627320-62732027.16227.18
3783130-78313033.90833.94
4709680-70968030.72830.76
5660949-66094928.61828.64
6664235-66423528.76028.79
15min1842425-84242536.47537.654.3136.5437.724.33
2845343-84534336.60236.67
3942651-94265140.81540.91
4869644-86964437.65437.74
5851783-85178336.88136.95
6865312-86531237.46637.54
20min1975923-97592342.25642.002.1742.3842.142.18
2971288-97128842.05542.18
31004664-100466443.50043.66
4971217-97121742.05242.20
5943159-94315940.83740.97
6954322-95432241.32041.46
30min11058021-105802145.81047.223.3646.0047.433.38
21086999-108699947.06547.26
31143880-114388049.52849.76
41122741-112274148.61248.83
51049456-104945645.43945.64
61082302-108230246.86247.07
45min11141696-114169649.43348.951.7749.7049.241.77
21108026-110802647.97548.25
31141373-114137349.41949.73
41138512-113851249.29549.59
51103116-110311647.76348.04
61151117-115111749.84150.12
60min11158341-115834150.15449.261.4650.5149.631.46
21119849-111984948.48748.84
31138290-113829049.28649.68
41130974-113097448.96949.35
51122453-112245348.60048.95
61156463-115646350.07350.44
极限11144311-114431149.54649.061.0249.9849.511.02
21134043-113404349.10249.54
31143204-114320449.49849.98
41127980-112798048.83949.30
51113063-111306348.19348.63
61135757-113575749.17649.62
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