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%
128.035616185653675677275684905683755663150.52
227.975726275732365729320.08
单位质量响应值RSD%判断
20203.8920483.800.98数据可信
加速6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%
5min1146982-14698211.70215.0321.3411.7015.0321.34
2242635-24263519.31719.32
3165319-16531913.16213.16
4169644-16964413.50613.51
5171971-17197113.69113.69
6236412-23641218.82218.82
10min1342911-34291127.30129.776.3727.3229.796.37
2410750-41075032.70232.73
3359685-35968528.63628.66
4376063-37606329.94029.96
5364947-36494729.05529.08
6388899-38889930.96230.99
15min1498555-49855539.69240.543.5839.7640.613.59
2531819-53181942.34142.43
3482949-48294938.45038.52
4510292-51029240.62740.70
5504424-50442440.16040.23
6527022-52702241.95942.04
20min1595228-59522847.38946.954.3247.5247.094.32
2617276-61727649.14449.30
3541215-54121543.08943.22
4592713-59271347.18947.33
5597827-59782747.59647.73
6593694-59369447.26747.42
30min1647602-64760251.55950.823.8451.7751.053.84
2648988-64898851.66951.91
3588521-58852146.85547.06
4645329-64532951.37851.60
5651111-65111151.83852.06
6648751-64875151.65051.88
45min1656699-65669952.28351.722.8452.5852.032.84
2651988-65198851.90852.23
3612860-61286048.79349.08
4660719-66071952.60352.91
5653481-65348152.02752.33
6662110-66211052.71453.03
60min1676101-67610153.82852.342.2554.2152.732.25
2654000-65400052.06852.48
3631375-63137550.26750.63
4662852-66285252.77353.17
5658442-65844252.42252.81
6661816-66181652.69153.10
极限1663698-66369852.84052.600.7353.3153.080.72
2654584-65458452.11552.61
3658414-65841452.42052.87
4662979-66297952.78353.26
5657108-65710852.31652.79
6667332-66733253.13053.62
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%
128.039730159820199833219837689833039810850.47
227.979918799927139922960.06
单位质量响应值RSD%判断
35001.2535477.150.96数据可信
加速6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%
5min1249985-24998510.85514.0321.9610.8614.0321.95
2418404-41840418.16918.17
3280572-28057212.18412.18
4289842-28984212.58612.59
5293213-29321312.73312.73
6406225-40622517.64017.64
10min1589981-58998125.61927.876.3125.6427.906.31
2704733-70473330.60230.63
3617993-61799326.83626.86
4644423-64442327.98428.00
5625699-62569927.17027.19
6668370-66837029.02329.05
15min1859889-85988937.34038.083.5737.4038.143.58
2914436-91443639.70939.79
3831255-83125536.09736.16
4879581-87958138.19538.26
5867426-86742637.66737.73
6908545-90854539.45339.53
20min11027702-102770244.62744.154.4344.7544.284.43
21064137-106413746.20946.36
3930480-93048040.40540.53
41020433-102043344.31144.44
51030768-103076844.76044.89
61026226-102622644.56344.71
30min11117581-111758148.53047.753.8448.7347.963.84
21114430-111443048.39348.62
31013765-101376544.02244.21
41111783-111178348.27848.48
51121304-112130448.69248.90
61118793-111879348.58348.80
45min11132201-113220149.16548.622.9449.4448.912.94
21120893-112089348.67448.98
31054779-105477945.80346.07
41140126-114012649.50949.79
51126958-112695848.93749.22
61143149-114314949.64049.94
60min11167938-116793850.71749.192.3751.0849.562.36
21123619-112361948.79249.18
31087075-108707547.20547.55
41142435-114243549.60949.98
51133949-113394949.24149.61
61141358-114135849.56349.94
极限11153381-115338150.08549.620.8350.5350.070.83
21130868-113086849.10749.57
31137785-113778549.40749.83
41144486-114448649.69850.15
51135851-113585149.32349.77
61153540-115354050.09250.56
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%
128.035705885716925723345710055703265711890.15
227.975702875714965708920.15
单位质量响应值RSD%判断
20377.7720410.870.12数据可信
加速6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%
5min1207314-20731416.46413.5914.0516.4613.5914.03
2164913-16491313.09613.10
3193668-19366815.38015.38
4160992-16099212.78512.79
5153465-15346512.18712.19
6146303-14630311.61911.62
10min1362812-36281228.81228.415.7728.8428.445.76
2361181-36118128.68328.70
3381954-38195430.33330.36
4374625-37462529.75129.77
5332284-33228426.38826.41
6333898-33389826.51626.54
15min1476902-47690237.87339.107.4637.9539.177.44
2526001-52600141.77241.84
3517999-51799941.13741.21
4528921-52892142.00442.07
5459529-45952936.49336.56
6444556-44455635.30435.37
20min1539455-53945542.84045.348.7942.9845.478.78
2614131-61413148.77148.91
3618599-61859949.12649.27
4615003-61500348.84048.98
5527052-52705241.85541.98
6511115-51111540.59040.71
30min1603162-60316247.90049.365.8248.1149.575.83
2648726-64872651.51851.74
3657074-65707452.18152.41
4653032-65303251.86052.08
5596211-59621147.34847.54
6570860-57086045.33445.52
45min1648871-64887151.53050.803.4251.8251.103.43
2654742-65474251.99652.30
3651307-65130751.72352.04
4654189-65418951.95252.26
5629822-62982250.01750.29
6599274-59927447.59147.86
60min1647412-64741251.41451.152.3251.7951.532.34
2654518-65451851.97852.37
3651336-65133651.72552.13
4655493-65549352.05652.45
5639933-63993350.82051.18
6616007-61600748.92049.26
极限1653915-65391551.93052.010.2752.3952.480.30
2656590-65659052.14352.62
3655457-65545752.05352.54
4657191-65719152.19052.67
5653874-65387451.92752.37
6652792-65279251.84152.27
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%
128.039876259903999900849882619874799887700.14
227.979879259893419886330.11
单位质量响应值RSD%判断
35275.4235346.190.15数据可信
加速6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%
5min1356186-35618615.43512.6714.5915.4412.6714.60
2281762-28176212.21012.21
3332528-33252814.41014.41
4274759-27475911.90611.91
5260748-26074811.29911.30
6247942-24794210.74410.74
10min1623073-62307327.00026.615.8727.0326.635.87
2620633-62063326.89526.91
3656536-65653628.45028.47
4642198-64219827.82927.85
5568941-56894124.65524.67
6572510-57251024.80924.83
15min1819447-81944735.51036.697.6735.5836.757.66
2908144-90814439.35439.42
3889863-88986338.56138.63
4911233-91123339.48839.55
5789294-78929434.20334.26
6761911-76191133.01733.08
20min1926554-92655440.15142.589.0040.2842.718.99
21060538-106053845.95846.09
31064545-106454546.13146.27
41061290-106129045.99046.12
5903504-90350439.15339.27
6879334-87933438.10538.22
30min11036625-103662544.92146.386.0145.1246.576.02
21118888-111888848.48648.69
31132118-113211849.05949.27
41127700-112770048.86849.08
51025231-102523144.42844.61
6980640-98064042.49542.67
45min11115588-111558848.34347.773.4948.6148.043.51
21128438-112843848.90049.19
31124481-112448148.72849.02
41130120-113012048.97349.26
51083567-108356746.95547.21
61032133-103213344.72744.98
60min11115772-111577248.35148.132.4548.7048.482.47
21129576-112957648.94949.32
31125064-112506448.75449.13
41132152-113215249.06149.43
51101256-110125647.72248.06
61060220-106022045.94446.27
极限11130302-113030248.98149.040.2049.4149.470.24
21133034-113303449.09949.55
31133099-113309949.10249.56
41134140-113414049.14749.60
51130677-113067748.99749.41
61128435-112843548.90049.30
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%
128.035722895740605733105733425721565730310.14
227.975670375681305675840.14
单位质量响应值RSD%判断
20443.4920292.600.53数据可信
加速6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%
5min1138648-13864811.02512.8314.5011.0212.8314.51
2201326-20132616.00916.01
3153738-15373812.22512.22
4142894-14289411.36311.36
5156185-15618512.41912.42
6175317-17531713.94113.94
10min1339587-33958727.00328.025.5627.0228.045.56
2377861-37786130.04730.07
3363574-36357428.91128.93
4325213-32521325.86025.88
5343040-34304027.27827.30
6364690-36469028.99929.02
15min1500138-50013839.77039.192.3939.8339.262.39
2488800-48880038.86838.95
3509962-50996240.55140.62
4474800-47480037.75537.82
5490921-49092139.03739.10
6492439-49243939.15839.23
20min1628692-62869249.99246.724.6150.1246.864.59
2563002-56300244.76944.91
3610995-61099548.58548.72
4578140-57814045.97246.10
5583681-58368146.41346.54
6560877-56087744.60044.74
30min1666228-66622852.97751.112.0953.1951.322.08
2643877-64387751.20051.42
3641358-64135850.99951.22
4633256-63325650.35550.56
5644481-64448151.24851.46
6626965-62696549.85550.07
45min1671483-67148353.39551.771.8653.7052.061.86
2651955-65195551.84252.14
3642240-64224051.07051.37
4635897-63589750.56550.85
5651893-65189351.83752.13
6652490-65249051.88552.18
60min1667804-66780453.10251.841.6653.4952.221.66
2656419-65641952.19752.58
3640663-64066350.94451.33
4638952-63895250.80851.18
5655932-65593252.15852.54
6651695-65169551.82152.20
极限1661151-66115152.57351.981.1953.0552.451.19
2663293-66329352.74453.22
3646899-64689951.44051.91
4643634-64363451.18051.63
5652296-65229651.86952.34
6654792-65479252.06852.53
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%
128.039904109929519922419912699902349914210.12
227.979809149835019822080.19
单位质量响应值RSD%判断
35370.0035116.480.51数据可信
加速6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%
5min1234898-23489810.19911.9114.8810.2011.9014.88
2344397-34439714.95314.95
3261339-26133911.34711.35
4241917-24191710.50410.50
5264846-26484611.49911.50
6297810-29781012.93012.93
10min1582320-58232025.28326.235.5925.3026.255.59
2646240-64624028.05828.08
3624563-62456327.11727.14
4556961-55696124.18224.20
5587830-58783025.52225.54
6627063-62706327.22627.25
15min1860973-86097337.38236.772.4737.4436.832.47
2839333-83933336.44236.51
3877354-87735438.09338.16
4815873-81587335.42335.48
5841780-84178036.54836.61
6845981-84598136.73136.80
20min11084831-108483147.10143.944.7347.2244.064.71
2965864-96586441.93642.07
31052091-105209145.67945.81
4998262-99826243.34243.46
51005226-100522643.64543.77
6965689-96568941.92842.06
30min11150683-115068349.96048.112.1850.1648.312.18
21108624-110862448.13448.34
31106085-110608548.02448.23
41091146-109114647.37547.56
51111728-111172848.26948.46
61079950-107995046.88947.09
45min11157201-115720150.24348.741.8550.5349.021.85
21121822-112182248.70748.99
31108823-110882348.14348.43
41095588-109558847.56847.84
51126562-112656248.91349.19
61126078-112607848.89249.17
60min11157315-115731550.24848.841.7750.6249.201.78
21128321-112832148.98949.35
31106197-110619748.02948.39
41101743-110174347.83548.18
51130619-113061949.08949.45
61125252-112525248.85649.21
极限11144794-114479449.70449.071.2950.1649.511.29
21148233-114823349.85450.30
31117129-111712948.50348.95
41112009-111200948.28148.71
51126292-112629248.90149.34
61132247-113224749.16049.60
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%
128.035694525711865713705726725734205716200.27
227.975728445744885736660.21
单位质量响应值RSD%判断
20393.1520510.050.41数据可信
长期6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%
5min1208874-20887416.54114.8611.7416.5414.8611.74
2156041-15604112.35712.36
3173800-17380013.76413.76
4210722-21072216.68816.69
5199501-19950115.79915.80
6177130-17713014.02714.03
10min1385068-38506830.49429.134.3730.5229.164.38
2343464-34346427.20027.22
3368298-36829829.16629.19
4381129-38112930.18330.21
5374627-37462729.66829.69
6354513-35451328.07528.10
15min1477840-47784037.84138.494.9137.9238.564.89
2473843-47384337.52537.59
3531909-53190942.12342.19
4488343-48834338.67338.75
5464180-46418036.76036.84
6479996-47999638.01238.08
20min1529986-52998641.97143.445.9942.1143.585.98
2542269-54226942.94443.07
3607603-60760348.11848.26
4554370-55437043.90244.04
5510068-51006840.39440.53
6547012-54701243.31943.45
30min1576878-57687845.68447.194.7545.9047.404.74
2600050-60005047.51947.72
3639211-63921150.62150.84
4596633-59663347.24947.46
5555552-55555243.99644.20
6606660-60666048.04348.25
45min1609091-60909148.23549.312.4548.5249.602.45
2625375-62537549.52549.80
3637743-63774350.50450.81
4631000-63100049.97050.26
5599226-59922647.45447.73
6633810-63381050.19350.48
60min1628254-62825449.75350.161.3850.1250.531.39
2633710-63371050.18550.55
3636172-63617250.38050.77
4640694-64069450.73851.12
5618954-61895449.01749.37
6642677-64267750.89551.26
极限1644022-64402251.00251.220.9551.4551.670.94
2645762-64576251.14051.58
3638890-63889050.59551.07
4654041-65404151.79552.26
5643726-64372650.97851.42
6654177-65417751.80652.26
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%
128.039858529887659894029905579905449890240.20
227.979919989943009931490.17
单位质量响应值RSD%判断
35284.4835507.650.45数据可信
长期6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%
5min1358193-35819315.48513.8612.0915.4813.8612.08
2264896-26489611.45211.45
3295954-29595412.79412.79
4360696-36069615.59315.59
5341493-34149314.76314.76
6302242-30224213.06613.07
10min1661890-66189028.61427.314.4828.6427.344.48
2589309-58930925.47625.50
3633792-63379227.39927.42
4654603-65460328.29928.32
5644211-64421127.84927.87
6607246-60724626.25126.27
15min1821378-82137835.50836.194.9635.5836.254.94
2815209-81520935.24235.30
3917314-91731439.65639.72
4840358-84035836.32936.40
5800737-80073734.61634.69
6827351-82735135.76735.83
20min1912354-91235439.44140.795.8739.5740.925.86
2933219-93321940.34340.46
31044524-104452445.15545.29
4950467-95046741.08941.22
5880464-88046438.06338.19
6940472-94047240.65740.78
30min1996221-99622143.06744.364.8643.2744.564.85
21032916-103291644.65344.84
31103908-110390847.72247.93
41027427-102742744.41644.62
5954255-95425541.25341.44
61041907-104190745.04245.23
45min11049790-104979045.38346.412.4945.6546.682.49
21076704-107670446.54646.81
31100373-110037347.56947.86
41087618-108761847.01847.29
51033003-103300344.65744.92
61094379-109437947.31047.58
60min11082435-108243546.79447.181.4247.1447.531.43
21091846-109184647.20147.54
31098503-109850347.48947.86
41104192-110419247.73448.09
51065353-106535346.05546.39
61106409-110640947.83048.18
极限11112233-111223348.08248.320.9748.5148.750.96
21116505-111650548.26748.68
31104198-110419847.73548.18
41131253-113125348.90449.34
51112331-111233148.08648.50
61130183-113018348.85849.28
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)900取样体积(ml)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%
128.035748735756755771675762175759175759700.15
227.975773015784565778780.15
单位质量响应值RSD%判断
20548.3420660.640.39数据可信
长期6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%
5min1199605-19960515.69015.0519.3915.6915.0619.38
2162379-16237912.76412.76
3148911-14891111.70511.71
4251311-25131119.75419.75
5210509-21050916.54716.55
6176432-17643213.86813.87
10min1391773-39177330.79530.528.4030.8230.548.40
2344503-34450327.08027.10
3359870-35987028.28828.31
4408377-40837732.10032.13
5434895-43489534.18534.21
6390318-39031830.68130.70
15min1520346-52034640.90240.063.2340.9840.143.23
2489207-48920738.45438.52
3516392-51639240.59140.66
4489863-48986338.50638.59
5528934-52893441.57741.66
6513365-51336540.35340.43
20min1591156-59115646.46845.673.3546.6145.813.34
2581091-58109145.67745.81
3587760-58776046.20146.34
4542621-54262142.65342.80
5596396-59639646.88047.03
6586630-58663046.11246.25
30min1634909-63490949.90749.552.4550.1349.772.44
2627949-62794949.36049.57
3633108-63310849.76549.98
4601197-60119747.25747.48
5642857-64285750.53250.76
6642428-64242850.49850.72
45min1639855-63985550.29650.630.7050.6050.940.70
2646635-64663550.82951.12
3637704-63770450.12750.42
4644228-64422850.63950.94
5647580-64758050.90351.22
6648881-64888151.00551.31
60min1645746-64574650.75951.080.7451.1551.460.75
2647327-64732750.88351.26
3644725-64472550.67851.06
4653084-65308451.33651.72
5657241-65724151.66252.06
6650645-65064551.14451.53
极限1643688-64368850.59751.020.8651.0751.490.86
2652682-65268251.30451.76
3641757-64175750.44550.91
4652963-65296351.32651.80
5655595-65559551.53352.02
6647894-64789450.92851.40
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%
128.039914469961019952379954509953059947080.19
227.979975039988529981780.10
单位质量响应值RSD%判断
35487.2635687.450.40数据可信
长期6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%
5min1343236-34323614.75814.0920.1014.7614.0920.11
2275278-27527811.83611.84
3251694-25169410.82210.82
4432963-43296318.61618.62
5361423-36142315.54015.54
6301347-30134712.95712.96
10min1672705-67270528.92528.718.5528.9528.738.56
2589851-58985125.36225.38
3619308-61930826.62926.65
4702356-70235630.20030.23
5749165-74916532.21232.24
6672314-67231428.90828.93
15min1896988-89698838.56837.733.3938.6437.803.38
2838744-83874436.06436.13
3889628-88962838.25238.31
4843766-84376636.28036.36
5912206-91220639.22339.30
6883964-88396438.00838.08
20min11021867-102186743.93843.053.4444.0843.183.43
2998407-99840742.92943.05
31013970-101397043.59843.72
4934178-93417840.16840.31
51028716-102871644.23244.38
61010153-101015343.43443.57
30min11094370-109437047.05546.712.5047.2746.922.49
21078842-107884246.38846.58
31092205-109220546.96247.16
41035808-103580844.53744.75
51107907-110790747.63747.86
61108669-110866947.67047.88
45min11103481-110348147.44747.780.7047.7448.070.71
21113057-111305747.85948.13
31101262-110126247.35247.63
41110571-111057147.75248.04
51119148-111914848.12148.42
61119954-111995448.15548.44
60min11114927-111492747.93948.240.6748.3148.600.67
21117831-111783148.06448.41
31114738-111473847.93148.29
41127953-112795348.49948.86
51132999-113299948.71649.09
61123420-112342048.30548.67
极限11112373-111237347.83048.260.8748.2848.710.86
21127953-112795348.49948.93
31110182-111018247.73548.17
41129621-112962148.57149.01
51133887-113388748.75549.21
61120873-112087348.19548.64
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%
128.035720815713225715685720405739505721920.19
227.975719135747715733420.36
单位质量响应值RSD%判断
20413.5620498.460.30数据可信
长期6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%
5min1156623-15662312.40113.8720.2012.4013.8720.19
2139540-13954011.04811.05
3193090-19309015.28815.29
4228286-22828618.07518.07
5140723-14072311.14211.14
6192851-19285115.26915.27
10min1369176-36917629.23028.8910.4629.2528.9210.47
2312517-31251724.74424.76
3392257-39225731.05731.08
4413981-41398132.77732.81
5328926-32892626.04326.06
6372771-37277129.51429.54
15min1507824-50782440.20738.155.1440.2838.235.15
2449377-44937735.57935.64
3501247-50124739.68639.76
4495399-49539939.22339.31
5454114-45411435.95536.02
6483413-48341338.27438.35
20min1573596-57359645.41542.923.7145.5543.063.71
2529249-52924941.90342.02
3559190-55919044.27444.42
4531074-53107442.04842.20
5521364-52136441.27941.40
6538053-53805342.60042.74
30min1613133-61313348.54546.763.2948.7646.973.28
2597441-59744147.30247.49
3609140-60914048.22948.45
4571211-57121145.22645.45
5566354-56635444.84145.03
6586320-58632046.42246.63
45min1634228-63422850.21549.591.9450.5149.881.94
2633428-63342850.15250.42
3639148-63914850.60550.90
4611663-61166348.42848.72
5611013-61101348.37748.64
6628781-62878149.78450.07
60min1646408-64640851.17950.561.5551.5650.921.55
2642606-64260650.87851.23
3647180-64718051.24151.62
4624229-62422949.42349.80
5628026-62802649.72450.07
6642853-64285350.89851.27
极限1651898-65189851.61451.590.7952.0852.040.79
2651508-65150851.58352.02
3656405-65640551.97152.44
4642053-64205350.83551.29
5651862-65186251.61152.04
6655594-65559451.90752.36
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%
128.039876629894679887619903879929769898510.21
227.979893979924069909020.22
单位质量响应值RSD%判断
35313.9935427.310.23数据可信
长期6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%
5min1265396-26539611.48112.9020.8811.4812.9020.88
2235174-23517410.17410.17
3329310-32931014.24614.25
4391627-39162716.94216.94
5237788-23778810.28710.29
6329174-32917414.24014.24
10min1631779-63177927.33127.0610.6627.3527.0810.67
2532928-53292823.05523.07
3673068-67306829.11829.14
4711347-71134730.77430.80
5564137-56413724.40524.42
6639864-63986427.68127.70
15min1871783-87178337.71435.775.2337.7835.845.24
2771268-77126833.36633.42
3861535-86153537.27137.34
4851021-85102136.81636.90
5777336-77733633.62833.69
6828491-82849135.84135.91
20min1985967-98596742.65440.323.6842.7840.453.68
2912938-91293839.49539.61
3961072-96107241.57741.71
4911472-91147239.43139.57
5896410-89641038.78038.89
6924288-92428839.98640.12
30min11055308-105530845.65443.933.3245.8544.123.31
21027901-102790144.46844.64
31046150-104615045.25745.46
4981369-98136942.45542.66
5973422-97342242.11142.29
61008833-100883343.64343.84
45min11090836-109083647.19146.651.9147.4746.921.91
21090879-109087947.19247.44
31100458-110045847.60747.89
41053639-105363945.58145.86
51052022-105202245.51145.76
61082076-108207646.81247.08
60min11110959-111095948.06147.551.4548.4147.891.44
21105681-110568147.83348.16
31113059-111305948.15248.51
41075425-107542546.52446.88
51082772-108277246.84247.17
61106517-110651747.86948.22
极限11125768-112576848.70248.740.8649.1449.170.85
21126679-112667948.74149.15
31138789-113878949.26549.70
41109891-110989148.01548.45
51126841-112684148.74849.15
61132454-113245448.99149.42
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