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%
1 28.135658065660995674085670825646815662150.20
2 28.055670665661685666170.12
单位质量响应值RSD%判断
20128.5120200.250.26数据可信
长期24月-供试品溶液-2024032421批-缬沙坦-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%
5min1153143-15314312.30014.4815.5512.3014.4815.55
2153269-15326912.31112.31
3172382-17238213.84613.85
4174044-17404413.97913.98
5219241-21924117.60917.61
6209254-20925416.80716.81
10min1324109-32410926.03230.6512.6326.0530.6812.64
2345904-34590427.78327.80
3394347-39434731.67431.70
4353769-35376928.41528.44
5446374-44637435.85335.88
6425138-42513834.14734.18
15min1444408-44440835.69540.799.5335.7640.879.53
2480947-48094738.63038.70
3559689-55968944.95445.03
4470745-47074537.81037.88
5545848-54584843.84343.93
6545704-54570443.83143.92
20min1515729-51572941.42345.907.1841.5546.057.18
2553335-55333544.44444.58
3616947-61694749.55349.70
4539593-53959343.34043.47
5606739-60673948.73348.90
6596583-59658347.91848.08
30min1572404-57240445.97649.775.1046.1749.995.12
2617397-61739749.58949.79
3645296-64529651.83052.06
4592471-59247147.58747.79
5650452-65045252.24452.49
6639807-63980751.38951.63
45min1604687-60468748.56950.792.9648.8451.102.99
2633068-63306850.84851.14
3646096-64609651.89552.21
4615760-61576049.45849.74
5653153-65315352.46152.79
6641613-64161351.53451.86
60min1619576-61957649.76451.201.8950.1151.581.93
2634759-63475950.98451.36
3642780-64278051.62852.03
4630071-63007150.60750.98
5654137-65413752.54052.96
6643210-64321051.66352.07
极限1641119-64111951.49551.820.9151.9352.300.92
2640956-64095651.48251.94
3643780-64378051.70852.20
4653552-65355252.49352.95
5651635-65163552.33952.84
6640288-64028851.42851.92
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%
1 28.139753569754399778639770809728419757160.20
2 28.059764189755779759980.07
单位质量响应值RSD%判断
34685.9634794.940.23数据可信
长期24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%
5min1258383-25838311.38113.4616.1911.3813.4616.21
2257524-25752411.34311.34
3291972-29197212.86012.86
4293829-29382912.94212.94
5374817-37481716.50916.51
6356343-35634315.69515.70
10min1552268-55226824.32528.7412.9124.3428.7612.91
2590815-59081526.02326.04
3674279-67427929.69929.72
4603318-60331826.57426.60
5766298-76629833.75233.78
6728477-72847732.08632.11
15min1760013-76001333.47538.329.7333.5338.409.74
2822243-82224336.21636.28
3962389-96238942.38942.46
4804656-80465635.44235.51
5935889-93588941.22241.31
6935522-93552241.20641.29
20min1883021-88302138.89343.177.4539.0143.307.45
2947031-94703141.71341.84
31060497-106049746.71046.85
4920452-92045240.54240.67
51043255-104325545.95146.10
61025898-102589845.18645.33
30min1982272-98227243.26546.855.2143.4447.055.24
21057788-105778846.59146.78
31109487-110948748.86849.09
41014850-101485044.70044.89
51117465-111746549.22049.45
61099644-109964448.43548.66
45min11035995-103599545.63147.843.1245.8848.133.15
21085298-108529847.80348.07
31112572-111257249.00449.30
41057073-105707346.56046.83
51122987-112298749.46349.77
61103511-110351148.60548.91
60min11061719-106171946.76448.232.0547.0948.592.09
21088071-108807147.92548.27
31106527-110652748.73849.12
41081249-108124947.62447.97
51124870-112487049.54649.94
61107008-110700848.75949.14
极限11103223-110322348.59248.941.0149.0049.391.02
21101758-110175848.52848.96
31108190-110819048.81149.27
41126883-112688349.63450.06
51123673-112367349.49349.97
61103336-110333648.59749.06
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%
1 28.135663865676045672355691755681785677160.19
2 28.055672605678225675410.08
单位质量响应值RSD%判断
20181.8720233.190.18数据可信
长期24月-供试品溶液-2024032521批-缬沙坦-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%
5min1232464-23246418.63214.9015.1718.6314.9015.17
2166011-16601113.30613.31
3176230-17623014.12514.12
4158736-15873612.72212.72
5207243-20724316.61016.61
6174862-17486214.01514.01
10min1395260-39526031.67928.966.1731.7128.996.17
2326706-32670626.18526.21
3364785-36478529.23729.26
4353885-35388528.36328.38
5369020-36902029.57629.60
6358611-35861128.74228.77
15min1496365-49636539.78338.734.8539.8738.814.84
2446288-44628835.76935.84
3499465-49946540.03140.10
4508375-50837540.74540.81
5483367-48336738.74138.82
6465730-46573037.32837.40
20min1549895-54989544.07344.346.3744.2244.486.35
2509444-50944440.83140.96
3581627-58162746.61746.76
4604675-60467548.46448.60
5548166-54816643.93544.08
6525170-52517042.09242.23
30min1602066-60206648.25548.415.0048.4848.634.99
2571247-57124745.78545.98
3641680-64168051.43051.65
4638805-63880551.19951.42
5593302-59330247.55247.77
6577099-57709946.25446.46
45min1626009-62600950.17449.833.0550.4850.123.06
2594220-59422047.62647.90
3647211-64721151.87352.18
4635171-63517150.90851.21
5619252-61925249.63249.93
6608373-60837348.76049.04
60min1632351-63235150.68250.502.0651.0750.872.07
2609422-60942248.84449.19
3647462-64746251.89352.28
4638398-63839851.16751.55
5628293-62829350.35750.73
6624467-62446750.05050.41
极限1645879-64587951.76651.630.8152.2452.090.81
2640645-64064551.34751.78
3648546-64854651.98052.46
4636191-63619150.99051.46
5643684-64368451.59052.05
6650256-65025652.11752.56
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0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 28.139759639797799791319809069800329791620.20
2 28.059779059790019784530.08
单位质量响应值RSD%判断
34808.4634882.460.16数据可信
长期24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%
5min1398044-39804417.47913.8715.7217.4813.8715.72
2280543-28054312.31912.32
3298897-29889713.12513.13
4268252-26825211.78011.78
5353105-35310515.50615.51
6296552-29655213.02213.02
10min1677001-67700129.72927.156.2329.7627.186.23
2558488-55848824.52524.55
3624344-62434427.41727.44
4606049-60604926.61326.63
5631174-63117427.71727.74
6612887-61288726.91426.94
15min1849536-84953637.30636.374.8837.3836.444.87
2764242-76424233.56033.62
3855889-85588937.58537.65
4872508-87250838.31438.38
5828196-82819636.36836.44
6798823-79882335.07935.15
20min1941947-94194741.36441.656.4641.5041.786.45
2872556-87255638.31638.43
3998208-99820843.83443.96
41037989-103798945.58145.71
5940958-94095841.32041.45
6899531-89953139.50139.63
30min11029503-102950345.20845.435.1445.4245.635.13
2977260-97726042.91443.10
31099964-109996448.30348.51
41097730-109773048.20548.41
51014477-101447744.54944.75
6988480-98848043.40743.60
45min11070374-107037447.00346.813.1247.2947.083.13
21017662-101766244.68844.94
31109805-110980548.73549.02
41092538-109253847.97748.26
51062673-106267346.66546.94
61042842-104284245.79446.06
60min11083826-108382647.59447.442.1547.9647.802.16
21044983-104498345.88846.22
31111838-111183848.82449.19
41096971-109697148.17148.54
51075485-107548547.22847.58
61069381-106938146.96047.30
极限11109200-110920048.70848.700.8349.1549.130.82
21102752-110275248.42548.83
31117593-111759349.07749.52
41095595-109559548.11148.56
51108527-110852748.67949.11
61120160-112016049.18949.61
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%
1 28.135672225679455683455657335673245673140.18
2 28.055666025654895660460.14
单位质量响应值RSD%判断
20167.5820179.890.05数据可信
长期24月-供试品溶液-2024032621批-缬沙坦-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%
5min1209794-20979416.84314.4921.8316.8414.4821.83
2172155-17215513.82113.82
3172734-17273413.86813.87
4242741-24274119.48819.49
5139870-13987011.22911.23
6145272-14527211.66311.66
10min1363259-36325929.16328.949.0829.1928.969.08
2374299-37429930.05030.07
3370248-37024829.72429.75
4406332-40633232.62132.65
5311492-31149225.00725.03
6336930-33693027.05027.07
15min1463265-46326537.19239.015.1737.2739.085.18
2494283-49428339.68239.76
3501453-50145340.25840.33
4515277-51527741.36841.45
5448275-44827535.98936.05
6493124-49312439.58939.65
20min1511800-51180041.08944.425.7341.2344.565.72
2550256-55025644.17644.32
3561588-56158845.08645.23
4577997-57799746.40346.56
5523589-52358942.03542.16
6594797-59479747.75247.88
30min1557935-55793544.79248.325.5345.0048.535.52
2580284-58028446.58746.80
3618688-61868849.67049.88
4625345-62534550.20450.44
5582974-58297446.80346.99
6645904-64590451.85552.06
45min1588416-58841647.24049.843.5247.5250.133.51
2607288-60728848.75549.05
3634441-63444150.93551.23
4633552-63355250.86351.18
5612956-61295649.21049.48
6647897-64789752.01552.31
60min1608747-60874748.87250.682.3449.2351.052.35
2620910-62091049.84850.22
3643087-64308751.62952.01
4638382-63838251.25151.65
5628490-62849050.45750.81
6647778-64777852.00552.39
极限1634940-63494050.97551.730.8551.4252.190.85
2649480-64948052.14252.60
3648851-64885152.09152.56
4641329-64132951.48851.97
5646508-64650851.90352.34
6645035-64503551.78552.25
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%
1 28.139763609776599780009761429754289767180.12
2 28.059774479747439760950.20
单位质量响应值RSD%判断
34721.5834798.400.16数据可信
长期24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%
5min1357053-35705315.71813.4422.7215.7213.4422.71
2290711-29071112.79712.80
3292064-29206412.85712.86
4415125-41512518.27418.27
5234025-23402510.30210.30
6243252-24325210.70810.71
10min1621810-62181027.37327.109.2527.4027.139.25
2639386-63938628.14628.17
3632694-63269427.85227.87
4695677-69567730.62430.65
5531169-53116923.38323.40
6573598-57359825.25025.27
15min1792884-79288434.90336.605.1934.9836.675.19
2847883-84788337.32537.39
3857701-85770137.75737.82
4881476-88147638.80338.88
5766438-76643833.73933.80
6842802-84280237.10137.16
20min1875761-87576138.55241.735.8238.6841.865.82
2941946-94194641.46541.60
3962906-96290642.38842.52
4989096-98909643.54143.69
5896331-89633139.45739.57
61021366-102136644.96145.08
30min1953660-95366041.98145.365.6442.1845.565.63
2992181-99218143.67743.88
31058628-105862846.60246.80
41071057-107105747.14947.37
5998831-99883143.96944.15
61108350-110835048.79148.99
45min11007567-100756744.35446.843.5844.6247.123.58
21040728-104072845.81446.09
31087431-108743147.87048.15
41083969-108396947.71748.01
51051609-105160946.29346.54
61113046-111304648.99749.28
60min11042294-104229445.88347.582.3446.2247.932.35
21062398-106239846.76847.12
31098237-109823748.34548.70
41093026-109302648.11648.49
51077851-107785147.44847.78
61111005-111100548.90749.27
极限11092055-109205548.07348.800.8948.4949.230.88
21118349-111834949.23149.66
31117240-111724049.18249.62
41103238-110323848.56649.02
51110577-111057748.88949.30
61109599-110959948.84649.29
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0.47699
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 28.135702615689405687905708645684985694710.19
2 28.055721925710905716410.14
单位质量响应值RSD%判断
20244.2620379.360.48数据可信
长期24月-供试品溶液-TAWW4批-缬沙坦-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%
5min1184096-18409614.67913.5312.1114.6813.5312.11
2145573-14557311.60811.61
3173580-17358013.84113.84
4142861-14286111.39111.39
5180715-18071514.41014.41
6191237-19123715.24915.25
10min1339333-33933327.05829.186.5927.0829.216.58
2367676-36767629.31829.34
3406542-40654232.41732.44
4351130-35113027.99828.02
5352938-35293828.14228.17
6378434-37843430.17530.20
15min1462035-46203536.84239.567.7536.9139.637.74
2489020-48902038.99339.06
3568166-56816645.30445.38
4487921-48792138.90638.97
5466714-46671437.21537.29
6503060-50306040.11340.19
20min1528789-52878942.16444.196.5242.3044.336.51
2535528-53552842.70242.83
3622678-62267849.65149.80
4556577-55657744.38044.51
5525536-52553641.90542.04
6556122-55612244.34444.49
30min1597331-59733147.63047.754.1447.8347.964.14
2572922-57292245.68445.89
3622301-62230149.62149.86
4631753-63175350.37550.58
5571281-57128145.55345.76
6597402-59740247.63547.85
45min1621493-62149349.55649.262.0649.8449.552.07
2601868-60186847.99248.27
3622385-62238549.62849.95
4637201-63720150.80951.10
5605781-60578148.30448.58
6617686-61768649.25349.55
60min1625839-62583949.90349.661.5550.2750.031.54
2609950-60995048.63649.00
3619474-61947449.39549.80
4638587-63858750.91951.29
5617673-61767349.25249.61
6624874-62487449.82650.20
极限1633755-63375550.53450.101.4650.9850.561.44
2618454-61845449.31449.76
3617998-61799849.27849.76
4640829-64082951.09851.56
5626184-62618449.93150.37
6632936-63293650.46950.93
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0.45065
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 28.139813589808689788519812239800629804720.11
2 28.059831569840019835780.07
单位质量响应值RSD%判断
34855.0335065.170.43数据可信
长期24月-供试品溶液-TAWW4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%
5min1312052-31205213.65812.5312.6213.6612.5312.61
2244156-24415610.68710.69
3293232-29323212.83512.83
4238927-23892710.45810.46
5305718-30571813.38113.38
6323908-32390814.17714.18
10min1577855-57785525.29227.356.7125.3227.376.70
2627812-62781227.47927.50
3695377-69537730.43630.46
4599613-59961326.24526.26
5602361-60236126.36526.39
6645816-64581628.26728.29
15min1789342-78934234.54937.197.8634.6137.267.86
2838628-83862836.70636.77
3974527-97452742.65442.73
4835958-83595836.58936.65
5798820-79882034.96435.03
6861304-86130437.69937.77
20min1902343-90234339.49541.526.7539.6241.656.75
2915377-91537740.06540.19
31070450-107045046.85347.00
4952966-95296641.71141.83
5899916-89991639.38939.51
6951141-95114141.63141.76
30min11022001-102200144.73244.884.3944.9245.074.39
2978815-97881542.84243.03
31071076-107107646.88047.10
41082948-108294847.40047.59
5975112-97511242.68042.87
61021772-102177244.72244.93
45min11065266-106526646.62646.372.1146.8946.642.11
21030448-103044845.10245.36
31069627-106962746.81747.12
41093066-109306647.84348.11
51040026-104002645.52145.78
61057964-105796446.30646.58
60min11074155-107415547.01546.751.6447.3647.101.64
21044681-104468145.72546.06
31063993-106399346.57046.95
41096336-109633647.98648.34
51057759-105775946.29746.63
61071883-107188346.91647.27
极限11091327-109132747.76747.311.4848.1947.741.46
21062463-106246346.50346.92
31062626-106262646.51046.97
41101257-110125748.20148.63
51078188-107818847.19147.61
61089193-108919347.67348.11
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