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0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.075815685825275826775825225820315822650.08
228.185816415807095811750.12
单位质量响应值RSD%判断
20743.3220623.670.41数据可信
供试品溶液-SDR304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%
5min1137495-13749511.6069.4927.9711.619.4927.99
2135866-13586611.46911.47
387965-879657.4257.43
460831-608315.1355.13
5117967-1179679.9589.96
6134098-13409811.32011.32
10min1374124-37412431.58128.0411.9231.6028.0611.92
2360843-36084330.46030.48
3364169-36416930.74130.75
4286062-28606224.14724.16
5288032-28803224.31424.33
6319806-31980626.99627.01
15min1482705-48270540.74738.515.7040.8238.575.71
2461572-46157238.96339.03
3480698-48069840.57740.64
4428909-42890936.20636.25
5420702-42070235.51335.57
6462570-46257039.04739.11
20min1588035-58803549.63845.826.0549.7845.946.05
2523692-52369244.20744.34
3554933-55493346.84446.97
4538783-53878345.48045.59
5492258-49225841.55341.67
6558996-55899647.18747.32
30min1602848-60284850.88848.545.3051.1148.745.29
2544726-54472645.98246.19
3578249-57824948.81249.02
4588731-58873149.69749.88
5531370-53137044.85545.04
6604036-60403650.98951.20
45min1608539-60853951.36949.254.9451.6849.544.94
2554465-55446546.80447.09
3587237-58723749.57149.86
4596803-59680350.37850.65
5542193-54219345.76846.03
6611483-61148351.61751.91
60min1611241-61124151.59749.224.5151.9949.594.51
2556644-55664446.98847.35
3585539-58553949.42749.80
4598809-59880950.54750.90
5545708-54570846.06546.40
6600853-60085350.72051.10
极限1612898-61289851.73750.922.0252.2251.372.03
2587511-58751149.59450.04
3614961-61496151.91152.37
4605439-60543951.10751.54
5588754-58875449.69950.11
6609857-60985751.48051.94
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0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.071007107100760510080381008169100727110076380.05
228.181006895100566010062780.09
单位质量响应值RSD%判断
35897.3335708.940.38数据可信
供试品溶液-SDR304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%
5min1237044-23704410.9218.7929.3910.928.8029.35
2234920-23492010.82310.82
3147493-1474936.7956.80
499308-993084.5754.58
5199380-1993809.1869.19
6227162-22716210.46610.47
10min1650215-65021529.95726.4712.3229.9726.4912.32
2625759-62575928.83028.85
3631762-63176229.10729.12
4493376-49337622.73122.74
5495238-49523822.81722.83
6551161-55116125.39325.41
15min1839997-83999738.70036.475.8838.7736.545.90
2802666-80266636.98137.05
3834526-83452638.44838.51
4743201-74320134.24134.29
5727759-72775933.52933.58
6801975-80197536.94937.01
20min11031087-103108747.50443.586.4247.6443.706.43
2910221-91022141.93642.06
3965276-96527644.47244.60
4939170-93917043.27043.37
5853545-85354539.32539.43
6976720-97672045.00045.12
30min11057672-105767248.72946.235.7148.9446.425.71
2946503-94650343.60743.80
31006819-100681946.38646.58
41028610-102861047.39047.56
5922594-92259442.50642.68
61058601-105860148.77248.97
45min11065050-106505049.06946.825.3549.3647.095.34
2960713-96071344.26244.53
31020166-102016647.00147.28
41046827-104682748.23048.48
5939250-93925043.27343.52
61065412-106541249.08649.36
60min11068943-106894349.24846.805.0549.6247.155.05
2963721-96372144.40144.74
31019427-101942746.96747.32
41046066-104606648.19448.53
5943458-94345843.46743.78
61053698-105369848.54648.91
极限11074598-107459849.50948.672.2949.9749.102.31
21023217-102321747.14247.56
31077881-107788149.66050.09
41064456-106445649.04249.46
51028675-102867547.39347.78
61070095-107009549.30249.74
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0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.075835135830945831135831895828995831620.04
228.185810625817675814140.09
单位质量响应值RSD%判断
20775.2820632.150.49数据可信
供试品溶液-SDR304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%
5min172440-724406.1098.5659.486.118.5659.49
2173953-17395314.67014.67
3146278-14627812.33612.34
460973-609735.1425.14
517078-170781.4401.44
6138256-13825611.65911.66
10min1293036-29303624.71226.1917.7224.7226.2117.74
2360480-36048030.40030.42
3350608-35060829.56729.59
4335848-33584828.32228.33
5210092-21009217.71717.72
6313587-31358726.44526.46
15min1424790-42479035.82337.009.3935.8737.069.41
2476308-47630840.16840.24
3456615-45661538.50738.58
4483066-48306640.73740.79
5374445-37444531.57731.61
6417303-41730335.19235.26
20min1509143-50914342.93743.046.1443.0543.166.16
2535203-53520345.13445.28
3529062-52906244.61644.75
4541807-54180745.69145.81
5462773-46277339.02639.11
6484399-48439940.85040.97
30min1560741-56074147.28846.573.9347.4746.763.95
2569189-56918948.00048.22
3562479-56247947.43447.64
4571218-57121848.17148.37
5521566-52156643.98444.13
6528152-52815244.54044.73
45min1562794-56279447.46147.742.3647.7248.012.37
2575376-57537648.52248.82
3569054-56905447.98948.28
4581684-58168449.05449.33
5564975-56497547.64547.87
6542860-54286045.78046.04
60min1570500-57050048.11148.132.2048.4548.482.21
2580258-58025848.93449.31
3570497-57049748.11148.48
4584735-58473549.31149.67
5570133-57013348.08048.38
6548350-54835046.24346.58
极限1590201-59020149.77250.351.0950.1950.781.11
2605818-60581851.08951.55
3599861-59986150.58751.03
4598470-59847050.47050.91
5599443-59944350.55250.93
6588670-58867049.64350.06
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0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.071008763100805210080461008559100851910083880.04
228.181005778100693610063570.09
单位质量响应值RSD%判断
35924.0535711.750.42数据可信
供试品溶液-SDR304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%
5min1121786-1217865.6097.9760.945.617.9760.90
2300545-30054513.84113.84
3250396-25039611.53211.53
4100459-1004594.6264.63
527257-272571.2551.26
6238308-23830810.97510.97
10min1506181-50618123.31124.7317.9523.3224.7417.97
2624293-62429328.75128.77
3607211-60721127.96427.98
4581756-58175626.79226.80
5361166-36116616.63316.63
6541287-54128724.92824.95
15min1737178-73717833.94935.069.4834.0035.119.49
2826641-82664138.06938.14
3792614-79261436.50236.57
4839238-83923838.65038.70
5649164-64916429.89629.93
6722350-72235033.26733.33
20min1883652-88365240.69540.806.3640.8040.926.38
2932990-93299042.96743.10
3918625-91862542.30642.43
4941564-94156443.36243.48
5801707-80170736.92137.00
6837376-83737638.56438.68
30min1974976-97497644.90144.204.1045.0744.384.12
2990319-99031945.60745.81
3976947-97694744.99245.19
4995608-99560845.85146.04
5903663-90366341.61741.76
6917096-91709642.23542.41
45min1980162-98016245.14045.322.5345.3945.582.54
21002359-100235946.16246.44
3987689-98768945.48645.76
41010720-101072046.54746.81
5984480-98448045.33845.55
6939158-93915843.25143.50
60min1989409-98940945.56545.582.3045.8945.912.31
21006832-100683246.36846.73
3989163-98916345.55445.90
41013616-101361646.68047.02
5990815-99081545.63045.92
6948226-94822643.66943.99
极限11032720-103272047.56048.091.0947.9648.501.10
21059549-105954948.79649.23
31050422-105042248.37548.80
41043448-104344848.05448.47
51049422-104942248.32948.69
61029772-102977247.42447.82
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0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.075806995811745813825803605801485807530.10
228.185807225812705809960.07
单位质量响应值RSD%判断
20689.4520617.320.25数据可信
供试品溶液-TXF22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%
5min1129486-12948610.94611.9713.3610.9511.9713.36
2157559-15755913.31913.32
3163575-16357513.82813.83
4111813-1118139.4529.45
5141520-14152011.96411.96
6145434-14543412.29412.29
10min1328202-32820227.74529.494.6127.7629.514.60
2357395-35739530.21330.23
3354970-35497030.00830.03
4373053-37305331.53631.55
5338819-33881928.64228.66
6340656-34065628.79828.82
15min1456617-45661738.60041.496.0838.6641.566.08
2528050-52805044.63944.71
3488642-48864241.30841.38
4525782-52578244.44744.52
5475844-47584440.22640.29
6469742-46974239.71039.78
20min1537792-53779245.46347.754.9145.5947.894.91
2588882-58888249.78249.93
3574481-57448148.56448.71
4601595-60159550.85651.00
5552376-55237646.69646.83
6534267-53426745.16545.30
30min1575607-57560748.65949.863.8148.8650.083.81
2598931-59893150.63150.86
3592038-59203850.04850.27
4623666-62366652.72252.95
5591618-59161850.01350.23
6556906-55690647.07847.29
45min1579890-57989049.02150.003.2749.3150.303.27
2599203-59920350.65450.97
3595464-59546450.33850.64
4617082-61708252.16652.48
5596619-59661950.43650.73
6560305-56030547.36647.65
60min1578767-57876748.92750.524.4949.2950.904.48
2601777-60177750.87251.27
3594671-59467150.27150.66
4645142-64514254.53854.94
5598195-59819550.56950.95
6566878-56687847.92148.29
极限1602102-60210250.89950.811.4851.3551.281.50
2599578-59957850.68651.17
3598839-59883950.62351.10
4615638-61563852.04352.54
5601975-60197550.88851.35
6587981-58798149.70550.15
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0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.071004752100616410062361004395100438010051850.10
228.181004941100601110054760.08
单位质量响应值RSD%判断
35809.9435680.480.26数据可信
供试品溶液-TXF22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%
5min1219822-21982210.14411.1313.8510.1411.1313.84
2269193-26919312.42212.42
3281080-28108012.97112.97
4189116-1891168.7278.73
5241136-24113611.12811.13
6247288-24728811.41111.41
10min1566934-56693426.16227.884.7526.1827.894.75
2619394-61939428.58328.60
3615401-61540128.39928.42
4646946-64694629.85429.87
5586745-58674527.07627.09
6589015-58901527.18127.20
15min1792105-79210536.55339.406.3336.6139.476.32
2920776-92077642.49142.56
3849345-84934539.19439.26
4917850-91785042.35642.42
5827656-82765638.19338.26
6815504-81550437.63337.70
20min1934760-93476043.13645.505.2743.2645.635.26
21030215-103021547.54147.68
31004197-100419746.34046.47
41055008-105500848.68548.82
5962551-96255144.41844.55
6929169-92916942.87843.01
30min11002943-100294346.28247.584.4246.4847.784.41
21046661-104666148.30048.52
31034584-103458447.74347.95
41103455-110345550.92151.14
51031043-103104347.57947.78
6967309-96730944.63844.84
45min11009591-100959146.58947.583.4246.8647.863.42
21046426-104642648.28948.59
31038802-103880247.93748.23
41078473-107847349.76850.07
51037666-103766647.88548.17
6975041-97504144.99545.27
60min11008941-100894146.55948.064.8446.9148.424.83
21049756-104975648.44348.82
31036869-103686947.84848.22
41131115-113111552.19752.58
51039472-103947247.96848.33
6982280-98228045.32945.68
极限11049048-104904848.41048.421.5048.8448.861.51
21047512-104751248.33948.80
31044139-104413948.18348.63
41075774-107577449.64350.11
51051976-105197648.54548.99
61026980-102698047.39247.82
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0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.075835245835075836005837005833655835390.03
228.185826995830385828680.05
单位质量响应值RSD%判断
20788.7120683.750.36数据可信
供试品溶液-TXF22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%
5min1119506-11950610.06213.2018.9310.0613.2118.93
2159805-15980513.45513.46
3198178-19817816.68616.69
4177520-17752014.94714.95
5158394-15839413.33713.34
6127507-12750710.73610.74
10min1312211-31221126.28829.857.9026.3029.877.91
2334941-33494128.20128.22
3380051-38005132.00032.03
4371061-37106131.24331.27
5346685-34668529.19029.21
6381959-38195932.16032.18
15min1471845-47184539.72941.224.1139.7941.294.12
2467526-46752639.36539.43
3519121-51912143.70943.79
4487969-48796941.08641.16
5483544-48354440.71440.78
6507160-50716042.70242.77
20min1535753-53575345.11046.784.6945.2446.924.69
2537191-53719145.23145.37
3583608-58360849.13949.29
4550983-55098346.39246.54
5533614-53361444.92945.07
6592567-59256749.89350.04
30min1567756-56775647.80448.774.1048.0148.994.09
2562606-56260647.37147.58
3585969-58596949.33849.57
4578218-57821848.68548.91
5558122-55812246.99347.21
6622957-62295752.45252.68
45min1572769-57276948.22649.404.2148.5149.704.21
2567807-56780747.80848.10
3604477-60447750.89651.21
4584457-58445749.21049.51
5563392-56339247.43747.73
6627017-62701752.79453.11
60min1571809-57180948.14549.174.0248.5149.554.02
2567277-56727747.76448.13
3588071-58807149.51549.92
4585541-58554149.30249.69
5563700-56370047.46347.83
6627394-62739452.82653.23
极限1594635-59463550.06750.222.8550.5150.692.85
2583995-58399549.17149.62
3592691-59269149.90450.39
4590432-59043249.71350.18
5587060-58706049.42949.88
6630244-63024453.06653.55
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0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.071008496100835210084961008769100839410085010.02
228.181008688100880810087480.01
单位质量响应值RSD%判断
35928.0735796.590.26数据可信
供试品溶液-TXF22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%
5min1202421-2024219.31112.3319.499.3112.3319.50
2272803-27280312.54812.55
3341052-34105215.68715.69
4304866-30486614.02314.02
5270561-27056112.44512.44
6216839-2168399.9749.97
10min1538509-53850924.76928.208.1224.7828.228.13
2577872-57787226.58026.60
3657807-65780730.25630.28
4642677-64267729.56029.58
5598810-59881027.54327.56
6663171-66317130.50330.52
15min1820483-82048337.73939.214.4537.8039.284.45
2812309-81230937.36337.43
3911497-91149741.92542.00
4848714-84871439.03739.11
5839491-83949138.61338.68
6881965-88196540.56740.63
20min1931689-93168942.85444.565.0242.9744.695.01
2933737-93373742.94843.08
31021741-102174146.99647.14
4963420-96342044.31344.45
5926028-92602842.59342.72
61035953-103595347.65047.78
30min1986694-98669445.38446.474.5945.5746.674.59
2977888-97788844.97945.18
31027004-102700447.23847.46
41008014-100801446.36446.58
5967543-96754344.50344.70
61094119-109411950.32550.54
45min1993214-99321445.68446.964.7045.9547.254.70
2984154-98415445.26745.54
31052304-105230448.40248.71
41018993-101899346.86947.16
5976471-97647144.91445.19
61101008-110100850.64250.94
60min1992060-99206045.63146.734.4145.9747.094.41
2984233-98423345.27145.62
31027060-102706047.24147.62
41018330-101833046.83947.21
5975866-97586644.88645.24
61097886-109788650.49850.88
极限11037019-103701947.69947.883.0748.1248.323.08
21015707-101570746.71847.14
31034079-103407947.56348.03
41031348-103134847.43847.88
51023490-102349047.07647.50
61104236-110423650.79051.26
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0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.075815495816435815665816585814915815810.02
228.185832635837915835270.07
单位质量响应值RSD%判断
20718.9520707.130.05数据可信
供试品溶液-TAWW4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%
5min1133937-13393711.29013.5022.1911.2913.5022.18
2151546-15154612.77412.77
3142911-14291112.04612.05
4125594-12559410.58710.59
5191173-19117316.11416.11
6215827-21582718.19318.19
10min1306796-30679625.86029.299.5325.8829.319.53
2375017-37501731.61131.63
3319075-31907526.89526.92
4347046-34704629.25329.27
5342292-34229228.85328.88
6394697-39469733.27033.30
15min1432777-43277736.48040.315.4836.5440.385.48
2469047-46904739.53739.61
3473478-47347839.91039.98
4500173-50017342.16142.23
5503162-50316242.41342.49
6490315-49031541.33041.42
20min1497293-49729341.91846.146.3042.0446.286.29
2524444-52444444.20644.35
3579118-57911848.81548.95
4587147-58714749.49249.63
5560749-56074947.26747.41
6535580-53558045.14545.30
30min1535815-53581545.16548.465.2645.3648.675.25
2554925-55492546.77646.99
3612275-61227551.61051.82
4596117-59611750.24850.47
5594933-59493350.14850.37
6555039-55503946.78547.02
45min1544505-54450545.89748.884.9146.1749.184.89
2560879-56087947.27847.57
3616192-61619251.94052.24
4597039-59703950.32650.63
5600537-60053750.62150.93
6560171-56017147.21847.53
60min1545997-54599746.02348.904.6746.3749.284.66
2559869-55986947.19347.56
3610075-61007551.42451.81
4600932-60093250.65451.04
5601222-60122250.67851.07
6562550-56255047.41947.81
极限1577201-57720148.65349.772.5349.0750.232.54
2581880-58188049.04849.50
3607131-60713151.17651.65
4600775-60077550.64151.11
5603062-60306250.83351.31
6572617-57261748.26748.73
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0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.071008495100856910083801008554100799810083990.03
228.181009812101080610103090.07
单位质量响应值RSD%判断
35924.4435851.990.15数据可信
供试品溶液-TAWW4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%
5min1227265-22726510.44612.5622.9410.4512.5622.94
2257490-25749011.83511.83
3243390-24339011.18711.19
4211715-2117159.7319.73
5328446-32844615.09615.10
6371007-37100717.05217.05
10min1528963-52896324.31327.679.5124.3327.699.51
2648541-64854129.80929.83
3559134-55913425.69925.72
4599852-59985227.57127.59
5590159-59015927.12527.15
6684894-68489431.48031.51
15min1752750-75275034.59838.165.5434.6638.225.54
2811307-81130737.29037.36
3821150-82115037.74237.80
4873572-87357240.15240.21
5874001-87400140.17140.24
6848359-84835938.99339.07
20min1862361-86236139.63643.746.6539.7543.876.63
2908296-90829641.74841.88
31011410-101141046.48746.61
41025050-102505047.11447.24
5975819-97581944.85144.99
6927098-92709842.61242.76
30min1928862-92886242.69345.945.6242.8746.145.61
2961035-96103544.17244.37
31069218-106921849.14449.35
41040189-104018947.81048.02
51035735-103573547.60547.82
6961572-96157244.19644.41
45min1941691-94169143.28346.285.2743.5446.565.25
2970404-97040444.60244.88
31074770-107477049.39949.68
41040828-104082847.83948.13
51043656-104365647.96948.26
6970194-97019444.59344.88
60min1943943-94394343.38646.295.0743.7146.645.06
2968636-96863644.52144.87
31065922-106592248.99349.36
41046272-104627248.08948.46
51044388-104438848.00348.37
6973343-97334344.73745.10
极限11005971-100597146.23747.332.6846.6347.762.69
21011638-101163846.49846.92
31064860-106486048.94449.39
41046530-104653048.10148.55
51050501-105050148.28448.74
6998863-99886345.91046.35
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0.5142
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.075811345807105807355802745807555807220.06
228.185830195830995830590.01
单位质量响应值RSD%判断
20688.3520690.530.01数据可信
供试品溶液-TAWW4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%
5min197500-975008.22813.7420.638.2313.7420.62
2178956-17895615.10215.10
3161636-16163613.64013.64
4179077-17907715.11215.11
5191346-19134616.14716.15
6168259-16825914.19914.20
10min1316679-31667926.72431.218.5226.7431.238.53
2380293-38029332.09232.12
3390958-39095832.99233.01
4356445-35644530.08030.10
5407174-40717434.36134.39
6367426-36742631.00631.03
15min1477197-47719740.27044.175.6840.3344.255.69
2528163-52816344.57144.65
3545085-54508545.99946.08
4514271-51427143.39843.47
5563254-56325447.53247.62
6512807-51280743.27543.35
20min1589479-58947949.74550.261.9949.8750.402.00
2597642-59764250.43450.59
3601737-60173750.78050.93
4605757-60575751.11951.27
5604110-60411050.98051.14
6574515-57451548.48248.63
30min1598211-59821150.48251.091.2350.6951.321.23
2602909-60290950.87851.12
3600781-60078150.69950.94
4617831-61783152.13852.37
5610623-61062351.52951.78
6601914-60191450.79451.02
45min1625955-62595552.82351.551.3853.1251.871.36
2606349-60634951.16951.49
3609610-60961051.44451.77
4614008-61400851.81552.13
5608017-60801751.30951.64
6601518-60151850.76151.07
60min1625441-62544152.78051.511.6953.1651.911.66
2606961-60696151.22051.63
3607904-60790451.30051.71
4620417-62041752.35652.76
5601012-60101250.71851.14
6600627-60062750.68651.08
极限1618176-61817652.16751.571.1752.6452.061.15
2599901-59990150.62551.12
3608430-60843051.34451.84
4619421-61942152.27252.77
5610696-61069651.53652.04
6609803-60980351.46051.94
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0.4858
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
128.071006229100551310057801004966100561410056200.05
228.181009807100962010097140.02
单位质量响应值RSD%判断
35825.4435830.870.02数据可信
供试品溶液-TAWW4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%
5min1163704-1637047.53712.7821.117.5412.7821.10
2305286-30528614.05514.06
3275713-27571312.69412.69
4306518-30651814.11214.11
5327604-32760415.08315.08
6286705-28670513.20013.20
10min1546063-54606325.14129.428.6525.1529.448.66
2658069-65806930.29730.32
3677533-67753331.19331.21
4614504-61450428.29228.32
5703371-70337132.38332.41
6634018-63401829.19029.21
15min1828190-82819038.13041.905.8138.1841.975.83
2918772-91877242.30042.37
3950112-95011243.74343.82
4893302-89330241.12741.20
5980084-98008445.12345.20
6889793-88979340.96641.04
20min11029138-102913847.38147.812.0747.5047.952.08
21041483-104148347.94948.09
31050460-105046048.36348.51
41056445-105644548.63848.78
51053706-105370648.51248.67
6999696-99969646.02646.16
30min11064504-106450449.00948.781.1049.2149.001.09
21053676-105367648.51148.74
31052325-105232548.44948.68
41077999-107799949.63149.85
51063782-106378248.97649.21
61045250-104525048.12348.34
45min11096593-109659350.48749.081.6550.7749.381.63
21054978-105497848.57148.88
31062810-106281048.93149.24
41075853-107585349.53249.83
51058390-105839048.72849.04
61048091-104809148.25448.55
60min11093466-109346650.34349.051.6850.7149.441.66
21056185-105618548.62649.01
31059447-105944748.77749.17
41080389-108038949.74150.13
51057772-105777248.69949.10
61045543-104554348.13648.51
极限11090747-109074750.21849.191.3750.6649.661.35
21050389-105038948.35948.83
31061449-106144948.86949.34
41080736-108073649.75750.23
51064627-106462749.01549.49
61062959-106295948.93849.39
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