沙库巴曲缬沙坦片项目信息
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125
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%
128.011143519114811611476951147563114521611464220.18
227.701139615114026911399420.05
单位质量响应值RSD%判断
40929.0341153.140.39数据可信
供试品溶液-2024032721批-缬沙坦-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min193761-9376115.95521.7218.1915.9621.7218.18
2156385-15638526.61226.61
3106217-10621718.07518.07
4138116-13811623.50323.50
5132289-13228922.51122.51
6138940-13894023.64323.64
10min1419656-41965671.41268.8110.9971.4468.8410.99
2431362-43136273.40473.45
3326038-32603855.48155.51
4424356-42435672.21172.25
5378797-37879764.45964.50
6445832-44583275.86675.91
15min1621052-621052105.682106.385.53105.83106.535.53
2661459-661459112.558112.73
3561012-56101295.46695.59
4640477-640477108.988109.15
5625144-625144106.379106.52
6641654-641654109.188109.35
20min1813185-813185138.377133.736.38138.70134.066.38
2789653-789653134.373134.73
3690685-690685117.532117.81
4835941-835941142.249142.59
5800827-800827136.274136.60
6785097-785097133.597133.95
30min1919219-919219156.421153.955.30156.97154.505.30
2905270-905270154.047154.63
3818891-818891139.348139.83
4966588-966588164.481165.06
5912234-912234155.232155.78
6906112-906112154.190154.76
45min1972308-972308165.455164.294.74166.27165.104.75
2974124-974124165.764166.60
3887629-887629151.045151.75
41028265-1028265174.977175.83
5952300-952300162.050162.86
6978167-978167166.452167.28
60min11009095-1009095171.715171.534.80172.80172.614.80
21033223-1033223175.820176.93
3932403-932403158.664159.63
41076008-1076008183.101184.24
5982624-982624167.210168.29
61014608-1014608172.653173.76
极限11229870-1229870209.283206.042.74210.66207.412.72
21247905-1247905212.352213.76
31228009-1228009208.966210.19
41215496-1215496206.837208.29
51157926-1157926197.041198.40
61185816-1185816201.787203.18
沙库巴曲缬沙坦片项目信息
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125
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%
128.011977987197770119787941980799197730919785180.08
227.701972519197454519735320.08
单位质量响应值RSD%判断
70636.1371246.640.61数据可信
供试品溶液-2024032721批-沙库巴曲-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1112901-11290110.50114.6019.1110.5014.6019.12
2194269-19426918.06918.07
3129611-12961112.05512.05
4170154-17015415.82615.83
5164155-16415515.26815.27
6170628-17062815.87015.87
10min1554177-55417751.54348.8210.9851.5648.8410.98
2554229-55422951.54851.58
3421401-42140139.19439.21
4558205-55820551.91851.94
5491952-49195245.75645.78
6569331-56933152.95352.98
15min1837583-83758377.90377.985.7478.0178.095.75
2886116-88611682.41782.53
3748047-74804769.57569.66
4867578-86757880.69280.81
5836833-83683377.83377.93
6854477-85447779.47479.59
20min11121653-1121653104.324100.276.91104.56100.516.91
21074977-107497799.982100.24
3943829-94382987.78487.99
41162640-1162640108.136108.38
51099836-1099836102.295102.53
61065516-106551699.10299.35
30min11314353-1314353122.246118.845.94122.65119.245.94
21273106-1273106118.410118.83
31144045-1144045106.406106.75
41374765-1374765127.865128.29
51287261-1287261119.727120.13
61272581-1272581118.361118.77
45min11427787-1427787132.797131.215.26133.41131.815.26
21424455-1424455132.487133.10
31287946-1287946119.790120.32
41515768-1515768140.980141.62
51384460-1384460128.767129.37
61423935-1423935132.439133.05
60min11516844-1516844141.080140.175.47141.91140.995.48
21546854-1546854143.871144.71
31387781-1387781129.076129.80
41627621-1627621151.383152.26
51448205-1448205134.696135.51
61515252-1515252140.932141.76
极限11949272-1949272181.300177.723.00182.37178.782.99
21982837-1982837184.421185.50
31910340-1910340177.679178.62
41930968-1930968179.597180.73
51825829-1825829169.818170.86
61865584-1865584173.516174.58
沙库巴曲缬沙坦片项目信息
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125
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%
128.011158133114702011436941146230114511811480390.51
227.701136418114042011384190.25
单位质量响应值RSD%判断
40986.7541098.160.20数据可信
供试品溶液-2024032821批-缬沙坦-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1161388-16138827.46220.3722.7627.4620.3722.76
2129257-12925721.99421.99
3117100-11710019.92619.93
4127343-12734321.66921.67
5102280-10228017.40417.40
680829-8082913.75413.75
10min1411538-41153870.02759.5617.5970.0759.5917.60
2403616-40361668.67968.72
3375872-37587263.95863.99
4360178-36017861.28861.32
5281708-28170847.93547.96
6267230-26723045.47245.49
15min1550509-55050993.67592.8812.8693.8493.0112.86
2635771-635771108.183108.33
3600561-600561102.192102.33
4558969-55896995.11495.25
5472625-47262580.42280.53
6456601-45660177.69577.79
20min1645152-645152109.779116.3210.56110.10116.6110.56
2790109-790109134.445134.78
3735041-735041125.075125.38
4705333-705333120.020120.32
5620199-620199105.533105.78
6605715-605715103.069103.30
30min1749026-749026127.454145.637.44127.96146.117.43
2925333-925333157.455158.01
3892526-892526151.872152.39
4888023-888023151.106151.60
5863727-863727146.972147.39
6816473-816473138.931139.33
45min1810097-810097137.846157.106.87138.56157.836.86
2982238-982238167.138167.96
3962075-962075163.707164.48
4932989-932989158.758159.51
5959218-959218163.221163.88
6893031-893031151.958152.59
60min1896125-896125152.485166.655.35153.43167.645.34
21020860-1020860173.710174.81
31021348-1021348173.793174.84
4968586-968586164.815165.83
51024002-1024002174.244175.18
6945176-945176160.831161.72
极限11167198-1167198198.611200.421.23199.81201.681.24
21184323-1184323201.525202.91
31185916-1185916201.796203.13
41175630-1175630200.045201.33
51196993-1196993203.681204.91
61156808-1156808196.843198.00
沙库巴曲缬沙坦片项目信息
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125
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%
128.011970328198155419801351983285198532519801250.30
227.701969809196645319681310.13
单位质量响应值RSD%判断
70693.5071051.660.36数据可信
供试品溶液-2024032821批-沙库巴曲-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1202673-20267318.86813.6424.9318.8713.6424.94
2159595-15959514.85814.86
3143760-14376013.38413.38
4156364-15636414.55714.56
5121078-12107811.27211.27
695586-955868.8998.90
10min1537593-53759350.04942.0118.8950.0842.0318.90
2522754-52275448.66748.69
3489747-48974745.59445.62
4464336-46433643.22943.25
5353814-35381432.93932.96
6338973-33897331.55831.57
15min1732980-73298068.23967.4513.9368.3567.5413.94
2853208-85320879.43279.54
3807051-80705175.13575.23
4738022-73802268.70868.80
5615454-61545457.29857.37
6600404-60040455.89655.96
20min1878723-87872381.80786.4011.4682.0486.6111.47
21083202-1083202100.844101.08
31008304-100830493.87194.09
4955644-95564488.96989.18
5825890-82589076.88977.06
6816698-81669876.03376.19
30min11047470-104747097.517111.587.8897.88111.937.87
21312383-1312383122.180122.59
31264945-1264945117.764118.14
41232107-1232107114.707115.07
51192219-1192219110.993111.29
61142253-1142253106.342106.63
45min11160476-1160476108.038124.537.69108.57125.077.67
21443966-1443966134.430135.04
31413542-1413542131.598132.17
41340665-1340665124.813125.36
51379958-1379958128.471128.95
61287313-1287313119.846120.31
60min11304482-1304482121.445134.866.28122.15135.616.27
21532593-1532593142.681143.52
31533392-1533392142.756143.55
41425838-1425838132.743133.50
51501285-1501285139.767140.46
61394201-1394201129.797130.46
极限11839541-1839541171.258172.411.70172.17173.381.72
21880883-1880883175.107176.18
31877103-1877103174.755175.79
41836663-1836663170.990171.97
51875467-1875467174.602175.53
61801748-1801748167.739168.62
沙库巴曲缬沙坦片项目信息
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125
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%
128.011143812114891311426641142363114068011436860.28
227.701140534114153111410320.07
单位质量响应值RSD%判断
40831.3541192.490.63数据可信
供试品溶液-2024032921批-缬沙坦-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min189891-8989115.30819.2322.2315.3119.2322.24
2112316-11231619.12619.13
3142925-14292524.33924.34
4125316-12531621.34021.34
5129900-12990022.12122.12
677178-7717813.14313.14
10min1410935-41093569.97860.2618.0070.0060.3017.99
2337493-33749357.47257.50
3317367-31736754.04454.08
4415802-41580270.80770.84
5389461-38946166.32166.36
6252306-25230642.96542.99
15min1655623-655623111.64698.7212.53111.7998.8512.54
2587827-587827100.101100.23
3533828-53382890.90691.04
4633743-633743107.920108.07
5608610-608610103.640103.79
6458518-45851878.08178.17
20min1782522-782522133.256127.975.41133.58128.265.42
2778159-778159132.513132.81
3739799-739799125.980126.26
4745558-745558126.961127.29
5784199-784199133.541133.86
6678537-678537115.548115.77
30min1911456-911456155.212155.342.87155.76155.852.86
2937432-937432159.635160.15
3925244-925244157.560158.05
4868891-868891147.963148.51
5934013-934013159.053159.60
6896176-896176152.610153.03
45min1990895-990895168.739169.411.97169.55170.181.97
21015321-1015321172.899173.68
3998163-998163169.977170.73
4965975-965975164.496165.29
51016661-1016661173.127173.93
6982059-982059167.235167.91
60min11040056-1040056177.111179.172.16178.20180.222.16
21087674-1087674185.220186.29
31042610-1042610177.546178.58
41043791-1043791177.747178.81
51071548-1071548182.474183.57
61027210-1027210174.923175.87
极限11219169-1219169207.612206.521.47209.00207.871.48
21238676-1238676210.934212.31
31218642-1218642207.522208.86
41197801-1197801203.973205.34
51213937-1213937206.721208.12
61188237-1188237202.345203.59
沙库巴曲缬沙坦片项目信息
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125
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%
128.011994193198232919785801981719197474819823140.37
227.701976593197390519752490.10
单位质量响应值RSD%判断
70771.6571308.630.54数据可信
供试品溶液-2024032921批-沙库巴曲-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1125842-12584211.68814.6022.6311.6914.6022.62
2169188-16918815.71415.71
3202477-20247718.80618.81
4165427-16542715.36515.36
5175558-17555816.30616.31
6104836-1048369.7379.74
10min1553824-55382451.43943.5019.2751.4643.5319.27
2449086-44908641.71141.74
3415479-41547938.58938.62
4552613-55261351.32651.35
5515644-51564447.89347.92
6323717-32371730.06730.08
15min1892141-89214182.86172.3113.8182.9772.4013.81
2790024-79002473.37773.47
3707192-70719265.68365.78
4857583-85758379.65279.76
5822821-82282176.42376.53
6601222-60122255.84155.91
20min11086457-1086457100.90995.396.46101.1595.616.47
21057757-105775798.24498.46
31001092-100109292.98193.19
41023818-102381895.09195.34
51082929-1082929100.582100.82
6910068-91006884.52684.69
30min11298558-1298558120.609119.123.06121.02119.503.07
21318645-1318645122.475122.86
31289640-1289640119.781120.14
41227465-1227465114.006114.41
51319304-1319304122.536122.94
61241544-1241544115.314115.61
45min11455250-1455250135.162134.162.27135.77134.732.28
21478466-1478466137.319137.90
31435408-1435408133.320133.88
41414566-1414566131.384131.98
51480653-1480653137.522138.13
61402198-1402198130.235130.73
60min11564227-1564227145.284144.792.27146.12145.592.28
21592658-1592658147.925148.74
31540979-1540979143.125143.91
41563451-1563451145.212146.02
51592710-1592710147.930148.77
61499275-1499275139.251139.96
极限11940215-1940215180.206178.212.14181.29179.252.15
21973406-1973406183.288184.35
31933029-1933029179.538180.56
41894903-1894903175.997177.05
51916685-1916685178.020179.10
61854154-1854154172.212173.15
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