缬沙坦左氨氯地平片项目信息
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.651172191172591171081170401170521171360.09
213.641151441167621159530.99
单位质量响应值RSD%判断
8581.398500.950.67数据可信
供试品溶液-AR7108E批-左氨氯地平-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%
5min1211735-211735156.522174.368.53156.52174.368.53
2249053-249053184.109184.11
3242864-242864179.534179.53
4212397-212397157.011157.01
5237528-237528175.589175.59
6261580-261580193.369193.37
10min1463824-463824342.875360.624.55343.14360.914.55
2509268-509268376.469376.78
3510283-510283377.219377.52
4459168-459168339.433339.69
5486725-486725359.804360.10
6497682-497682367.904368.23
15min1689732-689732509.874526.493.76510.71527.393.76
2734551-734551543.006543.94
3739631-739631546.761547.69
4673303-673303497.729498.56
5707146-707146522.747523.64
6728923-728923538.846539.78
20min1882829-882829652.618664.202.87654.30665.972.88
2920120-920120680.185682.02
3930823-930823688.097689.94
4859098-859098635.076636.73
5896695-896695662.869664.63
6901428-901428666.367668.20
30min11185494-1185494876.359888.472.43879.13891.342.44
21224374-1224374905.101908.07
31238968-1238968915.889918.88
41156862-1156862855.193857.91
51196741-1196741884.673887.54
61208813-1208813893.597896.54
45min11522358-15223581125.3811137.791.871129.611142.141.87
21567500-15675001158.7511163.23
31572390-15723901162.3661166.88
41495380-14953801105.4381109.58
51538886-15388861137.5991141.94
61538340-15383401137.1951141.63
60min11786411-17864111320.5781335.572.041326.681341.822.04
21824741-18247411348.9131355.33
31843763-18437631362.9751369.42
41744804-17448041289.8211295.80
51835383-18353831356.7801363.02
61805072-18050721334.3731340.70
90min12150915-21509151590.0321607.201.411598.341615.681.42
22196764-21967641623.9261632.59
32212477-22124771635.5411644.26
42128304-21283041573.3181581.45
52181226-21812261612.4391620.94
62175183-21751831607.9721616.53
120min12436540-24365401801.1771811.611.291812.131822.771.29
22469064-24690641825.2191836.59
32494955-24949551844.3591855.81
42406591-24065911779.0371789.79
52463847-24638471821.3631832.55
62432918-24329181798.4991809.73
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限12591035-25910351915.3851940.130.891929.341954.300.90
22646072-26460721956.0701970.48
32656106-26561061963.4881978.01
42615985-26159851933.8291947.55
52617996-26179961935.3151949.54
62619843-26198431936.6811950.91
缬沙坦左氨氯地平片项目信息
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100651-202006对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.0对照品水分(%)0对照品稀释倍数200
标示量(mg)80供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.014686432468503646845634685374468580546854420.02
215.994676081467641046762460.01
单位质量响应值RSD%判断
292657.21292448.160.06数据可信
供试品溶液-AR7108E批-缬沙坦-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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
90min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
120min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
缬沙坦左氨氯地平片项目信息
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.651167831169621169561167811169051168770.08
213.641149051171151160101.35
单位质量响应值RSD%判断
8562.428505.130.48数据可信
供试品溶液-AR7108E批-左氨氯地平-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%
5min1219730-219730162.571153.156.64162.57153.146.64
2226665-226665167.702167.70
3203586-203586150.627150.63
4192368-192368142.327142.33
5194091-194091143.602143.60
6205500-205500152.043152.04
10min1470875-470875348.385336.374.94348.66336.634.94
2491104-491104363.352363.63
3449565-449565332.619332.87
4435211-435211321.999322.24
5432586-432586320.057320.30
6448492-448492331.825332.08
15min1688706-688706509.552496.604.00510.40497.414.00
2715541-715541529.406530.29
3662154-662154489.907490.71
4651161-651161481.773482.55
5642514-642514475.376476.15
6667102-667102493.568494.37
20min1867327-867327641.708633.103.86643.41634.743.86
2912814-912814675.362677.13
3840197-840197621.635623.26
4836307-836307618.757620.33
5818093-818093605.281606.85
6859389-859389635.835637.46
30min11159628-1159628857.972852.563.37860.74855.263.38
21220681-1220681903.143906.04
31133871-1133871838.915841.57
41138969-1138969842.687845.29
51104604-1104604817.261819.84
61156119-1156119855.376858.06
45min11490057-14900571102.4461101.542.821106.651105.662.83
21557489-15574891152.3371156.73
31469128-14691281086.9611091.02
41481810-14818101096.3441100.36
51430315-14303151058.2451062.18
61504163-15041631112.8821117.00
60min11739729-17397291287.1701291.682.681293.211297.632.68
21821527-18215271347.6901354.01
31718204-17182041271.2441277.11
41750643-17506431295.2451301.08
51682319-16823191244.6941250.39
61762500-17625001304.0181309.99
90min12090777-20907771546.8991570.032.841555.081578.142.83
22199276-21992761627.1741635.74
32091057-20910571547.1061555.09
42113658-21136581563.8281571.83
52047872-20478721515.1551522.93
62189623-21896231620.0321628.17
120min12370790-23707901754.0721772.612.361764.831783.332.36
22471432-24714321828.5341839.81
32364294-23642941749.2661759.83
42406032-24060321780.1461790.75
52317933-23179331714.9651725.26
62444588-24445881808.6731819.52
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限12545990-25459901883.6971892.962.331897.381906.642.33
22650715-26507151961.1801975.50
32520167-25201671864.5911878.07
42569436-25694361901.0441914.62
52477477-24774771833.0061846.16
62587264-25872641914.2341928.09
缬沙坦左氨氯地平片项目信息
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100651-202006对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.0对照品水分(%)0对照品稀释倍数200
标示量(mg)80供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.014676940468188746826214678797468302246806530.06
215.994711500471431947129100.05
单位质量响应值RSD%判断
292358.09294741.090.58数据可信
供试品溶液-AR7108E批-缬沙坦-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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
90min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
120min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
缬沙坦左氨氯地平片项目信息
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.651178541179401179871179451179731179400.05
213.641148031152711150370.29
单位质量响应值RSD%判断
8640.298433.801.72数据可信
供试品溶液-AR7108E批-左氨氯地平-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%
5min11655210-16552101224.3331228.357.371224.331228.357.37
21624255-16242551201.4361201.44
31668006-16680061233.7981233.80
41527917-15279171130.1771130.18
51599521-15995211183.1411183.14
61888941-18889411397.2201397.22
10min12730872-27308722019.9842024.995.762022.022027.045.76
22660189-26601891967.7011969.70
32725179-27251792015.7732017.83
42573273-25732731903.4101905.29
52699767-26997671996.9761998.95
63036574-30365742246.1072248.44
15min13389857-33898572507.4252496.425.492512.832501.845.49
23257714-32577142409.6812414.96
33328661-33286612462.1592467.58
43199151-31991512366.3632371.42
53347805-33478052476.3202481.62
63726655-37266552756.5492762.62
20min13814763-38147632821.7212808.845.702831.312818.425.70
23663711-36637112709.9902719.29
33726409-37264092756.3672765.89
43607787-36077872668.6242677.62
53757998-37579982779.7332789.16
64213388-42133883116.5783127.24
30min14317936-43179363193.9113163.184.093208.203177.444.09
24162551-41625513078.9753092.79
34192736-41927363101.3023115.42
44122563-41225633049.3963062.84
54259581-42595813150.7463164.81
64602945-46029453404.7273420.59
45min14682117-46821173463.2903424.212.803482.903443.742.81
24536036-45360363355.2363374.18
34546563-45465633363.0223382.30
44514294-45142943339.1543357.68
54639283-46392833431.6063450.92
64857391-48573913592.9373614.47
60min14846664-48466643585.0033530.872.253610.393556.122.27
24687561-46875613467.3163491.85
34691099-46910993469.9343494.82
44679372-46793723461.2593485.35
54793504-47935043545.6813570.71
64942721-49427213656.0543683.58
90min14938050-49380503652.5993581.652.133683.963612.772.15
24765555-47655553525.0073555.32
34740932-47409323506.7943537.46
44757674-47576743519.1783549.04
54866760-48667603599.8673630.81
64983794-49837943686.4353720.05
120min14950873-49508733662.0843603.132.143699.533640.222.15
24793073-47930733545.3623581.55
34763061-47630613523.1633559.68
44785972-47859723540.1103575.84
54921222-49212223640.1523677.09
65012816-50128163707.9033747.66
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限15192752-51927523840.9983763.841.783884.553806.941.79
24998218-49982183697.1053739.21
35045869-50458693732.3513774.74
44984107-49841073686.6673728.30
55147227-51472273807.3243850.33
65162427-51624273818.5683864.51
缬沙坦左氨氯地平片项目信息
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100651-202006对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.0对照品水分(%)0对照品稀释倍数200
标示量(mg)80供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.014768287477102747754014779798477881347746650.11
215.994687335468947246884040.04
单位质量响应值RSD%判断
298230.17293208.511.21数据可信
供试品溶液-AR7108E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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
90min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
120min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
缬沙坦左氨氯地平片项目信息
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100546-202105对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
113.651157761157821157631157481158141157770.03
213.641161691165691163690.25
单位质量响应值RSD%判断
8481.838531.450.42数据可信
供试品溶液-AR7108E批-左氨氯地平-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%
5min11618367-16183671201.1941290.577.951201.191290.577.95
21753396-17533961301.4161301.42
31650803-16508031225.2691225.27
41750570-17505701299.3191299.32
51661920-16619201233.5201233.52
61997637-19976371482.6981482.70
10min12674477-26744771985.0662073.935.461987.072076.085.46
22818379-28183792091.8742094.04
32699875-26998752003.9172005.96
42759149-27591492047.9122050.08
52725315-27253152022.8002024.86
63088031-30880312292.0172294.49
15min13306410-33064102454.1042536.144.282459.412541.744.28
23417970-34179702536.9062542.56
33322606-33226062466.1252471.51
43375019-33750192505.0272510.61
53376062-33760622505.8012511.23
63703531-37035312748.8572755.15
20min13715694-37156942757.8852842.003.712767.292851.843.72
23849401-38494012857.1262867.01
33739226-37392262775.3512784.84
43763136-37631362793.0972802.85
53804505-38045052823.8032833.41
64102208-41022083044.7663055.64
30min14231763-42317633140.9253209.262.673154.923223.832.68
24388112-43881123256.9713271.62
34241988-42419883148.5143162.63
44234112-42341123142.6683157.08
54325569-43255693210.5503224.86
64521443-45214433355.9333371.88
45min14594606-45946063410.2363463.361.873429.473483.281.88
24764927-47649273536.6533556.73
34608698-46086983420.6963440.06
44577770-45777703397.7403417.39
54676771-46767713471.2213490.88
64774268-47742683543.5863565.13
60min14750388-47503883525.8623563.221.673550.783588.911.67
24929852-49298523659.0643685.03
34761820-47618203534.3473559.41
44704371-47043713491.7073517.02
54818380-48183803576.3273601.77
64839498-48394983592.0013619.45
90min14811994-48119943571.5873614.361.873602.383645.991.86
25017311-50173113723.9793756.05
34828608-48286083583.9183614.88
44759442-47594423532.5823563.71
54910141-49101413644.4343675.84
64890213-48902133629.6433663.08
120min14842738-48427383594.4063606.921.923631.153644.571.91
25034517-50345173736.7503775.02
34839589-48395893592.0693629.00
44757679-47576793531.2733568.29
54821180-48211803578.4053615.89
64861865-48618653608.6033648.09
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限15043664-50436643743.5393766.791.303786.273810.461.29
25195569-51955693856.2873900.79
35036428-50364283738.1683781.08
45081828-50818283771.8653814.77
55084860-50848603774.1153817.56
65007584-50075843716.7593762.26
缬沙坦左氨氯地平片项目信息
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100651-202006对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.0对照品水分(%)0对照品稀释倍数200
标示量(mg)80供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.014703166470603047081854708318471076347072920.07
215.994760503476162147610620.02
单位质量响应值RSD%判断
294021.99297752.470.90数据可信
供试品溶液-AR7108E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%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
20min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
30min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
45min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
60min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
90min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
120min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
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