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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1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%
115.86 4721584472213147210364720875472087747213010.02
215.954746333475143647488840.08
单位质量响应值RSD%判断
297686.07297735.670.02数据可信
供试品溶液-24080801批-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%
5min1607984-60798411.38410.357.7711.3810.347.75
2524640-5246409.8239.82
3541791-54179110.14510.14
4572557-57255710.72110.72
5579706-57970610.85410.85
6488593-4885939.1489.15
10min11128743-112874321.13519.416.2021.1519.436.20
2991910-99191018.57318.59
31011229-101122918.93418.95
41054937-105493719.75319.77
51081375-108137520.24820.27
6952029-95202917.82617.84
15min11522276-152227628.50326.385.4828.5626.435.49
21342268-134226825.13325.18
31384031-138403125.91525.96
41428093-142809326.74026.79
51462243-146224327.37927.43
61315715-131571524.63624.68
20min11893635-189363535.45732.665.1035.5632.755.11
21633919-163391930.59430.68
31687605-168760531.59931.69
41738619-173861932.55432.65
51783877-178387733.40233.50
61728079-172807932.35732.44
30min12398394-239839444.90841.814.8345.0741.964.84
22107048-210704839.45339.59
32186373-218637340.93841.08
42252911-225291142.18442.33
52305060-230506043.16043.31
62148239-214823940.22440.36
45min13002536-300253656.22052.794.1356.4653.014.14
22670596-267059650.00550.21
32748079-274807951.45551.67
42834722-283472253.07853.30
52887506-288750654.06654.29
62774110-277411051.94352.15
60min13447331-344733164.54861.333.0064.8861.633.01
23193045-319304559.78760.08
33177389-317738959.49459.79
43267485-326748561.18161.49
53315838-331583862.08662.40
63250691-325069160.86661.16
90min14092016-409201676.61973.442.6077.0673.842.60
23948336-394833673.92974.32
33780786-378078670.79271.19
43879846-387984672.64773.06
53929995-392999573.58674.00
63901005-390100573.04373.44
120min14501013-450101384.27881.392.1884.8481.922.18
24404227-440422782.46582.98
34233870-423387079.27679.79
44284305-428430580.22080.75
54335146-433514681.17281.71
64321350-432135080.91381.43
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14877891-487789191.33488.391.9292.0489.061.93
24741601-474160188.78289.43
34602801-460280186.18386.83
44680226-468022687.63388.30
54707174-470717488.13888.81
64713942-471394288.26488.92
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1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%
115.86 4727052472810247272154728337472908247279580.02
215.954759943476224047610920.04
单位质量响应值RSD%判断
298105.80298501.070.10数据可信
供试品溶液-24080803批-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%
5min11757694-175769432.84632.533.9532.8532.533.95
21799861-179986133.63433.63
31808338-180833833.79233.79
41766890-176689033.01833.02
51644831-164483130.73730.74
61667222-166722231.15531.16
10min12671389-267138949.92049.783.9249.9749.843.92
22788699-278869952.11252.17
32734014-273401451.09051.15
42713201-271320150.70150.76
52529052-252905247.26047.31
62548566-254856647.62547.68
15min13285963-328596361.40561.242.9461.5461.382.94
23368466-336846662.94663.09
33361152-336115262.81062.95
43327442-332744262.18062.32
53140459-314045958.68658.82
63178572-317857259.39859.53
20min13722091-372209169.55469.352.6669.7969.592.66
23810280-381028071.20271.45
33793068-379306870.88171.13
43758570-375857070.23670.48
53567446-356744666.66566.89
63616599-361659967.58367.81
30min14303075-430307580.41180.212.2580.7780.572.25
24388282-438828282.00482.37
34371308-437130881.68682.05
44340964-434096481.11981.48
54151964-415196477.58777.93
64199089-419908978.46878.81
45min14765690-476569089.05688.721.9289.5589.211.93
24846453-484645390.56591.07
34827816-482781690.21790.72
44767239-476723989.08589.58
54615044-461504486.24186.71
64664211-466421187.16087.63
60min14976626-497662692.99893.201.5193.6493.841.52
25066336-506633694.67495.33
35046950-504695094.31294.96
44994669-499466993.33593.98
54852116-485211690.67191.28
64989447-498944793.23793.86
90min15126391-512639195.79795.841.7096.5996.641.70
25223134-522313497.60498.42
35225358-522535897.64698.45
45136679-513667995.98996.79
55017718-501771893.76694.53
65044215-504421594.26195.04
120min15136931-513693195.99496.311.7596.9597.261.76
25254936-525493698.19999.17
35255564-525556498.21099.18
45160018-516001896.42597.38
55034146-503414694.07394.99
65080562-508056294.94095.87
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15157037-515703796.36996.371.7997.4897.491.79
25250365-525036598.11399.25
35267138-526713898.42799.56
45158443-515844396.39597.52
55034733-503473394.08495.16
65076195-507619594.85995.95
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1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%
115.86 4709845471592647164114715493471967347154700.08
215.954709881470776247088220.04
单位质量响应值RSD%判断
297318.41295223.950.50数据可信
供试品溶液-24080805批-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%
5min11081776-108177620.35420.486.9120.3520.476.91
21210426-121042622.77522.77
31020556-102055619.20219.20
41087766-108776620.46720.47
51125773-112577321.18221.18
61002896-100289618.87018.87
10min11864305-186430535.07834.695.6435.1134.725.64
22000760-200076037.64537.68
31756070-175607033.04133.07
41822342-182234234.28834.32
51905731-190573135.85735.89
61713552-171355232.24132.27
15min12418707-241870745.50945.075.0345.6045.165.03
22588672-258867248.70748.81
32301481-230148143.30343.39
42356556-235655644.33944.43
52455884-245588446.20846.30
62252246-225224642.37742.46
20min12840059-284005953.43753.054.6853.6053.224.68
23027062-302706256.95557.14
32713189-271318951.05051.21
42767884-276788452.07952.24
52900970-290097054.58354.75
62668884-266888450.21650.37
30min13457070-345707065.04664.504.2365.3064.754.23
23636997-363699768.43168.71
33260648-326064861.35061.59
43402784-340278464.02564.28
53529063-352906366.40166.66
63281436-328143661.74161.98
45min14061480-406148076.41875.824.1776.7876.184.17
24270760-427076080.35680.75
33801616-380161671.52971.88
44002158-400215875.30275.66
54140790-414079077.91078.28
63900952-390095273.39873.74
60min14377276-437727682.36082.653.4982.8583.143.50
24589470-458947086.35286.88
34170335-417033578.46678.93
44378797-437879782.38982.87
54536659-453665985.35985.86
64303094-430309480.96481.43
90min14785790-478579090.04690.312.9890.6890.942.98
24950877-495087793.15293.82
34577844-457784486.13486.73
44767604-476760489.70490.33
54962784-496278493.37694.02
64755246-475524689.47290.07
120min14986745-498674593.82793.822.6694.6194.602.67
25106140-510614096.07496.90
34776541-477654189.87290.61
44946890-494689093.07793.85
55149414-514941496.88897.69
64951094-495109493.15793.91
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15054215-505421595.09795.302.2096.0396.242.21
25160194-516019497.09198.07
34898909-489890992.17593.06
45006817-500681794.20595.13
55212444-521244498.07499.04
65058482-505848295.17796.08
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